U

Ublituximab (Briumvi)

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

A risk to the breast-fed infant cannot be excluded during this short period. Afterwards, ublituximab could be used during breast-feeding if clinically needed.

Disease modifying therapy, ublituximab [2] ---> SmPC of [2] of EMA

Caution should be exercised when prescribing Briumvi taking into consideration the pharmacodynamics of other disease modifying MS therapies.

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

Preclinical data reveal no special hazard on reproductive organs based on studies of general toxicity in cynomolgus monkeys (see section 5.3).

Immunosuppressives, ublituximab [2] ---> SmPC of [2] of EMA

It is not recommended to use other immunosuppressives concomitantly with ublituximab except corticosteroids for symptomatic treatment of relapses.

Pregnancy, ublituximab [2] ---> SmPC of [2] of EMA

Postponing vaccination with live or live-attenuated vaccines should be considered for neonates and infants born to mothers who have been exposed to ublituximab during pregnancy.

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

The safety of immunisation with live or live-attenuated vaccines, during or following therapy has not been studied and vaccination with live-attenuated or live vaccines is not recommended during treatment and not until B-cell repletion (see section 5.1).

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

Women of child-bearing potential should use effective contraception while receiving ublituximab and for at least 4 months after the last infusion

             CONTRAINDICATIONS of Ublituximab (Briumvi)           

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

             - Severe active infection (see section 4.4).

             - Patients in a severely immunocompromised state (see section 4.4).

             - Known active malignancies.

             https://www.ema.europa.eu/en/documents/product-information/briumvi-epar-product-information_en.pdf  06/05/2025 

Ulipristal (ellaOne)

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

Ulipristal acetate has minor or moderate influence on the ability to drive or use machines: mild to moderate dizziness is common after ellaOne intake, somnolence and blurred vision are uncommon; disturbance in attention has been rarely reported.

Barbiturates, ulipristal [2] ---> SmPC of [2] of EMA

Concomitant use of ellaOne with CYP3A4 inducers therefore reduces plasma concentrations of ulipristal acetate and may result in a decreased efficacy of ellaOne.

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

After intake of ulipristal acetate for emergency contraception, breast-feeding is not recommended for one week. During this time it is recommended to express and discard the breast milk in order to stimulate lactation.

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

Concomitant use of ellaOne with CYP3A4 inducers therefore reduces plasma concentrations of ulipristal acetate and may result in a decreased efficacy of ellaOne.

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

No dose adjustment is considered necessary for administration of ulipristal acetate to patients receiving concomitant mild CYP3A4 inhibitors.

Drugs metabolised by CYP1A2, ulipristal [2] ---> SmPC of [2] of EMA

Thus, administration of ulipristal acetate is unlikely to alter the clearance of medicinal products that are metabolised by these enzymes.

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

Thus, administration of ulipristal acetate is unlikely to alter the clearance of medicinal products that are metabolised by these enzymes.

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

Concomitant use of ellaOne with CYP3A4 inducers therefore reduces plasma concentrations of ulipristal acetate and may result in a decreased efficacy of ellaOne.

Enzyme inductors, ulipristal [2] ---> SmPC of [2] of EMA

For women who have used enzyme-inducing drugs in the past 4 weeks, ellaOne is not recommended (see section 4.4) and non-hormonal emergency contraception (i.e. a copper intrauterine device (Cu-IUD)) should be considered.

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

Following administration of the moderate CYP3A4 inhibitor erythromycin propionate (500 mg twice daily for 9 days) to healthy female volunteers, Cmax and AUC of ulipristal acetate increased 1.2 and 2.9 fold, respectively

Esomeprazole, ulipristal [2] ---> SmPC of [2] of EMA

Administration of ulipristal acetate together with the proton pump inhibitor esomeprazole resulted in approximately 65% lower mean Cmax, a delayed Tmax (from a median of 0.75 hours to 1.0 hours) and 13% higher mean AUC.

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

A rapid return of fertility is likely following treatment with ulipristal acetate for emergency contraception. Women should be advised to use a reliable barrier method for all subsequent acts of intercourse until the next menstrual period.

Fexofenadine, ulipristal [2] ---> SmPC of [2] of EMA

Results in vivo with the P-gp substrate fexofenadine were inconclusive. The effects of the P-gp substrates are unlikely to have any clinical consequences.

Fosphenytoin, ulipristal [2] ---> SmPC of [2] of EMA

Concomitant use of ellaOne with CYP3A4 inducers therefore reduces plasma concentrations of ulipristal acetate and may result in a decreased efficacy of ellaOne.

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

Concomitant use of ellaOne with CYP3A4 inducers therefore reduces plasma concentrations of ulipristal acetate and may result in a decreased efficacy of ellaOne.

Hormonal contraceptives, ulipristal [2] ---> SmPC of [2] of EMA

Because ulipristal acetate binds to the progesterone receptor with high affinity, it may interfere with the action of progestogen-containing medicinal products

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

Concomitant use of ulipristal acetate and emergency contraception containing levonorgestrel is not recommended (see section 4.4).

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

In vivo results show that administration of ulipristal with a potent and a moderate CYP3A4 inhibitor increased Cmax and AUC of ulipristal with a maximum of 2- and 5.9-fold. The effects of CYP3A4 inhibitors are unlikely to have any clinical consequences.

