P

Paclitaxel (Abraxane)

Ability to drive, paclitaxel [2] ---> SmPC of [2] of EMA

Abraxane may cause adverse reactions such as tiredness (very common) and dizziness (common) that may affect the ability to drive and use machinery.

Antineoplastics, paclitaxel [2] ---> SmPC of [2] of EMA

Paclitaxel should not be used in combination with other anticancer agents

Axitinib [1], paclitaxel ---> SmPC of [1] of EMA

Co-administration of axitinib with paclitaxel, a known CYP2C8 substrate, did not result in increased plasma concentrations of paclitaxel in patients with advanced cancer, indicating lack of clinical CYP2C8 inhibition.

Azole antifungals, paclitaxel [2] ---> SmPC of [2] of EMA

The strong CYP3A4 inhibition may increase the plasma concentrations of paclitaxel

Breast-feeding, paclitaxel [2] ---> SmPC of [2] of EMA

Because of potential serious adverse reactions in breast-feeding infants, Abraxane is contraindicated during lactation. Breast-feeding must be discontinued for the duration of therapy.

Bulevirtide [1], paclitaxel ---> SmPC of [1] of EMA

In vitro an inhibition of OATP1B1/3 transporters by bulevirtide was observed, albeit only at a concentration ≥ 0.5 µM. As a precautionary measure, close clinical monitoring is warranted when OATP1B1/3 substrates are co-administered.

Carbamazepine, paclitaxel [2] ---> SmPC of [2] of EMA

Administering paclitaxel concomitantly with medicines known to induce either CYP2C8 or CYP3A4 is not recommended because efficacy may be compromised because of lower paclitaxel exposures.

Carboplatin, paclitaxel [2] ---> SmPC of [2] of EMA

A pharmacokinetic study was conducted with Abraxane and carboplatin in non-small cell lung cancer patients. There were no clinically relevant pharmacokinetic interactions between Abraxane and carboplatin.

Cimetidine, paclitaxel [2] ---> SmPC of [2] of EMA

Caution should be exercised when administering paclitaxel concomitantly with medicines known to inhibit either CYP2C8 or CYP3A4 because toxicity of paclitaxel may be increased due to higher paclitaxel exposure.

Cisplatin [1], paclitaxel ---> SmPC of [1] of eMC

Treatment with cisplatin prior to an infusion with paclitaxel may reduce the clearance of paclitaxel by 33% and therefore can intensify neurotoxicity.

Clopidogrel [1], paclitaxel ---> SmPC of [1] of EMA

Due to the risk of increased plasma concentrations, concomitant administration of clopidogrel and drugs primarily cleared by CYP2C8 metabolism (e.g., repaglinide, paclitaxel) should be undertaken with caution

Clopidogrel/acetylsalicylic acid [1], paclitaxel ---> SmPC of [1] of EMA

Due to the risk of increased plasma concentrations, concomitant administration of clopidogrel and drugs primarily cleared by CYP2C8 metabolism (e.g., repaglinide, paclitaxel) should be undertaken with caution

Cyclophosphamide, paclitaxel

The co-administration may increase the hematotoxicity and/or immunosuppression

CYP2C8 inductors, paclitaxel [2] ---> SmPC of [2] of EMA

Administering paclitaxel concomitantly with medicines known to induce either CYP2C8 or CYP3A4 is not recommended because efficacy may be compromised because of lower paclitaxel exposures.

CYP2C8 inhibitors, paclitaxel [2] ---> SmPC of [2] of EMA

Caution should be exercised when administering paclitaxel concomitantly with medicines known to inhibit either CYP2C8 or CYP3A4 because toxicity of paclitaxel may be increased due to higher paclitaxel exposure.

CYP3A4 inductors, paclitaxel [2] ---> SmPC of [2] of EMA

Administering paclitaxel concomitantly with medicines known to induce either CYP2C8 or CYP3A4 is not recommended because efficacy may be compromised because of lower paclitaxel exposures.

CYP3A4 inhibitors, paclitaxel [2] ---> SmPC of [2] of EMA

Caution should be exercised when administering paclitaxel concomitantly with medicines known to inhibit either CYP2C8 or CYP3A4 because toxicity of paclitaxel may be increased due to higher paclitaxel exposure.

Darunavir/ritonavir, paclitaxel ---> SmPC of [darunavir] of EMA

Co-administration of darunavir and ritonavir and medicinal products primarily metabolised by CYP2C8 may result in decreased systemic exposure to such medicinal products, which could decrease or shorten their therapeutic effect.

Deferasirox [1], paclitaxel ---> SmPC of [1] of EMA

An interaction between deferasirox and other CYP2C8 substrates like paclitaxel cannot be excluded.

Doxorubicine [1], paclitaxel ---> SmPC of [1] of eMC

Paclitaxel administered shortly before doxorubicin may decrease clearance and increase plasma concentrations of doxorubicin. Some data indicate that this interaction is less pronounced when doxorubicin is administered before paclitaxel.

Efavirenz, paclitaxel [2] ---> SmPC of [2] of EMA

Administering paclitaxel concomitantly with medicines known to induce either CYP2C8 or CYP3A4 is not recommended because efficacy may be compromised because of lower paclitaxel exposures.

Epirubicin [1], paclitaxel ---> SmPC of [1] of eMC

Coadministration of paclitaxel or docetaxel did not affect the pharmacokinetics of epirubicin when epirubicin was administered prior to the taxane. One study has shown that paclitaxel clearance is reduced by epirubicin.

Erlotinib [1], paclitaxel ---> SmPC of [1] of EMA

In clinical practice, there may be other co-factors leading to an increased exposure to carboplatin like renal impairment. There were no significant effects of carboplatin or paclitaxel on the pharmacokinetics of erlotinib.

Erythromycin, paclitaxel [2] ---> SmPC of [2] of EMA

Caution should be exercised when administering paclitaxel concomitantly with medicines known to inhibit either CYP2C8 or CYP3A4 because toxicity of paclitaxel may be increased due to higher paclitaxel exposure.

Fertility, paclitaxel [2] ---> SmPC of [2] of EMA

Abraxane induced infertility in male rats (see section 5.3). Based on findings in animals, male and female fertility may be compromised.

Fluoxetine, paclitaxel [2] ---> SmPC of [2] of EMA

Caution should be exercised when administering paclitaxel concomitantly with medicines known to inhibit either CYP2C8 or CYP3A4 because toxicity of paclitaxel may be increased due to higher paclitaxel exposure.

Gemcitabine, paclitaxel [2] ---> SmPC of [2] of EMA

Abraxane is indicated as monotherapy for breast cancer, in combination with gemcitabine for pancreatic adenocarcinoma, or in combination with carboplatin for non-small cell lung cancer (see section 4.1).

Gemfibrozil, paclitaxel [2] ---> SmPC of [2] of EMA

Caution should be exercised when administering paclitaxel concomitantly with medicines known to inhibit either CYP2C8 or CYP3A4 because toxicity of paclitaxel may be increased due to higher paclitaxel exposure.

Idelalisib [1], paclitaxel ---> SmPC of [1] of EMA

Caution is advised if idelalisib is used together with narrow therapeutic index drugs that are substrates of CYP2C8

Indinavir, paclitaxel [2] ---> SmPC of [2] of EMA

Caution should be exercised when administering paclitaxel concomitantly with medicines known to inhibit either CYP2C8 or CYP3A4 because toxicity of paclitaxel may be increased due to higher paclitaxel exposure.

Iptacopan [1], paclitaxel ---> SmPC of [1] of EMA

In vitro data showed iptacopan has potential for time-dependent inhibition of CYP2C8 and may increase the exposure of sensitive CYP2C8 substrates, such as repaglinide, dasabuvir or paclitaxel. Caution should be exercised

Ivosidenib [1], paclitaxel ---> SmPC of [1] of EMA

Patients should be monitored for loss of substrate efficacy (substrate with a narrow therapeutic index) if use of such medicinal products cannot be avoided (see section 5.2).

Ketoconazole [1], paclitaxel ---> SmPC of [1] of EMA

No change in plasma concentration were shown with paclitaxel concentrate. No studies were performed with albumin bound nanoparticles. Careful monitoring. Dose adjustment of paclitaxel may be required.

Ketoconazole, paclitaxel [2] ---> SmPC of [2] of EMA

Caution should be exercised when administering paclitaxel concomitantly with medicines known to inhibit either CYP2C8 or CYP3A4 because toxicity of paclitaxel may be increased due to higher paclitaxel exposure.

Lapatinib [1], paclitaxel ---> SmPC of [1] of EMA

Co-administration of lapatinib with intravenous paclitaxel increased the exposure of paclitaxel by 23%, due to lapatinib inhibition of CYP2C8 and/or Pgp. Caution is advised if lapatinib is co-administered with paclitaxel.

Leflunomide [1], paclitaxel ---> SmPC of [1] of EMA

Monitoring patients with concomitant use of medicinal products metabolised by CYP2C8, such as repaglinide, paclitaxel, pioglitazone or rosiglitazone, is recommended as they may have higher exposure.

Linzagolix [1], paclitaxel ---> SmPC of [1] of EMA

Use of Yselty should be avoided in patients using CYP2C8 sensitive substrate medicinal products with a narrow therapeutic index (e.g., paclitaxel, sorafenib and repaglinide, see section 4.5).

Liposome-encapsulated doxorubicin-citrate complex [1], paclitaxel ---> SmPC of [1] of EMA

Plasma levels of doxorubicin and its metabolite, doxorubicinol, may be increased when doxorubicin is administered with cyclosporine, verapamil, paclitaxel or other agents that inhibit P-glycoprotein (P-Gp).

Men, paclitaxel [2] ---> SmPC of [2] of EMA

Male patients with female partners of reproductive potential are advised to use effective contraception and to avoid fathering a child during treatment with Abraxane and for at least three months after the last dose of Abraxane.

Mitapivat [1], paclitaxel ---> SmPC of [1] of EMA

If co-administration is unavoidable, patients should be monitored for loss of therapeutic effect of substrates of these enzymes, especially for those with a narrow therapeutic index

Nelfinavir, paclitaxel [2] ---> SmPC of [2] of EMA

Caution should be exercised when administering paclitaxel concomitantly with medicines known to inhibit either CYP2C8 or CYP3A4 because toxicity of paclitaxel may be increased due to higher paclitaxel exposure.

Nevirapine, paclitaxel [2] ---> SmPC of [2] of EMA

Administering paclitaxel concomitantly with medicines known to induce either CYP2C8 or CYP3A4 is not recommended because efficacy may be compromised because of lower paclitaxel exposures.

Oxaliplatin [1], paclitaxel ---> SmPC of [1] of eMC

In vitro, no significant displacement of oxaliplatin binding to plasma proteins has been observed

P-gp inhibitors, paclitaxel

The inhibition of P-glycoprotein may increase the exposure to paclitaxel

Paclitaxel [1], phenytoin ---> SmPC of [1] of EMA

Administering paclitaxel concomitantly with medicines known to induce either CYP2C8 or CYP3A4 is not recommended because efficacy may be compromised because of lower paclitaxel exposures.

Paclitaxel [1], pregnancy ---> SmPC of [1] of EMA

Abraxane should not be used in pregnancy, and in women of childbearing potential not using effective contraception, unless the clinical condition of the mother requires treatment with paclitaxel.

Paclitaxel [1], rifampicin ---> SmPC of [1] of EMA

Administering paclitaxel concomitantly with medicines known to induce either CYP2C8 or CYP3A4 is not recommended because efficacy may be compromised because of lower paclitaxel exposures.

Paclitaxel [1], ritonavir ---> SmPC of [1] of EMA

Caution should be exercised when administering paclitaxel concomitantly with medicines known to inhibit either CYP2C8 or CYP3A4 because toxicity of paclitaxel may be increased due to higher paclitaxel exposure.

Paclitaxel [1], saquinavir ---> SmPC of [1] of EMA

Caution should be exercised when administering paclitaxel concomitantly with medicines known to inhibit either CYP2C8 or CYP3A4 because toxicity of paclitaxel may be increased due to higher paclitaxel exposure.

Paclitaxel [1], strong CYP2C8 inductors ---> SmPC of [1] of EMA

Administering paclitaxel concomitantly with medicines known to induce either CYP2C8 or CYP3A4 is not recommended because efficacy may be compromised because of lower paclitaxel exposures.

Paclitaxel [1], strong CYP2C8 inhibitors ---> SmPC of [1] of EMA

Caution should be exercised when administering paclitaxel concomitantly with medicines known to inhibit either CYP2C8 or CYP3A4 because toxicity of paclitaxel may be increased due to higher paclitaxel exposure.

Paclitaxel [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA

Administering paclitaxel concomitantly with medicines known to induce either CYP2C8 or CYP3A4 is not recommended because efficacy may be compromised because of lower paclitaxel exposures.

Paclitaxel [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA

Caution should be exercised when administering paclitaxel concomitantly with medicines known to inhibit either CYP2C8 or CYP3A4 because toxicity of paclitaxel may be increased due to higher paclitaxel exposure.

Paclitaxel [1], women of childbearing potential ---> SmPC of [1] of EMA

Women of childbearing potential should use effective contraception during treatment and for at least six months after the last dose of Abraxane.

Paclitaxel [1], women of childbearing potential ---> SmPC of [1] of EMA

Studies in animals have shown reproductive toxicity (see section 5.3). Women of childbearing potential should have a pregnancy test prior to starting treatment with Abraxane.

Paclitaxel+carboplatin, sorafenib [2] ---> SmPC of [2] of EMA

These data indicate no need for dose adjustments when paclitaxel and carboplatin are co-administered with sorafenib with a 3-day break in sorafenib dosing (two days prior to and on the day of paclitaxel/carboplatin administration).

Paclitaxel, pazopanib [2] ---> SmPC of [2] of EMA

Co-administration of pazopanib 800 mg once daily and paclitaxel 80 mg/m2 (CYP3A4 and CYP2C8 substrate) once weekly resulted in a mean increase of 26% and 31% in paclitaxel AUC and Cmax, respectively.

Paclitaxel, pertuzumab/trastuzumab [2] ---> SmPC of [2] of EMA

Individual and mean trastuzumab trough serum concentrations varied within and across studies but there was no clear effect of the concomitant administration of paclitaxel on the pharmacokinetics of trastuzumab.

Paclitaxel, pixantrone [2] ---> SmPC of [2] of EMA

Although a risk to inhibition of pixantrone towards CYP2C8 could not be ascertained, caution should be observed when co-administering substances that are primarily metabolised via CYP2C8

Paclitaxel, pralsetinib [2] ---> SmPC of [2] of EMA

Co-administration of pralsetinib can alter the exposure of substrates of CYP enzymes (CYP3A4, CYP2C9 and CYP2C8) and transporters (P-gp, BCRP, OATP1B1, OATP1B3, OAT1, MATE1 and MATE2-K). The substrate drugs with narrow therapeutic index should be avoided

Paclitaxel, pretomanid [2] ---> SmPC of [2] of EMA

If pretomanid is co-administered with substrates of CYP2C8, 2C9 and 2C19, e.g., paclitaxel, warfarin, mephenytoin, prescribers and their patients should be observant for potentially reduced efficacy of these substrates.

Paclitaxel, proteolytic enzymes enriched in bromelain [2] ---> SmPC of [2] of EMA

NexoBrid, when absorbed, is an inhibitor of CYP2C8 and CYP2C9. This should be taken into account if it is used in patients receiving CYP2C8 substrates

Paclitaxel, ramucirumab [2] ---> SmPC of [2] of EMA

The pharmacokinetics of paclitaxel were not affected when co-administered with ramucirumab and the pharmacokinetics of ramucirumab were not affected when co-administered with paclitaxel.

Paclitaxel, ripretinib [2] ---> SmPC of [2] of EMA

In vitro studies suggested ripretinib may inhibit CYP2C8. QINLOCK is to be used with caution in combination with substrates of CYP2C8 (e.g. repaglinide, paclitaxel), as co-administration may lead to increased exposure of CYP2C8 substrates.

Paclitaxel, selpercatinib [2] ---> SmPC of [2] of EMA

Selpercatinib increased the Cmax and AUC of repaglinide (a substrate of CYP2C8) by approximately 91% and 188% respectively. Therefore, coadministration with sensitive CYP2C8 substrates should be avoided.

Paclitaxel, sotagliflozin [2] ---> SmPC of [2] of EMA

It cannot be ruled out that sotagliflozin may interact with other sensitive OAT3, OATP- and/or BCRP- substrates resulting in potentially larger increases of exposure than seen for rosuvastatin.

Paclitaxel, strong CYP3A4 and CYP2C8 inductors

The strong CYP3A4 and CYP2C8 induction may decrease the plasma concentrations of paclitaxel

Paclitaxel, temsirolimus [2] ---> SmPC of [2] of EMA

When temsirolimus is co-administered with medicinal products which are P-gp substrates close monitoring for adverse events related to the co-administered medicinal products should be observed.

Paclitaxel, teriflunomide [2] ---> SmPC of [2] of EMA

Teriflunomide, CYP2C8 inhibitor, increases teriflunomide AUC. Medicinal products metabolised by CYP2C8 should be used with caution during treatment with teriflunomide.

Paclitaxel, trastuzumab [2] ---> SmPC of [2] of EMA

Pharmacokinetic data suggested that exposure to paclitaxel and doxorubicin (and their major metabolites 6-? hydroxylpaclitaxel, POH, and doxorubicinol, DOL) was not altered in the presence of trastuzumab

Paclitaxel, vinflunine [2] ---> SmPC of [2] of EMA

A possible interaction with paclitaxel and docetaxel (CYP3 substrates) has been suggested from an in vitro study (slight inhibition of vinflunine metabolism).

            CONTRAINDICATIONS of Paclitaxel (Abraxane)

            - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

            - Lactation

            - Patients who have baseline neutrophil counts < 1500 cells/ mm³ 

            https://www.ema.europa.eu/en/documents/product-information/abraxane-epar-product-information_en.pdf 21/01/2026 

Other trade names: Apealea, Apexelsin, Naveruclif, Paclitaxel Accord, Paclitaxel Actavis, Paclitaxel GP-Pharm, Paclitaxel Hospira, Paclitaxel Kabi, Paclitaxel Mylan, Paclitaxel Sandoz, Paclitaxel Teva, Paxene, Pazenir, Taxol,

Padeliporfin (Tookad)

Ability to drive, padeliporfin [2] ---> SmPC of [2] of EMA

TOOKAD has no influence on the ability to drive or use machines. However, as the procedure includes general anaesthesia, patients should not perform complex tasks like driving or using machines until 24 hours after a general anaesthetic is employed.

Acetylsalicylic acid, padeliporfin [2] ---> SmPC of [2] of EMA

Anticoagulant medicinal products and those that decrease platelet aggregation (e.g. acetylsalicylic acid) should be stopped at least 10 days before the procedure with TOOKAD.

Amiodarone, padeliporfin [2] ---> SmPC of [2] of EMA

Medicinal products which have potential photosensitising should be stopped at least 10 days before the procedure with TOOKAD and for at least 3 days after the procedure or replaced by other treatments without photosensitizing properties.

Anticoagulants, padeliporfin [2] ---> SmPC of [2] of EMA

Anticoagulant medicinal products and those that decrease platelet aggregation (e.g. acetylsalicylic acid) should be stopped at least 10 days before the procedure with TOOKAD.

Atorvastatin, padeliporfin [2] ---> SmPC of [2] of EMA

The use of medicinal products that are substrates of OATP1B1 or OATP1B3 for which concentration-dependent serious adverse events have been observed should be avoided on the day of TOOKAD infusion and for at least 24 hours after administration.

Bosentan, padeliporfin [2] ---> SmPC of [2] of EMA

The use of medicinal products that are substrates of OATP1B1 or OATP1B3 for which concentration-dependent serious adverse events have been observed should be avoided on the day of TOOKAD infusion and for at least 24 hours after administration.

Breast-feeding, padeliporfin [2] ---> SmPC of [2] of EMA

TOOKAD is not indicated for the treatment of women.

Cytochrome P450, padeliporfin [2] ---> SmPC of [2] of EMA

In vitro studies predict that TOOKAD at therapeutic concentrations is unlikely to inhibit cytochrome P450 enzymes but could inhibit OATP1B1 and OATP1B3 transporters (see section 5.2).

Fertility, padeliporfin [2] ---> SmPC of [2] of EMA

However, all stages of spermatogenesis have been observed in animal. Minimal seminiferous epithelial degeneration was also recorded in one high-dose male with vacuolation. All these changes were considered to be incidental

Glyburide, padeliporfin [2] ---> SmPC of [2] of EMA

The use of medicinal products that are substrates of OATP1B1 or OATP1B3 for which concentration-dependent serious adverse events have been observed should be avoided on the day of TOOKAD infusion and for at least 24 hours after administration.

Griseofulvin, padeliporfin [2] ---> SmPC of [2] of EMA

Medicinal products which have potential photosensitising should be stopped at least 10 days before the procedure with TOOKAD and for at least 3 days after the procedure or replaced by other treatments without photosensitizing properties.

OATP1B1 substrates, padeliporfin [2] ---> SmPC of [2] of EMA

The use of medicinal products that are substrates of OATP1B1 or OATP1B3 for which concentration-dependent serious adverse events have been observed should be avoided on the day of TOOKAD infusion and for at least 24 hours after administration.

OATP1B3 substrates, padeliporfin [2] ---> SmPC of [2] of EMA

The use of medicinal products that are substrates of OATP1B1 or OATP1B3 for which concentration-dependent serious adverse events have been observed should be avoided on the day of TOOKAD infusion and for at least 24 hours after administration.

Padeliporfin [1], phenothiazines ---> SmPC of [1] of EMA

Medicinal products which have potential photosensitising should be stopped at least 10 days before the procedure with TOOKAD and for at least 3 days after the procedure or replaced by other treatments without photosensitizing properties.

Padeliporfin [1], photosensitizing agents ---> SmPC of [1] of EMA

Medicinal products which have potential photosensitising should be stopped at least 10 days before the procedure with TOOKAD and for at least 3 days after the procedure or replaced by other treatments without photosensitizing properties.

Padeliporfin [1], pitavastatin ---> SmPC of [1] of EMA

The use of medicinal products that are substrates of OATP1B1 or OATP1B3 for which concentration-dependent serious adverse events have been observed should be avoided on the day of TOOKAD infusion and for at least 24 hours after administration.

Padeliporfin [1], platelet aggregation inhibitors ---> SmPC of [1] of EMA

Anticoagulant medicinal products and those that decrease platelet aggregation (e.g. acetylsalicylic acid) should be stopped at least 10 days before the procedure with TOOKAD.

Padeliporfin [1], pravastatine ---> SmPC of [1] of EMA

The use of medicinal products that are substrates of OATP1B1 or OATP1B3 for which concentration-dependent serious adverse events have been observed should be avoided on the day of TOOKAD infusion and for at least 24 hours after administration.

Padeliporfin [1], pregnancy ---> SmPC of [1] of EMA

TOOKAD is not indicated for the treatment of women.

Padeliporfin [1], quinolones ---> SmPC of [1] of EMA

Medicinal products which have potential photosensitising should be stopped at least 10 days before the procedure with TOOKAD and for at least 3 days after the procedure or replaced by other treatments without photosensitizing properties.

Padeliporfin [1], repaglinide ---> SmPC of [1] of EMA

The use of medicinal products that are substrates of OATP1B1 or OATP1B3 for which concentration-dependent serious adverse events have been observed should be avoided on the day of TOOKAD infusion and for at least 24 hours after administration.

Padeliporfin [1], rosuvastatin ---> SmPC of [1] of EMA

The use of medicinal products that are substrates of OATP1B1 or OATP1B3 for which concentration-dependent serious adverse events have been observed should be avoided on the day of TOOKAD infusion and for at least 24 hours after administration.

Padeliporfin [1], simvastatine ---> SmPC of [1] of EMA

The use of medicinal products that are substrates of OATP1B1 or OATP1B3 for which concentration-dependent serious adverse events have been observed should be avoided on the day of TOOKAD infusion and for at least 24 hours after administration.

Padeliporfin [1], sulfonylureas ---> SmPC of [1] of EMA

Medicinal products which have potential photosensitising should be stopped at least 10 days before the procedure with TOOKAD and for at least 3 days after the procedure or replaced by other treatments without photosensitizing properties.

Padeliporfin [1], sulphonamides ---> SmPC of [1] of EMA

Medicinal products which have potential photosensitising should be stopped at least 10 days before the procedure with TOOKAD and for at least 3 days after the procedure or replaced by other treatments without photosensitizing properties.

Padeliporfin [1], tetracyclines ---> SmPC of [1] of EMA

Medicinal products which have potential photosensitising should be stopped at least 10 days before the procedure with TOOKAD and for at least 3 days after the procedure or replaced by other treatments without photosensitizing properties.

Padeliporfin [1], thiazides ---> SmPC of [1] of EMA

Medicinal products which have potential photosensitising should be stopped at least 10 days before the procedure with TOOKAD and for at least 3 days after the procedure or replaced by other treatments without photosensitizing properties.

Padeliporfin [1], women of childbearing potential ---> SmPC of [1] of EMA

If the patient is sexually active with women who are capable of getting pregnant, he and/or his partner should use an effective form of birth control to prevent getting pregnant during a period of 90 days after the VTP procedure.

            CONTRAINDICATIONS of Padeliporfin (Tookad)    

            - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

            - Any previous prostatic interventions where the internal urinary sphincter may have been damaged, including trans-urethral resection of the prostate (TURP) for benign prostatic hypertrophy.

            - Current or prior treatment for prostate cancer.            

            - Patients who have been diagnosed with cholestasis.   

            - Current exacerbation of rectal inflammatory bowel disease (see section 4.4).  

            - Any medical condition that precludes the administration of a general anaesthetic or invasive procedures.     

            https://www.ema.europa.eu/en/documents/product-information/tookad-epar-product-information_en.pdf 07/12/2022             

Palbociclib (Ibrance)

Ability to drive, palbociclib [2] ---> SmPC of [2] of EMA

IBRANCE may cause fatigue and patients should exercise caution when driving or using machines.

Alfentanyl, palbociclib [2] ---> SmPC of [2] of EMA

The dose of sensitive CYP3A substrates with a narrow therapeutic index may need to be reduced when coadministered with IBRANCE as IBRANCE may increase their exposure.

Antacids, palbociclib [2] ---> SmPC of [2] of EMA

Given the reduced effect on gastric pH of H2-receptor antagonists and local antacids compared to PPIs, no clinically relevant effect of H2-receptor antagonists or local antacids on palbociclib exposure is expected when palbociclib is taken with food.

BCRP substrates, palbociclib [2] ---> SmPC of [2] of EMA

Administration of palbociclib with medicinal products that are substrates of BCRP (e.g., rosuvastatin, sulfasalazine) may increase their therapeutic effect and adverse reactions.

Breast-feeding, palbociclib [2] ---> SmPC of [2] of EMA

It is unknown whether palbociclib is excreted in human milk. Patients receiving palbociclib should not breast-feed.

Carbamazepine, palbociclib [2] ---> SmPC of [2] of EMA

The concomitant use of strong CYP3A inducers including, but not limited to: carbamazepine, enzalutamide, phenytoin, rifampin, and St. John's Wort should be avoided (see sections 4.3 and 4.4).

Clarithromycin, palbociclib [2] ---> SmPC of [2] of EMA

The concomitant use of strong CYP3A inhibitors and grapefruit or grapefruit juice, should be avoided (see sections 4.2 and 4.4)

Colchicine, palbociclib [2] ---> SmPC of [2] of EMA

Administration of palbociclib with medicinal products that are substrates of P-gp (e.g., digoxin, dabigatran, colchicine, pravastatin) may increase their therapeutic effect and adverse reactions.