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

Concomitant use of ellaOne with CYP3A4 inducers therefore reduces plasma concentrations of ulipristal acetate and may result in a decreased efficacy of ellaOne.

Oxcarbazepine, ulipristal [2] ---> SmPC of [2] of EMA

Concomitant use of ellaOne with CYP3A4 inducers therefore reduces plasma concentrations of ulipristal acetate and may result in a decreased efficacy of ellaOne.

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

The effects of the P-gp substrates are unlikely to have any clinical consequences.

Phenobarbital, ulipristal [2] ---> SmPC of [2] of EMA

Concomitant use of ellaOne with CYP3A4 inducers therefore reduces plasma concentrations of ulipristal acetate and may result in a decreased efficacy of ellaOne.

Phenytoin, ulipristal [2] ---> SmPC of [2] of EMA

Concomitant use of ellaOne with CYP3A4 inducers therefore reduces plasma concentrations of ulipristal acetate and may result in a decreased efficacy of ellaOne.

Pregnancy, ulipristal [2] ---> SmPC of [2] of EMA

ellaOne is not intended for use during pregnancy and should not be taken by any woman suspected or known to be pregnant (see section 4.2). Ulipristal acetate does not interrupt an existing pregnancy.

Primidone, ulipristal [2] ---> SmPC of [2] of EMA

Concomitant use of ellaOne with CYP3A4 inducers therefore reduces plasma concentrations of ulipristal acetate and may result in a decreased efficacy of ellaOne.

Progestagens, ulipristal [2] ---> SmPC of [2] of EMA

Contraceptive action of combined hormonal contraceptives and progestogen-only contraception may be reduced

Proton pump inhibitors, ulipristal [2] ---> SmPC of [2] of EMA

Administration of ulipristal acetate together with the proton pump inhibitor esomeprazole resulted in approximately 65% lower mean Cmax, a delayed Tmax (from a median of 0.75 hours to 1.0 hours) and 13% higher mean AUC.

Rifabutin, ulipristal [2] ---> SmPC of [2] of EMA

Concomitant use of ellaOne with CYP3A4 inducers therefore reduces plasma concentrations of ulipristal acetate and may result in a decreased efficacy of ellaOne.

Rifampicin, ulipristal [2] ---> SmPC of [2] of EMA

Concomitant use of ellaOne with CYP3A4 inducers therefore reduces plasma concentrations of ulipristal acetate and may result in a decreased efficacy of ellaOne.

Ritonavir, ulipristal [2] ---> SmPC of [2] of EMA

The CYP3A4 inhibitor ritonavir can also have an inducing effect on CYP3A4 when ritonavir is used for a longer period.

Ritonavir, ulipristal [2] ---> SmPC of [2] of EMA

Concomitant use of ellaOne with CYP3A4 inducers therefore reduces plasma concentrations of ulipristal acetate and may result in a decreased efficacy of ellaOne.

St. John's wort, ulipristal [2] ---> SmPC of [2] of EMA

Concomitant use of ellaOne with CYP3A4 inducers therefore reduces plasma concentrations of ulipristal acetate and may result in a decreased efficacy of ellaOne.

Strong CYP3A4 inductors, ulipristal [2] ---> SmPC of [2] of EMA

Concomitant use of ellaOne with CYP3A4 inducers therefore reduces plasma concentrations of ulipristal acetate and may result in a decreased efficacy of ellaOne.

Strong CYP3A4 inhibitors, ulipristal [2] ---> SmPC of [2] of EMA

In vivo results show that administration of ulipristal with a potent and a moderate CYP3A4 inhibitor increased Cmax and AUC of ulipristal with a maximum of 2- and 5.9-fold. The effects of CYP3A4 inhibitors are unlikely to have any clinical consequences.

            CONTRAINDICATIONS of Ulipristal (ellaOne)

            - 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/ellaone-epar-product-information_en.pdf 29/09/2025 

Other trade names: Esmya (withdrawn), Ulipristal Acetate Gedeon Richter,

Ulipristal (Esmya)

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

Ulipristal acetate may have minor influence on the ability to drive or use machines as mild dizziness has been observed after ulipristal acetate intake.

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

The effect of medicinal products that increase gastric pH is not expected to be of clinical relevance for daily administration of ulipristal acetate tablets.

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

Ulipristal acetate is contraindicated during breast-feeding

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

Administration of the potent CYP3A4 inducers markedly decreased Cmax and AUC of ulipristal acetate and its active metabolite. Concomitant use of ulipristal acetate and potent CYP3A4 inducers is not recommended

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

No dose adjustment is considered necessary for administration of ulipristal acetate to patients receiving concomitant mild CYP3A4 inhibitors.

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

In vitro data indicate that ulipristal may be an inhibitor of P-gp in the gastrointestinal wall during absorption. It is recommended that co-administration of ulipristal acetate and P-gp substrates should be separated in time by at least 1.5 hours.

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

In vitro data indicate that ulipristal may be an inhibitor of P-gp in the gastrointestinal wall during absorption. It is recommended that co-administration of ulipristal acetate and P-gp substrates should be separated in time by at least 1.5 hours.

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

Administration of the potent CYP3A4 inducers markedly decreased Cmax and AUC of ulipristal acetate and its active metabolite. Concomitant use of ulipristal acetate and potent CYP3A4 inducers is not recommended

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

Following administration of the moderate CYP3A4 inhibitor erythromycin propionate (500 mg twice daily for 9 days) to healthy female volunteers, Cmax and AUC of ulipristal acetate increased 1.2 and 2.9 fold, respectively

Esomeprazole, ulipristal [2] ---> SmPC of [2] of EMA

The effect of medicinal products that increase gastric pH is not expected to be of clinical relevance for daily administration of ulipristal acetate tablets.

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

A majority of women taking a therapeutic dose of ulipristal acetate have anovulation, however, the level of fertility while taking multiple doses of ulipristal acetate has not been studied.

Fexofenadine, ulipristal [2] ---> SmPC of [2] of EMA

In vitro data indicate that ulipristal may be an inhibitor of P-gp in the gastrointestinal wall during absorption. It is recommended that co-administration of ulipristal acetate and P-gp substrates should be separated in time by at least 1.5 hours.

Fosphenytoin, ulipristal [2] ---> SmPC of [2] of EMA

Administration of the potent CYP3A4 inducers markedly decreased Cmax and AUC of ulipristal acetate and its active metabolite. Concomitant use of ulipristal acetate and potent CYP3A4 inducers is not recommended

Gastric pH increasing medication, ulipristal [2] ---> SmPC of [2] of EMA

The effect of medicinal products that increase gastric pH is not expected to be of clinical relevance for daily administration of ulipristal acetate tablets.

Gestagens, ulipristal [2] ---> SmPC of [2] of EMA

Hormonal contraceptives and progestagens are likely to reduce ulipristal acetate efficacy by competitive action on the progesterone receptor. Therefore concomitant administration of medicinal products containing progestagen is not recommended

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

The effect of medicinal products that increase gastric pH is not expected to be of clinical relevance for daily administration of ulipristal acetate tablets.

Hormonal contraceptives, ulipristal [2] ---> SmPC of [2] of EMA

Ulipristal acetate has a steroid structure and acts as a selective progesterone receptor modulator with predominantly inhibitory effects on the progesterone receptor.

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

Following administration of the potent CYP3A4 inhibitor ketoconazole (400 mg once daily for 7 days) to healthy female volunteers, Cmax and AUC of ulipristal acetate increased 2 and 5.9 fold, respectively

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

Co-administration of moderate or potent CYP3A4 inhibitors and ulipristal acetate is not recommended (see section 4.4).

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

Administration of the potent CYP3A4 inducers markedly decreased Cmax and AUC of ulipristal acetate and its active metabolite. Concomitant use of ulipristal acetate and potent CYP3A4 inducers is not recommended

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

Ulipristal acetate may interfere with the action of hormonal contraceptive products. Medicinal products containing progestagen should not be taken within 12 days after cessation of ulipristal acetate treatment.

Oxcarbazepine, ulipristal [2] ---> SmPC of [2] of EMA

Administration of the potent CYP3A4 inducers markedly decreased Cmax and AUC of ulipristal acetate and its active metabolite. Concomitant use of ulipristal acetate and potent CYP3A4 inducers is not recommended

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

In vitro data indicate that ulipristal may be an inhibitor of P-gp in the gastrointestinal wall during absorption. It is recommended that co-administration of ulipristal acetate and P-gp substrates should be separated in time by at least 1.5 hours.

Phenobarbital, ulipristal [2] ---> SmPC of [2] of EMA

Administration of the potent CYP3A4 inducers markedly decreased Cmax and AUC of ulipristal acetate and its active metabolite. Concomitant use of ulipristal acetate and potent CYP3A4 inducers is not recommended

Phenytoin, ulipristal [2] ---> SmPC of [2] of EMA

Administration of the potent CYP3A4 inducers markedly decreased Cmax and AUC of ulipristal acetate and its active metabolite. Concomitant use of ulipristal acetate and potent CYP3A4 inducers is not recommended

Pregnancy, ulipristal [2] ---> SmPC of [2] of EMA

Ulipristal acetate is contraindicated during pregnancy

Primidone, ulipristal [2] ---> SmPC of [2] of EMA

Administration of the potent CYP3A4 inducers markedly decreased Cmax and AUC of ulipristal acetate and its active metabolite. Concomitant use of ulipristal acetate and potent CYP3A4 inducers is not recommended

Progestagens, ulipristal [2] ---> SmPC of [2] of EMA

Ulipristal acetate has a steroid structure and acts as a selective progesterone receptor modulator with predominantly inhibitory effects on the progesterone receptor.

Proton pump inhibitors, ulipristal [2] ---> SmPC of [2] of EMA

The effect of medicinal products that increase gastric pH is not expected to be of clinical relevance for daily administration of ulipristal acetate tablets.