Contraceptives, palbociclib [2] ---> SmPC of [2] of EMA

Women of childbearing potential or their male partners must use a highly effective method of contraception while taking IBRANCE

Cyclosporine, palbociclib [2] ---> SmPC of [2] of EMA

The dose of sensitive CYP3A substrates with a narrow therapeutic index may need to be reduced when coadministered with IBRANCE as IBRANCE may increase their exposure.

CYP3A4 inhibitors, palbociclib [2] ---> SmPC of [2] of EMA

No dose adjustments are needed for mild and moderate CYP3A inhibitors.

CYP3A4 substrates with narrow therapeutic index, palbociclib [2] ---> SmPC of [2] of EMA

The dose of sensitive CYP3A substrates with a narrow therapeutic index may need to be reduced when coadministered with IBRANCE as IBRANCE may increase their exposure.

Dabigatran, palbociclib [2] ---> SmPC of [2] of EMA

Administration of palbociclib with medicinal products that are substrates of P-gp (e.g., digoxin, dabigatran, colchicine, pravastatin) may increase their therapeutic effect and adverse reactions.

Digoxin, palbociclib [2] ---> SmPC of [2] of EMA

Administration of palbociclib with medicinal products that are substrates of P-gp (e.g., digoxin, dabigatran, colchicine, pravastatin) may increase their therapeutic effect and adverse reactions.

Dihydroergotamine, palbociclib [2] ---> SmPC of [2] of EMA

The dose of sensitive CYP3A substrates with a narrow therapeutic index may need to be reduced when coadministered with IBRANCE as IBRANCE may increase their exposure.

Drugs primarily metabolised by CYP3A4 with narrow therapeutic index, palbociclib [2] ---> SmPC of [2] of EMA

The dose of sensitive CYP3A substrates with a narrow therapeutic index may need to be reduced when coadministered with IBRANCE as IBRANCE may increase their exposure.

Enzalutamide, palbociclib [2] ---> SmPC of [2] of EMA

The concomitant use of strong CYP3A inducers including, but not limited to: carbamazepine, enzalutamide, phenytoin, rifampin, and St. John's Wort should be avoided (see sections 4.3 and 4.4).

Ergotamine, palbociclib [2] ---> SmPC of [2] of EMA

The dose of sensitive CYP3A substrates with a narrow therapeutic index may need to be reduced when coadministered with IBRANCE as IBRANCE may increase their exposure.

Everolimus, palbociclib [2] ---> SmPC of [2] of EMA

The dose of sensitive CYP3A substrates with a narrow therapeutic index may need to be reduced when coadministered with IBRANCE as IBRANCE may increase their exposure.

Fentanyl, palbociclib [2] ---> SmPC of [2] of EMA

The dose of sensitive CYP3A substrates with a narrow therapeutic index may need to be reduced when coadministered with IBRANCE as IBRANCE may increase their exposure.

Fertility, palbociclib [2] ---> SmPC of [2] of EMA

Male fertility may be compromised by treatment with palbociclib (see section 5.3). Thus, men may consider sperm preservation prior to beginning therapy with IBRANCE.

Foods, palbociclib [2] ---> SmPC of [2] of EMA

Therefore, IBRANCE should be taken with food, preferably a meal (see sections 4.2 and 5.2).

Fulvestrant, palbociclib [2] ---> SmPC of [2] of EMA

Data from a clinical study in patients with breast cancer showed that there was no clinically relevant drug interaction between palbociclib and fulvestrant when the two medicinal products were coadministered.

Grapefruit juice, palbociclib [2] ---> SmPC of [2] of EMA

The concomitant use of strong CYP3A inhibitors and grapefruit or grapefruit juice, should be avoided (see sections 4.2 and 4.4)

Grapefruit, palbociclib [2] ---> SmPC of [2] of EMA

The concomitant use of strong CYP3A inhibitors and grapefruit or grapefruit juice, should be avoided (see sections 4.2 and 4.4)

H2 antagonists, palbociclib [2] ---> SmPC of [2] of EMA

Given the reduced effect on gastric pH of H2-receptor antagonists and local antacids compared to PPIs, no clinically relevant effect of H2-receptor antagonists or local antacids on palbociclib exposure is expected when palbociclib is taken with food.

Indinavir, palbociclib [2] ---> SmPC of [2] of EMA

The concomitant use of strong CYP3A inhibitors and grapefruit or grapefruit juice, should be avoided (see sections 4.2 and 4.4)

Itraconazol, palbociclib [2] ---> SmPC of [2] of EMA

The concomitant use of strong CYP3A inhibitors and grapefruit or grapefruit juice, should be avoided (see sections 4.2 and 4.4)

Ketoconazole, palbociclib [2] ---> SmPC of [2] of EMA

The concomitant use of strong CYP3A inhibitors and grapefruit or grapefruit juice, should be avoided (see sections 4.2 and 4.4)

Letrozol, palbociclib [2] ---> SmPC of [2] of EMA

Data from the drug-drug interaction (DDI) evaluation portion of a clinical study in patients with breast cancer showed that there was no drug interaction between palbociclib and letrozole when the 2 medicinal products were coadministered.

Lopinavir/ritonavir, palbociclib [2] ---> SmPC of [2] of EMA

The concomitant use of strong CYP3A inhibitors and grapefruit or grapefruit juice, should be avoided (see sections 4.2 and 4.4)

Metformin, palbociclib [2] ---> SmPC of [2] of EMA

Based on in vitro data, palbociclib may inhibit the uptake transporter organic cationic transporter OCT1 and then may increase the exposure of medical product substrates of this transporter (e.g., metformin).

Midazolam, palbociclib [2] ---> SmPC of [2] of EMA

Coadministration of multiple doses of palbociclib with midazolam increased the midazolam AUCinf and Cmax values by 61% and 37%, respectively, as compared with administration of midazolam alone.

Modafinil, palbociclib [2] ---> SmPC of [2] of EMA

No dose adjustments are required for coadministration of palbociclib with moderate CYP3A inducers

Moderate CYP3A4 inductors, palbociclib [2] ---> SmPC of [2] of EMA

No dose adjustments are required for coadministration of palbociclib with moderate CYP3A inducers

Moderate CYP3A4 inhibitors, palbociclib [2] ---> SmPC of [2] of EMA

No dose adjustments are needed for mild and moderate CYP3A inhibitors.

Nefazodone, palbociclib [2] ---> SmPC of [2] of EMA

The concomitant use of strong CYP3A inhibitors and grapefruit or grapefruit juice, should be avoided (see sections 4.2 and 4.4)

Nelfinavir, palbociclib [2] ---> SmPC of [2] of EMA

The concomitant use of strong CYP3A inhibitors and grapefruit or grapefruit juice, should be avoided (see sections 4.2 and 4.4)

OCT1 substrates, palbociclib [2] ---> SmPC of [2] of EMA

Based on in vitro data, palbociclib may inhibit the uptake transporter organic cationic transporter OCT1 and then may increase the exposure of medical product substrates of this transporter (e.g., metformin).

Oral contraceptives, palbociclib [2] ---> SmPC of [2] of EMA

DDI studies of palbociclib with oral contraceptives have not been conducted

P-glycoprotein substrates, palbociclib [2] ---> SmPC of [2] of EMA

Administration of palbociclib with medicinal products that are substrates of P-gp (e.g., digoxin, dabigatran, colchicine, pravastatin) may increase their therapeutic effect and adverse reactions.

Palbociclib [1], phenytoin ---> SmPC of [1] of EMA

The concomitant use of strong CYP3A inducers including, but not limited to: carbamazepine, enzalutamide, phenytoin, rifampin, and St. John's Wort should be avoided (see sections 4.3 and 4.4).

Palbociclib [1], pimozide ---> SmPC of [1] of EMA

The dose of sensitive CYP3A substrates with a narrow therapeutic index may need to be reduced when coadministered with IBRANCE as IBRANCE may increase their exposure.

Palbociclib [1], posaconazole ---> SmPC of [1] of EMA

The concomitant use of strong CYP3A inhibitors and grapefruit or grapefruit juice, should be avoided (see sections 4.2 and 4.4)

Palbociclib [1], pravastatine ---> SmPC of [1] of EMA

Administration of palbociclib with medicinal products that are substrates of P-gp (e.g., digoxin, dabigatran, colchicine, pravastatin) may increase their therapeutic effect and adverse reactions.

Palbociclib [1], pregnancy ---> SmPC of [1] of EMA

IBRANCE is not recommended during pregnancy and in women of childbearing potential not using contraception.

Palbociclib [1], quinidine ---> SmPC of [1] of EMA

The dose of sensitive CYP3A substrates with a narrow therapeutic index may need to be reduced when coadministered with IBRANCE as IBRANCE may increase their exposure.

Palbociclib [1], rabeprazole ---> SmPC of [1] of EMA

Under fasting conditions, the coadministration of multiple doses of the proton pump inhibitor (PPI) rabeprazole with a single dose of 125 mg IBRANCE decreased palbociclib AUCinf and Cmax by 62% and 80%, respectively.

Palbociclib [1], rifampicin ---> SmPC of [1] of EMA

The concomitant use of strong CYP3A inducers including, but not limited to: carbamazepine, enzalutamide, phenytoin, rifampin, and St. John's Wort should be avoided (see sections 4.3 and 4.4).

Palbociclib [1], rosuvastatin ---> SmPC of [1] of EMA

Administration of palbociclib with medicinal products that are substrates of BCRP (e.g., rosuvastatin, sulfasalazine) may increase their therapeutic effect and adverse reactions.

Palbociclib [1], saquinavir ---> SmPC of [1] of EMA

The concomitant use of strong CYP3A inhibitors and grapefruit or grapefruit juice, should be avoided (see sections 4.2 and 4.4)

Palbociclib [1], sirolimus ---> SmPC of [1] of EMA

The dose of sensitive CYP3A substrates with a narrow therapeutic index may need to be reduced when coadministered with IBRANCE as IBRANCE may increase their exposure.

Palbociclib [1], St. John's wort ---> SmPC of [1] of EMA

The concomitant use of strong CYP3A inducers including, but not limited to: carbamazepine, enzalutamide, phenytoin, rifampin, and St. John's Wort should be avoided (see sections 4.3 and 4.4).

Palbociclib [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA

The concomitant use of strong CYP3A inducers including, but not limited to: carbamazepine, enzalutamide, phenytoin, rifampin, and St. John's Wort should be avoided (see sections 4.3 and 4.4).

Palbociclib [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA

The concomitant use of strong CYP3A inhibitors and grapefruit or grapefruit juice, should be avoided (see sections 4.2 and 4.4)

Palbociclib [1], sulfasalazine ---> SmPC of [1] of EMA

Administration of palbociclib with medicinal products that are substrates of BCRP (e.g., rosuvastatin, sulfasalazine) may increase their therapeutic effect and adverse reactions.

Palbociclib [1], tacrolimus ---> SmPC of [1] of EMA

The dose of sensitive CYP3A substrates with a narrow therapeutic index may need to be reduced when coadministered with IBRANCE as IBRANCE may increase their exposure.

Palbociclib [1], tamoxifen ---> SmPC of [1] of EMA

Data from a DDI study in healthy male subjects indicated that palbociclib exposures were comparable when a single dose of palbociclib was coadministered with multiple doses of tamoxifen and when palbociclib was given alone.

Palbociclib [1], telaprevir ---> SmPC of [1] of EMA

The concomitant use of strong CYP3A inhibitors and grapefruit or grapefruit juice, should be avoided (see sections 4.2 and 4.4)

Palbociclib [1], telithromycin ---> SmPC of [1] of EMA

The concomitant use of strong CYP3A inhibitors and grapefruit or grapefruit juice, should be avoided (see sections 4.2 and 4.4)

Palbociclib [1], voriconazole ---> SmPC of [1] of EMA

The concomitant use of strong CYP3A inhibitors and grapefruit or grapefruit juice, should be avoided (see sections 4.2 and 4.4)

Palbociclib [1], women of childbearing potential ---> SmPC of [1] of EMA

Females of childbearing potential, or their male partners should use adequate contraceptive methods (e.g., double-barrier contraception) during therapy and for at least 3 weeks or 14 weeks after completing therapy for females and males, respectively

             CONTRAINDICATIONS of Palbociclib (Ibrance)

             - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

             - Use of preparations containing St. John's Wort          

             https://www.ema.europa.eu/en/documents/product-information/ibrance-epar-product-information_en.pdf 15/05/2024      

Palifermin (Kepivance)

Breast-feeding, palifermin [2] ---> SmPC of [2] of EMA

Kepivance should not be administered to women who are breast-feeding.

Fertility, palifermin [2] ---> SmPC of [2] of EMA

Systemic toxicity (clinical signs and/or changes in body weight) and adverse effects on male and female fertility parameters were seen at doses ≥ 300 micrograms/kg/day (5-fold higher than the recommended human dose).

Heparin, palifermin [2] ---> SmPC of [2] of EMA

Due to limited data in patients, heparins should be used with care in patients receiving palifermin and appropriate blood coagulation tests should be carried out to monitor their treatment.

Palifermin [1], pregnancy ---> SmPC of [1] of EMA

Kepivance should not be used during pregnancy unless clearly necessary.

             CONTRAINDICATIONS of Palifermin (Kepivance)        

             - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or to Escherichia coli-derived proteins.         

             https://www.ema.europa.eu/en/documents/product-information/kepivance-epar-product-information_en.pdf 08/04/2016 (withdrawn)           

Paliperidone (Invega)

Ability to drive, paliperidone [2] ---> SmPC of [2] of EMA

Paliperidone can have minor or moderate influence on the ability to drive and use machines due to potential nervous system and visual effects

Alcohol, paliperidone [2] ---> SmPC of [2] of EMA

Given the primary CNS effects of paliperidone (see section 4.8), INVEGA should be used with caution in combination with other centrally acting medicines, e.g., anxiolytics, most antipsychotics, hypnotics, opiates, etc. or alcohol.

Amiodarone, paliperidone [2] ---> SmPC of [2] of EMA

Caution is advised when prescribing INVEGA with medicines known to prolong the QT interval, e.g., class IA antiarrhythmics (e.g., quinidine, disopyramide) and class III antiarrhythmics (e.g., amiodarone, sotalol), some antihistaminics,

Anxiolytics, paliperidone [2] ---> SmPC of [2] of EMA

Given the primary CNS effects of paliperidone (see section 4.8), INVEGA should be used with caution in combination with other centrally acting medicines, e.g., anxiolytics, most antipsychotics, hypnotics, opiates, etc. or alcohol.

Breast-feeding, paliperidone [2] ---> SmPC of [2] of EMA

Paliperidone is excreted in the breast milk to such an extent that effects on the breast-fed infant are likely if therapeutic doses are administered to breast-feeding women. INVEGA should not be used while breast feeding.

Butyrophenones, paliperidone [2] ---> SmPC of [2] of EMA

Caution is advised if paliperidone is combined with other medicines known to lower the seizure threshold (i.e., phenothiazines or butyrophenones, clozapine, tricyclics or SSRIs, tramadol, mefloquine, etc.).

Carbamazepine, paliperidone [2] ---> SmPC of [2] of EMA

This decrease is caused, to a substantial degree, by a 35% increase in renal clearance of paliperidone likely as a result of induction of renal P-gp by carbamazepine.

Class IA antiarrhythmic agents, paliperidone [2] ---> SmPC of [2] of EMA

Caution is advised when prescribing INVEGA with medicines known to prolong the QT interval, e.g., class IA antiarrhythmics (e.g., quinidine, disopyramide) and class III antiarrhythmics (e.g., amiodarone, sotalol), some antihistaminics,

Class III antiarrhythmic agents, paliperidone [2] ---> SmPC of [2] of EMA

Caution is advised when prescribing INVEGA with medicines known to prolong the QT interval, e.g., class IA antiarrhythmics (e.g., quinidine, disopyramide) and class III antiarrhythmics (e.g., amiodarone, sotalol), some antihistaminics,

Clozapine, paliperidone [2] ---> SmPC of [2] of EMA

Caution is advised if paliperidone is combined with other medicines known to lower the seizure threshold (i.e., phenothiazines or butyrophenones, clozapine, tricyclics or SSRIs, tramadol, mefloquine, etc.).

CNS depressants, paliperidone [2] ---> SmPC of [2] of EMA

Given the primary CNS effects of paliperidone (see section 4.8), INVEGA should be used with caution in combination with other centrally acting medicines, e.g., anxiolytics, most antipsychotics, hypnotics, opiates, etc. or alcohol.

Cytochrome P450, paliperidone [2] ---> SmPC of [2] of EMA

Paliperidone is not expected to cause clinically important pharmacokinetic interactions with medicines that are metabolised by cytochrome P-450 isozymes. In vitro studies indicate that paliperidone is not an inducer of CYP1A2 activity.

Disopyramide, paliperidone [2] ---> SmPC of [2] of EMA

Caution is advised when prescribing INVEGA with medicines known to prolong the QT interval, e.g., class IA antiarrhythmics (e.g., quinidine, disopyramide) and class III antiarrhythmics (e.g., amiodarone, sotalol), some antihistaminics,

Divalproex sodium, paliperidone [2] ---> SmPC of [2] of EMA

Co-administration of INVEGA with divalproex sodium prolonged-release tablets increased the exposure to paliperidone (see below).

Dopamine agonists, paliperidone [2] ---> SmPC of [2] of EMA

Paliperidone may antagonise the effect of levodopa and other dopamine agonists. If this combination is deemed necessary, particularly in end-stage Parkinson's disease, the lowest effective dose of each treatment should be prescribed.

Fertility, paliperidone [2] ---> SmPC of [2] of EMA

There were no relevant effects observed in the non-clinical studies.

Hypnotics, paliperidone [2] ---> SmPC of [2] of EMA

Given the primary CNS effects of paliperidone (see section 4.8), INVEGA should be used with caution in combination with other centrally acting medicines, e.g., anxiolytics, most antipsychotics, hypnotics, opiates, etc. or alcohol.

Levodopa, paliperidone [2] ---> SmPC of [2] of EMA

Paliperidone may antagonise the effect of levodopa and other dopamine agonists. If this combination is deemed necessary, particularly in end-stage Parkinson's disease, the lowest effective dose of each treatment should be prescribed.

Lithium, paliperidone [2] ---> SmPC of [2] of EMA

No interaction study between INVEGA and lithium has been performed, however, a pharmacokinetic interaction is unlikely to occur.

Mefloquine, paliperidone [2] ---> SmPC of [2] of EMA

Caution is advised when prescribing INVEGA with medicines known to prolong the QT interval, e.g., class IA antiarrhythmics (e.g., quinidine, disopyramide) and class III antiarrhythmics (e.g., amiodarone, sotalol), some antihistaminics,

Methylphenidate, paliperidone [2] ---> SmPC of [2] of EMA

The combined use of psychostimulants (e.g., methylphenidate) with paliperidone can lead to extrapyramidal symptoms upon change of either or both treatments (see section 4.4).

Metoclopramide, paliperidone [2] ---> SmPC of [2] of EMA

Medicinal products affecting gastrointestinal transit time may affect the absorption of paliperidone, e.g., metoclopramide.

Neuroleptics, orthostatic hypotension ---> SmPC of [paliperidone] of EMA

Because of its potential for inducing orthostatic hypotension (see section 4.4), an additive effect may be observed when INVEGA is administered with other therapeutic agents that have this potential, e.g., other antipsychotics, tricyclics.

Neuroleptics, paliperidone [2] ---> SmPC of [2] of EMA

Given the primary CNS effects of paliperidone (see section 4.8), INVEGA should be used with caution in combination with other centrally acting medicines, e.g., anxiolytics, most antipsychotics, hypnotics, opiates, etc. or alcohol.

Opiates, paliperidone [2] ---> SmPC of [2] of EMA

Given the primary CNS effects of paliperidone (see section 4.8), INVEGA should be used with caution in combination with other centrally acting medicines, e.g., anxiolytics, most antipsychotics, hypnotics, opiates, etc. or alcohol.

Orthostatic hypotension, paliperidone [2] ---> SmPC of [2] of EMA

Because of its potential for inducing orthostatic hypotension, an additive effect may be observed when paliperidone is administered with other therapeutic agents that have this potential, e.g., other antipsychotics, tricyclics.

Orthostatic hypotension, tricyclic antidepressant ---> SmPC of [paliperidone] of EMA

Because of its potential for inducing orthostatic hypotension (see section 4.4), an additive effect may be observed when INVEGA is administered with other therapeutic agents that have this potential, e.g., other antipsychotics, tricyclics.

Paliperidone [1], paroxetine ---> SmPC of [1] of EMA

Concomitant administration of INVEGA with paroxetine, a potent CYP2D6 inhibitor, showed no clinically significant effect on the pharmacokinetics of paliperidone.

Paliperidone [1], phenothiazines ---> SmPC of [1] of EMA

Caution is advised if paliperidone is combined with other medicines known to lower the seizure threshold (i.e., phenothiazines or butyrophenones, clozapine, tricyclics or SSRIs, tramadol, mefloquine, etc.).

Paliperidone [1], pregnancy ---> SmPC of [1] of EMA

INVEGA should not be used during pregnancy unless clearly necessary. If discontinuation during pregnancy is necessary, it should not be done abruptly.

Paliperidone [1], prokinetics ---> SmPC of [1] of EMA

Medicinal products affecting gastrointestinal transit time may affect the absorption of paliperidone, e.g., metoclopramide.

Paliperidone [1], psychostimulants ---> SmPC of [1] of EMA

The combined use of psychostimulants (e.g., methylphenidate) with paliperidone can lead to extrapyramidal symptoms upon change of either or both treatments (see section 4.4).

Paliperidone [1], QT interval prolonging drugs ---> SmPC of [1] of EMA

Caution is advised when prescribing INVEGA with medicines known to prolong the QT interval, e.g., class IA antiarrhythmics (e.g., quinidine, disopyramide) and class III antiarrhythmics (e.g., amiodarone, sotalol), some antihistaminics,

Paliperidone [1], quinidine ---> SmPC of [1] of EMA

Caution is advised when prescribing INVEGA with medicines known to prolong the QT interval, e.g., class IA antiarrhythmics (e.g., quinidine, disopyramide) and class III antiarrhythmics (e.g., amiodarone, sotalol), some antihistaminics,

Paliperidone [1], rifampicin ---> SmPC of [1] of EMA

Other medicinal products or herbals which are inducers, e.g., rifampicin and St. John´s wort (Hypericum perforatum) may have similar effects on paliperidone.

Paliperidone [1], risperidone ---> SmPC of [1] of EMA

Concomitant use of INVEGA with oral risperidone is not recommended as paliperidone is the active metabolite of risperidone and the combination of the two may lead to additive paliperidone exposure.

Paliperidone [1], seizure-threshold lowering drugs ---> SmPC of [1] of EMA

Caution is advised if paliperidone is combined with other medicines known to lower the seizure threshold (i.e., phenothiazines or butyrophenones, clozapine, tricyclics or SSRIs, tramadol, mefloquine, etc.).

Paliperidone [1], sodium valproate ---> SmPC of [1] of EMA

Co-administration of paliperidone with divalproex sodium prolonged-release tablets increased the exposure to paliperidone

Paliperidone [1], sotalol ---> SmPC of [1] of EMA

Caution is advised when prescribing INVEGA with medicines known to prolong the QT interval, e.g., class IA antiarrhythmics (e.g., quinidine, disopyramide) and class III antiarrhythmics (e.g., amiodarone, sotalol), some antihistaminics,

Paliperidone [1], SSRI ---> SmPC of [1] of EMA

Caution is advised if paliperidone is combined with other medicines known to lower the seizure threshold (i.e., phenothiazines or butyrophenones, clozapine, tricyclics or SSRIs, tramadol, mefloquine, etc.).

Paliperidone [1], St. John's wort ---> SmPC of [1] of EMA

Other medicinal products or herbals which are inducers, e.g., rifampicin and St. John´s wort (Hypericum perforatum) may have similar effects on paliperidone.

Paliperidone [1], tramadol ---> SmPC of [1] of EMA

Caution is advised if paliperidone is combined with other medicines known to lower the seizure threshold (i.e., phenothiazines or butyrophenones, clozapine, tricyclics or SSRIs, tramadol, mefloquine, etc.).

Paliperidone [1], tricyclic antidepressant ---> SmPC of [1] of EMA

Because of its potential for inducing orthostatic hypotension (see section 4.4), an additive effect may be observed when INVEGA is administered with other therapeutic agents that have this potential, e.g., other antipsychotics, tricyclics.

Paliperidone [1], valproic acid ---> SmPC of [1] of EMA

Co-administration of paliperidone with divalproex sodium prolonged-release tablets increased the exposure to paliperidone

             CONTRAINDICATIONS of Paliperidone (Invega)            

             - Hypersensitivity to the active substance, risperidone, or to any of the excipients listed in section 6.1.

             https://www.ema.europa.eu/en/documents/product-information/invega-epar-product-information_en.pdf 12/07/2024

Other trade names: Byannli (previously Paliperidone Janssen-Cilag International), Trevicta (previously Paliperidone Janssen), Paliperidone Janssen-Cilag International, Xeplion,

Palivizumab (Synagis)

Antigen detection, palivizumab [2] ---> SmPC of [2] of EMA

Palivizumab may interfere with immune-based RSV diagnostic tests, such as some antigen detection based assays.

Breast-feeding, palivizumab [2] ---> SmPC of [2] of EMA

Not relevant. Synagis is not indicated for use in adults. Data on fertility, pregnancy and lactation are not available.

Culture, palivizumab [2] ---> SmPC of [2] of EMA

In addition, palivizumab inhibits virus replication in cell culture and, therefore, may also interfere with viral culture assays.

Fertility, palivizumab [2] ---> SmPC of [2] of EMA

Not relevant. Synagis is not indicated for use in adults. Data on fertility, pregnancy and lactation are not available.

Palivizumab [1], pregnancy ---> SmPC of [1] of EMA

Not relevant. Synagis is not indicated for use in adults. Data on fertility, pregnancy and lactation are not available.

Palivizumab [1], vaccinations ---> SmPC of [1] of EMA

Since the monoclonal antibody is specific for RSV, palivizumab is not expected to interfere with the immune response to vaccines.

             CONTRAINDICATIONS of Palivizumab (Synagis)            

             - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or to other humanised monoclonal antibodies.

             https://www.ema.europa.eu/en/documents/product-information/synagis-epar-product-information_en.pdf. 11/10/2023

Palonosetron (Aloxi)

5-HT3 receptor antagonists, hypokaliemia ---> SmPC of [palonosetron] of EMA

Hypokalemia and hypomagnesemia should be corrected prior to 5-HT3-antagonist administration.

5-HT3 receptor antagonists, hypomagnesemia ---> SmPC of [palonosetron] of EMA

Hypokalemia and hypomagnesemia should be corrected prior to 5-HT3-antagonist administration.

5-HT3 receptor antagonists, serotonergic medicines ---> SmPC of [palonosetron] of EMA

There have been reports of serotonin syndrome following concomitant use of 5-HT3 antagonists and other serotonergic drugs (including SSRIs and SNRIs).

Ability to drive, palonosetron [2] ---> SmPC of [2] of EMA

Since palonosetron may induce dizziness, somnolence or fatigue, patients should be cautioned when driving or operating machines.

Amiodarone, palonosetron [2] ---> SmPC of [2] of EMA

In a population pharmacokinetic analysis, it has been shown that there was no significant effect on palonosetron clearance when co-administered with CYP2D6 inducers and inhibitors

Antiarrhythmics, palonosetron [2] ---> SmPC of [2] of EMA

As for other 5-HT3 antagonists, caution should be exercised in the use of palonosetron in patients who have or are likely to develop prolongation of the QT interval.

Breast-feeding, palonosetron [2] ---> SmPC of [2] of EMA

As there are no data concerning palonosetron excretion in breast milk, breast-feeding should be discontinued during therapy.

Celecoxib, palonosetron [2] ---> SmPC of [2] of EMA

In a population pharmacokinetic analysis, it has been shown that there was no significant effect on palonosetron clearance when co-administered with CYP2D6 inducers and inhibitors

Chemotherapeutic agents tested, palonosetron [2] ---> SmPC of [2] of EMA

In preclinical studies, palonosetron did not inhibit the antitumour activity of the five chemotherapeutic agents tested (cisplatin, cyclophosphamide, cytarabine, doxorubicin and mitomycin C).

Chlorpromazine, palonosetron [2] ---> SmPC of [2] of EMA

In a population pharmacokinetic analysis, it has been shown that there was no significant effect on palonosetron clearance when co-administered with CYP2D6 inducers and inhibitors

Cimetidine, palonosetron [2] ---> SmPC of [2] of EMA

In a population pharmacokinetic analysis, it has been shown that there was no significant effect on palonosetron clearance when co-administered with CYP2D6 inducers and inhibitors

Corticosteroids, palonosetron [2] ---> SmPC of [2] of EMA

Palonosetron has been administered safely with corticosteroids.

CYP2D6 inductors, palonosetron [2] ---> SmPC of [2] of EMA

In a population pharmacokinetic analysis, it has been shown that there was no significant effect on palonosetron clearance when co-administered with CYP2D6 inducers and inhibitors

CYP2D6 inhibitors, palonosetron [2] ---> SmPC of [2] of EMA

In a population pharmacokinetic analysis, it has been shown that there was no significant effect on palonosetron clearance when co-administered with CYP2D6 inducers and inhibitors

Cytochrome P450, palonosetron [2] ---> SmPC of [2] of EMA

Based on in vitro studies, palonosetron does not inhibit or induce cytochrome P450 isoenzyme at clinically relevant concentrations.

Dexamethasone, palonosetron [2] ---> SmPC of [2] of EMA

In a population pharmacokinetic analysis, it has been shown that there was no significant effect on palonosetron clearance when co-administered with CYP2D6 inducers and inhibitors

Doxorubicine, palonosetron [2] ---> SmPC of [2] of EMA

In a population pharmacokinetic analysis, it has been shown that there was no significant effect on palonosetron clearance when co-administered with CYP2D6 inducers and inhibitors

Fertility, palonosetron [2] ---> SmPC of [2] of EMA

There are no data concerning the effect of palonosetron on fertility.

Fluoxetine, palonosetron [2] ---> SmPC of [2] of EMA

In a population pharmacokinetic analysis, it has been shown that there was no significant effect on palonosetron clearance when co-administered with CYP2D6 inducers and inhibitors

Haloperidol, palonosetron [2] ---> SmPC of [2] of EMA

In a population pharmacokinetic analysis, it has been shown that there was no significant effect on palonosetron clearance when co-administered with CYP2D6 inducers and inhibitors

Ketoconazole, palonosetron ---> SmPC of [netupitant/palonosetron] of EMA

Co-administration with ketoconazole did not affect the pharmacokinetics of palonosetron.

Metoclopramide, palonosetron [2] ---> SmPC of [2] of EMA

In a clinical study, no significant pharmacokinetic interaction was shown between a single intravenous dose of palonosetron and steady state concentration of oral metoclopramide, which is a CYP2D6 inhibitor.

Other medicinal products, palonosetron [2] ---> SmPC of [2] of EMA

Palonosetron has been administered safely with analgesics, antiemetic/antinauseants, antispasmodics and anticholinergic medicinal products.

Palonosetron [1], paroxetine ---> SmPC of [1] of EMA

In a population pharmacokinetic analysis, it has been shown that there was no significant effect on palonosetron clearance when co-administered with CYP2D6 inducers and inhibitors

Palonosetron [1], pregnancy ---> SmPC of [1] of EMA

Palonosetron should not be used in pregnant women unless it is considered essential by the physician.

Palonosetron [1], QT interval prolonging drugs ---> SmPC of [1] of EMA

As for other 5-HT3 antagonists, caution should be exercised in the use of palonosetron in patients who have or are likely to develop prolongation of the QT interval.

Palonosetron [1], quinidine ---> SmPC of [1] of EMA

In a population pharmacokinetic analysis, it has been shown that there was no significant effect on palonosetron clearance when co-administered with CYP2D6 inducers and inhibitors

Palonosetron [1], ranitidine ---> SmPC of [1] of EMA

In a population pharmacokinetic analysis, it has been shown that there was no significant effect on palonosetron clearance when co-administered with CYP2D6 inducers and inhibitors

Palonosetron [1], rifampicin ---> SmPC of [1] of EMA

In a population pharmacokinetic analysis, it has been shown that there was no significant effect on palonosetron clearance when co-administered with CYP2D6 inducers and inhibitors

Palonosetron [1], ritonavir ---> SmPC of [1] of EMA

In a population pharmacokinetic analysis, it has been shown that there was no significant effect on palonosetron clearance when co-administered with CYP2D6 inducers and inhibitors

Palonosetron [1], serotonergic medicines ---> SmPC of [1] of EMA

There have been reports of serotonin syndrome following concomitant use of 5-HT3 antagonists and other serotonergic drugs (including SSRIs and SNRIs).

Palonosetron [1], sertraline ---> SmPC of [1] of EMA

In a population pharmacokinetic analysis, it has been shown that there was no significant effect on palonosetron clearance when co-administered with CYP2D6 inducers and inhibitors

Palonosetron [1], SNRIs ---> SmPC of [1] of EMA

There have been reports of serotonin syndrome following concomitant use of 5-HT3 antagonists and other serotonergic drugs (including SSRIs and SNRIs).

Palonosetron [1], SSRI ---> SmPC of [1] of EMA

There have been reports of serotonin syndrome following concomitant use of 5-HT3 antagonists and other serotonergic drugs (including SSRIs and SNRIs).

Palonosetron [1], terbinafine ---> SmPC of [1] of EMA

In a population pharmacokinetic analysis, it has been shown that there was no significant effect on palonosetron clearance when co-administered with CYP2D6 inducers and inhibitors

             CONTRAINDICATIONS of Palonosetron (Aloxi)

             - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

             https://www.ema.europa.eu/en/documents/product-information/aloxi-epar-product-information_en.pdf 24/02/2023

Other trade names: Palonosetron Accord, Palonosetron Hospira,

Palopegteriparatide (Yorvipath)

Ability to drive, palopegteriparatide [2] ---> SmPC of [2] of EMA

Dizziness, presyncope, syncope and/or orthostatic hypotension was observed in some patients. These patients should refrain from driving or the use of machines until symptoms have subsided.

Biphosphonates, palopegteriparatide [2] ---> SmPC of [2] of EMA

Other medicinal products can exert effects on serum calcium and may alter the therapeutic response to Yorvipath. Patients should be monitored for changes in serum calcium when treated concomitantly with these medicinal products.

Breast-feeding, palopegteriparatide [2] ---> SmPC of [2] of EMA

A decision to discontinue breast-feeding or Yorvipath therapy should take into account the benefit of breast-feeding for the child and the benefit of therapy for the female.

Cardiac glycosides, palopegteriparatide [2] ---> SmPC of [2] of EMA

Hypercalcaemia of any cause may predispose to digitalis toxicity. In patients using Yorvipath concomitantly with cardiac glycosides (such as digoxin or digitoxin), serum calcium and cardiac glycoside levels should be monitored

Corticosteroids, palopegteriparatide [2] ---> SmPC of [2] of EMA

Other medicinal products can exert effects on serum calcium and may alter the therapeutic response to Yorvipath. Patients should be monitored for changes in serum calcium when treated concomitantly with these medicinal products.

Denosumab, palopegteriparatide [2] ---> SmPC of [2] of EMA

Other medicinal products can exert effects on serum calcium and may alter the therapeutic response to Yorvipath. Patients should be monitored for changes in serum calcium when treated concomitantly with these medicinal products.

Digitoxin, palopegteriparatide [2] ---> SmPC of [2] of EMA

Hypercalcaemia of any cause may predispose to digitalis toxicity. In patients using Yorvipath concomitantly with cardiac glycosides (such as digoxin or digitoxin), serum calcium and cardiac glycoside levels should be monitored

Digoxin, palopegteriparatide [2] ---> SmPC of [2] of EMA

Hypercalcaemia of any cause may predispose to digitalis toxicity. In patients using Yorvipath concomitantly with cardiac glycosides (such as digoxin or digitoxin), serum calcium and cardiac glycoside levels should be monitored

Fertility, palopegteriparatide [2] ---> SmPC of [2] of EMA

No studies have been performed on the effects of palopegteriparatide on human fertility. Data from animal studies do not indicate that administration of palopegteriparatide impairs fertility (see section 5.3).

Lithium, palopegteriparatide [2] ---> SmPC of [2] of EMA

Other medicinal products can exert effects on serum calcium and may alter the therapeutic response to Yorvipath. Patients should be monitored for changes in serum calcium when treated concomitantly with these medicinal products.

Palopegteriparatide [1], pregnancy ---> SmPC of [1] of EMA

A decision to initiate or discontinue treatment with Yorvipath during pregnancy should take into account the possible risks versus the benefits for the pregnant female.

Palopegteriparatide [1], romosozumab ---> SmPC of [1] of EMA

Other medicinal products can exert effects on serum calcium and may alter the therapeutic response to Yorvipath. Patients should be monitored for changes in serum calcium when treated concomitantly with these medicinal products.

Palopegteriparatide [1], thiazides ---> SmPC of [1] of EMA

Other medicinal products can exert effects on serum calcium and may alter the therapeutic response to Yorvipath. Patients should be monitored for changes in serum calcium when treated concomitantly with these medicinal products.

             CONTRAINDICATIONS of Palopegteriparatide (Yorvipath)                   

             -Hypersensitivity to the active substance or to any of the excipients listed in section 6.1         

             -Patients with pseudohypoparathyroidism     

             https://www.ema.europa.eu/en/documents/product-information/yorvipath-epar-product-information_en.pdf 06/03/2025        

Pamidronate

Ability to drive, pamidronate [2] ---> SmPC of [2] of eMC

Patients should be warned that somnolence and/or dizziness may occur following pamidronate infusion

Biphosphonates, pamidronate

Possible hypocalcemia with clinic symptoms (paresthesias, tetania, hypotension)

Breast-feeding, pamidronate [2] ---> SmPC of [2] of eMC

Due to extremely limited experience and the potential of pamidronate to have an important impact on bone mineralisation breastfeeding during the therapy is not recommended.

Calcitonin, pamidronate [2] ---> SmPC of [2] of eMC

Pamidronate has been used in combination with calcitonin in patients with severe hypercalcaemia, resulting in a synergistic effect producing a more rapid fall in serum calcium.

Hypocalcemia, pamidronate

Possible hypocalcemia with clinic symptoms (paresthesias, tetania, hypotension)

Mithramycin, pamidronate

Enhanced hypocalcemic effect

Nephrotoxic substances, pamidronate [2] ---> SmPC of [2] of eMC

Caution is warranted when pamidronate is used with other potentially nephrotoxic drugs.

Pamidronate [1], pregnancy ---> SmPC of [1] of eMC

Pamidronate should not be administered to pregnant women except in cases of life-threatening hypercalcaemia.

Pamidronate [1], thalidomide ---> SmPC of [1] of eMC

In multiple myeloma patients, the risk of renal dysfunction may be increased when pamidronate is used in combination with thalidomide.

           CONTRAINDICATIONS of Pamidronate

           Aredia is contraindicated

           - in patients with known hypersensitivity to pamidronate or to other bisphosphonates, or to any of the excipients

           http://www.medicines.org.uk/emc/

Polihexanide (Akantior)

Ability to drive, polihexanide [2] ---> SmPC of [2] of EMA

AKANTIOR has minor influence on the ability to drive and use machines, as it may cause temporary blurred vision or other visual disturbances, which is expected to last a few minutes after instillation.

Breast-feeding, polihexanide [2] ---> SmPC of [2] of EMA

A decision must be made as to whether to discontinue breast-feeding or to discontinue/abstain from AKANTIOR therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Fertility, polihexanide [2] ---> SmPC of [2] of EMA

There are no data on the effects of polihexanide on human fertility.

Medicinal products, polihexanide [2] ---> SmPC of [2] of EMA

Local interactions with other medicinal products cannot be excluded.

Phosphates, polihexanide [2] ---> SmPC of [2] of EMA

AKANTIOR contains phosphates. Cases of corneal calcification have been reported very rarely in association with the use of phosphate containing eye drops in some patients with significantly damaged corneas.

Polihexanide [1], pregnancy ---> SmPC of [1] of EMA

As a precautionary measure, it is preferable to avoid the use of AKANTIOR during pregnancy.

            CONTRAINDICATIONS of Polihexanide (Akantior)            

            - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

            - Subjects with urgent need of ocular surgery due to advanced Acanthamoeba keratitis.

            https://www.ema.europa.eu/en/documents/product-information/akantior-epar-product-information_en.pdf 29/10/2024             

Pancreas powder (Enzepi)

Ability to drive, pancreas powder [2] ---> SmPC of [2] of EMA

Enzepi should be taken during meals or snacks, with a drink of water or juice. For paediatric patients below 1 year of age, Enzepi must be administered immediately prior to each feed.

Breast-feeding, pancreas powder [2] ---> SmPC of [2] of EMA

A decision must be made whether to discontinue breastfeeding or to discontinue/abstain from Enzepi therapy taking into account the benefit of breast-feeding for the child and the benefit of continued Enzepi therapy for the breastfeeding woman.

Pancreas powder [1], pregnancy ---> SmPC of [1] of EMA

The risk and benefit of this medicinal product should be considered in the context of the need to provide adequate nutritional support to a pregnant woman with exocrine pancreatic insufficiency.

           CONTRAINDICATIONS of Pancreas powder (Enzepi)

           - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

           https://www.ema.europa.eu/en/documents/product-information/enzepi-epar-product-information_en.pdf 17/02/2021 (withdrawn) 

Pancreatin

Breast-feeding, pancreatin [2] ---> SmPC of [2] of eMC

Pancreatic enzymes can be used during breast-feeding.

Intestinal adsorbents, pancreatin

The intestinal adsorbent may reduce the effect of the pancreatin inhibitor and should not therefore be taken concomitantly.

Miglitol, pancreatin

Possible decrease of miglitol effect. It is recommended to avoid the concomitant use

Pancreatin [1], pregnancy ---> SmPC of [1] of eMC

Caution should be exercised when prescribing to pregnant women.

           CONTRAINDICATIONS of Pancreatin

           - Hypersensitivity to pancreatin of porcine origin or to any of the excipients.

           http://www.medicines.org.uk/emc/

Pandemic influenza vaccine (H5N1) (Incellipan)

Ability to drive [1], pandemic influenza vaccine (H5N1) ---> SmPC of [1] of EMA

Incellipan has no or negligible influence on the ability to drive and use machines. However, some of the undesirable effects mentioned under section 4.8 may affect the ability to drive or operate machinery.

Breast-feeding [1], pandemic influenza vaccine (H5N1) ---> SmPC of [1] of EMA

Incellipan has not been evaluated during breast-feeding. The vaccine is not expected to be excreted in human milk and no effects on the breastfed newborn/infant are anticipated.

Fertility [1], pandemic influenza vaccine (H5N1) ---> SmPC of [1] of EMA

A reproductive and developmental toxicity study in female rabbits dosed with Incellipan revealed no impairment of fertility.

Pandemic influenza vaccine (H5N1) [1], pregnancy ---> SmPC of [1] of EMA

Healthcare providers need to assess the benefit and potential risks of administering the vaccine to pregnant women taking into consideration official recommendations.

Pandemic influenza vaccine (H5N1), vaccinations [2] ---> SmPC of [2] of EMA

If Incellipan is given at the same time as another injectable vaccine(s), the vaccine(s) should always be administered to separate limbs. It should be noted that adverse reactions may be intensified.

             CONTRAINDICATIONS of Pandemic influenza vaccine (H5N1) (Incellipan)

             - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1, or to possible trace residues such as beta-propiolactone, cetyltrimethylammonium bromide, and polysorbate 80.             

             - History of an anaphylactic (i.e. life-threatening) reaction after a previous dose of an influenza vaccine.        

             https://www.ema.europa.eu/en/documents/product-information/incellipan-epar-product-information_en.pdf 02/05/2024      

Panitumumab (Vectibix)

Ability to drive, panitumumab [2] ---> SmPC of [2] of EMA

If patients experience treatment-related symptoms affecting their vision and/or ability to concentrate and react, it is recommended that they do not drive or use machines until the effect subsides.

Bevacizumab, panitumumab [2] ---> SmPC of [2] of EMA

Vectibix should not be administered in combination with bevacizumab containing chemotherapy (see sections 4.5 and 5.1).

Breast-feeding, panitumumab [2] ---> SmPC of [2] of EMA

It is recommended that women do not breast feed during treatment with Vectibix and for 2 months after the last dose

Fertility, panitumumab [2] ---> SmPC of [2] of EMA

Animal studies have shown reversible effects on the menstrual cycle and reduced female fertility in monkeys (see section 5.3). Panitumumab may impact the ability of a woman to become pregnant.

Irinotecan, panitumumab [2] ---> SmPC of [2] of EMA

Results from a cross-study comparison indicated that irinotecan-containing regimens (IFL or FOLFIRI) have no effect on the pharmacokinetics of panitumumab.

Irinotecan/fluorouracil/leucovorin, panitumumab [2] ---> SmPC of [2] of EMA

Patients receiving Vectibix in combination with the IFL regimen experienced a high incidence of severe diarrhoea (see section 4.8). Therefore, administration of Vectibix in combination with IFL should be avoided (see section 4.5).

Oxaliplatin, panitumumab [2] ---> SmPC of [2] of EMA

The combination of panitumumab with oxaliplatin-containing chemotherapy is contraindicated for patients with mutant KRAS mCRC or for whom KRAS mCRC status is unknown.

Panitumumab [1], pharmacokinetics ---> SmPC of [1] of EMA

Data from an interaction study involving Vectibix and irinotecan in patients with mCRC indicated that the pharmacokinetics of irinotecan and its active metabolite, SN-38, are not altered when the medicinal products are co-administered.

Panitumumab [1], pregnancy ---> SmPC of [1] of EMA

Vectibix has the potential to cause foetal harm when administered to pregnant women

Panitumumab [1], women of childbearing potential ---> SmPC of [1] of EMA

In women of childbearing potential, appropriate contraceptive measures must be used during treatment with Vectibix, and for 2 months following the last dose.

Panitumumab [1], women of childbearing potential ---> SmPC of [1] of EMA

If Vectibix is used during pregnancy or if the patient becomes pregnant while receiving this medicinal product, she should be advised of the potential risk for loss of the pregnancy or potential hazard to the foetus.

            CONTRAINDICATIONS of Panitumumab (Vectibix)           

            - Patients with a history of severe or life-threatening hypersensitivity to the active substance or to any of the excipients listed in section 6.1  

            - Patients with interstitial pneumonitis or pulmonary fibrosis      

            - The combination of panitumumab with oxaliplatin-containing chemotherapy is contraindicated for patients with mutant RAS mCRC or for whom RAS mCRC status is unknown  

            https://www.ema.europa.eu/en/documents/product-information/vectibix-epar-product-information_en.pdf 07/05/2025             

Panobinostat (Farydak)

Ability to drive, panobinostat [2] ---> SmPC of [2] of EMA

Farydak has a minor influence on the ability to drive and use machines. Dizziness may occur following administration of Farydak (see section 4.8).

Amiodarone, panobinostat [2] ---> SmPC of [2] of EMA

Based on preclinical and clinical data, panobinostat has the potential to prolong the QT interval. Concomitant use of panobinostat and other substances that are known to prolong the QT interval is not recommended.

Antiarrhythmics, panobinostat [2] ---> SmPC of [2] of EMA

Based on preclinical and clinical data, panobinostat has the potential to prolong the QT interval. Concomitant use of panobinostat and other substances that are known to prolong the QT interval is not recommended.

Atomoxetine, panobinostat [2] ---> SmPC of [2] of EMA

Panobinostat increased the Cmax and the AUC of dextromethorphan (a substrate of CYP2D6) by 1.8- and 1.6-fold, respectively, and it cannot be excluded that the effect may be larger on a more sensitive CYP2D6 substrate.

Bepridil, panobinostat [2] ---> SmPC of [2] of EMA

Based on preclinical and clinical data, panobinostat has the potential to prolong the QT interval. Concomitant use of panobinostat and other substances that are known to prolong the QT interval is not recommended.

Breast-feeding, panobinostat [2] ---> SmPC of [2] of EMA

It is unknown whether panobinostat is excreted in human milk. Given its cytostatic/cytotoxic mode of action, breast-feeding is contraindicated during Farydak treatment

Carbamazepine, panobinostat [2] ---> SmPC of [2] of EMA

Strong inducers may reduce the efficacy of panobinostat, therefore the concomitant use of strong CYP3A4 inducers should be avoided.

Chloroquine, panobinostat [2] ---> SmPC of [2] of EMA

Based on preclinical and clinical data, panobinostat has the potential to prolong the QT interval. Concomitant use of panobinostat and other substances that are known to prolong the QT interval is not recommended.

Clarithromycin, panobinostat [2] ---> SmPC of [2] of EMA

Based on preclinical and clinical data, panobinostat has the potential to prolong the QT interval. Concomitant use of panobinostat and other substances that are known to prolong the QT interval is not recommended.

Dexamethasone, panobinostat [2] ---> SmPC of [2] of EMA

When panobinostat is administered together with dexamethasone, which is known to be a weak to moderate inducer of CYP3A4 as well as other enzymes and transporters, the risk for reduced efficacy of hormonal contraceptives needs to be considered.

Dextromethorphan, panobinostat [2] ---> SmPC of [2] of EMA

Panobinostat increased the Cmax and the AUC of dextromethorphan (a substrate of CYP2D6) by 1.8- and 1.6-fold, respectively, and it cannot be excluded that the effect may be larger on a more sensitive CYP2D6 substrate.

Disopyramide, panobinostat [2] ---> SmPC of [2] of EMA

Based on preclinical and clinical data, panobinostat has the potential to prolong the QT interval. Concomitant use of panobinostat and other substances that are known to prolong the QT interval is not recommended.

Dolasetron, panobinostat [2] ---> SmPC of [2] of EMA

Based on preclinical and clinical data, panobinostat has the potential to prolong the QT interval. Concomitant use of panobinostat and other substances that are known to prolong the QT interval is not recommended.

Drugs primarily metabolised by CYP2D6 with narrow therapeutic index, panobinostat [2] ---> SmPC of [2] of EMA

Avoid panobinostat use in patients who are taking CYP2D6 substrates with a narrow therapeutic index

Drugs primarily metabolised by CYP2D6, panobinostat [2] ---> SmPC of [2] of EMA

Panobinostat increased the Cmax and the AUC of dextromethorphan (a substrate of CYP2D6) by 1.8- and 1.6-fold, respectively, and it cannot be excluded that the effect may be larger on a more sensitive CYP2D6 substrate.

Drugs primarily metabolised by CYP3A4, panobinostat [2] ---> SmPC of [2] of EMA

No data is available that can be used to exclude the risk that panobinostat could be a weak inducer of the enzyme CYP3A4 in the gastrointestinal tract. This could potentially lead to slightly decreased exposure to sensitive CYP3A4 substrates.

Fertility, panobinostat [2] ---> SmPC of [2] of EMA

Based on non-clinical findings, male fertility may be compromised by treatment with Farydak (see section 5.3).

Granisetron, panobinostat [2] ---> SmPC of [2] of EMA

Based on preclinical and clinical data, panobinostat has the potential to prolong the QT interval. Concomitant use of panobinostat and other substances that are known to prolong the QT interval is not recommended.

Grapefruit juice, panobinostat [2] ---> SmPC of [2] of EMA

Patients should be instructed to avoid star fruit, grapefruit, grapefruit juice, pomegranates and pomegranate juice, as these are known to inhibit cytochrome P450 3A enzymes and may increase the bioavailability of panobinostat.

Grapefruit, panobinostat [2] ---> SmPC of [2] of EMA

Patients should be instructed to avoid star fruit, grapefruit, grapefruit juice, pomegranates and pomegranate juice, as these are known to inhibit cytochrome P450 3A enzymes and may increase the bioavailability of panobinostat.

Halofantrine, panobinostat [2] ---> SmPC of [2] of EMA

Based on preclinical and clinical data, panobinostat has the potential to prolong the QT interval. Concomitant use of panobinostat and other substances that are known to prolong the QT interval is not recommended.

Itraconazol, panobinostat [2] ---> SmPC of [2] of EMA

In patients who take concomitant medicinal products which are strong CYP3A and/or Pgp inhibitors, the dose of panobinostat should be reduced

Ketoconazole, panobinostat [2] ---> SmPC of [2] of EMA

In patients who take concomitant medicinal products which are strong CYP3A and/or Pgp inhibitors, the dose of panobinostat should be reduced

Men, panobinostat [2] ---> SmPC of [2] of EMA

Sexually active men taking Farydak and their female partners should use a highly effective method of contraception during the man's treatment and for six months after his last dose of Farydak.

Methadone, panobinostat [2] ---> SmPC of [2] of EMA

Based on preclinical and clinical data, panobinostat has the potential to prolong the QT interval. Concomitant use of panobinostat and other substances that are known to prolong the QT interval is not recommended.

Metoprolol, panobinostat [2] ---> SmPC of [2] of EMA

Panobinostat increased the Cmax and the AUC of dextromethorphan (a substrate of CYP2D6) by 1.8- and 1.6-fold, respectively, and it cannot be excluded that the effect may be larger on a more sensitive CYP2D6 substrate.

Moxifloxacin, panobinostat [2] ---> SmPC of [2] of EMA

Based on preclinical and clinical data, panobinostat has the potential to prolong the QT interval. Concomitant use of panobinostat and other substances that are known to prolong the QT interval is not recommended.

Nebivolol, panobinostat [2] ---> SmPC of [2] of EMA

Panobinostat increased the Cmax and the AUC of dextromethorphan (a substrate of CYP2D6) by 1.8- and 1.6-fold, respectively, and it cannot be excluded that the effect may be larger on a more sensitive CYP2D6 substrate.

Nefazodone, panobinostat [2] ---> SmPC of [2] of EMA

In patients who take concomitant medicinal products which are strong CYP3A and/or Pgp inhibitors, the dose of panobinostat should be reduced

Ondansetron, panobinostat [2] ---> SmPC of [2] of EMA

Based on preclinical and clinical data, panobinostat has the potential to prolong the QT interval. Concomitant use of panobinostat and other substances that are known to prolong the QT interval is not recommended.

Oral contraceptives, panobinostat [2] ---> SmPC of [2] of EMA

Women using hormonal contraceptives should additionally use a barrier method of contraception.

Panobinostat [1], perphenazine ---> SmPC of [1] of EMA

Panobinostat increased the Cmax and the AUC of dextromethorphan (a substrate of CYP2D6) by 1.8- and 1.6-fold, respectively, and it cannot be excluded that the effect may be larger on a more sensitive CYP2D6 substrate.

Panobinostat [1], phenobarbital ---> SmPC of [1] of EMA

Strong inducers may reduce the efficacy of panobinostat, therefore the concomitant use of strong CYP3A4 inducers should be avoided.

Panobinostat [1], phenytoin ---> SmPC of [1] of EMA

Strong inducers may reduce the efficacy of panobinostat, therefore the concomitant use of strong CYP3A4 inducers should be avoided.

Panobinostat [1], pimozide ---> SmPC of [1] of EMA

Avoid panobinostat use in patients who are taking CYP2D6 substrates with a narrow therapeutic index

Panobinostat [1], pomegranate ---> SmPC of [1] of EMA

Patients should be instructed to avoid star fruit, grapefruit, grapefruit juice, pomegranates and pomegranate juice, as these are known to inhibit cytochrome P450 3A enzymes and may increase the bioavailability of panobinostat.