Rifabutin, ulipristal [2] ---> SmPC of [2] of EMA

Administration of the potent CYP3A4 inducers markedly decreased Cmax and AUC of ulipristal acetate and its active metabolite. Concomitant use of ulipristal acetate and potent CYP3A4 inducers is not recommended

Rifampicin, ulipristal [2] ---> SmPC of [2] of EMA

Administration of the potent CYP3A4 inducers markedly decreased Cmax and AUC of ulipristal acetate and its active metabolite. Concomitant use of ulipristal acetate and potent CYP3A4 inducers is not recommended

Ritonavir, ulipristal [2] ---> SmPC of [2] of EMA

Administration of the potent CYP3A4 inducers markedly decreased Cmax and AUC of ulipristal acetate and its active metabolite. Concomitant use of ulipristal acetate and potent CYP3A4 inducers is not recommended

St. John's wort, ulipristal [2] ---> SmPC of [2] of EMA

Administration of the potent CYP3A4 inducers markedly decreased Cmax and AUC of ulipristal acetate and its active metabolite. Concomitant use of ulipristal acetate and potent CYP3A4 inducers is not recommended

Strong CYP3A4 inductors, ulipristal [2] ---> SmPC of [2] of EMA

Administration of the potent CYP3A4 inducers markedly decreased Cmax and AUC of ulipristal acetate and its active metabolite. Concomitant use of ulipristal acetate and potent CYP3A4 inducers is not recommended

Strong CYP3A4 inhibitors, ulipristal [2] ---> SmPC of [2] of EMA

Co-administration of moderate or potent CYP3A4 inhibitors and ulipristal acetate is not recommended (see section 4.4).

Ulipristal [1], women ---> SmPC of [1] of EMA

Although a majority of women taking a therapeutic dose of ulipristal acetate have anovulation, a non hormonal contraceptive method is recommended during treatment (see sections 4.4 and 4.5).

             CONTRAINDICATIONS of Ulipristal (Esmya)     

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

             - Pregnancy and breastfeeding.

             - Genital bleeding of unknown aetiology or for reasons other than uterine fibroids.

             - Uterine, cervical, ovarian or breast cancer.

             - Underlying hepatic disorder.

             https://www.ema.europa.eu/en/documents/product-information/esmya-epar-product-information_en.pdf 03/02/2021 (withdrawn) 

Other trade names: ellaOne, Ulipristal Acetate Gedeon Richter,

Umeclidinium (Incruse Ellipta) 

Anticholinergics, umeclidinium [2] ---> SmPC of [2] of EMA

Co-administration of umeclidinium bromide with other long-acting muscarinic antagonists is not recommended as it may potentiate known inhaled muscarinic antagonist adverse reactions.

Antimuscarinic agents, umeclidinium [2] ---> SmPC of [2] of EMA

It is not recommended as it may potentiate known inhaled muscarinic antagonist adverse reactions.

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

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

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

Based on the magnitude of these changes, no clinically relevant drug interaction is expected when umeclidinium is co-administered with CYP2D6 inhibitors or when administered to subjects genetically deficient in CYP2D6 activity (poor metabolisers).

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

There are no data on the effects of umeclidinium on human fertility. Animal studies indicate no effects of umeclidinium on fertility.

Interactions, umeclidinium [2] ---> SmPC of [2] of EMA

Clinically significant interactions mediated by umeclidinium at clinical doses are considered unlikely due to the low plasma concentrations achieved after inhaled dosing.

P-gp inhibitors, umeclidinium [2] ---> SmPC of [2] of EMA

No clinically relevant drug interaction is expected when umeclidinium is co-administered with P-gp inhibitors

Pregnancy, umeclidinium [2] ---> SmPC of [2] of EMA

Umeclidinium bromide should be used during pregnancy only if the expected benefit to the mother justifies the potential risk to the fetus.

Strong CYP2D6 inhibitors, umeclidinium [2] ---> SmPC of [2] of EMA

Based on the magnitude of these changes, no clinically relevant drug interaction is expected when umeclidinium is co-administered with CYP2D6 inhibitors or when administered to subjects genetically deficient in CYP2D6 activity (poor metabolisers).

Strong P-gp inhibitors, umeclidinium [2] ---> SmPC of [2] of EMA

No clinically relevant drug interaction is expected when umeclidinium is co-administered with P-gp inhibitors

Sympathomimetics, umeclidinium [2] ---> SmPC of [2] of EMA

Inhaled umeclidinium has been used concomitantly with other COPD medicinal products including short and long acting sympathomimetic bronchodilators and inhaled corticosteroids without clinical evidence of interactions.

Umeclidinium [1], verapamil ---> SmPC of [1] of EMA

No effect of verapamil was observed on umeclidinium bromide Cmax.

             CONTRAINDICATIONS of Umeclidinium (Incruse Ellipta)                       

             - 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/incruse-ellipta-epar-product-information_en.pdf 13/02/2024

Other trade names: Incruse Ellipta (previously Incruse), Anoro Ellipta, Rolufta Ellipta (previously Rolufta),

Umeclidinium/vilanterol (Laventair Ellipta)

Anticholinergics, umeclidinium/vilanterol [2] ---> SmPC of [2] of EMA

Co-administration of umeclidinium bromide with other long-acting muscarinic antagonists is not recommended as it may potentiate known inhaled muscarinic antagonist adverse reactions.

Beta-adrenergic receptor blockers, beta2-adrenergic agonists ---> SmPC of [umeclidinium/vilanterol] of EMA

Beta-adrenergic blockers may weaken or antagonise the effect of beta2-adrenergic agonists. Concurrent use of either non-selective or selective betablockers should be avoided unless there are compelling reasons for their use.