Panobinostat [1], posaconazole ---> SmPC of [1] of EMA

In patients who take concomitant medicinal products which are strong CYP3A and/or Pgp inhibitors, the dose of panobinostat should be reduced

Panobinostat [1], pregnancy ---> SmPC of [1] of EMA

Given panobinostat's cytostatic/cytotoxic mode of action, the potential risk to the foetus is high. Farydak should only be used during pregnancy if the expected benefits outweigh the potential risks to the foetus.

Panobinostat [1], procainamide ---> SmPC of [1] of EMA

Based on preclinical and clinical data, panobinostat has the potential to prolong the QT interval. Concomitant use of panobinostat and other substances that are known to prolong the QT interval is not recommended.

Panobinostat [1], QT interval prolonging drugs ---> SmPC of [1] of EMA

Based on preclinical and clinical data, panobinostat has the potential to prolong the QT interval. Concomitant use of panobinostat and other substances that are known to prolong the QT interval is not recommended.

Panobinostat [1], quinidine ---> SmPC of [1] of EMA

Based on preclinical and clinical data, panobinostat has the potential to prolong the QT interval. Concomitant use of panobinostat and other substances that are known to prolong the QT interval is not recommended.

Panobinostat [1], rifabutin ---> SmPC of [1] of EMA

Strong inducers may reduce the efficacy of panobinostat, therefore the concomitant use of strong CYP3A4 inducers should be avoided.

Panobinostat [1], rifampicin ---> SmPC of [1] of EMA

Strong inducers may reduce the efficacy of panobinostat, therefore the concomitant use of strong CYP3A4 inducers should be avoided.

Panobinostat [1], ritonavir ---> SmPC of [1] of EMA

In patients who take concomitant medicinal products which are strong CYP3A and/or Pgp inhibitors, the dose of panobinostat should be reduced

Panobinostat [1], saquinavir ---> SmPC of [1] of EMA

In patients who take concomitant medicinal products which are strong CYP3A and/or Pgp inhibitors, the dose of panobinostat should be reduced

Panobinostat [1], sotalol ---> SmPC of [1] of EMA

Based on preclinical and clinical data, panobinostat has the potential to prolong the QT interval. Concomitant use of panobinostat and other substances that are known to prolong the QT interval is not recommended.

Panobinostat [1], St. John's wort ---> SmPC of [1] of EMA

Strong inducers may reduce the efficacy of panobinostat, therefore the concomitant use of strong CYP3A4 inducers should be avoided.

Panobinostat [1], star fruit ---> SmPC of [1] of EMA

Patients should be instructed to avoid star fruit, grapefruit, grapefruit juice, pomegranates and pomegranate juice, as these are known to inhibit cytochrome P450 3A enzymes and may increase the bioavailability of panobinostat.

Panobinostat [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA

Strong inducers may reduce the efficacy of panobinostat, therefore the concomitant use of strong CYP3A4 inducers should be avoided.

Panobinostat [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA

In patients who take concomitant medicinal products which are strong CYP3A and/or Pgp inhibitors, the dose of panobinostat should be reduced

Panobinostat [1], strong P-gp inhibitors ---> SmPC of [1] of EMA

In patients who take concomitant medicinal products which are strong CYP3A and/or Pgp inhibitors, the dose of panobinostat should be reduced

Panobinostat [1], telithromycin ---> SmPC of [1] of EMA

In patients who take concomitant medicinal products which are strong CYP3A and/or Pgp inhibitors, the dose of panobinostat should be reduced

Panobinostat [1], tropisetron ---> SmPC of [1] of EMA

Based on preclinical and clinical data, panobinostat has the potential to prolong the QT interval. Concomitant use of panobinostat and other substances that are known to prolong the QT interval is not recommended.

Panobinostat [1], voriconazole ---> SmPC of [1] of EMA

In patients who take concomitant medicinal products which are strong CYP3A and/or Pgp inhibitors, the dose of panobinostat should be reduced

Panobinostat [1], women of childbearing potential ---> SmPC of [1] of EMA

Women of child-bearing potential should have a pregnancy test prior to the initiation of treatment with Farydak and must use a highly effective method of contraception during treatment and for three months after the last dose of Farydak.

             CONTRAINDICATIONS of Panobinostat (Farydak)        

             - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

             - Breast-feeding

             https://www.ema.europa.eu/en/documents/product-information/farydak-epar-product-information_en.pdf 01/10/2025 

 Pantoprazole (Pantozol Control)

Ability to drive, pantoprazole [2] ---> SmPC of [2] of EMA

Adverse reactions such as dizziness and visual disturbances may occur (see section 4.8). If affected, patients should not drive or use machines.

Alpelisib [1], pantoprazole ---> SmPC of [1] of EMA

Caution and monitoring for toxicity are advised during concomitant treatment with inhibitors of BCRP (e.g. eltrombopag, lapatinib, pantoprazole).

Antacids, pantoprazole [2] ---> SmPC of [2] of EMA

There were no interactions with concomitantly administered antacids.

Atazanavir, pantoprazole [2] ---> SmPC of [2] of EMA

Co-administration of pantoprazole is contraindicated with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH such as atazanavir, nelfinavir; due to significant reduction in their bioavailability (see section 4.3).

Breast-feeding, pantoprazole [2] ---> SmPC of [2] of EMA

PANTOZOL Control should not be used during breast-feeding

Caffeine, pantoprazole [2] ---> SmPC of [2] of EMA

No clinically significant interactions were observed

Carbamazepine, pantoprazole [2] ---> SmPC of [2] of EMA

No clinically significant interactions were observed

Cefditoren, pantoprazole

Pantoprazole may decrease the serum concentration of cefditoren

Cinacalcet [1], pantoprazole ---> SmPC of [1] of EMA

Co-administration of pantoprazole (80 mg od) did not alter the pharmacokinetics of cinacalcet.

Clopidogrel [1], pantoprazole ---> SmPC of [1] of EMA

These results indicate that clopidogrel can be administered with pantoprazole.

Clopidogrel/acetylsalicylic acid [1], pantoprazole ---> SmPC of [1] of EMA

The plasma concentrations of the active metabolite was 20% reduced (loading dose) and 14% reduced (maintenance dose) during concomitant treatment with pantoprazole 80 mg once daily. Clopidogrel can be administered with pantoprazole.

Coumarin anticoagulants, pantoprazole [2] ---> SmPC of [2] of EMA

In patients treated with coumarin anticoagulants monitoring of prothrombin time/INR is recommended after initiation, termination or during irregular use of pantoprazole.

Cytochrome P450, pantoprazole [2] ---> SmPC of [2] of EMA

However, an interaction of pantoprazole with other substances which are metabolised by the same enzyme system cannot be excluded.

Dabigatran etexilate [1], pantoprazole ---> SmPC of [1] of EMA

Pantoprazole and other proton-pump inhibitors (PPI) were co-administered with Pradaxa in clinical trials, and concomitant PPI treatment did not appear to reduce the efficacy of Pradaxa.

Dabigatran [1], pantoprazole ---> SmPC of [1] of EMA

Pantoprazole and other proton-pump inhibitors (PPI)were co-administered with dabigatran in clinical trials, and concomitant PPI treatment did not appear to reduce the efficacy of dabigatran.

Darunavir/cobicistat [1], pantoprazole ---> SmPC of [1] of EMA

Based on theoretical considerations, no mechanistic interaction is expected. REZOLSTA can be co-administered with proton pump inhibitors without dose adjustments.

Darunavir/cobicistat/emtricitabine/tenofovir alafenamide [1], pantoprazole ---> SmPC of [1] of EMA

Based on theoretical considerations, no mechanistic interaction is expected. Symtuza can be co-administered with proton pump inhibitors without dose adjustments.

Digoxin, pantoprazole [2] ---> SmPC of [2] of EMA

No clinically significant interactions were observed

Dolutegravir/rilpivirine [1], pantoprazole ---> SmPC of [1] of EMA

Co-administration may significantly decrease rilpivirine plasma concentration. This may result in loss of therapeutic effect of Juluca. Co-administration of Juluca with proton pump inhibitors is contraindicated

Doravirine [1], pantoprazole ---> SmPC of [1] of EMA

No dose adjustment is required.

Doravirine/lamivudine/tenofovir disoproxil [1], pantoprazole ---> SmPC of [1] of EMA

No dose adjustment is required.

Dronedarone [1], pantoprazole ---> SmPC of [1] of EMA

Pantoprazole (40 mg once daily), a medicinal product which increases gastric pH without any effect on cytochrome P450, did not interact significantly on dronedarone pharmacokinetics.

Drugs with pH dependent absorption, pantoprazole [2] ---> SmPC of [2] of EMA

Pantoprazole may reduce the absorption of active substances whose bioavailability is dependent on the gastric pH

Elbasvir/grazoprevir [1], pantoprazole ---> SmPC of [1] of EMA

No dose adjustment is required.

Emtricitabine/rilpivirine/tenofovir alafenamide [1], pantoprazole ---> SmPC of [1] of EMA

Significant decreases in rilpivirine plasma concentrations are expected (reduced absorption, increase in gastric pH). Co-administration is contraindicated.

Emtricitabine/rilpivirine/tenofovir disoproxil [1], pantoprazole ---> SmPC of [1] of EMA

Co-administration of proton pump inhibitors has been observed to decrease the plasma concentrations of rilpivirine (due to an increase in gastric pH) which could potentially lead to loss of therapeutic effect. Concomitant use contraindicated

Ethinyl estradiol, pantoprazole [2] ---> SmPC of [2] of EMA

No clinically significant interactions were observed

Fertility, pantoprazole [2] ---> SmPC of [2] of EMA

There was no evidence of impaired fertility following the administration of pantoprazole in animal studies (see section 5.3).

Glibenclamide, pantoprazole [2] ---> SmPC of [2] of EMA

No clinically significant interactions were observed

Ketoconazole, pantoprazole [2] ---> SmPC of [2] of EMA

Pantoprazole may reduce the absorption of active substances whose bioavailability is dependent on the gastric pH (e.g. ketoconazole).

Ledipasvir/sofosbuvir [1], pantoprazole ---> SmPC of [1] of EMA

Proton pump inhibitor doses comparable to omeprazole 20 mg can be administered simultaneously with ledipasvir/sofosbuvir. Proton pump inhibitors should not be taken before ledipasvir/sofosbuvir.

Letermovir [1], pantoprazole ---> SmPC of [1] of EMA

Letermovir has the potential to decrease the exposure of CYP2C9 and/or CYP2C19 substrates potentially resulting in subtherapeutic levels.

Levonorgestrel, pantoprazole [2] ---> SmPC of [2] of EMA

No clinically significant interactions were observed

Maribavir [1], pantoprazole ---> SmPC of [1] of EMA

No dose adjustment is required.

Methotrexate, pantoprazole [2] ---> SmPC of [2] of EMA

Concomitant use of high-dose methotrexate (e.g., 300 mg) and proton pump inhibitors has been reported to increase methotrexate levels in some patients.

Metoprolol, pantoprazole [2] ---> SmPC of [2] of EMA

No clinically significant interactions were observed

Mycophenolate mofetil [1], pantoprazole ---> SmPC of [1] of EMA

Decreased mycophenolic acid (MPA) exposure has been observed when antacids, such as magnesium and aluminium hydroxides, and PPIs, including lansoprazole and pantoprazole, were administered with mycophenolate mofetil.

Mycophenolate [1], pantoprazole ---> SmPC of [1] of EMA

Decreased mycophenolic acid (MPA) exposure has been observed when antacids, such as magnesium and aluminium hydroxides, and PPIs, including lansoprazole and pantoprazole, were administered with mycophenolate mofetil.

Naproxen, pantoprazole [2] ---> SmPC of [2] of EMA

No clinically significant interactions were observed

Nelfinavir, pantoprazole [2] ---> SmPC of [2] of EMA

Co-administration of pantoprazole is contraindicated with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH such as atazanavir, nelfinavir; due to significant reduction in their bioavailability (see section 4.3).

Nifedipine, pantoprazole [2] ---> SmPC of [2] of EMA

No clinically significant interactions were observed

Pantoprazole [1], phenprocoumon ---> SmPC of [1] of EMA

In patients treated with coumarin anticoagulants monitoring of prothrombin time/INR is recommended after initiation, termination or during irregular use of pantoprazole.

Pantoprazole [1], phenytoin ---> SmPC of [1] of EMA

No clinically significant interactions were observed

Pantoprazole [1], piroxicam ---> SmPC of [1] of EMA

No clinically significant interactions were observed

Pantoprazole [1], pregnancy ---> SmPC of [1] of EMA

Pantoprazole should not be used during pregnancy.

Pantoprazole [1], protease inhibitors ---> SmPC of [1] of EMA

Co-administration of pantoprazole is contraindicated with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH such as atazanavir, nelfinavir; due to significant reduction in their bioavailability (see section 4.3).

Pantoprazole [1], tetrahydrocannabinol ---> SmPC of [1] of EMA

There have been reports of false-positive results in some urine screening tests for tetrahydrocannabinol (THC) in patients receiving pantoprazole. An alternative confirmatory method should be considered to verify positive results.

Pantoprazole [1], theophylline ---> SmPC of [1] of EMA

No clinically significant interactions were observed

Pantoprazole [1], warfarin ---> SmPC of [1] of EMA

In patients treated with coumarin anticoagulants monitoring of prothrombin time/INR is recommended after initiation, termination or during irregular use of pantoprazole.

Pantoprazole, rilpivirine [2] ---> SmPC of [2] of EMA

The increase of the gastric pH decreases the absorption, plasma level and therapeutic effect of rilpivirine. Rilpivirine must not be used with proton pump inhibitors

Pantoprazole, ripretinib [2] ---> SmPC of [2] of EMA

No clinically significant differences in the plasma exposure to ripretinib and DP-5439 were observed when QINLOCK was co-administered with pantoprazole (a proton pump inhibitor).

Pantoprazole, simeprevir [2] ---> SmPC of [2] of EMA

No clinically relevant drug-drug interaction is expected. No dose adjustment is required

Pantoprazole, sofosbuvir/velpatasvir [2] ---> SmPC of [2] of EMA

If it is considered necessary to co-administer, then Epclusa should be administered with food and taken 4 hours before proton pump inhibitor at max doses comparable to omeprazole 20 mg.

Pantoprazole, sofosbuvir/velpatasvir/voxilaprevir [2] ---> SmPC of [2] of EMA

Increase in gastric pH decreases velpatasvir solubility. Proton pump inhibitors may be administered with Vosevi at a dose that does not exceed doses comparable with omeprazole 20 mg.

Pantoprazole, tipranavir/ritonavir ---> SmPC of [tipranavir] of EMA

The plasma concentrations of pantoprazole are difficult to predict due to inhibition of CYP3A4 and induction of CYP2C19. The combined use of tipranavir/ritonavir with proton pump inhibitors is not recommended

Pantoprazole, vorapaxar [2] ---> SmPC of [2] of EMA

No clinically relevant differences in vorapaxar pharmacokinetics were observed following daily co-administration of an aluminium hydroxide/magnesium carbonate antacid or pantoprazole (a proton pump inhibitor)

             CONTRAINDICATIONS of Pantoprazole (Pantozol Control)      

             - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

             - Co-administration of pantoprazole is not recommended with HIV protease inhibitors for which absorption is dependent on acidic intragastric pH such as atazanavir, nelfinavir; due to significant reduction in their bioavailability (see section 4.5).

             https://www.ema.europa.eu/en/documents/product-information/pantozol-control-epar-product-information_en.pdf  25/05/2023

Other trade names: Alapanzol, Anagastra, Citrel, Controloc Control, Nolpaza, Normogastrol, Panproton, Pantecta Control, Pantoloc Control, Pantozol Control, Somac Control, Ulcotenal,

Human papillomavirus vaccine (Gardasil)

Breast-feeding, human papillomavirus vaccine [2] ---> SmPC of [2] of EMA

Therefore, Gardasil can be used during breast-feeding.

Fertility, human papillomavirus vaccine [2] ---> SmPC of [2] of EMA

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). No effects on male fertility were observed in rats (see section 5.3).

Hormonal contraceptives, human papillomavirus vaccine [2] ---> SmPC of [2] of EMA

Use of hormonal contraceptives did not appear to affect the immune response to Gardasil.

Human papillomavirus vaccine [1], pregnancy ---> SmPC of [1] of EMA

Vaccination should be postponed until completion of pregnancy

             CONTRAINDICATIONS of Human papillomavirus vaccine (Gardasil)     

             - Hypersensitivity to the active substances or to any of the excipients.

             - Individuals who develop symptoms indicative of hypersensitivity after receiving a dose of Gardasil should not receive further doses of Gardasil.

             Administration of Gardasil should be postponed in individuals suffering from an acute severe febrile illness. However, the presence of a minor infection, such as a mild upper respiratory tract infection or low-grade fever, is not a contraindication for immunisation.

             https://www.ema.europa.eu/en/documents/product-information/gardasil-epar-product-information_en.pdf 20/10/2025 

Other trade names: Cervarix, Silgard,

Para-aminosalicylic acid (Granupas)

Ability to drive, para-aminosalicylic acid [2] ---> SmPC of [2] of EMA

Para-aminosalicylic acid has negligible influence on the ability to drive and use machines.

Acenocoumarol [1], para-aminosalicylic acid ---> SmPC of [1] of eMC

Drugs altering haemostasis may potentiate the anticoagulant activity and increase the risk of haemorrhage. The use concomitant is not recommended

BCG intravesical [1], para-aminosalicylic acid ---> SmPC of [1] of eMC

The treatment with anti-tuberculosis drugs is contraindicated

Breast-feeding, para-aminosalicylic acid [2] ---> SmPC of [2] of EMA

Para-aminosalicylic acid is excreted in human milk. There is insufficient information on the effects of para-aminosalicylic acid in newborns/infants.. GRANUPAS should not be used during breast-feeding.

Cotrimoxazole, para-aminosalicylic acid

The administration of para-aminosalicylic acid increases toxicity of cotrimoxazole

Cyanocobalamin [1], para-aminosalicylic acid ---> SmPC of [1] of eMC

Reduced absorption of vitamin B12

Digoxin, para-aminosalicylic acid [2] ---> SmPC of [2] of EMA

Para-aminosalicylic acid may decrease the gastrointestinal absorption of digoxin, by inhibiting the absorption function of intestinal cells. Serum digoxin levels should be monitored in patients on concomitant therapy.

Diphenhydramine, para-aminosalicylic acid [2] ---> SmPC of [2] of EMA

This medicinal product decreases the gastrointestinal absorption of para-aminosalicylic acid, and should not be administered concomitantly.

Ethionamide, para-aminosalicylic acid [2] ---> SmPC of [2] of EMA

Co-administration of para-aminosalicylic acid and ethionamide may intensify adverse reactions of para-aminosalicylic acid, mainly the gastrointestinal effects, including jaundice, hepatitis, nausea, vomiting, diarrhoea, abdominal pain or anorexia.

Fertility, para-aminosalicylic acid [2] ---> SmPC of [2] of EMA

There is no evidence available on the effect of para-aminosalicylic acid on fertility.

Glibenclamide, para-aminosalicylic acid

The co-administration may enhance the hypoglycemic effect

Glimepiride [1], para-aminosalicylic acid ---> SmPC of [1] of eMC

Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia

Gliquidone, para-aminosalicylic acid

Hypoglycemic reactions may occur as expression of enhancement effect of gliquidone with gliquidone is co-administered with para-aminosalicylic acid

Isoniazid, para-aminosalicylic acid

Increased half-time of isoniazid

Lidocaine/prilocaine [1], para-aminosalicylic acid ---> SmPC of [1] of EMA

Methaemoglobinaemia may be accentuated in patients already taking medicinal products known to induce the condition

Local anaesthetics, para-aminosalicylic acid ---> SmPC of [liposomal bupivacaine] of EMA

Patients that are administered local anaesthetics may be at increased risk of developing methaemoglobinamia when concurrently exposed to these oxidizing medicinal products

Malabsorption syndrome, para-aminosalicylic acid [2] ---> SmPC of [2] of EMA

A malabsorption syndrome can develop in patients on para-aminosalicylic acid, but is usually not complete.

Metildigoxin, para-aminosalicylic acid

Decreased plasma levels of metildigoxin

Para-aminosalicylic acid [1], pregnancy ---> SmPC of [1] of EMA

Studies in animals have shown some reproductive toxicity (see section 5.3). GRANUPAS is not recommended during pregnancy and in women of childbearing potential not using contraception.

Para-aminosalicylic acid [1], tenofovir ---> SmPC of [1] of EMA

The exposure of tenofovir decreased approximately 3-fold when co-administered with multiple doses of 4000 mg PAS-Ca compared with administration of tenofovir alone.

Para-aminosalicylic acid [1], trimethoprim ---> SmPC of [1] of eMC

Trimethoprim may induce folate deficiency in patients predisposed to folate deficiency such as those receiving concomitant folate antagonists or anticonvulsants.

Para-aminosalicylic acid [1], vitamin B12 ---> SmPC of [1] of EMA

Vitamin B12 absorption may be reduced by para-aminosalicylic acid with clinically significant erythrocyte abnormalities developing after depletion; patients on therapy of more than one month should be considered for maintenance of vitamin B12.

Para-aminosalicylic acid, phenytoin

The phenytoin plasma concentrations can increase

Para-aminosalicylic acid, pioglitazone/glimepiride [2] ---> SmPC of [2] of EMA

Potentiation of the blood-glucose-lowering effect and, thus, in some instances hypoglycaemia may occur

Para-aminosalicylic acid, probenecide

The co-administration may delay the elimination of para-aminosalicylic acid and increase its plasma levels, effects and adverse reactions

Para-aminosalicylic acid, rifabutin [2] ---> SmPC of [2] of eMC

As p-aminosalicylic acid has been shown to impede GI absorption of rifamycins it is recommended that when it and rifabutin are both to be administered they be given with an interval of 8-12 hours.

Para-aminosalicylic acid, rifamicyn ---> SmPC of [rifabutin] of eMC

As p-aminosalicylic acid has been shown to impede GI absorption of rifamycins it is recommended that when it and rifabutin are both to be administered they be given with an interval of 8-12 hours.

Para-aminosalicylic acid, rifampicin [2] ---> SmPC of [2] of eMC

If p-aminosalicylic acid and rifampicin are both included in the treatment regimen, they should be given not less than eight hours apart to ensure satisfactory blood levels.

Para-aminosalicylic acid, trimethoprim/sulfamethoxazol

The administration of para-aminosalicylic acid increases toxicity of cotrimoxazole

Para-aminosalicylic acid, tuberculosis vaccine

BCG bacteria are susceptible to tuberculostatic agents

             CONTRAINDICATIONS of Para-aminosalicylic acid (Granupas)  

             - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

             - Severe renal disease. Patients with severe renal impairment should not receive para-aminosalicylic acid. Patients with severe renal disease will accumulate the inactive acetyl metabolite of para-aminosalicylic acid.

             https://www.ema.europa.eu/en/documents/product-information/granupas-epar-product-information_en.pdf 16/08/2024 

Other trade names: Granupas (previously Para-aminosalicylic acid Lucane),

Paracetamol

5-HT3 receptor antagonists, paracetamol ---> SmPC of [granisetron] of EMA

Co-administration of intravenous 5-HT3 receptor antagonists with oral paracetamol in human subjects has been reported to result in a block in the analgesic effect via a pharmacodynamic mechanism.

Acenocoumarol [1], paracetamol ---> SmPC of [1] of eMC

The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk

Alcohol, paracetamol

The enzymatic inductor may decrease the plasma levels of paracetamol and increase its hepatotoxicity. Caution is recommended

Barbiturates, paracetamol

The enzymatic inductor may decrease the plasma levels of paracetamol and increase its hepatotoxicity. Caution is recommended

Bile-acid sequestrants, paracetamol

Decreased speed of absorption of paracetamol

Breast-feeding, paracetamol [2] ---> SmPC of [2] of eMC

Paracetamol is excreted in breast milk but not in a clinically significant amount. Available published data do not contraindicate breast feeding.

Busulfan [1], paracetamol ---> SmPC of [1] of EMA

Paracetamol decreases glutathione levels in blood and tissues, and may decrease busulfan clearance when used in combination

Carbamazepine [1], paracetamol ---> SmPC of [1] of eMC

Carbamazepine may lower the plasma level of paracetamol

Chloramphenicol, paracetamol [2] ---> SmPC of [2] of eMC

Increased plasma concentration of chloramphenicol.

Cholestyramine [1], paracetamol ---> SmPC of [1] of eMC

The speed of absorption of paracetamol is reduced by cholestyramine. Therefore, the cholestyramine should not be taken within 1 hour if maximal analgesia is required.

Contraceptives, paracetamol

Oral contraceptive may increase the paracetamol clearance.

Coumarin anticoagulants, paracetamol [2] ---> SmPC of [2] of eMC

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

CYP2E1 inductors, paracetamol

The CYP2E1 induction may decrease plasma concentrations of paracetamol

Cyproterone/ethinylestradiol, paracetamol

Active principles which inhibit ethinylestradiol sulphonation in the intestinal wall, e. g. paracetamol, may increase plasma concentrations of ethinylestradiol

Dabrafenib [1], paracetamol ---> SmPC of [1] of EMA

The risk for liver injury after paracetamol administration is suspected to be higher in patients concomitantly treated with enzyme inducers

Dasabuvir with ombitasvir/paritaprevir/ritonavir, paracetamol ---> SmPC of [dasabuvir] of EMA

No dose adjustment needed for paracetamol when administered with Exviera + ombitasvir/paritaprevir/ritonavir.

Dihydrocodeine, paracetamol

Possible mutual potentiation of the analgetic effect

Dolutegravir/rilpivirine [1], paracetamol ---> SmPC of [1] of EMA

No dose adjustment is required.

Domperidone, paracetamol [2] ---> SmPC of [2] of eMC

The absorption of paracetamol is increased by domperidone.

Dulaglutide [1], paracetamol ---> SmPC of [1] of EMA

No dose adjustment of paracetamol is necessary when administered with dulaglutide.

Emtricitabine/rilpivirine/tenofovir alafenamide [1], paracetamol ---> SmPC of [1] of EMA

No dose adjustment is required.

Emtricitabine/rilpivirine/tenofovir disoproxil [1], paracetamol ---> SmPC of [1] of EMA

No dose adjustment is required.

Ethinyl estradiol, paracetamol ---> SmPC of [ethinylestradiol/chlormadinone] of EMA

Paracetamol inhibits ethinylestradiol sulphonation in the intestinal wall and may increase plasma concentrations of ethinylestradiol. Ethinylestradiol, hepatic glucuronidation inductor, may decrease plasma concentrations of paracetamol

Ethinylestradiol/chlormadinone, paracetamol

Paracetamol inhibits ethinylestradiol sulphonation in the intestinal wall and may increase plasma concentrations of ethinylestradiol. Ethinylestradiol, hepatic glucuronidation inductor, may decrease plasma concentrations of paracetamol

Ethinylestradiol/gestodene, paracetamol

Active principles which inhibit ethinylestradiol sulphonation in the intestinal wall, e. g. paracetamol, may increase plasma concentrations of ethinylestradiol

Ethinylestradiol/norgestimate [1], paracetamol ---> SmPC of [1] of eMC

Increase in plasma hormone levels associated with co-administered drug. Decreased paracetamol plasma concentration (due to glucuronidation induction)

Exenatide [1], paracetamol ---> SmPC of [1] of EMA

When 1,000 mg paracetamol tablets were administered, either with or without a meal, following 14 weeks of prolonged-release exenatide therapy, no significant changes in paracetamol AUC were observed compared to the control period.

Flupirtine, paracetamol

The co-administration should be avoided

Hepatotoxic drugs, paracetamol [2] ---> SmPC of [2] of eMC

Too much paracetamol can cause delayed, serious liver damage.

Imatinib [1], paracetamol ---> SmPC of [1] of EMA

Caution should therefore be exercised when using high doses of imatinib and paracetamol concomitantly.

Insulin degludec/liraglutide [1], paracetamol ---> SmPC of [1] of EMA

Paracetamol Cmax was decreased by 31% and median tmax was delayed up to 15 min. No dose adjustment for concomitant use of paracetamol is required.

Isoniazid, paracetamol

The enzymatic inductor may decrease the plasma levels of paracetamol and increase its hepatotoxicity. Caution is recommended

Lamotrigine, paracetamol

Paracetamol may decrease the bioavailability and effect of lamotrigine

Liraglutide [1], paracetamol ---> SmPC of [1] of EMA

Paracetamol Cmax was decreased by 31% and median tmax was delayed up to 15 min. No dose adjustment for concomitant use of paracetamol is required.

Lixisenatide [1], paracetamol ---> SmPC of [1] of EMA

No dose adjustment for paracetamol is required but the delayed tmax observed when paracetamol is administered 1-4 hours after lixisenatide should be taken into account when a rapid onset of action is required for efficacy.

Lomitapide [1], paracetamol ---> SmPC of [1] of EMA

Caution should be exercised when lomitapide is used with other medicinal products known to have potential for hepatotoxicity

Loop diuretics, paracetamol

The effects of diuretic agents may be decreased due to paracetamol may decrease the renal excretion of prostaglandins and the activity of the plasmatic renin

Methoxsalen, paracetamol

Increased plasma levels of paracetamol

Methylphenobarbital, paracetamol

The enzymatic inductor may decrease the plasma levels of paracetamol and increase its hepatotoxicity. Caution is recommended

Metoclopramide, paracetamol [2] ---> SmPC of [2] of eMC

The absorption of paracetamol is increased by metoclopramide

Nabumetone [1], paracetamol ---> SmPC of [1] of eMC

Paracetamol doesn't affect nabumetone metabolism and bioavailability

Norgestimate, paracetamol

The co-administration may increase the plasma levels of norgestimate

Ombitasvir/paritaprevir/ritonavir [1], paracetamol ---> SmPC of [1] of EMA

Paracetamol (as given in a fixed-dose hydrocodone/paracetamol). No dose adjustment needed for paracetamol when administered with Viekirax with or without dasabuvir.

Oral anticoagulants, paracetamol

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

Paracetamol [1], pregnancy ---> SmPC of [1] of eMC

Epidemiological studies in human pregnancy have shown no ill effects due to paracetamol used in the recommended dosage, but patients should follow the advice of the doctor regarding its use.

Paracetamol [1], warfarin ---> SmPC of [1] of eMC

The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.

Paracetamol, phenobarbital

The enzymatic inductor may decrease the plasma levels of paracetamol and increase its hepatotoxicity. Caution is recommended

Paracetamol, phenytoin

The enzymatic inductor may decrease the plasma levels of paracetamol and increase its hepatotoxicity. Caution is recommended

Paracetamol, piperaquine/artenimol [2] ---> SmPC of [2] of EMA

Piperaquine, CYP2E1 inductor, may decrease the plasma concentrations of the medicinal products metabolized by CYP2E1

Paracetamol, pitolisant [2] ---> SmPC of [2] of EMA

With other CYP3A4, CYP2B6 (e.g. efavirenz, bupropion), CYP2C (e.g. repaglinide, phenytoin, warfarin), P-gp (e.g. dabigatran, digoxin) and UGT (e.g. morphine, paracetamol, irinotecan) substrates, caution should be made

Paracetamol, primidone

The enzymatic inductor may decrease the plasma levels of paracetamol and increase its hepatotoxicity. Caution is recommended

Paracetamol, probenecide

The co-administration may delay the elimination of paracetamol and increase its plasma levels, effects and adverse reactions

Paracetamol, prokinetics

The propulsive may increase the absorption rate of paracetamol

Paracetamol, propantheline [2] ---> SmPC of [2] of eMC

The absorption of paracetamol has been reported to be reduced and retarded.

Paracetamol, propranolol

Propranolol inhibits the metabolizing enzymes of paracetamol and may potentiate its effect

Paracetamol, rifampicin

The enzymatic inductor may decrease the plasma levels of paracetamol and increase its hepatotoxicity. Caution is recommended

Paracetamol, rilpivirine [2] ---> SmPC of [2] of EMA

No dose adjustment is required.

Paracetamol, salicylamide

Salicylamide may prolong the elimination half-time of paracetamol

Paracetamol, serotonin antagonists

Block in the analgesic effect

Paracetamol, St. John's wort

The enzymatic inductor may decrease the plasma levels of paracetamol and increase its hepatotoxicity. St. John's Wort should be avoided

Paracetamol, tapentadol

The co-administration may increase the systemic exposition of tapentadol

Paracetamol, zidovudine

The co-administration may enhance the tendency to neutropenia

           CONTRAINDICATIONS of Paracetamol

           - Hypersensitivity to paracetamol or any of the constituents.

           http://www.medicines.org.uk/emc/

Light paraffin

Breast-feeding, light paraffin [2] ---> SmPC of [2] of eMC

Patients should be advised to ensure that any residual product is fully washed off the breast prior to breast-feeding.

Coumarin anticoagulants, light paraffin

The co-administration of paraffin oil and oral anticoagulant may decrease the absorption of the oral anticoagulant

Digoxin, light paraffin

Agents causing hypokalaemia or intracellular potassium deficiency may cause increased sensitivity to digoxin

Docusate, light paraffin

The co-administration of sodium docusate may increase the absorption of the light paraffin

Estrogens, light paraffin

The co-administration of paraffin oil and estrogens may decrease the absorption of estrogen

Fat-soluble vitamins, light paraffin

The co-administration may decrease the absortion of the fat-soluble vitamins. It is recommended to separate the times of administration by at least 2 hours

Foods, light paraffin

It should be administered 2 hours before or 2 hours after eating

Indandione, light paraffin

The co-administration of paraffin oil and oral anticoagulant may decrease the absorption of the oral anticoagulant

Light paraffin [1], pregnancy ---> SmPC of [1] of eMC

No effects during pregnancy are anticipated, since systemic exposure to Oilatum Emollient is expected to be low.

Light paraffin, oral contraceptives

The co-administration of paraffin oil and oral contraceptives may decrease the absorption of the oral contraceptive

           CONTRAINDICATIONS of Light paraffin

           None

           http://www.medicines.org.uk/emc/

Parathyroid hormone (Natpar)

Ability to drive, parathyroid hormone [2] ---> SmPC of [2] of EMA

Patients with disturbances in cognition or attention should be advised to refrain from driving or using machines until symptoms have subsided.

Alendronic acid, parathyroid hormone [2] ---> SmPC of [2] of EMA

Co-administration of alendronic acid and Natpar may lead to a reduction in the calcium sparing effect, which can interfere with the normalisation of serum calcium. Concomitant use of Natpar with bisphosphonates is not recommended.

Asfotase alfa [1], parathyroid hormone ---> SmPC of [1] of EMA

It is recommended that serum parathyroid hormone and calcium be monitored in patients treated with asfotase alfa.

Biphosphonates, parathyroid hormone [2] ---> SmPC of [2] of EMA

Co-administration of alendronic acid and Natpar may lead to a reduction in the calcium sparing effect, which can interfere with the normalisation of serum calcium. Concomitant use of Natpar with bisphosphonates is not recommended.

Breast-feeding, parathyroid hormone [2] ---> SmPC of [2] of EMA

A decision must be made whether to discontinue breast-feeding or to discontinue therapy with Natpar, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman

Cytochrome P450, parathyroid hormone [2] ---> SmPC of [2] of EMA

Natpar is a protein that is not metabolised by and does not inhibit hepatic microsomal drug-metabolising enzymes (e.g., cytochrome P450 isoenzymes). Natpar is not protein bound and has a low volume of distribution.

Digital glycosides, parathyroid hormone [2] ---> SmPC of [2] of EMA

The combined use of parathyroid hormone and digital glycosides may predispose to digitalis toxicity if hypercalcemia develops.

Digitoxin, parathyroid hormone [2] ---> SmPC of [2] of EMA

The inotropic effects of cardiac glycosides are affected by serum calcium levels. Combined use of Natpar and cardiac glycosides (e.g., digoxin or digitoxin) may predispose patients to digitalis toxicity if hypercalcaemia develops

Digoxin, parathyroid hormone [2] ---> SmPC of [2] of EMA

The inotropic effects of cardiac glycosides are affected by serum calcium levels. Combined use of Natpar and cardiac glycosides (e.g., digoxin or digitoxin) may predispose patients to digitalis toxicity if hypercalcaemia develops

Fertility, parathyroid hormone [2] ---> SmPC of [2] of EMA

There are no data on the effects of Natpar on human fertility. Animal data do not indicate any impairment of fertility.

Lithium, parathyroid hormone [2] ---> SmPC of [2] of EMA

For any drug that affects serum calcium levels (e.g., lithium, thiazides), patients' serum calcium levels should be monitored.

Parathyroid hormone [1], pregnancy ---> SmPC of [1] of EMA

A decision must be made whether to initiate or discontinue treatment with Natpar during pregnancy taking into account the known risks of therapy versus the benefit for the woman.

Parathyroid hormone [1], thiazides ---> SmPC of [1] of EMA

For any drug that affects serum calcium levels (e.g., lithium, thiazides), patients' serum calcium levels should be monitored.

             CONTRAINDICATIONS of Parathyroid hormone (Natpar)                     

             Natpar is contraindicated in patients:     

             - with hypersensitivity to the active substance or to any of the excipients listed in section 6.1

             - who are receiving or who have previously received radiation therapy to the skeleton           

             - with skeletal malignancies or bone metastases          

             - who are at increased baseline risk for osteosarcoma such as patients with Paget's disease of bone or hereditary disorders         

             - with unexplained elevations of bone-specific alkaline phosphatase     

             - with pseudohypoparathyroidism.     

             https://www.ema.europa.eu/en/documents/product-information/natpar-epar-product-information_en.pdf  15/07/2025    

Parecoxib (Dynastat)

Ability to drive, parecoxib [2] ---> SmPC of [2] of EMA

Patients who experience dizziness, vertigo or somnolence after receiving Dynastat should refrain from driving or operating machines.

ACE inhibitors, parecoxib [2] ---> SmPC of [2] of EMA

Inhibition of prostaglandins by NSAIDs, including COX-2 inhibitors, may diminish the effect of angiotensin converting enzyme (ACE) inhibitors

Acetylsalicylic acid, hypertensive drugs ---> SmPC of [parecoxib] of EMA

As with all NSAIDs, parecoxib can lead to the onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of cardiovascular events.

Acetylsalicylic acid, parecoxib [2] ---> SmPC of [2] of EMA

There is further increase in the risk of gastrointestinal adverse effects (gastrointestinal ulceration or other gastrointestinal complications), when parecoxib is taken concomitantly with acetylsalicylic acid (even at low doses).

AIIRA, coxibs ---> SmPC of [parecoxib] of EMA

In patients with compromised renal function, co-administration of NSAIDs with ACE inhibitors or Angiotensin-II antagonists, may result in further deterioration of renal function, including possible acute renal failure.

AIIRA, parecoxib [2] ---> SmPC of [2] of EMA

Inhibition of prostaglandins by NSAIDs, including COX-2 inhibitors, may diminish the effect of angiotensin II antagonists

Alfentanyl, parecoxib [2] ---> SmPC of [2] of EMA

Administration of IV parecoxib 40 mg had no significant effect on the pharmacokinetics of either IV fentanyl or IV alfentanil (CYP3A4 substrates).

Anticoagulants, parecoxib [2] ---> SmPC of [2] of EMA

The concomitant use of NSAIDs with oral anticoagulants increases the risk of bleeding. Oral anticoagulants include warfarin/coumarin-type and novel oral anticoagulants (e.g. apixaban, dabigatran, and rivaroxaban)

Betablockers, parecoxib [2] ---> SmPC of [2] of EMA

Inhibition of prostaglandins by NSAIDs, including COX-2 inhibitors, may diminish the effect of beta-blockers

Breast-feeding, parecoxib [2] ---> SmPC of [2] of EMA

Dynastat must not be administered to women who breast-feed

Carbamazepine, parecoxib [2] ---> SmPC of [2] of EMA

The metabolism of valdecoxib may increase when co-administered with enzyme inducers

Coumarin anticoagulants, parecoxib [2] ---> SmPC of [2] of EMA

The concomitant use of NSAIDs with oral anticoagulants increases the risk of bleeding. Oral anticoagulants include warfarin/coumarin-type and novel oral anticoagulants (e.g. apixaban, dabigatran, and rivaroxaban)

Coxibs, parecoxib [2] ---> SmPC of [2] of EMA

In patients with compromised renal function, co-administration of NSAIDs with ACE inhibitors or Angiotensin-II antagonists, may result in further deterioration of renal function, including possible acute renal failure.

Cyclosporine, parecoxib [2] ---> SmPC of [2] of EMA

Co-administration of NSAIDs and cyclosporin has been suggested to increase the nephrotoxic effect of cyclosporin. Renal function should be monitored when these medicinal products are co-administered.

Dabigatran, parecoxib [2] ---> SmPC of [2] of EMA

The concomitant use of NSAIDs with oral anticoagulants increases the risk of bleeding. Oral anticoagulants include warfarin/coumarin-type and novel oral anticoagulants (e.g. apixaban, dabigatran, and rivaroxaban)

Dexamethasone, parecoxib [2] ---> SmPC of [2] of EMA

The metabolism of valdecoxib may increase when co-administered with enzyme inducers

Dextromethorphan, parecoxib [2] ---> SmPC of [2] of EMA

Treatment with valdecoxib produced a 3-fold increase in plasma concentrations of dextromethorphan (CYP2D6 substrate)

Diazepam, parecoxib [2] ---> SmPC of [2] of EMA

Therefore, caution should be observed when administering Dynastat with medicinal products known to be substrates of CYP2C19 (e.g. phenytoin, diazepam, or imipramine).

Diuretics, NSAID ---> SmPC of [parecoxib] of EMA

NSAIDs may reduce the effect of diuretics.

Diuretics, parecoxib [2] ---> SmPC of [2] of EMA

Inhibition of prostaglandins by NSAIDs, including COX-2 inhibitors, may diminish the effect of diuretics

Drugs primarily metabolised by CYP2C19, parecoxib [2] ---> SmPC of [2] of EMA

Caution should be observed when administering valdecoxib with medicinal products known to be substrates of CYP2C19

Drugs primarily metabolised by CYP2D6 with narrow therapeutic index, parecoxib [2] ---> SmPC of [2] of EMA

Caution should be observed when co-administering parecoxib (CYP2D6 inhibitor) and drugs that are mainly metabolised by CYP2D6 and which have narrow therapeutic margins

Drugs primarily metabolised by CYP2D6, parecoxib [2] ---> SmPC of [2] of EMA

Caution should be observed when co-administering valdecoxib (CYP2D6 inhibitor) and drugs that are mainly metabolised by CYP2D6

Enzyme inductors, parecoxib [2] ---> SmPC of [2] of EMA

The metabolism of valdecoxib may increase when co-administered with enzyme inducers

Fentanyl, parecoxib [2] ---> SmPC of [2] of EMA

Administration of IV parecoxib 40 mg had no significant effect on the pharmacokinetics of either IV fentanyl or IV alfentanil (CYP3A4 substrates).

Fertility, NSAID ---> SmPC of [parecoxib] of EMA

Based on the mechanism of action, the use of NSAIDs, may delay or prevent rupture of ovarian follicles, which has been associated with reversible infertility in some women.

Fertility, parecoxib [2] ---> SmPC of [2] of EMA

The use of Dynastat, as with any medicinal product known to inhibit cyclooxygenase/prostaglandin synthesis, is not recommended in women attempting to conceive

Flecainide, parecoxib [2] ---> SmPC of [2] of EMA

Caution should be observed when co-administering parecoxib and medicinal products that are predominantly metabolised by CYP2D6 and which have narrow therapeutic margins

Fluconazole, parecoxib [2] ---> SmPC of [2] of EMA

Plasma exposure (AUC and Cmax) to valdecoxib was increased (62% and 19%, respectively) when co-administered with fluconazole (predominantly a CYP2C9 inhibitor)

Glibenclamide, parecoxib [2] ---> SmPC of [2] of EMA

Co-administration of valdecoxib with glibenclamide (CYP3A4 substrate) did not affect either the pharmacokinetics (exposure) or the pharmacodynamics (blood glucose and insulin levels) of glibenclamide.

Heparin, parecoxib [2] ---> SmPC of [2] of EMA

Coadministration of parecoxib and heparin did not affect the pharmacodynamics of heparin (activated partial thromboplastin time) compared to heparin alone.

Hypertensive drugs, NSAID ---> SmPC of [parecoxib] of EMA

As with all NSAIDs, parecoxib can lead to the onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of cardiovascular events.

Hypertensive drugs, parecoxib [2] ---> SmPC of [2] of EMA

As with all NSAIDs, parecoxib can lead to the onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of cardiovascular events.

Imipramine, parecoxib [2] ---> SmPC of [2] of EMA

Therefore, caution should be observed when administering Dynastat with medicinal products known to be substrates of CYP2C19 (e.g. phenytoin, diazepam, or imipramine).

Isoflurane, parecoxib [2] ---> SmPC of [2] of EMA

In surgery studies in which parecoxib was administered pre-operatively, no evidence of pharmacodynamic interaction was observed in patients receiving parecoxib and the inhalation anaesthetic agents nitrous oxide and isoflurane

Ketoconazole, parecoxib [2] ---> SmPC of [2] of EMA

Plasma exposure (AUC and Cmax) to valdecoxib was increased (38% and 24%, respectively) when co-administered with ketoconazole (CYP3A4 inhibitor); however, a dosage adjustment should not generally be necessary

Lithium, parecoxib [2] ---> SmPC of [2] of EMA

Lithium serum concentration should be monitored closely when initiating or changing parecoxib therapy in patients receiving lithium.

Methotrexate, NSAID ---> SmPC of [parecoxib] of EMA

However caution is advised when methotrexate is administered concurrently with NSAIDs, because NSAID administration may result in increased plasma levels of methotrexate.

Methotrexate, parecoxib [2] ---> SmPC of [2] of EMA

Little or no effect on the steady-state plasma concentrations of methotrexate. Adequate monitoring of methotrexate-related toxicity should be considered when coadministering parecoxib and methotrexate.

Metoprolol, parecoxib [2] ---> SmPC of [2] of EMA

Caution should be observed when co-administering parecoxib and medicinal products that are predominantly metabolised by CYP2D6 and which have narrow therapeutic margins

Midazolam, parecoxib [2] ---> SmPC of [2] of EMA

Additionally, coadministration of valdecoxib had no clinically significant effect on the hepatic or intestinal CYP 3A4-mediated metabolism of orally administered midazolam.

Midazolam, parecoxib [2] ---> SmPC of [2] of EMA

Coadministration of did not affect either the pharmacokinetics (metabolism and exposure) or the pharmacodynamics (EEG effects, psychomotor tests and waking from sedation) of IV propofol or IV midazolam.

Nitrous oxide, parecoxib [2] ---> SmPC of [2] of EMA

In surgery studies in which parecoxib was administered pre-operatively, no evidence of pharmacodynamic interaction was observed in patients receiving parecoxib and the inhalation anaesthetic agents nitrous oxide and isoflurane

NSAID, parecoxib [2] ---> SmPC of [2] of EMA

As with all NSAIDs, parecoxib can lead to the onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of cardiovascular events.

Omeprazole, parecoxib [2] ---> SmPC of [2] of EMA

Therefore, caution should be observed when administering Dynastat with medicinal products known to be substrates of CYP2C19 (e.g. phenytoin, diazepam, or imipramine).

Opiate agonists, parecoxib [2] ---> SmPC of [2] of EMA

Parecoxib may be co-administered with opioid analgesics. In clinical trials, the daily requirement for PRN opioids was significantly reduced when coadministered with parecoxib.

Opioid analgesics, parecoxib [2] ---> SmPC of [2] of EMA

Dynastat may be coadministered with opioid analgesics. In clinical trials, the daily requirement for PRN opioids was significantly reduced when coadministered with parecoxib.

Parecoxib [1], phenytoin ---> SmPC of [1] of EMA

The metabolism of valdecoxib may increase when co-administered with enzyme inducers. Caution should be observed when administering parecoxib with medicinal products known to be substrates of CYP2C19

Parecoxib [1], phenytoin ---> SmPC of [1] of EMA

Therefore, caution should be observed when administering Dynastat with medicinal products known to be substrates of CYP2C19 (e.g. phenytoin, diazepam, or imipramine).

Parecoxib [1], platelet aggregation inhibitors ---> SmPC of [1] of EMA

Dynastat had no effect on acetylsalicylic acid-mediated inhibition of platelet aggregation or bleeding times.

Parecoxib [1], pregnancy ---> SmPC of [1] of EMA

Strict indication in the first and second trimester. Dynastat is contraindicated during the third trimester of pregnancy

Parecoxib [1], propafenone ---> SmPC of [1] of EMA

Caution should be observed when co-administering parecoxib and medicinal products that are predominantly metabolised by CYP2D6 and which have narrow therapeutic margins

Parecoxib [1], propofol ---> SmPC of [1] of EMA

Coadministration of did not affect either the pharmacokinetics (metabolism and exposure) or the pharmacodynamics (EEG effects, psychomotor tests and waking from sedation) of IV propofol or IV midazolam.

Parecoxib [1], rifampicin ---> SmPC of [1] of EMA

The metabolism of valdecoxib may increase when co-administered with enzyme inducers

Parecoxib [1], rivaroxaban ---> SmPC of [1] of EMA

The concomitant use of NSAIDs with oral anticoagulants increases the risk of bleeding. Oral anticoagulants include warfarin/coumarin-type and novel oral anticoagulants (e.g. apixaban, dabigatran, and rivaroxaban)

Parecoxib [1], strong CYP2C9 inhibitors ---> SmPC of [1] of EMA

The strong CYP2C9 inhibition may increase the plasma levels of valdecoxib

Parecoxib [1], tacrolimus ---> SmPC of [1] of EMA

Co-administration of NSAIDs and tacrolimus has been suggested to increase the nephrotoxic effect of tacrolimus. Renal function should be monitored when these medicinal products are co-administered.

Parecoxib [1], warfarin ---> SmPC of [1] of EMA

The concomitant use of NSAIDs with oral anticoagulants increases the risk of bleeding. Oral anticoagulants include warfarin/coumarin-type and novel oral anticoagulants (e.g. apixaban, dabigatran, and rivaroxaban)

Parecoxib, strong CYP3A4 inductors

The strong CYP3A4 induction may increase the metabolism and decrease the plasma levels of valdecoxib

Parecoxib, strong CYP3A4 inhibitors

The strong CYP3A4 inhibition may increase the plasma levels of valdecoxib

             CONTRAINDICATIONS of Parecoxib (Dynastat)                         

             - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

             - History of previous serious allergic drug reaction of any type, especially cutaneous reactions such as Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms syndrome (DRESS syndrome), toxic epidermal necrolysis, erythema multiforme or patients with known hypersensitivity to sulfonamides (see sections 4.4 and 4.8).              

             - Active peptic ulceration or gastrointestinal (GI) bleeding.     

             - Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid or nonsteroidal anti-inflammatory drugs (NSAIDs) including COX-2 inhibitors.          

             - The third trimester of pregnancy and breast-feeding (see sections 4.6 and 5.3).       

             - Severe hepatic impairment (serum albumin <25 g/l or Child-Pugh score ?10).             

             - Inflammatory bowel disease.              

             - Congestive heart failure (NYHA II-IV).             

             - Treatment of post-operative pain following coronary artery bypass graft (CABG) surgery (see sections 4.8 and 5.1).    

             - Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.     

             https://www.ema.europa.eu/en/documents/product-information/dynastat-epar-product-information_en.pdf 19/02/2024

Paricalcitol

Aluminium, paricalcitol [2] ---> SmPC of [2] of eMC

Aluminium-containing preparations (e.g., antacids) should not be administered chronically with Vitamin D medicinal products, as increased blood levels of aluminum and aluminum bone toxicity may occur.

Bile-acid sequestrants, paricalcitol

The co-administration may decrease the absorption of paricalcitol

Breast-feeding, paricalcitol [2] ---> SmPC of [2] of eMC

A decision on whether to continue/discontinue breastfeeding or to continue/discontinue therapy with paricalcitol should be made taking into account the benefit of breastfeeding to the child and to the woman.

Calcium, paricalcitol [2] ---> SmPC of [2] of eMC

High doses of calcium-containing preparations or thiazide diuretics may increase the risk of hypercalcaemia.

Cholestyramine, paricalcitol [2] ---> SmPC of [2] of eMC

Cholestyramine may delay/decrease the absorption of the fat-soluble vitamin. The vitamin should be administered 1 hour before or 4-6 hours after colestyramine

Digital glycosides, paricalcitol [2] ---> SmPC of [2] of eMC

Digitalis toxicity is potentiated by hypercalcaemia of any cause, so caution should be applied when digitalis is prescribed concomitantly with paricalcitol

Hypercalcemia, paricalcitol [2] ---> SmPC of [2] of eMC

Digitalis toxicity is potentiated by hypercalcaemia of any cause, so caution should be applied when digitalis is prescribed concomitantly with paricalcitol

Ketoconazole, paricalcitol [2] ---> SmPC of [2] of eMC

Ketoconazole, enzymatic inhibitor, may increase the mean half-life of paricalcitol. Caution is recommended.

Magnesium, paricalcitol [2] ---> SmPC of [2] of eMC

Magnesium-containing preparations (e.g. antacids) should not be taken concomitantly with vitamin D preparations, because hypermagnesemia may occur.

Paricalcitol [1], phosphate binders ---> SmPC of [1] of eMC

Aluminium-containing preparations (e.g., phosphate-binders) should not be administered chronically with Vitamin D medicinal products, as increased blood levels of aluminum and aluminum bone toxicity may occur.

Paricalcitol [1], phosphates ---> SmPC of [1] of eMC

Phosphate or vitamin D-related medicinal products should not be taken concomitantly with paricalcitol, due to an increased risk of hypercalcaemia and Ca x P product elevation.

Paricalcitol [1], pregnancy ---> SmPC of [1] of eMC

The potential risk for humans is unknown. Paricalcitol should not be used in pregnancy unless clearly necessary.

Paricalcitol [1], thiazides ---> SmPC of [1] of eMC

High doses of calcium-containing preparations or thiazide diuretics may increase the risk of hypercalcaemia.

Paricalcitol [1], vitamin D ---> SmPC of [1] of eMC

Phosphate or vitamin D-related medicinal products should not be taken concomitantly with paricalcitol, due to an increased risk of hypercalcaemia and Ca x P product elevation.

Paricalcitol [1], vitamin D and analogues ---> SmPC of [1] of eMC

Phosphate or vitamin D-related medicinal products should not be taken concomitantly with paricalcitol, due to an increased risk of hypercalcaemia and Ca x P product elevation.

           CONTRAINDICATIONS of Paricalcitol

           - Hypersensitivity to active substance or to any of the excipients.

           - Vitamin D toxicity

           - Hypercalcaemia

           http://www.medicines.org.uk/emc/

Paroxetine

Ability to drive, paroxetine [2] ---> SmPC of [2] of eMC

As with all psychoactive drugs, patients should be cautioned about their ability to drive a car and operate machinery.

Acenocoumarol [1], paroxetine ---> SmPC of [1] of eMC

The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk

Acetylsalicylic acid, paroxetine [2] ---> SmPC of [2] of eMC

Concomitant use of paroxetine and NSAIDs/acetylsalicylic acid can lead to an increased haemorrhagic risk.