Beta-adrenergic receptor blockers, umeclidinium/vilanterol [2] ---> SmPC of [2] of EMA

Beta-adrenergic blockers may weaken or antagonise the effect of beta2-adrenergic agonists. Concurrent use of either non-selective or selective betablockers should be avoided unless there are compelling reasons for their use.

Beta-adrenergic receptor blockers, vilanterol ---> SmPC of [umeclidinium/vilanterol] of EMA

Beta-adrenergic blockers may weaken or antagonise the effect of beta2-adrenergic agonists. Concurrent use of either non-selective or selective betablockers should be avoided unless there are compelling reasons for their use.

Beta2-adrenergic agonists, non-potassium-sparing diuretics ---> SmPC of [umeclidinium/vilanterol] of EMA

Concomitant hypokalaemic treatment with non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, therefore use with caution

Beta2-adrenergic agonists, umeclidinium/vilanterol [2] ---> SmPC of [2] of EMA

Co-administration of umeclidinium/vilanterol with long-acting beta2-adrenergic agonists is not recommended as it may potentiate beta2-adrenergic agonist adverse reactions

Beta2-adrenergic agonists, vilanterol ---> SmPC of [umeclidinium/vilanterol] of EMA

Co-administration of vilanterol with long-acting beta2-adrenergic agonists is not recommended as it may potentiate beta2-adrenergic agonist adverse reactions

Beta2-adrenergic agonists, xanthines ---> SmPC of [umeclidinium/vilanterol] of EMA

Concomitant hypokalaemic treatment with methylxanthine may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, therefore use with caution

Betablockers, umeclidinium/vilanterol [2] ---> SmPC of [2] of EMA

Betablockers may weaken or antagonise the effect of beta2-adrenergic agonists, such as vilanterol. Concurrent use of either non-selective or selective betablockers should be avoided unless there are compelling reasons for their use.

Breast-feeding, umeclidinium/vilanterol [2] ---> SmPC of [2] of EMA

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

Clarithromycin, umeclidinium/vilanterol [2] ---> SmPC of [2] of EMA

Care is advised when co-administering umeclidinium/vilanterol with ketoconazole and other known strong CYP3A4 inhibitors as there is potential for an increased systemic exposure to vilanterol

Clarithromycin, vilanterol ---> SmPC of [umeclidinium/vilanterol] of EMA

Concomitant administration of strong CYP3A4 inhibitors may inhibit the metabolism of, and increase the systemic exposure to, vilanterol. Care is advised

CYP2D6 inhibitors, umeclidinium/vilanterol [2] ---> SmPC of [2] of EMA

Based on the magnitude of these changes, no clinically relevant interaction is expected when umeclidinium/vilanterol is co-administered with CYP2D6 inhibitors or when administered to patients genetically deficient in CYP2D6 activity (poor metabolisers).

Fertility, umeclidinium/vilanterol [2] ---> SmPC of [2] of EMA

There are no data on the effects of umeclidinium/vilanterol on human fertility. Animal studies indicate no effects of umeclidinium or vilanterol on fertility.

Hypokalemia, umeclidinium/vilanterol [2] ---> SmPC of [2] of EMA

Concomitant hypokalaemic treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, therefore use with caution (see section 4.4).

Interactions, umeclidinium/vilanterol [2] ---> SmPC of [2] of EMA

Inhaled umeclidinium/vilanterol has been used concomitantly with other COPD medicinal products including short acting sympathomimetic bronchodilators and inhaled corticosteroids without clinical evidence of drug interactions.

Interactions, umeclidinium/vilanterol [2] ---> SmPC of [2] of EMA

Clinically significant interactions mediated by umeclidinium/vilanterol at clinical doses are considered unlikely due to the low plasma concentrations achieved after inhaled dosing.

Itraconazol, umeclidinium/vilanterol [2] ---> SmPC of [2] of EMA

Care is advised when co-administering umeclidinium/vilanterol with ketoconazole and other known strong CYP3A4 inhibitors as there is potential for an increased systemic exposure to vilanterol

Itraconazol, vilanterol ---> SmPC of [umeclidinium/vilanterol] of EMA

Concomitant administration of strong CYP3A4 inhibitors may inhibit the metabolism of, and increase the systemic exposure to, vilanterol. Care is advised

Ketoconazole, umeclidinium/vilanterol [2] ---> SmPC of [2] of EMA

Care is advised when co-administering umeclidinium/vilanterol with ketoconazole and other known strong CYP3A4 inhibitors as there is potential for an increased systemic exposure to vilanterol

Ketoconazole, vilanterol ---> SmPC of [umeclidinium/vilanterol] of EMA

Concomitant administration of strong CYP3A4 inhibitors may inhibit the metabolism of, and increase the systemic exposure to, vilanterol. Care is advised

Non-potassium-sparing diuretics, umeclidinium/vilanterol [2] ---> SmPC of [2] of EMA

Concomitant hypokalaemic treatment with non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, therefore use with caution

Non-potassium-sparing diuretics, vilanterol ---> SmPC of [umeclidinium/vilanterol] of EMA

Concomitant hypokalaemic treatment with non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, therefore use with caution

P-gp inhibitors, umeclidinium/vilanterol [2] ---> SmPC of [2] of EMA

Based on the magnitude of these changes, no clinically relevant drug interaction is expected when umeclidinium/vilanterol is co-administered with P-gp inhibitors.