Agomelatine [1], paroxetine ---> SmPC of [1] of EMA

No evidence of pharmacokinetic or pharmacodynamic interaction was found in phase I clinical trials

Alcohol, paroxetine [2] ---> SmPC of [2] of eMC

As with other psychotropic drugs patients should be advised to avoid alcohol use while taking paroxetine.

Amitriptyline, paroxetine

Increased plasma concentrations of amitriptyline

Amprenavir [1], paroxetine ---> SmPC of [1] of EMA

Decreased plasma concentrations of paroxetine.

Amprenavir/ritonavir, paroxetine ---> SmPC of [amprenavir] of EMA

Decreased plasma concentrations of paroxetine.

Aripiprazole [1], paroxetine ---> SmPC of [1] of EMA

Strong inhibitors of CYP2D6 may increase the AUC of aripiprazole. A dose reduction should, therefore, be applied

Asenapine [1], paroxetine ---> SmPC of [1] of EMA

In vivo asenapine appears to be at most a weak inhibitor of CYP2D6. However, asenapine may enhance the inhibitory effects of paroxetine on its own metabolism.

Atomoxetine, paroxetine [2] ---> SmPC of [2] of eMC

Paroxetine inhibits the hepatic cytochrome P450 enzyme CYP2D6. Inhibition of CYP2D6 may lead to increased plasma concentrations of co-administered drugs metabolised by this enzyme.

Bimatoprost/timolol [1], paroxetine ---> SmPC of [1] of EMA

Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors and timolol.

Breast-feeding, paroxetine [2] ---> SmPC of [2] of eMC

Since no effects are anticipated, breast-feeding can be considered.

Brexpiprazole [1], paroxetine ---> SmPC of [1] of EMA

Based on results of interaction studies, dose adjustment of brexpiprazole to half the dose is recommended when administered concomitantly with strong CYP2D6 inhibitors (quinidine, paroxetine, and fluoxetine).

Brinzolamide/timolol [1], paroxetine ---> SmPC of [1] of EMA

Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors and timolol.

Buflomedil, paroxetine

The risk of neurological adverse effects increases if buflomedil is administered with CYP2D6 inhibitors to patients with renal or hepatic disorder

Carbamazepine, paroxetine [2] ---> SmPC of [2] of eMC

No initial dosage adjustment is considered necessary when the drug is to be co-administered with known drug metabolising enzyme inducers

Catecholamine-O-methyltransferase inhibitors, paroxetine

The COMT-inhibition may increase the plasma levels of paroxetine

Clobazam [1], paroxetine ---> SmPC of [1] of eMC

Clobazam is a weak CYP2D6 inhibitor. Dose adjustment of drugs metabolized by CYP2D6 may be necessary.

Clomipramine, paroxetine [2] ---> SmPC of [2] of eMC

Paroxetine inhibits the hepatic cytochrome P450 enzyme CYP2D6. Inhibition of CYP2D6 may lead to increased plasma concentrations of co-administered drugs metabolised by this enzyme.

Clozapine [1], paroxetine ---> SmPC of [1] of eMC

Concomitant administration of substances known to inhibit the activity of some cytochrome P450 isozymes (CYP2D6) may increase the levels of clozapine, and the dose of clozapine may need to be reduced to prevent undesirable effects.

Coxibs, paroxetine [2] ---> SmPC of [2] of eMC

Concomitant use of paroxetine and NSAIDs/acetylsalicylic acid can lead to an increased haemorrhagic risk.

Darifenacin [1], paroxetine ---> SmPC of [1] of EMA

Concomitant treatment with potent CYP2D6 inhibitors results in an increase in darifenacin exposure

Darunavir/cobicistat [1], paroxetine ---> SmPC of [1] of EMA

Concomitant use of boosted darunavir/cobicistat (CYP2D6 and/or CYP3A inhibition) and this antidepressant may increase concentrations of the antidepressant.

Darunavir/cobicistat/emtricitabine/tenofovir alafenamide [1], paroxetine ---> SmPC of [1] of EMA

If this anti-depressant is to be used with Symtuza clinical monitoring is recommended and a dose adjustment of the anti-depressant may be needed.

Darunavir/ritonavir, paroxetine ---> SmPC of [darunavir] of EMA

The co-administration may decrease the plasma levels of paroxetine

Desipramine, paroxetine [2] ---> SmPC of [2] of eMC

Paroxetine inhibits the hepatic cytochrome P450 enzyme CYP2D6. Inhibition of CYP2D6 may lead to increased plasma concentrations of co-administered drugs metabolised by this enzyme.

Dextromethorphan, paroxetine

The CYP2D6 inhibition may increase the plasma concentrations of dextromethorphan

Dorzolamide/timolol [1], paroxetine ---> SmPC of [1] of eMC

Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors and timolol.

Drugs metabolised by CYP2D6, paroxetine [2] ---> SmPC of [2] of eMC

Paroxetine inhibits the hepatic cytochrome P450 enzyme CYP2D6. Inhibition of CYP2D6 may lead to increased plasma concentrations of co-administered drugs metabolised by this enzyme.

Drugs primarily metabolised by CYP2D6, paroxetine [2] ---> SmPC of [2] of eMC

Paroxetine inhibits the hepatic cytochrome P450 enzyme CYP2D6. Inhibition of CYP2D6 may lead to increased plasma concentrations of co-administered drugs metabolised by this enzyme.

Efavirenz [1], paroxetine ---> SmPC of [1] of EMA

No dose adjustment is necessary for either medicinal product.

Efavirenz/emtricitabine/tenofovir disoproxil [1], paroxetine ---> SmPC of [1] of EMA

No dosage adjustment necessary.

Eliglustat [1], paroxetine ---> SmPC of [1] of EMA

A dose of eliglustat 84 mg once daily should be considered when a strong CYP2D6 inhibitor is used concomitantly in intermediate and extensive metabolisers

Enzyme inductors, paroxetine [2] ---> SmPC of [2] of eMC

No initial dosage adjustment is considered necessary when the drug is to be co-administered with known drug metabolising enzyme inducers

Enzyme inhibitors, paroxetine [2] ---> SmPC of [2] of eMC

When paroxetine is to be co-administered with a known drug metabolising inhibitor, consideration should be given to using paroxetine doses at the lower end of the range.

Etravirine [1], paroxetine ---> SmPC of [1] of EMA

Etravirine can be co-administered with paroxetine without dose adjustments.

Felodipine/metoprolol, paroxetine

CYP2D6 inhibitors may increase the plasma levels of metoprolol

Flecainide, paroxetine [2] ---> SmPC of [2] of eMC

Paroxetine inhibits the hepatic cytochrome P450 enzyme CYP2D6. Inhibition of CYP2D6 may lead to increased plasma concentrations of co-administered drugs metabolised by this enzyme.

Fluphenazine, paroxetine

The co-administration of fluphenazine with drugs that may increase the plasma levels of fluphenazine should be avoided

Fosamprenavir/ritonavir, paroxetine ---> SmPC of [fosamprenavir] of EMA

Concomitant use may decrease paroxetine exposition. Dose titration of paroxetine based on a clinical assessment of antidepressant response is recommended.

Fosphenytoin [1], paroxetine ---> SmPC of [1] of eMC

Concomitant use of paroxetine with phenytoin may lower the seizure threshold. Blood levels and/or effects of paroxetine may be altered by phenytoin

Frovatriptan [1], paroxetine ---> SmPC of [1] of eMC

Potential risk of hypertension, coronary vasoconstriction or serotonin syndrome. Strict adherence to the recommended dose is an essential factor to prevent this syndrome.

Galantamine [1], paroxetine ---> SmPC of [1] of eMC

The co-administration of galantamine with strong CYP2D6 inhibitors may increase the bioavailability of galantamine and the incidence of cholinergic adverse reactions, predominantly nausea and vomiting.

Haloperidol [1], paroxetine ---> SmPC of [1] of eMC

Inhibition of the CYP2D6 by another drug may result in increased haloperidol concentrations and an increased risk of adverse events, including QT-prolongation.

IMAOs, paroxetine [2] ---> SmPC of [2] of eMC

Concomitant use of paroxetine and MAOIs is contraindicated because of the risk of serotonin syndrome

Imipramine, paroxetine

Co-medication of SSRIs and imipramine may lead to additive effects on the serotonergic system.

Insulin, paroxetine [2] ---> SmPC of [2] of eMC

In patients with diabetes, treatment with an SSRI may alter glycaemic control. Insulin and/or oral hypoglycaemic dosage may need to be adjusted.

Latanoprost/timolol [1], paroxetine ---> SmPC of [1] of eMC

Potentiated systemic beta-blockade (e.g. decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors (e.g. quinidine, fluoxetine, paroxetine) and timolol.

Levomepromazine [1], paroxetine ---> SmPC of [1] of eMC

Co-administration of levomepromazine and drugs primarily metabolised by the CYP2D6 may result in increased plasma concentrations of the drugs that could increase or prolong both therapeutic or adverse effects of those drugs.

Linezolid, paroxetine [2] ---> SmPC of [2] of eMC

As with other SSRIs, co-administration with serotonergic drugs may lead to an incidence of 5-HT associated effects (serotonin syndrome)

Lithium, paroxetine [2] ---> SmPC of [2] of eMC

As with other SSRIs, co-administration with serotonergic drugs may lead to an incidence of 5-HT associated effects (serotonin syndrome)

Mequitazine, paroxetine

Mequitazine should not be used with CYP2D6 inhibitor drugs. The increased plasma levels of mequitazine may increase the risk of QT interval prolongation

Methadone, paroxetine

Paroxetine is a strong CYP2D6 inhibitor und significantly increased the plasma concentrations of R-methadone

Metoclopramide, paroxetine

The strong CYP2D6 inhibition may increase the plasma levels of metoclopramide

Metoprolol, paroxetine [2] ---> SmPC of [2] of eMC

Paroxetine, CYP2D6 inhibitor, may increase metoprolol levels. It is not recommended to use paroxetine combined with metoprolol when given in cardiac insufficiency, due to the narrow therapeutic index of metoprolol in this indication

Mivacurium, paroxetine

Selective serotonin reuptake inhibitors may reduce the activity of plasma cholinesterase, what may cause prolongation of neuromuscular blocking action of mivacurium and suxamethonium

Naltrexone/bupropion [1], paroxetine ---> SmPC of [1] of EMA

Co-administration of bupropion with drugs that are metabolised by CYP2D6 isozyme should be approached with caution and should be initiated at the lower end of the dose range of the concomitant medicinal product.

Nebivolol [1], paroxetine ---> SmPC of [1] of eMC

The CYP2D6 inhibition may lead to increased plasma levels of nebivolol (metabolized by CYP2D6) that is associated with an increased risk of excessive bradycardia and adverse events.

Nelfinavir [1], paroxetine ---> SmPC of [1] of EMA

Co-administration of nelfinavir with inhibitors of CYP2C19 may be expected to reduce the conversion of nelfinavir to its major active metabolite M8 (tert-butyl hydroxy nelfinavir) with a concomitant increase in plasma nelfinavir levels

Nortriptyline, paroxetine [2] ---> SmPC of [2] of eMC

Paroxetine inhibits the hepatic cytochrome P450 enzyme CYP2D6. Inhibition of CYP2D6 may lead to increased plasma concentrations of co-administered drugs metabolised by this enzyme.

NSAID, paroxetine [2] ---> SmPC of [2] of eMC

Concomitant use of paroxetine and NSAIDs/acetylsalicylic acid can lead to an increased haemorrhagic risk.

Oral anticoagulants, paroxetine [2] ---> SmPC of [2] of eMC

Concomitant use of paroxetine and oral anticoagulants can lead to an increased anticoagulant activity and haemorrhagic risk. Therefore, paroxetine should be used with caution in patients who are treated with oral anticoagulants.

Oral anticoagulants, SSRI ---> SmPC of [paroxetine] of eMC

Caution is advised in patients taking SSRIs, concomitantly with oral anticoagulants, drugs known to affect platelet function or increase risk of bleeding

Oral antidiabetics, paroxetine [2] ---> SmPC of [2] of eMC

In patients with diabetes, treatment with an SSRI may alter glycaemic control. Insulin and/or oral hypoglycaemic dosage may need to be adjusted.

Paroxetine [1], perphenazine ---> SmPC of [1] of eMC

Paroxetine inhibits the hepatic cytochrome P450 enzyme CYP2D6. Inhibition of CYP2D6 may lead to increased plasma concentrations of co-administered drugs metabolised by this enzyme.

Paroxetine [1], pethidine ---> SmPC of [1] of eMC

As with other SSRIs, co-administration with serotonergic drugs may lead to an incidence of 5-HT associated effects (serotonin syndrome)

Paroxetine [1], phenobarbital ---> SmPC of [1] of eMC

No initial dosage adjustment is considered necessary when the drug is to be co-administered with known drug metabolising enzyme inducers

Paroxetine [1], phenothiazines ---> SmPC of [1] of eMC

Caution is advised in patients taking SSRIs, concomitantly with oral anticoagulants, drugs known to affect platelet function or increase risk of bleeding

Paroxetine [1], phenytoin ---> SmPC of [1] of eMC

Concomitant use of paroxetine with phenytoin may lower the seizure threshold.

Paroxetine [1], pimozide ---> SmPC of [1] of eMC

Paroxetine, CYP2D6 inhibitor, may increase the plasma levels of pimozide. Due to the narrow therapeutic index of pimozide and its known ability to prolong QT interval, concomitant use of pimozide and paroxetine is contraindicated

Paroxetine [1], platelet aggregation inhibitors ---> SmPC of [1] of eMC

Caution is advised in patients taking SSRIs, concomitantly with oral anticoagulants, drugs known to affect platelet function or increase risk of bleeding

Paroxetine [1], pregnancy ---> SmPC of [1] of eMC

Paroxetine should only be used during pregnancy when strictly indicated.

Paroxetine [1], procyclidine ---> SmPC of [1] of eMC

Daily administration of paroxetine increases significantly the plasma levels of procyclidine. If anticholinergic effects are seen, the dose of procyclidine should be reduced.

Paroxetine [1], propafenone ---> SmPC of [1] of eMC

Paroxetine inhibits the hepatic cytochrome P450 enzyme CYP2D6. Inhibition of CYP2D6 may lead to increased plasma concentrations of co-administered drugs metabolised by this enzyme.

Paroxetine [1], rifampicin ---> SmPC of [1] of eMC

No initial dosage adjustment is considered necessary when the drug is to be co-administered with known drug metabolising enzyme inducers

Paroxetine [1], serotonergic medicines ---> SmPC of [1] of eMC

As with other SSRIs, co-administration with serotonergic drugs may lead to an incidence of 5-HT associated effects (serotonin syndrome)

Paroxetine [1], sodium valproate ---> SmPC of [1] of eMC

Concomitant administration does not seem to show any effect on pharmacokinetic/dynamic profile in epileptic patients.

Paroxetine [1], SSRI ---> SmPC of [1] of eMC

As with other SSRIs, co-administration with serotonergic drugs may lead to an incidence of 5-HT associated effects (serotonin syndrome)

Paroxetine [1], strong CYP2D6 inhibitors ---> SmPC of [1] of eMC

When paroxetine is to be co-administered with a known drug metabolising inhibitor, consideration should be given to using paroxetine doses at the lower end of the range.

Paroxetine [1], thioridazine ---> SmPC of [1] of eMC

Paroxetine, CYP2D6 inhibitor, may increase the plasma levels of thioridazine. Both active principles may prolong the QT interval. The combination is contraindicated

Paroxetine [1], tramadol ---> SmPC of [1] of eMC

As with other SSRIs, co-administration with serotonergic drugs may lead to an incidence of 5-HT associated effects (serotonin syndrome)

Paroxetine [1], triptans ---> SmPC of [1] of eMC

As with other SSRIs, co-administration with serotonergic drugs may lead to an incidence of 5-HT associated effects (serotonin syndrome)

Paroxetine [1], tryptophan ---> SmPC of [1] of eMC

As with other SSRIs, co-administration with serotonergic drugs may lead to an incidence of 5-HT associated effects (serotonin syndrome)

Paroxetine, pirfenidone [2] ---> SmPC of [2] of EMA

Special care should be exercised if CYP1A2 inhibitors are being used concomitantly with potent inhibitors of one or more other CYP isoenzymes involved in the metabolism of pirfenidone

Paroxetine, pitolisant [2] ---> SmPC of [2] of EMA

Given the 2-fold increase of pitolisant exposure, its coadministration with CYP2D6 inhibitors should be done with caution. A dosage adjustment during the combination could eventually be considered.

Paroxetine, propranolol

Paroxetine may increase the bradycardic effect of propranolol

Paroxetine, ranolazine [2] ---> SmPC of [2] of EMA

Ranolazine is partially metabolised by CYP2D6; therefore, inhibitors of this enzyme may increase plasma concentrations of ranolazine. No dosage adjustment necessary.

Paroxetine, risperidone [2] ---> SmPC of [2] of eMC

Paroxetine, strong CYP2D6 inhibitor, may increase the plasma concentrations of risperidone (narrow therapeutic index). Caution is recommended

Paroxetine, ritonavir [2] ---> SmPC of [2] of EMA

Ritonavir dosed as an antiretroviral agent is likely to inhibit CYP2D6 and as a result is expected to increase concentrations of imipramine, amitriptyline, nortriptyline, fluoxetine, paroxetine or sertraline.

Paroxetine, sertindole

The plasma concentration of sertindole is increased in patients concurrently taking potent CYP2D6 inhibitors; sertindole should therefore only be used concomitantly with CYP2D6 inhibitors with extreme caution.

Paroxetine, St. John's wort [2] ---> SmPC of [2] of eMC

As with other SSRIs, co-administration with serotonergic drugs may lead to an incidence of 5-HT associated effects (serotonin syndrome)

Paroxetine, stiripentol [2] ---> SmPC of [2] of EMA

Stiripentol is an inhibitor of the enzymes CYP2D6 and may markedly increase the plasma concentrations of substances metabolised by these enzymes and increase the risk of adverse reactions

Paroxetine, suxamethonium

Selective serotonin reuptake inhibitors may reduce the activity of plasma cholinesterase, what may cause prolongation of neuromuscular blocking action of mivacurium and suxamethonium

Paroxetine, tamoxifen [2] ---> SmPC of [2] of eMC

Concomitant medications that inhibit CYP2D6 may lead to reduced concentrations of the active metabolite endoxifen. Therefore, potent inhibitors of CYP2D6 should whenever possible be avoided during tamoxifen treatment

Paroxetine, terfenadine

The CYP3A4 inhibition may increase the terfenadine plasma levels and prolong the QT interval (risk of life-threatening arrythmias). The combination is contraindicated

Paroxetine, tetrabenazine [2] ---> SmPC of [2] of eMC

Inhibitors of CYP2D6 may result in increased plasma concentrations of the active metabolite dihydrotetrabenazine, why they should only be combined with caution. A reduction of the tetrabenazine dose may be necessary.

Paroxetine, ticagrelor [2] ---> SmPC of [2] of EMA

Due to reports of cutaneous bleeding abnormalities with SSRIs, caution is advised when administering SSRIs with ticagrelor as this may increase the risk of bleeding.

Paroxetine, timolol ---> SmPC of [travoprost/timolol] of EMA

Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors and timolol.

Paroxetine, travoprost/timolol [2] ---> SmPC of [2] of EMA

Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors and timolol.

Paroxetine, triazolam

Caution is advised when combining triazolam with paroxetine

Paroxetine, trimipramine

The previous or concomitant treatment of SSRIs with trimipramine may increase the plasma levels of both antidepressants by substrate competition

Paroxetine, vortioxetine [2] ---> SmPC of [2] of EMA

Depending on individual patient response, a lower dose of vortioxetine may be considered if strong CYP2D6 inhibitor is added to vortioxetine treatment

           CONTRAINDICATIONS of Paroxetine

           - Known hypersensitivity to paroxetine or any of the excipients.

           - Paroxetine is contraindicated in combination with monoamine oxidase inhibitors (MAOIs). In exceptional circumstances, linezolid (an antibiotic which is a reversible non-selective MAOI) can be given in combination with paroxetine provided that there are facilities for close observation of symptoms of serotonin syndrome and monitoring of blood pressure

           - Treatment with paroxetine can be initiated:

           - two weeks after discontinuation of an irreversible MAOI, or

           - at least 24 hours after discontinuation of a reversible MAOI (e.g. moclobemide, linezolid, methylthioninium chloride (methylene blue; a preoperative visualising agent which is a reversible non-selective MAOI)).

           - At least one week should elapse between discontinuation of paroxetine and initiation of therapy with any MAOI.

           - Paroxetine should not be used in combination with thioridazine, because, as with other drugs which inhibit the hepatic enzyme CYP450 2D6, paroxetine can elevate plasma levels of thioridazine (see section 4.5 Interactions with other medical products and other forms of interaction). Administration of thioridazine alone can lead to QTc interval prolongation with associated serious ventricular arrhythmia such as torsades de pointes, and sudden death.

           - Paroxetine should not be used in combination with pimozide

           - Purified soya lecithin may contain peanut protein. The PhEur monograph does not contain a test for residual protein.

           http://www.medicines.org.uk/emc/

Pasireotide (Signifor)

Ability to drive, pasireotide [2] ---> SmPC of [2] of EMA

Patients should be advised to be cautious when driving or using machines if they experience fatigue or headache during treatment with Signifor.

Amiodarone, pasireotide [2] ---> SmPC of [2] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

Amisulpride, pasireotide [2] ---> SmPC of [2] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

Anticholinesterase, pasireotide [2] ---> SmPC of [2] of EMA

Clinical monitoring of heart rate, notably at the beginning of treatment, is recommended in patients receiving pasireotide concomitantly with bradycardic medicinal products

Antidiabetics, pasireotide [2] ---> SmPC of [2] of EMA

Dose adjustments (decrease or increase) of insulin and antidiabetic medicinal products may be required when administered concomitantly with pasireotide

Antimalarial agents, pasireotide [2] ---> SmPC of [2] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

Astemizole, pasireotide [2] ---> SmPC of [2] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

Bepridil, pasireotide [2] ---> SmPC of [2] of EMA

Clinical monitoring of heart rate, notably at the beginning of treatment, is recommended in patients receiving pasireotide concomitantly with bradycardic medicinal products

Betablockers, pasireotide [2] ---> SmPC of [2] of EMA

Clinical monitoring of heart rate, notably at the beginning of treatment, is recommended in patients receiving pasireotide concomitantly with bradycardic medicinal products

Breast-feeding, pasireotide [2] ---> SmPC of [2] of EMA

Breast-feeding should be discontinued during treatment with Signifor.

Carteolol, pasireotide [2] ---> SmPC of [2] of EMA

Clinical monitoring of heart rate, notably at the beginning of treatment, is recommended in patients receiving pasireotide concomitantly with bradycardic medicinal products

Chloroquine, pasireotide [2] ---> SmPC of [2] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

Chlorpromazine, pasireotide [2] ---> SmPC of [2] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

Cisapride, pasireotide [2] ---> SmPC of [2] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

Clarithromycin, pasireotide [2] ---> SmPC of [2] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

Class IA antiarrhythmic agents, pasireotide [2] ---> SmPC of [2] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

Class III antiarrhythmic agents, pasireotide [2] ---> SmPC of [2] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

Cyclosporine, pasireotide [2] ---> SmPC of [2] of EMA

Pasireotide may decrease the relative bioavailability of ciclosporin. Concomitant administration of pasireotide and ciclosporin may require adjustment of the ciclosporin dose to maintain therapeutic levels.

Diltiazem, pasireotide [2] ---> SmPC of [2] of EMA

Clinical monitoring of heart rate, notably at the beginning of treatment, is recommended in patients receiving pasireotide concomitantly with bradycardic medicinal products

Diphemanil, pasireotide [2] ---> SmPC of [2] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

Disopyramide, pasireotide [2] ---> SmPC of [2] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

Dofetilide, pasireotide [2] ---> SmPC of [2] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

Dronedarone, pasireotide [2] ---> SmPC of [2] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

Drugs inducing bradycardia, pasireotide [2] ---> SmPC of [2] of EMA

Clinical monitoring of heart rate, notably at the beginning of treatment, is recommended in patients receiving pasireotide concomitantly with bradycardic medicinal products

Erythromycin, pasireotide [2] ---> SmPC of [2] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

Fertility, pasireotide [2] ---> SmPC of [2] of EMA

Studies in rats have shown effects on female reproductive parameters (see section 5.3). The clinical relevance of these effects in humans is unknown.

Fluphenazine, pasireotide [2] ---> SmPC of [2] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

Halofantrine, pasireotide [2] ---> SmPC of [2] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

Haloperidol, pasireotide [2] ---> SmPC of [2] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

Ibutilide, pasireotide [2] ---> SmPC of [2] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

Insulin, pasireotide [2] ---> SmPC of [2] of EMA

Dose adjustments (decrease or increase) of insulin and antidiabetic medicinal products may be required when administered concomitantly with pasireotide

Ketoconazole, pasireotide [2] ---> SmPC of [2] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

Liraglutide, pasireotide [2] ---> SmPC of [2] of EMA

Dose adjustments (decrease or increase) of insulin and antidiabetic medicinal products may be required when administered concomitantly with pasireotide

Lumefantrine, pasireotide [2] ---> SmPC of [2] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

Metformin, pasireotide [2] ---> SmPC of [2] of EMA

Dose adjustments (decrease or increase) of insulin and antidiabetic medicinal products may be required when administered concomitantly with pasireotide

Methadone, pasireotide [2] ---> SmPC of [2] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

Metoprolol, pasireotide [2] ---> SmPC of [2] of EMA

Clinical monitoring of heart rate, notably at the beginning of treatment, is recommended in patients receiving pasireotide concomitantly with bradycardic medicinal products

Mizolastine, pasireotide [2] ---> SmPC of [2] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

Moxifloxacin, pasireotide [2] ---> SmPC of [2] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

Nateglinide, pasireotide [2] ---> SmPC of [2] of EMA

Dose adjustments (decrease or increase) of insulin and antidiabetic medicinal products may be required when administered concomitantly with pasireotide

Osilodrostat [1], pasireotide ---> SmPC of [1] of EMA

A washout period should be considered when switching from other products known to affect the QT interval such as pasireotide or ketoconazole.

Oxybutynine, pasireotide [2] ---> SmPC of [2] of EMA

Clinical monitoring of heart rate, notably at the beginning of treatment, is recommended in patients receiving pasireotide concomitantly with bradycardic medicinal products

Pasireotide [1], pentamidine ---> SmPC of [1] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

Pasireotide [1], physostigmine ---> SmPC of [1] of EMA

Clinical monitoring of heart rate, notably at the beginning of treatment, is recommended in patients receiving pasireotide concomitantly with bradycardic medicinal products

Pasireotide [1], pimozide ---> SmPC of [1] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

Pasireotide [1], pregnancy ---> SmPC of [1] of EMA

Pasireotide is not recommended for use during pregnancy and in women of childbearing potential who are not using contraception

Pasireotide [1], procainamide ---> SmPC of [1] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

Pasireotide [1], propranolol ---> SmPC of [1] of EMA

Clinical monitoring of heart rate, notably at the beginning of treatment, is recommended in patients receiving pasireotide concomitantly with bradycardic medicinal products

Pasireotide [1], QT interval prolonging drugs ---> SmPC of [1] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

Pasireotide [1], quinidine ---> SmPC of [1] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

Pasireotide [1], rivastigmine ---> SmPC of [1] of EMA

Clinical monitoring of heart rate, notably at the beginning of treatment, is recommended in patients receiving pasireotide concomitantly with bradycardic medicinal products

Pasireotide [1], sertindole ---> SmPC of [1] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

Pasireotide [1], sotalol ---> SmPC of [1] of EMA

Clinical monitoring of heart rate, notably at the beginning of treatment, is recommended in patients receiving pasireotide concomitantly with bradycardic medicinal products

Pasireotide [1], terfenadine ---> SmPC of [1] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

Pasireotide [1], thioridazine ---> SmPC of [1] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

Pasireotide [1], tiapride ---> SmPC of [1] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

Pasireotide [1], verapamil ---> SmPC of [1] of EMA

Clinical monitoring of heart rate, notably at the beginning of treatment, is recommended in patients receiving pasireotide concomitantly with bradycardic medicinal products

Pasireotide [1], vildagliptin ---> SmPC of [1] of EMA

Dose adjustments (decrease or increase) of insulin and antidiabetic medicinal products may be required when administered concomitantly with pasireotide

Pasireotide [1], vincamine ---> SmPC of [1] of EMA

Pasireotide should be used with caution in patients who are concomitantly receiving medicinal products that prolong the QT interval

             CONTRAINDICATIONS of Pasireotide (Signifor)

             - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

             - Severe hepatic impairment (Child Pugh C).   

             https://www.ema.europa.eu/en/documents/product-information/signifor-epar-product-information_en.pdf 02/10/2024    

Patiromer (Veltassa)

Amlodipine, patiromer [2] ---> SmPC of [2] of EMA

Concomitant administration of patiromer did not affect the bioavailability as measured by the area under the curve (AUC). For these medicinal products no separation is needed.

Bioavailability, patiromer [2] ---> SmPC of [2] of EMA

Concomitant administration of Veltassa did not affect the bioavailability as measured by the area under the curve (AUC) of amlodipine, cinacalcet, clopidogrel, furosemide, lithium, metoprolol, trimethoprim, verapamil and warfarin.

Bisoprolol, patiromer [2] ---> SmPC of [2] of EMA

In vitro studies have shown potential interaction of patiromer with bisoprolol, carvedilol, mycophenolate mofetil, nebivolol, quinidine, and telmisartan.

Breast-feeding, patiromer [2] ---> SmPC of [2] of EMA

A decision must be made whether to discontinue breast feeding or to discontinue/abstain from patiromer therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.

Canagliflozin, patiromer [2] ---> SmPC of [2] of EMA

In vitro studies have shown no potential interaction of patiromer with the other active substances

Candesartan, patiromer [2] ---> SmPC of [2] of EMA

In vitro studies have shown no potential interaction of patiromer with the other active substances

Captopril, patiromer [2] ---> SmPC of [2] of EMA

In vitro studies have shown no potential interaction of patiromer with the other active substances

Carvedilol, patiromer [2] ---> SmPC of [2] of EMA

In vitro studies have shown potential interaction of patiromer with bisoprolol, carvedilol, mycophenolate mofetil, nebivolol, quinidine, and telmisartan.

Cephalexin, patiromer [2] ---> SmPC of [2] of EMA

In vitro studies have shown no potential interaction of patiromer with the other active substances

Cinacalcet, patiromer [2] ---> SmPC of [2] of EMA

Concomitant administration of patiromer did not affect the bioavailability as measured by the area under the curve (AUC). For these medicinal products no separation is needed.

Ciprofloxacin, patiromer [2] ---> SmPC of [2] of EMA

Concomitant administration of patiromer showed reduced bioavailability of ciprofloxacin, levothyroxine and metformin. However, there was no interaction when patiromer and these medicinal products were taken 3 hours apart.

Clopidogrel, patiromer [2] ---> SmPC of [2] of EMA

Concomitant administration of patiromer did not affect the bioavailability as measured by the area under the curve (AUC). For these medicinal products no separation is needed.

Dapagliflozin, patiromer [2] ---> SmPC of [2] of EMA

In vitro studies have shown no potential interaction of patiromer with the other active substances

Digoxin, patiromer [2] ---> SmPC of [2] of EMA

In vitro studies have shown no potential interaction of patiromer with the other active substances

Empagliflozin, patiromer [2] ---> SmPC of [2] of EMA

In vitro studies have shown no potential interaction of patiromer with the other active substances

Enalapril, patiromer [2] ---> SmPC of [2] of EMA

In vitro studies have shown no potential interaction of patiromer with the other active substances

Eplerenone, patiromer [2] ---> SmPC of [2] of EMA

In vitro studies have shown no potential interaction of patiromer with the other active substances

Fertility, patiromer [2] ---> SmPC of [2] of EMA

There are no data on the effect of patiromer on fertility in humans. Animal studies showed no effects on reproductive function or fertility (see section 5.3).

Finerenone, patiromer [2] ---> SmPC of [2] of EMA

In vitro studies have shown no potential interaction of patiromer with the other active substances

Foods, patiromer [2] ---> SmPC of [2] of EMA

Veltassa should be taken with food. It should not be heated (e.g. microwaved) or added to heated foods or liquids. It should not be taken in its dry form.

Fosinopril, patiromer [2] ---> SmPC of [2] of EMA

In vitro studies have shown no potential interaction of patiromer with the other active substances

Furosemide, patiromer [2] ---> SmPC of [2] of EMA

Concomitant administration of patiromer did not affect the bioavailability as measured by the area under the curve (AUC). For these medicinal products no separation is needed.

Glipizide, patiromer [2] ---> SmPC of [2] of EMA

In vitro studies have shown no potential interaction of patiromer with the other active substances

Irbesartan, patiromer [2] ---> SmPC of [2] of EMA

In vitro studies have shown no potential interaction of patiromer with the other active substances

Levothyroxine, patiromer [2] ---> SmPC of [2] of EMA

Concomitant administration of patiromer showed reduced bioavailability of ciprofloxacin, levothyroxine and metformin. However, there was no interaction when patiromer and these medicinal products were taken 3 hours apart.

Lisinopril, patiromer [2] ---> SmPC of [2] of EMA

In vitro studies have shown no potential interaction of patiromer with the other active substances

Lithium, patiromer [2] ---> SmPC of [2] of EMA

Concomitant administration of patiromer did not affect the bioavailability as measured by the area under the curve (AUC). For these medicinal products no separation is needed.

Losartan, patiromer [2] ---> SmPC of [2] of EMA

In vitro studies have shown no potential interaction of patiromer with the other active substances

Medicinal products, patiromer [2] ---> SmPC of [2] of EMA

As precautionary measure, and based on the data summarised below, administration of patiromer should therefore be separated by at least 3 hours from other oral medicinal products.

Metformin, patiromer [2] ---> SmPC of [2] of EMA

Concomitant administration of patiromer showed reduced bioavailability of ciprofloxacin, levothyroxine and metformin. However, there was no interaction when patiromer and these medicinal products were taken 3 hours apart.

Metoprolol, patiromer [2] ---> SmPC of [2] of EMA

Concomitant administration of patiromer did not affect the bioavailability as measured by the area under the curve (AUC). For these medicinal products no separation is needed.

Mycophenolate mofetil, patiromer [2] ---> SmPC of [2] of EMA

In vitro studies have shown potential interaction of patiromer with bisoprolol, carvedilol, mycophenolate mofetil, nebivolol, quinidine, and telmisartan.

Nebivolol, patiromer [2] ---> SmPC of [2] of EMA

In vitro studies have shown potential interaction of patiromer with bisoprolol, carvedilol, mycophenolate mofetil, nebivolol, quinidine, and telmisartan.

Olmesartan, patiromer [2] ---> SmPC of [2] of EMA

In vitro studies have shown no potential interaction of patiromer with the other active substances

Oral medicinal products, patiromer [2] ---> SmPC of [2] of EMA

Patiromer has the potential to bind some oral co administered medicinal products. As precautionary measure, administration of Veltassa should therefore be separated by at least 3 hours from other oral medicinal products.

Patiromer [1], perindopril ---> SmPC of [1] of EMA

In vitro studies have shown no potential interaction of patiromer with the other active substances

Patiromer [1], phenytoin ---> SmPC of [1] of EMA

In vitro studies have shown no potential interaction of patiromer with the other active substances

Patiromer [1], pregnancy ---> SmPC of [1] of EMA

As a precautionary measure, it is preferable to avoid the use of patiromer during pregnancy.

Patiromer [1], quinapril ---> SmPC of [1] of EMA

In vitro studies have shown no potential interaction of patiromer with the other active substances

Patiromer [1], quinidine ---> SmPC of [1] of EMA

In vitro studies have shown potential interaction of patiromer with bisoprolol, carvedilol, mycophenolate mofetil, nebivolol, quinidine, and telmisartan.

Patiromer [1], ramipril ---> SmPC of [1] of EMA

In vitro studies have shown no potential interaction of patiromer with the other active substances

Patiromer [1], riboflavin ---> SmPC of [1] of EMA

In vitro studies have shown no potential interaction of patiromer with the other active substances

Patiromer [1], rivaroxaban ---> SmPC of [1] of EMA

In vitro studies have shown no potential interaction of patiromer with the other active substances

Patiromer [1], sevelamer ---> SmPC of [1] of EMA

In vitro studies have shown no potential interaction of patiromer with the other active substances

Patiromer [1], spironolactone ---> SmPC of [1] of EMA

In vitro studies have shown no potential interaction of patiromer with the other active substances

Patiromer [1], tacrolimus ---> SmPC of [1] of EMA

In vitro studies have shown no potential interaction of patiromer with the other active substances

Patiromer [1], telmisartan ---> SmPC of [1] of EMA

In vitro studies have shown potential interaction of patiromer with bisoprolol, carvedilol, mycophenolate mofetil, nebivolol, quinidine, and telmisartan.

Patiromer [1], torasemid ---> SmPC of [1] of EMA

In vitro studies have shown no potential interaction of patiromer with the other active substances

Patiromer [1], trandolapril ---> SmPC of [1] of EMA

In vitro studies have shown no potential interaction of patiromer with the other active substances

Patiromer [1], trimethoprim ---> SmPC of [1] of EMA

Concomitant administration of patiromer did not affect the bioavailability as measured by the area under the curve (AUC). For these medicinal products no separation is needed.

Patiromer [1], valsartan ---> SmPC of [1] of EMA

In vitro studies have shown no potential interaction of patiromer with the other active substances

Patiromer [1], verapamil ---> SmPC of [1] of EMA

Concomitant administration of patiromer did not affect the bioavailability as measured by the area under the curve (AUC). For these medicinal products no separation is needed.

Patiromer [1], warfarin ---> SmPC of [1] of EMA

Concomitant administration of patiromer did not affect the bioavailability as measured by the area under the curve (AUC). For these medicinal products no separation is needed.

             CONTRAINDICATIONS of Patiromer (Veltassa)                          

             - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

             https://www.ema.europa.eu/en/documents/product-information/veltassa-epar-product-information_en.pdf. 16/01/2024      

Patisiran (Onpattro)

Breast-feeding, patisiran [2] ---> SmPC of [2] of EMA

A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Onpattro, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Cytochrome P450, patisiran [2] ---> SmPC of [2] of EMA

Onpattro is not expected to cause interactions or be affected by inhibitors or inducers of cytochrome P450 enzymes.

Fertility, patisiran [2] ---> SmPC of [2] of EMA

There are no data on the effects of Onpattro on human fertility. No impact on male or female fertility was detected in animal studies (see section 5.3).

Patisiran [1], pregnancy ---> SmPC of [1] of EMA

Due to the potential teratogenic risk arising from unbalanced vitamin A levels, Onpattro should not be used during pregnancy, unless the clinical condition of the woman requires treatment.

Patisiran [1], vitamin A ---> SmPC of [1] of EMA

During treatment with Onpattro, laboratory tests for serum vitamin A do not reflect the total amount of vitamin A in the body and should not be used to guide vitamin A supplementation (see sections 4.4 and 5.1).

Patisiran [1], women of childbearing potential ---> SmPC of [1] of EMA

Pregnancy should be excluded before initiation of treatment and women of childbearing potential should use effective contraception.

Patisiran [1], women of childbearing potential ---> SmPC of [1] of EMA

If a woman intends to become pregnant, Onpattro and vitamin A supplementation should be discontinued and serum vitamin A levels should be monitored and have returned to normal before conception is attempted.

             CONTRAINDICATIONS of Patisiran (Onpattro)                

             - Severe hypersensitivity (e.g., anaphylaxis) to the active substance or any of the excipients listed in section 6.1.              

             https://www.ema.europa.eu/en/documents/product-information/onpattro-epar-product-information_en.pdf  25/03/2025        

Pazopanib (Votrient)

Ability to drive, pazopanib [2] ---> SmPC of [2] of EMA

Patients should avoid driving or using machines if they feel dizzy, tired or weak

Antacids, pazopanib [2] ---> SmPC of [2] of EMA

Pazopanib should be administered at least 1 hour before or 2 hours after administration of short-acting antacids.

Antiarrhythmics, pazopanib [2] ---> SmPC of [2] of EMA

Pazopanib should be used with caution in patients with a history of QT interval prolongation, in patients taking antiarrhythmics or other medicinal products that may prolong QT interval and those with relevant pre-existing cardiac disease.

Atazanavir, pazopanib [2] ---> SmPC of [2] of EMA

Co-administration of pazopanib with other strong inhibitors of the CYP3A4 family may increase pazopanib concentrations. Concomitant use of pazopanib with a strong CYP3A4 inhibitor should be avoided

BCRP and P-gp substrates, pazopanib [2] ---> SmPC of [2] of EMA

Care should be taken when pazopanib (BCRP and P-gp inhibitor) is co-administered with other oral BCRP and P-gp substrates

BCRP substrates, pazopanib [2] ---> SmPC of [2] of EMA

Care should be taken when pazopanib is co-administered with other oral BCRP and P-gp substrates.

Boceprevir, pazopanib

The inhibition of the transporters of the P-glycoprotein and breast cancer resistant protein (BCRP) may increase the plasma concentrations of boceprevir.

Breast-feeding, pazopanib [2] ---> SmPC of [2] of EMA

Breast-feeding should be discontinued during treatment with pazopanib.

Caffeine, pazopanib [2] ---> SmPC of [2] of EMA

Pazopanib does not have a clinically relevant effect on the pharmacokinetics of caffeine (CYP1A2 probe substrate), warfarin (CYP2C9 probe substrate), or omeprazole (CYP2C19 probe substrate) in cancer patients.

Clarithromycin, pazopanib [2] ---> SmPC of [2] of EMA

Co-administration of pazopanib with other strong inhibitors of the CYP3A4 family may increase pazopanib concentrations. Concomitant use of pazopanib with a strong CYP3A4 inhibitor should be avoided

Cyclophosphamide, pazopanib

The CYP2B6 and CYP3A4 inhibition may decrease the efficacy of cyclophosphamide (prodrug)

Cyclosporine, pazopanib [2] ---> SmPC of [2] of EMA

The possible strong inhibition of CYP3A4, BCRP and P-glycoprotein may increase the plasma concentrations of pazopanib. The combination should be avoided

CYP3A4, P-gp, and BCRP inhibitors, pazopanib [2] ---> SmPC of [2] of EMA

Co-administration of pazopanib with a CYP3A4, P-gp, and BCRP inhibitor, such as lapatinib, will result in an increase in plasma pazopanib concentrations.

Dextromethorphan, pazopanib [2] ---> SmPC of [2] of EMA

Increases of 33% to 64% in the ratio of dextrometrophan to dextrophan concentrations in the urine after oral administration of dextromethorphan (CYP2D6 probe substrate).

Drugs primarily metabolised by UGT1A1, pazopanib [2] ---> SmPC of [2] of EMA

Concomitant administration of pazopanib with uridine diphosphate glucuronosyl transferase 1A1 (UGT1A1) substrates (e.g. irinotecan) should be undertaken with caution since pazopanib is an inhibitor of UGT1A1

Esomeprazole, pazopanib [2] ---> SmPC of [2] of EMA

Concomitant administration of pazopanib with esomeprazole decreases the bioavailability of pazopanib by approximately 40% (AUC and Cmax), and co-administration of pazopanib with medicines that increase gastric pH should be avoided.

Fertility, pazopanib [2] ---> SmPC of [2] of EMA

Animal studies indicate that male and female fertility may be affected by treatment with pazopanib (see section 5.3).

Foods, pazopanib [2] ---> SmPC of [2] of EMA

Administration of pazopanib with a high-fat or low-fat meal results in an approximately 2-fold increase in AUC and Cmax. Therefore, pazopanib should be administered at least 1 hour before or 2 hours after a meal.

Gastric pH increasing medication, pazopanib [2] ---> SmPC of [2] of EMA

Co-administration of pazopanib with medicines that increase gastric pH should be avoided.

Gastrointestinal perforation, pazopanib [2] ---> SmPC of [2] of EMA

Pazopanib should be used with caution in patients at risk for GI perforation or fistula.

Grapefruit juice, pazopanib [2] ---> SmPC of [2] of EMA

Grapefruit juice contains an inhibitor of CYP3A4 and may increase plasma concentrations of pazopanib. Grapefruit juice should be avoided during treatment with pazopanib (see section 4.5).

H2 antagonists, pazopanib [2] ---> SmPC of [2] of EMA

If the concomitant administration of an H2-receptor antagonist is medically necessary, pazopanib should be taken without food at least 2 hours before or at least 10 hours after a dose of an H2-receptor antagonist.

Haemorrhage, pazopanib [2] ---> SmPC of [2] of EMA

Pazopanib should be used with caution in patients with significant risk of haemorrhage.

Indinavir, pazopanib [2] ---> SmPC of [2] of EMA

Co-administration of pazopanib with other strong inhibitors of the CYP3A4 family may increase pazopanib concentrations. Concomitant use of pazopanib with a strong CYP3A4 inhibitor should be avoided

Irinotecan, pazopanib [2] ---> SmPC of [2] of EMA

Concomitant administration of pazopanib with uridine diphosphate glucuronosyl transferase 1A1 (UGT1A1) substrates (e.g. irinotecan) should be undertaken with caution since pazopanib is an inhibitor of UGT1A1

Itraconazol, pazopanib [2] ---> SmPC of [2] of EMA

Co-administration of pazopanib with other strong inhibitors of the CYP3A4 family may increase pazopanib concentrations. Concomitant use of pazopanib with a strong CYP3A4 inhibitor should be avoided

Ketoconazole, pazopanib [2] ---> SmPC of [2] of EMA

The possible strong inhibition of CYP3A4, BCRP and P-glycoprotein may increase the plasma concentrations of pazopanib. The combination should be avoided

Lapatinib, pazopanib [2] ---> SmPC of [2] of EMA

Co-administration of pazopanib with a CYP3A4, P-gp, and BCRP inhibitor, such as lapatinib, will result in an increase in plasma pazopanib concentrations.

Lomitapide [1], pazopanib ---> SmPC of [1] of EMA

Weak CYP3A4 inhibitors are expected to increase the exposure of lomitapide when taken simultaneously. Separate the dose of the medications by 12 hours OR decrease the dose of Lojuxta by half.

Men, pazopanib [2] ---> SmPC of [2] of EMA

Male patients (including those who have had vasectomies) should use condoms during sexual intercourse while taking pazopanib and for at least 2 weeks after the last dose of pazopanib to avoid potential exposure to the medicinal product for pregnant partners and female partners of reproductive potential.

Methotrexate, pazopanib

Care should be taken when pazopanib (BCRP and P-gp inhibitor) is co-administered with other oral BCRP and P-gp substrates

Miconazole, pazopanib

Oral miconazole is contraindicated with medicinal products that are metabolised by CYP3A4 and may prolong also the QT interval

Midazolam, pazopanib [2] ---> SmPC of [2] of EMA

Pazopanib resulted in an increase of approximately 30 %in the mean AUC and Cmax of midazolam (CYP3A4 probe substrate)

Nefazodone, pazopanib [2] ---> SmPC of [2] of EMA

Co-administration of pazopanib with other strong inhibitors of the CYP3A4 family may increase pazopanib concentrations. Concomitant use of pazopanib with a strong CYP3A4 inhibitor should be avoided

Nelfinavir, pazopanib [2] ---> SmPC of [2] of EMA

Co-administration of pazopanib with other strong inhibitors of the CYP3A4 family may increase pazopanib concentrations. Concomitant use of pazopanib with a strong CYP3A4 inhibitor should be avoided

Nevirapine, pazopanib [2] ---> SmPC of [2] of EMA

The possible induction of CYP3A4 and P-glycoprotein may decrease the plasma concentrations of pazopanib. The combination should be avoided

OATP1B1 substrates, pazopanib [2] ---> SmPC of [2] of EMA

In vitro pazopanib inhibited human organic anion transporting polypeptide (OATP1B1). It cannot be excluded that pazopanib will affect the pharmacokinetics of substrates of OATP1B1 (e.g. statins)

Omeprazole, pazopanib [2] ---> SmPC of [2] of EMA

Pazopanib does not have a clinically relevant effect on the pharmacokinetics of caffeine (CYP1A2 probe substrate), warfarin (CYP2C9 probe substrate), or omeprazole (CYP2C19 probe substrate) in cancer patients.

Oxcarbamazepine, pazopanib [2] ---> SmPC of [2] of EMA

The possible induction of CYP3A4 and P-glycoprotein may decrease the plasma concentrations of pazopanib. The combination should be avoided

P-glycoprotein or BCRP potent inductors, pazopanib [2] ---> SmPC of [2] of EMA

Co-administration of pazopanib with potent P-gp or BCRP inducers may alter the exposure and distribution of pazopanib, including distribution into the CNS.

P-glycoprotein or BCRP potent inhibitors, pazopanib [2] ---> SmPC of [2] of EMA

Combination with strong P-gp or BCRP inhibitors should be avoided, or selection of an alternate concomitant medicinal product with no or minimal potential to inhibit P-gp or BCRP is recommended.

P-glycoprotein substrates, pazopanib [2] ---> SmPC of [2] of EMA

Care should be taken when pazopanib is co-administered with other oral BCRP and P-gp substrates.

Paclitaxel, pazopanib [2] ---> SmPC of [2] of EMA

Co-administration of pazopanib 800 mg once daily and paclitaxel 80 mg/m2 (CYP3A4 and CYP2C8 substrate) once weekly resulted in a mean increase of 26% and 31% in paclitaxel AUC and Cmax, respectively.

Pazopanib [1], pregnancy ---> SmPC of [1] of EMA

Pazopanib should not be used during pregnancy unless the clinical condition of the women requires treatment with pazopanib.

Pazopanib [1], pregnancy ---> SmPC of [1] of EMA

If pazopanib is used during pregnancy, or if the patient becomes pregnant while receiving pazopanib, the potential hazard to the foetus should be explained to the patient.

Pazopanib [1], proton pump inhibitors ---> SmPC of [1] of EMA

If the concomitant use of a proton-pump inhibitor (PPI) is medically necessary, it is recommended that the dose of pazopanib be taken without food once daily in the evening concomitantly with the PPI.

Pazopanib [1], QT interval prolonging drugs ---> SmPC of [1] of EMA

Pazopanib should be used with caution in patients with a history of QT interval prolongation, in patients taking antiarrhythmics or other medicinal products that may prolong QT interval and those with relevant pre-existing cardiac disease.

Pazopanib [1], quinidine ---> SmPC of [1] of EMA

The possible strong inhibition of CYP3A4, BCRP and P-glycoprotein may increase the plasma concentrations of pazopanib. The combination should be avoided

Pazopanib [1], rifabutin ---> SmPC of [1] of EMA

The possible induction of CYP3A4 and P-glycoprotein may decrease the plasma concentrations of pazopanib. The combination should be avoided

Pazopanib [1], rifampicin ---> SmPC of [1] of EMA

CYP3A4 inducers such as rifampin may decrease plasma pazopanib concentrations.

Pazopanib [1], ritonavir ---> SmPC of [1] of EMA

Co-administration of pazopanib with other strong inhibitors of the CYP3A4 family may increase pazopanib concentrations. Concomitant use of pazopanib with a strong CYP3A4 inhibitor should be avoided

Pazopanib [1], saquinavir ---> SmPC of [1] of EMA

Co-administration of pazopanib with other strong inhibitors of the CYP3A4 family may increase pazopanib concentrations. Concomitant use of pazopanib with a strong CYP3A4 inhibitor should be avoided

Pazopanib [1], simvastatine ---> SmPC of [1] of EMA

Concomitant use of pazopanib and simvastatin increases the incidence of ALT elevations.

Pazopanib [1], statins ---> SmPC of [1] of EMA

It cannot be excluded that pazopanib will affect the pharmacokinetics of other statins (e.g. atorvastatin, fluvastatin, pravastatin, rosuvastatin).

Pazopanib [1], strong BCRP inhibitors ---> SmPC of [1] of EMA

Concomitant treatment with strong inhibitors of breast cancer resistance protein (BCRP) should be avoided due to risk of increased exposure to pazopanib

Pazopanib [1], strong CYP3A4 inductors ---> SmPC of [1] of EMA

Concomitant treatment with inducers of CYP3A4 should be avoided due to risk of decreased exposure to pazopanib

Pazopanib [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA

Co-administration of pazopanib with other strong inhibitors of the CYP3A4 family may increase pazopanib concentrations. Concomitant use of pazopanib with a strong CYP3A4 inhibitor should be avoided

Pazopanib [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA

If no medically acceptable alternative to a strong CYP34A inhibitor is available, the dose of pazopanib should be reduced to 400 mg daily during concomitant administration.

Pazopanib [1], strong P-gp inductors ---> SmPC of [1] of EMA

Co-administration of pazopanib with potent P-gp or BCRP inducers may alter the exposure and distribution of pazopanib, including distribution into the central nervous systems (CNS).

Pazopanib [1], strong P-gp inhibitors ---> SmPC of [1] of EMA

Concomitant treatment with strong inhibitors of P-glycoprotein (P-gp) should be avoided due to risk of increased exposure to pazopanib

Pazopanib [1], telithromycin ---> SmPC of [1] of EMA

Co-administration of pazopanib with other strong inhibitors of the CYP3A4 family may increase pazopanib concentrations. Concomitant use of pazopanib with a strong CYP3A4 inhibitor should be avoided

Pazopanib [1], UGT1A1 substrates ---> SmPC of [1] of EMA

Care should be taken when pazopanib (UGT1A1 inhibitor) is co-administered with substrates of UGT1A1.

Pazopanib [1], voriconazole ---> SmPC of [1] of EMA

Co-administration of pazopanib with other strong inhibitors of the CYP3A4 family may increase pazopanib concentrations. Concomitant use of pazopanib with a strong CYP3A4 inhibitor should be avoided

Pazopanib [1], warfarin ---> SmPC of [1] of EMA

Pazopanib does not have a clinically relevant effect on the pharmacokinetics of caffeine (CYP1A2 probe substrate), warfarin (CYP2C9 probe substrate), or omeprazole (CYP2C19 probe substrate) in cancer patients.

Pazopanib [1], women of childbearing potential ---> SmPC of [1] of EMA

Women of childbearing potential should be advised to use adequate contraception during treatment and for at least 2 weeks after the last dose of pazopanib and to avoid becoming pregnant while receiving treatment with pazopanib.

Pazopanib, rivaroxaban

Care should be taken when pazopanib (BCRP and P-gp inhibitor) is co-administered with other oral BCRP and P-gp substrates

Pazopanib, topotecan

Care should be taken when pazopanib (BCRP and P-gp inhibitor) is co-administered with other oral BCRP and P-gp substrates

            CONTRAINDICATIONS of Pazopanib (Votrient)  

            - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

            https://www.ema.europa.eu/en/documents/product-information/votrient-epar-product-information_en.pdf  06/01/2025            

Peanut protein (Palforzia)

Ability to drive, peanut protein [2] ---> SmPC of [2] of EMA

Caution should be exercised for 2 hours after dosing in case any symptoms of an allergic reaction occur that could impact the ability to drive or use machines.

Adrenaline, peanut protein [2] ---> SmPC of [2] of EMA

Severe allergic reactions may be treated with adrenaline (see section 4.4). Please refer to the SmPC for adrenaline for further information on medicines that may potentiate or inhibit the effects of adrenaline.