Pregnancy, umeclidinium/vilanterol [2] ---> SmPC of [2] of EMA

Umeclidinium/vilanterol should be used during pregnancy only if the expected benefit to the mother justifies the potential risk to the fetus.

Ritonavir, umeclidinium/vilanterol [2] ---> SmPC of [2] of EMA

Care is advised when co-administering umeclidinium/vilanterol with ketoconazole and other known strong CYP3A4 inhibitors as there is potential for an increased systemic exposure to vilanterol

Ritonavir, vilanterol ---> SmPC of [umeclidinium/vilanterol] of EMA

Concomitant administration of strong CYP3A4 inhibitors may inhibit the metabolism of, and increase the systemic exposure to, vilanterol. Care is advised

Strong CYP3A4 inhibitors, umeclidinium/vilanterol [2] ---> SmPC of [2] of EMA

Care is advised when co-administering umeclidinium/vilanterol with ketoconazole and other known strong CYP3A4 inhibitors as there is potential for an increased systemic exposure to vilanterol

Strong CYP3A4 inhibitors, vilanterol ---> SmPC of [umeclidinium/vilanterol] of EMA

Concomitant administration of strong CYP3A4 inhibitors may inhibit the metabolism of, and increase the systemic exposure to, vilanterol. Care is advised

Strong P-gp inhibitors, umeclidinium/vilanterol [2] ---> SmPC of [2] of EMA

No clinically relevant drug interaction is expected when umeclidinium is co-administered with P-gp inhibitors

Telithromycin, umeclidinium/vilanterol [2] ---> SmPC of [2] of EMA

Care is advised when co-administering umeclidinium/vilanterol with ketoconazole and other known strong CYP3A4 inhibitors as there is potential for an increased systemic exposure to vilanterol

Telithromycin, vilanterol ---> SmPC of [umeclidinium/vilanterol] of EMA

Concomitant administration of strong CYP3A4 inhibitors may inhibit the metabolism of, and increase the systemic exposure to, vilanterol. Care is advised

Umeclidinium/vilanterol [1], verapamil ---> SmPC of [1] of EMA

Verapamil, a moderate CYP3A4 inhibitor, did not significantly affect the pharmacokinetics of vilanterol.

Umeclidinium/vilanterol [1], xanthines ---> SmPC of [1] of EMA

Concomitant hypokalaemic treatment with methylxanthine may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, therefore use with caution

Vilanterol, xanthines ---> SmPC of [umeclidinium/vilanterol] of EMA

Concomitant hypokalaemic treatment with methylxanthine may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists, therefore use with caution

            CONTRAINDICATIONS of Umeclidinium/vilanterol (Laventair Ellipta)

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

            https://www.ema.europa.eu/en/documents/product-information/laventair-ellipta-epar-product-information_en.pdf 27/08/2025 

Other trade names: Anoro Ellipta (previously Anoro),

Upadacitinib (Rinvoq)

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

Upadacitinib may have a minor influence on the ability to drive and use machines because dizziness and vertigo may occur during treatment with RINVOQ (see section 4.8).

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

Methotrexate and pH modifying medicinal products (e.g., antacids or proton pump inhibitors) have no effect on upadacitinib plasma exposures.

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

No dose adjustment is recommended for CYP3A substrates or for rosuvastatin or atorvastatin when coadministered with upadacitinib.

Azathioprine, upadacitinib [2] ---> SmPC of [2] of EMA

Combination with other potent immunosuppressants has not been evaluated in clinical studies and is not recommended as a risk of additive immunosuppression cannot be excluded.

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

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

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

Upadacitinib exposure is increased when co-administered with strong CYP3A4 inhibitors. Consider alternatives to strong CYP3A4 inhibitor medications when used in the long-term.

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

Combination with other potent immunosuppressants has not been evaluated in clinical studies and is not recommended as a risk of additive immunosuppression cannot be excluded.

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

Administration of multiple 45 mg once daily doses of upadacitinib to healthy subjects led to a limited increase in AUC and Cmax of dextromethorphan (sensitive CYP2D6 substrate) by 30% and 35%, respectively,

Disease modifying anti-rheumatic drug, upadacitinib [2] ---> SmPC of [2] of EMA

Combination with other potent immunosuppressants has not been evaluated in clinical studies and is not recommended as a risk of additive immunosuppression cannot be excluded.

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

No dose adjustment is recommended for CYP3A substrates, CYP2D6 substrates, rosuvastatin or atorvastatin when coadministered with upadacitinib.

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

Upadacitinib has no relevant effects on plasma exposures of ethinylestradiol, levonorgestrel, methotrexate, or medicinal products that are substrates for metabolism by CYP1A2, CYP2B6, CYP2C9, CYP2C19, or CYP2D6.

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

The effect of upadacitinib on human fertility has not been evaluated. Animal studies do not indicate effects with respect to fertility (see section 5.3).

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

Food or drink containing grapefruit should be avoided during treatment with upadacitinib.