Alcohol, peanut protein [2] ---> SmPC of [2] of EMA

Alcohol should not be taken for 2 hours before or 2 hours after a dose (see section 4.4, Table 5).

Breast-feeding, peanut protein [2] ---> SmPC of [2] of EMA

The developmental and health benefits of breastfeeding should be considered, along with the mother's clinical need for treatment and any other potential adverse effects on the breastfed child from PALFORZIA or from the underlying maternal condition.

Fertility, peanut protein [2] ---> SmPC of [2] of EMA

There are no specific clinical or nonclinical data on the effects of defatted powder of Arachis hypogaea L., semen (peanuts) on fertility.

Foods, peanut protein [2] ---> SmPC of [2] of EMA

Each dose should be consumed with a meal.

NSAID, peanut protein [2] ---> SmPC of [2] of EMA

The potential for allergic reactions to occur if taking non- steroidal anti-inflammatory medicines whilst on PALFORZIA treatment should be considered.

Peanut protein [1], pregnancy ---> SmPC of [1] of EMA

Initiation of treatment with PALFORZIA is not recommended during pregnancy. Treatment with this medicinal product may cause anaphylaxis, which is a risk to pregnant women.

            CONTRAINDICATIONS of Peanut protein (Palforzia)       

            - Current severe or uncontrolled asthma             

            - A history of, or current, eosinophilic oesophagitis (EoE); other eosinophilic gastrointestinal disease; chronic, recurrent, or severe gastroesophageal reflux disease (GERD); dysphagia            

            - A history of, or current, severe mast cell disorder         

            - Severe or life-threatening anaphylaxis within 60 days before initiating treatment with PALFORZIA       

            - Hypersensitivity to any of the excipients listed in section 6.1    

            https://www.ema.europa.eu/en/documents/product-information/palforzia-epar-product-information_en.pdf 16/09/2024             

Pefloxacine

Ability to drive, pefloxacine

Patients should be advised that pefloxacin may have effects on the CNS

Algeldrate/magnesium hydroxide, pefloxacine

The co-administration of aluminium-containing antacids with other drugs may decrease the absorption of these drugs by chelate formation

Aminophylline [1], pefloxacine ---> SmPC of [1] of eMC

Quinolone antibiotics may decrease aminophylline clearance resulting in increased plasma theophylline concentrations and the potential for increased toxicity

Antacids, pefloxacine

The co-administration of antacids may decrease the absorption of quinolones due to formation of insoluble complexes. Separate administration by 3-4 hours

Breast-feeding, pefloxacine

Pefloxacin, like other quinolones, should not be used during breastfeeding

Magnesium hydroxide [1], pefloxacine ---> SmPC of [1] of eMC

The co-administration of magnesium hydroxide may decrease the absorption of quinolones due to formation of insoluble complexes. Separate administration by 2-3 hours

Oral anticoagulants, pefloxacine

Close monitoring of the prothrombin time is recommended when administering pefloxacin with oral anticoagulants

Pefloxacine, pregnancy

Pefloxacin, like other quinolones, should not be used during pregnancy

Pefloxacine, sun

Patients taking pefloxacin should be advised to avoid direct exposure to either extensive sunlight or UV irradiation during treatment and during 36 hours after treatment

Pefloxacine, theophylline [2] ---> SmPC of [2] of eMC

Quinolone reduce clearance of theophylline and a reduced dosage may therefore be necessary to avoid side-effects

Pefloxacine, tizanidine [2] ---> SmPC of [2] of eMC

Concomitant administration of drugs known to inhibit the activity of CYP1A2 may increase the plasma levels of tizanidine. Co-administration of tizanidine inhibitors of CYP1A2 is not recommended

Pefloxacine, warfarin

The enzymatic inhibitor may decrease the metabolism of warfarin and increase its plasma levels, the anticoagulant effect and the bleeding risk

Pegaptanib (Macugen)

Ability to drive, pegaptanib [2] ---> SmPC of [2] of EMA

Macugen has a minor influence on the ability to drive and use machines due to the possible temporary visual blurring after administration of Macugen by intravitreal injection.

Breast-feeding, pegaptanib [2] ---> SmPC of [2] of EMA

Macugen is not recommended during breast-feeding.

Cytochrome P450, pegaptanib [2] ---> SmPC of [2] of EMA

Pegaptanib is metabolised by nucleases and therefore cytochrome P450 mediated drug interactions are unlikely.

Fertility, pegaptanib [2] ---> SmPC of [2] of EMA

No human data on the effect of Macugen on fertility are available. In animal studies no effects on male or female fertility in mice were observed. See section 5.3.

Pegaptanib [1], photodynamic therapy ---> SmPC of [1] of EMA

Two early clinical studies conducted in patients who received Macugen alone and in combination with PDT (photodynamic therapy) revealed no apparent difference in the plasma pharmacokinetics of pegaptanib.

Pegaptanib [1], pregnancy ---> SmPC of [1] of EMA

Macugen should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the foetus

             CONTRAINDICATIONS of Pegaptanib (Macugen)

             - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

             - Active or suspected ocular or periocular infection.    

             https://www.ema.europa.eu/en/documents/product-information/macugen-epar-product-information_en.pdf 27/06/2019 (withdrawn)           

Pegaspargase (Oncaspar)

Ability to drive, pegaspargase [2] ---> SmPC of [2] of EMA

Patients should be advised not to drive or operate machines if they experience confusion or somnolence or other adverse reactions which can impair their ability to drive or operate machines.

Acetylsalicylic acid, pegaspargase [2] ---> SmPC of [2] of EMA

The use of Oncaspar can lead to fluctuating coagulation factors. This can promote the tendency to bleeding and/or thrombosis. Caution is therefore needed when anticoagulants are given concomitantly.

Anticoagulants, pegaspargase [2] ---> SmPC of [2] of EMA

The use of Oncaspar can lead to fluctuating coagulation factors. This can promote the tendency to bleeding and/or thrombosis. Caution is therefore needed when anticoagulants are given concomitantly.

Breast-feeding, pegaspargase [2] ---> SmPC of [2] of EMA

As a precautionary measure, breast-feeding should be discontinued during treatment with Oncaspar and should not be restarted after discontinuation of Oncaspar.

Cell division, pegaspargase [2] ---> SmPC of [2] of EMA

Addition, by inhibiting protein synthesis and cell division, pegaspargase can disturb the mechanism of action of other substances which require cell division for their effect, e.g., methotrexate.

Coumarin anticoagulants, pegaspargase [2] ---> SmPC of [2] of EMA

The use of Oncaspar can lead to fluctuating coagulation factors. This can promote the tendency to bleeding and/or thrombosis. Caution is therefore needed when anticoagulants are given concomitantly.

Cytarabine, pegaspargase [2] ---> SmPC of [2] of EMA

Methotrexate and cytarabine can interfere differently: prior administration of these substances can increase the action of Oncaspar synergistically. If these substances are given subsequently, the effect of Oncaspar can be weakened antagonistically.

Dipyridamole, pegaspargase [2] ---> SmPC of [2] of EMA

The use of Oncaspar can lead to fluctuating coagulation factors. This can promote the tendency to bleeding and/or thrombosis. Caution is therefore needed when anticoagulants are given concomitantly.

Drugs with high protein binding, pegaspargase [2] ---> SmPC of [2] of EMA

The decrease in serum proteins caused by pegaspargase can increase the toxicity of other medicinal products that are protein bound.

Fertility, pegaspargase [2] ---> SmPC of [2] of EMA

No studies investigating the effect of pegaspargase on fertility have been performed.

Glucocorticoids, pegaspargase [2] ---> SmPC of [2] of EMA

Pegaspargase may increase the risk of glucocorticoid-induced osteonecrosis in children and adolescents when both treatments are given simultaneously, with a higher incidence seen in girls, through a potential increase in exposure of dexamethasone.

Glucocorticoids, pegaspargase [2] ---> SmPC of [2] of EMA

When glucocorticoids (e.g. prednisone) and Oncaspar are given at the same time, alterations in coagulation parameters (e.g. fall in fibrinogen and Antithrombin III deficiency, ATIII) can be more pronounced.

Heparin, pegaspargase [2] ---> SmPC of [2] of EMA

The use of Oncaspar can lead to fluctuating coagulation factors. This can promote the tendency to bleeding and/or thrombosis. Caution is therefore needed when anticoagulants are given concomitantly.

Hepatotoxic drugs, pegaspargase [2] ---> SmPC of [2] of EMA

Caution is required when Oncaspar is given in combination with other hepatotoxic substances, especially if there is pre-existing hepatic impairment.

Men, pegaspargase [2] ---> SmPC of [2] of EMA

Men and women should use effective contraception during treatment and for at least 6 months after Oncaspar discontinuation.

Metabolism, pegaspargase [2] ---> SmPC of [2] of EMA

Pegaspargase can interfere with metabolism and clearance of other medicinal products, based on its effects on protein synthesis and hepatic function, as well as from its combined use with other chemotherapy products known to interact with CYP enzymes.

Methotrexate, pegaspargase [2] ---> SmPC of [2] of EMA

Methotrexate and cytarabine can interfere differently: prior administration of these substances can increase the action of Oncaspar synergistically. If these substances are given subsequently, the effect of Oncaspar can be weakened antagonistically.

NSAID, pegaspargase [2] ---> SmPC of [2] of EMA

The use of Oncaspar can lead to fluctuating coagulation factors. This can promote the tendency to bleeding and/or thrombosis. Caution is therefore needed when anticoagulants are given concomitantly.

Oral contraceptives, pegaspargase [2] ---> SmPC of [2] of EMA

An indirect interaction cannot be ruled out between pegaspargase and oral contraceptives due to pegaspargase hepatotoxicity that may impair the hepatic clearance of oral contraceptives.

Pegaspargase [1], prednisone ---> SmPC of [1] of EMA

When glucocorticoids (e.g. prednisone) and Oncaspar are given at the same time, alterations in coagulation parameters (e.g. fall in fibrinogen and Antithrombin III deficiency, ATIII) can be more pronounced.

Pegaspargase [1], pregnancy ---> SmPC of [1] of EMA

Oncaspar should not be used during pregnancy unless the clinical conditions of the woman require treatment with pegaspargase.

Pegaspargase [1], protein synthesis ---> SmPC of [1] of EMA

Addition, by inhibiting protein synthesis and cell division, pegaspargase can disturb the mechanism of action of other substances which require cell division for their effect, e.g., methotrexate.

Pegaspargase [1], vaccinations with live organism vaccines ---> SmPC of [1] of EMA

Vaccination with live vaccines should be given 3 months at the earliest after termination of the entire antileukaemic treatment.

Pegaspargase [1], vincristine ---> SmPC of [1] of EMA

Therefore, vincristine should be given at least 12 hours prior to administration of Oncaspar in order to minimise toxicity.

Pegaspargase [1], women of childbearing potential ---> SmPC of [1] of EMA

A method other than oral contraception should be used in women of childbearing potential (see sections 4.4 and 4.5).

             CONTRAINDICATIONS of Pegaspargasa (Oncaspar)                 

             - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

             - Severe hepatic impairment (bilirubin > 3 times upper limit of normal [ULN]; transaminases > 10 times ULN).              

             - History of serious thrombosis with prior L-asparaginase therapy.      

             - History of pancreatitis, including the related to previous asparaginase therapy (see section 4.4).      

             - History of serious hemorrhagic events with prior L-asparaginase therapy (see section 4.4).

             https://www.ema.europa.eu/en/documents/product-information/oncaspar-epar-product-information_en.pdf 09/07/2024       

Pegcetacoplan (Aspaveli)

Breast-feeding, pegcetacoplan [2] ---> SmPC of [2] of EMA

It is recommended to discontinue breast-feeding during pegcetacoplan treatment.

Fertility, pegcetacoplan [2] ---> SmPC of [2] of EMA

In toxicity studies, there were no microscopic abnormalities in male or female reproductive organs in monkeys

Pegcetacoplan [1], pregnancy ---> SmPC of [1] of EMA

Pegcetacoplan is not recommended during pregnancy and in women of childbearing potential not using contraception.

Pegcetacoplan [1], women of childbearing potential ---> SmPC of [1] of EMA

It is recommended that women of childbearing potential use effective contraception methods to prevent pregnancy during treatment with pegcetacoplan and for at least 8 weeks after the last dose of pegcetacoplan.

            CONTRAINDICATIONS of Pegcetacoplan (Aspaveli)        

            - Hypersensitivity to pegcetacoplan or to any of the excipients listed in section 6.1.         

            - Pegcetacoplan therapy must not be initiated in patients:           

              with unresolved infection caused by encapsulated bacteria including Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus influenzae (see section 4.4).         

              who are not currently vaccinated against Neisseria meningitidis, Streptococcus pneumoniae, and Haemophilus  influenzae unless they receive prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination (see section 4.4).             

            https://www.ema.europa.eu/en/documents/product-information/aspaveli-epar-product-information_en.pdf 05/09/2024             

Pegfilgrastim (Neulasta)

Antimetabolites, pegfilgrastim [2] ---> SmPC of [2] of EMA

In animal models concomitant administration of Neulasta and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression.

Breast-feeding, pegfilgrastim [2] ---> SmPC of [2] of EMA

A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from pegfilgrastim therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Cytotoxic chemotherapy, pegfilgrastim [2] ---> SmPC of [2] of EMA

Due to the potential sensitivity of rapidly dividing myeloid cells to cytotoxic chemotherapy, pegfilgrastim should be administered at least 24 hours after administration of cytotoxic chemotherapy.

Fertility, pegfilgrastim [2] ---> SmPC of [2] of EMA

Pegfilgrastim did not affect reproductive performance or fertility in male or female rats at cumulative weekly doses approximately 6 to 9 times higher than the recommended human dose (based on body surface area) (see section 5.3).

Fluorouracil, pegfilgrastim [2] ---> SmPC of [2] of EMA

In animal models concomitant administration of Neulasta and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression.

Interactions, pegfilgrastim [2] ---> SmPC of [2] of EMA

Specific interaction or metabolism studies have not been performed, however, clinical trials have not indicated an interaction of Neulasta with any other medicinal products.

Lithium, pegfilgrastim [2] ---> SmPC of [2] of EMA

The potential for interaction with lithium, which also promotes the release of neutrophils, has not been specifically investigated. There is no evidence that such an interaction would be harmful.

Nitrosourea, pegfilgrastim [2] ---> SmPC of [2] of EMA

The safety and efficacy of Neulasta have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e.g. nitrosoureas.

Pegfilgrastim [1], pregnancy ---> SmPC of [1] of EMA

Studies in animals have shown reproductive toxicity (see section 5.3). Pegfilgrastim is not recommended during pregnancy and in women of childbearing potential not using contraception.

            CONTRAINDICATIONS of Pegfilgrastim (Neulasta)

            - Hypersensitivity to the active substance or to any of the excipients.

            https://www.ema.europa.eu/en/documents/product-information/neulasta-epar-product-information_en.pdf 28/06/2024

Other trade names: Cavoley, Cegfila (previously Pegfilgrastim Mundipharma), Efgratin, Fulphila, Grasustek, Nyvepria, Pelgraz, Pelmeg, Ristempa, Udenyca, Ziextenzo,  

Peginterferon alfa-2a (Pegasys)

Ability to drive, peginterferon alfa-2a [2] ---> SmPC of [2] of EMA

Pegasys has minor or moderate influence on the ability to drive and use machines. Patients who develop dizziness, confusion, somnolence or fatigue should be cautioned to avoid driving or operating machinery.

Azathioprine, peginterferon alfa-2a/ribavirin ---> SmPC of [peginterferon alfa-2a] of EMA

Ribavirin, inosine monophosphate dehydrogenase inhibitor, may interfere with azathioprine metabolism with possible myelotoxicity. The use of peginterferon alfa-2a and ribavirin concomitantly with azathioprine should be avoided.

Breast-feeding, peginterferon alfa-2a [2] ---> SmPC of [2] of EMA

Because of the potential for adverse reactions in breastfed infants, breastfeeding should be discontinued prior to initiation of treatment.

Didanosine, peginterferon alfa-2a/ribavirin ---> SmPC of [peginterferon alfa-2a] of EMA

Co-administration of ribavirin and didanosine is not recommended. Reports of fatal hepatic failure as well as peripheral neuropathy, pancreatitis, and symptomatic hyperlactataemia/lactic acidosis have been reported with use of ribavirin.

Fertility, peginterferon alfa-2a [2] ---> SmPC of [2] of EMA

There are no data on the effects of peginterferon alfa-2a on fertility in women. A prolongation of the menstrual cycle has been seen with peginterferon alfa-2a in female monkeys (see section 5.3).

Fertility, peginterferon alfa-2a/ribavirin ---> SmPC of [peginterferon alfa-2a] of EMA

Ribavirin therapy is contraindicated in women who are pregnant. Extreme care must be taken to avoid pregnancy in female patients or in partners of male patients taking Pegasys in combination with ribavirin.

Lamivudine, peginterferon alfa-2a [2] ---> SmPC of [2] of EMA

Results from pharmacokinetic substudies of pivotal phase III trials demonstrated no pharmacokinetic interaction of lamivudine on Pegasys in HBV patients or between Pegasys and ribavirin in HCV patients.

Men, peginterferon alfa-2a/ribavirin ---> SmPC of [peginterferon alfa-2a] of EMA

Male patients or their female partners must use an effective contraceptive during treatment and for 7 months after treatment has been concluded. Please refer to the ribavirin SmPC.

Metabolic activity, peginterferon alfa-2a [2] ---> SmPC of [2] of EMA

Administration of Pegasys 180 micrograms once weekly for 4 weeks in healthy male subjects did not show any effect on mephenytoin, dapsone, debrisoquine and tolbutamide pharmacokinetics profiles, suggesting that Pegasys has no effect on in vivo metabolic activity of cytochrome P450 3A4, 2C9, 2C19 and 2D6 isozymes.

Methadone, peginterferon alfa-2a [2] ---> SmPC of [2] of EMA

Small increased methadone levels. Patients should be monitored for the signs and symptoms of methadone toxicity and possible prolongation of QTc-interval

Peginterferon alfa-2a [1], pregnancy ---> SmPC of [1] of EMA

Pegasys is to be used during pregnancy only if the potential benefit justifies the potential risk to the foetus.

Peginterferon alfa-2a [1], ribavirin ---> SmPC of [1] of EMA

The use of peginterferon alfa-2a and ribavirin concomitantly with azathioprine should be avoided.

Peginterferon alfa-2a [1], ribavirin ---> SmPC of [1] of EMA

It is recommended that close haematologic monitoring be done during concomitant azathioprine use to identify signs of myelotoxicity, at which time treatment with these medicinal products should be stopped

Peginterferon alfa-2a [1], theophylline ---> SmPC of [1] of EMA

Peginterferon alfa-2a, CYP1A2 inhibitor, may increase the plasma levels of theophylline

Peginterferon alfa-2a, telbivudine [2] ---> SmPC of [2] of EMA

The co-administration may increase the risk of peripheral neuropathy. The combination of telbivudine with any interferon alfa-containing product is contraindicated

Peginterferon alfa-2a/ribavirin, women of childbearing potential ---> SmPC of [peginterferon alfa-2a] of EMA

Female patients of childbearing potential must use an effective contraceptive during treatment and for 4 months after treatment has been concluded.

Peginterferon alfa-2a/ribavirin, zidovudine ---> SmPC of [peginterferon alfa-2a] of EMA

Exacerbation of anaemia due to ribavirin has been reported when zidovudine is part of the regimen used to treat HIV although the exact mechanism remains to be elucidated. The concomitant use of ribavirin with zidovudine is not recommended

             CONTRAINDICATIONS of Peginterferon alfa-2a (Pegasys)

             - Hypersensitivity to the active substance, to alfa interferons, or to any of the excipients listed in section 6.1  

             - Autoimmune hepatitis           

             - Severe hepatic dysfunction or decompensated cirrhosis of the liver    

             - A history of severe pre-existing cardiac disease, including unstable or uncontrolled cardiac disease in the previous 6 months         

             - HIV-HCV patients with cirrhosis and a Child-Pugh score ≥ 6, except if only due to indirect hyperbilirubinemia caused by medicinal products such as atazanavir and indinavir              

             - Combination with telbivudine             

             - Neonates and young children up to 3 years old, because of the excipient benzyl alcohol

             - In paediatric patients, the presence of, or history of severe psychiatric condition, particularly severe depression, suicidal ideation or suicidal attempt.   

             https://www.ema.europa.eu/en/documents/product-information/pegasys-epar-product-information_en.pdf 05/11/2025 

Peginterferon alfa-2b

Ability to drive, peginterferon alfa-2b [2] ---> SmPC of [2] of EMA

Fatigue, somnolence or confusion may occur

Antipyrine, peginterferon alfa-2b [2] ---> SmPC of [2] of EMA

Elevation of blood concentrations of antipyrine has been reported when administered in combination with other interferon preparations and therefore care should be taken. Metabolism of other medicines in the liver may be suppressed.

Breast-feeding, peginterferon alfa-2b [2] ---> SmPC of [2] of EMA

Because of the potential for adverse reactions in breast-fed infants, breast-feeding should be discontinued prior to initiation of treatment.

By N-acetyltransferase metabolized, peginterferon alfa-2b [2] ---> SmPC of [2] of EMA

No dosing adjustment is necessary when peginterferon alfa-2b (PegIntron) is administered with medicines metabolized by CYP2C9, CYP3A4 and N-acetyltransferase.

Caffeine, peginterferon alfa-2b [2] ---> SmPC of [2] of EMA

When patients are administered PegIntron with medications metabolized by CYP1A2 or CYP2D6, the extent of the decrease in cytochrome P 450 activity is unlikely to have a clinical impact, except with medicines which have a narrow therapeutic margin

CYP1A2 substrates with narrow therapeutic index, peginterferon alfa-2b [2] ---> SmPC of [2] of EMA

When patients are administered PegIntron with medications metabolized by CYP1A2 or CYP2D6, the extent of the decrease in cytochrome P 450 activity is unlikely to have a clinical impact, except with medicines which have a narrow therapeutic margin

Dapsone, peginterferon alfa-2b [2] ---> SmPC of [2] of EMA

No dosing adjustment is necessary when peginterferon alfa-2b (PegIntron) is administered with medicines metabolized by CYP2C9, CYP3A4 and N-acetyltransferase.

Desipramine, peginterferon alfa-2b [2] ---> SmPC of [2] of EMA

When patients are administered PegIntron with medications metabolized by CYP1A2 or CYP2D6, the extent of the decrease in cytochrome P 450 activity is unlikely to have a clinical impact, except with medicines which have a narrow therapeutic margin

Didanosine, peginterferon alfa-2b/ribavirin ---> SmPC of [peginterferon alfa-2b] of EMA

Co-administration of ribavirin and didanosine is not recommended. Reports of mitochondrial toxicity, in particular lactic acidosis and pancreatitis, of which some fatal, have been reported

Drugs metabolised by CYP2C9, peginterferon alfa-2b [2] ---> SmPC of [2] of EMA

No dosing adjustment is necessary when peginterferon alfa-2b (PegIntron) is administered with medicines metabolized by CYP2C9, CYP3A4 and N-acetyltransferase.

Drugs metabolised by CYP3A4, peginterferon alfa-2b [2] ---> SmPC of [2] of EMA

No dosing adjustment is necessary when peginterferon alfa-2b (PegIntron) is administered with medicines metabolized by CYP2C9, CYP3A4 and N-acetyltransferase.

Drugs primarily metabolised by CYP2C9, peginterferon alfa-2b [2] ---> SmPC of [2] of EMA

No dosing adjustment is necessary when peginterferon alfa-2b (PegIntron) is administered with medicines metabolized by CYP2C9, CYP3A4 and N-acetyltransferase.

Drugs primarily metabolised by CYP2D6 with narrow therapeutic index, peginterferon alfa-2b [2] ---> SmPC of [2] of

When patients are administered PegIntron with medications metabolized by CYP1A2 or CYP2D6, the extent of the decrease in cytochrome P 450 activity is unlikely to have a clinical impact, except with medicines which have a narrow therapeutic margin

Drugs primarily metabolised by CYP3A4, peginterferon alfa-2b [2] ---> SmPC of [2] of EMA

No dosing adjustment is necessary when peginterferon alfa-2b (PegIntron) is administered with medicines metabolized by CYP2C9, CYP3A4 and N-acetyltransferase.

Immunosuppressives, peginterferon ---> SmPC of [peginterferon alfa-2b] of EMA

When administered in combination with other interferon preparations, effect of immunosuppressive therapy may be weakened in transplant (kidney, bone marrow, etc.) patients. It is considered that graft rejection reactions may be induced.

Immunosuppressives, peginterferon alfa-2b [2] ---> SmPC of [2] of EMA

When administered in combination with other interferon preparations, effect of immunosuppressive therapy may be weakened in transplant (kidney, bone marrow, etc.) patients. It is considered that graft rejection reactions may be induced.

Methadone, peginterferon alfa-2b [2] ---> SmPC of [2] of EMA

Patients should be monitored for signs and symptoms of increased sedative effect, as well as respiratory depression. Especially in patients on a high dose of methadone, the risk for QTc prolongation should be considered.

Midazolam, peginterferon alfa-2b [2] ---> SmPC of [2] of EMA

No dosing adjustment is necessary when peginterferon alfa-2b (PegIntron) is administered with medicines metabolized by CYP2C9, CYP3A4 and N-acetyltransferase.

Nucleoside analogues, peginterferon alfa-2b [2] ---> SmPC of [2] of EMA

Use of nucleoside analogs, alone or in combination with other nucleosides, has resulted in lactic acidosis.

Peginterferon alfa-2b [1], pregnancy ---> SmPC of [1] of EMA

Peginterferon alfa-2b is to be used during pregnancy only if the potential benefit justifies the potential risk to the foetus

Peginterferon alfa-2b [1], theophylline ---> SmPC of [1] of EMA

Co-administration of theophylline with the product (PegIntron) may increase the blood concentrations of theophylline. Metabolism of theophylline is suppressed by inhibitory action of the product (PegIntron) on CYP1A2.

Peginterferon alfa-2b [1], thioridazine ---> SmPC of [1] of EMA

Co-administration of thioridazine with the product (PegIntron) may increase the blood concentrations of thioridazine. Metabolism of thioridazine is suppressed by inhibitory action of the product (PegIntron) on CYP2D6.

Peginterferon alfa-2b [1], tolbutamide ---> SmPC of [1] of EMA

No dosing adjustment is necessary when peginterferon alfa-2b (PegIntron) is administered with medicines metabolized by CYP2C9, CYP3A4 and N-acetyltransferase.

Peginterferon alfa-2b [1], warfarin ---> SmPC of [1] of EMA

Elevation of blood concentrations of warfarin has been reported when administered in combination with other interferon preparations and therefore care should be taken. Metabolism of other medicines in the liver may be suppressed.

Peginterferon alfa-2b [1], zidovudine ---> SmPC of [1] of EMA

When administered in combination with other interferon preparations, suppressive effect on bone marrow function may be strengthened and aggravation of blood cell reduction such as white blood cells decreased may occur.

Peginterferon alfa-2b, ribavirin [2] ---> SmPC of [2] of EMA

Initiation of peginterferon alfa-2b is contraindicated in HCV/HIV patients with cirrhosis and a Child-Pugh score ≥ 6.

Peginterferon alfa-2b, telbivudine [2] ---> SmPC of [2] of EMA

This combination is associated with an increased risk of developing peripheral neuropathy. The combination of PegIntron with telbivudine is contraindicated

Peginterferon alfa-2b/ribavirin, pregnancy ---> SmPC of [peginterferon alfa-2b] of EMA

Ribavirin causes serious birth defects when administered during pregnancy, therefore ribavirin therapy is contraindicated in women who are pregnant.