Gastric pH increasing medication, upadacitinib [2] ---> SmPC of [2] of EMA

Methotrexate and pH modifying medicinal products (e.g., antacids or proton pump inhibitors) have no effect on upadacitinib plasma exposures.

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

Upadacitinib exposure is increased when co-administered with strong CYP3A4 inhibitors. Consider alternatives to strong CYP3A4 inhibitor medications when used in the long-term.

Immunosuppressives, upadacitinib [2] ---> SmPC of [2] of EMA

Combination with other potent immunosuppressants has not been evaluated in clinical studies and is not recommended as a risk of additive immunosuppression cannot be excluded.

Infection, upadacitinib [2] ---> SmPC of [2] of EMA

Serious and sometimes fatal infections have been reported in patients receiving upadacitinib.

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

Upadacitinib exposure is increased when co-administered with strong CYP3A4 inhibitors. Consider alternatives to strong CYP3A4 inhibitor medications when used in the long-term.

Janus kinase inhibitor, upadacitinib [2] ---> SmPC of [2] of EMA

Combination with other potent immunosuppressants has not been evaluated in clinical studies and is not recommended as a risk of additive immunosuppression cannot be excluded.

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

Upadacitinib exposure is increased when co-administered with strong CYP3A4 inhibitors. Consider alternatives to strong CYP3A4 inhibitor medications when used in the long-term.

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

Upadacitinib has no relevant effects on plasma exposures of ethinylestradiol, levonorgestrel, methotrexate, or medicinal products that are substrates for metabolism by CYP1A2, CYP2B6, CYP2C9, CYP2C19, or CYP2D6.

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

Methotrexate and pH modifying medicinal products (e.g., antacids or proton pump inhibitors) have no effect on upadacitinib plasma exposures.

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

No dose adjustment is recommended for CYP3A substrates or for rosuvastatin or atorvastatin when coadministered with upadacitinib.

Phenytoin, upadacitinib [2] ---> SmPC of [2] of EMA

Upadacitinib exposure is decreased when co-administered with strong CYP3A4 inducers (such as rifampin and phenytoin), which may lead to reduced therapeutic effect of upadacitinib.

Posaconazole, upadacitinib [2] ---> SmPC of [2] of EMA

Upadacitinib exposure is increased when co-administered with strong CYP3A4 inhibitors. Consider alternatives to strong CYP3A4 inhibitor medications when used in the long-term.

Pregnancy, upadacitinib [2] ---> SmPC of [2] of EMA

Upadacitinib is contraindicated during pregnancy (see section 4.3). If a patient becomes pregnant while taking upadacitinib the parents should be informed of the potential risk to the foetus.

Proton pump inhibitors, upadacitinib [2] ---> SmPC of [2] of EMA

Methotrexate and pH modifying medicinal products (e.g., antacids or proton pump inhibitors) have no effect on upadacitinib plasma exposures.

Rifampicin, upadacitinib [2] ---> SmPC of [2] of EMA

Upadacitinib exposure is decreased when co-administered with strong CYP3A4 inducers (such as rifampin and phenytoin), which may lead to reduced therapeutic effect of upadacitinib.

Rosuvastatin, upadacitinib [2] ---> SmPC of [2] of EMA

No dose adjustment is recommended for CYP3A substrates or for rosuvastatin or atorvastatin when coadministered with upadacitinib.

Strong CYP3A4 inductors, upadacitinib [2] ---> SmPC of [2] of EMA

Upadacitinib exposure is decreased when co-administered with strong CYP3A4 inducers (such as rifampin and phenytoin), which may lead to reduced therapeutic effect of upadacitinib.

Strong CYP3A4 inhibitors, upadacitinib [2] ---> SmPC of [2] of EMA

Upadacitinib exposure is increased when co-administered with strong CYP3A4 inhibitors. Consider alternatives to strong CYP3A4 inhibitor medications when used in the long-term.

Tacrolimus, upadacitinib [2] ---> SmPC of [2] of EMA

Combination with other potent immunosuppressants has not been evaluated in clinical studies and is not recommended as a risk of additive immunosuppression cannot be excluded.

Upadacitinib [1], vaccinations with live organism vaccines ---> SmPC of [1] of EMA

Live vaccines are not recommended while using RINVOQ

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

Upadacitinib exposure is increased when co-administered with strong CYP3A4 inhibitors. Consider alternatives to strong CYP3A4 inhibitor medications when used in the long-term.

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

Women of childbearing potential should be advised to use effective contraception during treatment and for 4 weeks following the final dose of upadacitinib.

            CONTRAINDICATIONS of Upadacitinib (Rinvoq)    

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

            - Active tuberculosis (TB) or active serious infections (see section 4.4).   

            - Severe hepatic impairment (see section 4.2).  

            - Pregnancy (see section 4.6).   

            https://www.ema.europa.eu/en/documents/product-information/rinvoq-epar-product-information_en.pdf 24/07/2024             

Urapidil

ACE inhibitors, urapidil

The co-administration of ACE inhibitors and urapidil is not recommended

Ability to drive, urapidil

It may alter the capacity to react

Alcohol, urapidil

The antihypertensive effect of urapidil may be enhanced with alcohol intake

Alfa-adrenergic receptor blockers, urapidil

The antihypertensive effect of urapidil may be enhanced with the concomitant use of alfa-receptor antagonists

Antihypertensives, urapidil

The antihypertensive effect of urapidil may be enhanced with the concomitant use of other antihypertensive drugs

Barbiturates, urapidil

Urapidil at large doses may prolong the effect duration of barbiturates

Breast-feeding, urapidil

Urapidil should not be used during breastfeeding

Cimetidine, urapidil

The co-administration of urapidil and cimetidine may increase the plasma levels of urapidil

Corticosteroids, urapidil

The co-administration may decrease the hypotensive effect due to water and sodium retention

Diuretics, urapidil

The antihypertensive effect of urapidil may be enhanced with the concomitant use of other antihypertensive drugs

Imipramine, urapidil

Hypotensive effect and risk of orthostatic hypotension

Levomethadone, urapidil

Possible enhancement of levomethadone effect

Neuroleptics, urapidil

Hypotensive effect and risk of orthostatic hypotension

Pregnancy, urapidil

Urapidil should not be used during pregnancy

Urofollitropin

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

Urofollitropin is contraindicated in women who are lactating

Clomiphene, urofollitropin [2] ---> SmPC of [2] of eMC

Although there is no clinical experience, it is expected that the concomitant use of urofollitropin and clomiphene citrate may enhance the follicular response.

GnRH agonists, urofollitropin [2] ---> SmPC of [2] of eMC

When using a GnRH agonist for pituitary desensitisation, a higher dose of urofollitropin may be necessary to achieve adequate follicular response.

Pregnancy, urofollitropin [2] ---> SmPC of [2] of eMC

Urofollitropin is contraindicated in women who are pregnant

Urokinase

Acetylsalicylic acid, urokinase [2] ---> SmPC of [2] of eMC

Due to increased risk of haemorrhage, concomitant use of urokinase and active substances that affect platelet function should be avoided

Allopurinol, urokinase

Due to increased risk of haemorrhage, concomitant use of urokinase and active substances that affect platelet function should be avoided

Aminocaproic acid, urokinase

Effect inhibition of urokinase

Antifibrinolytics, urokinase

Effect inhibition of urokinase

Aprotinin, urokinase

Aprotinin has a dose-dependent inhibitor effect on the effect of thrombolytic agents

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

It is unknown whether urokinase is excreted into human breast milk. Breast-feeding should be avoided during treatment with urokinase.

Clopidogrel, urokinase [2] ---> SmPC of [2] of eMC

Due to increased risk of haemorrhage, concomitant use of urokinase and active substances that affect platelet function should be avoided

Dextran, urokinase [2] ---> SmPC of [2] of eMC

Due to increased risk of haemorrhage, concomitant use of urokinase and active substances that affect platelet function should be avoided

Fibrates, urokinase

Due to increased risk of haemorrhage, concomitant use of urokinase and active substances that affect platelet function should be avoided

Heparin, urokinase [2] ---> SmPC of [2] of eMC

Oral anticoagulants or heparin may increase the risk of haemorrhage and should not be used concomitantly with urokinase.

Indometacin, urokinase [2] ---> SmPC of [2] of eMC

Due to increased risk of haemorrhage, concomitant use of urokinase and active substances that affect platelet function should be avoided

NSAID, urokinase [2] ---> SmPC of [2] of eMC

Due to increased risk of haemorrhage, concomitant use of urokinase and active substances that affect platelet function should be avoided

Oral anticoagulants, urokinase [2] ---> SmPC of [2] of eMC

Oral anticoagulants or heparin may increase the risk of haemorrhage and should not be used concomitantly with urokinase.

Paraaminobenzoic acid, urokinase

Effect inhibition of urokinase

Phenylbutazone, urokinase [2] ---> SmPC of [2] of eMC

Due to increased risk of haemorrhage, concomitant use of urokinase and active substances that affect platelet function should be avoided

Platelet aggregation inhibitors, urokinase [2] ---> SmPC of [2] of eMC

Due to increased risk of haemorrhage, concomitant use of urokinase and active substances that affect platelet function should be avoided

Pregnancy, urokinase [2] ---> SmPC of [2] of eMC

Urokinase should not be used during pregnancy or in the immediate post-partum period unless clearly necessary.

Radiologic contrasts, urokinase [2] ---> SmPC of [2] of eMC

Contrast agents may delay fibrinolysis.

Sulphamides, urokinase

Due to increased risk of haemorrhage, concomitant use of urokinase and active substances that affect platelet function should be avoided

Sulphonamides, urokinase

Due to increased risk of haemorrhage, concomitant use of urokinase and active substances that affect platelet function should be avoided

Tetracyclines, urokinase

Due to increased risk of haemorrhage, concomitant use of urokinase and active substances that affect platelet function should be avoided

Thiouracil, urokinase

Due to increased risk of haemorrhage, concomitant use of urokinase and active substances that affect platelet function should be avoided

Ticlopidine, urokinase [2] ---> SmPC of [2] of eMC

Due to increased risk of haemorrhage, concomitant use of urokinase and active substances that affect platelet function should be avoided

Tranexamic acid, urokinase

Effect inhibition of urokinase

Urokinase, valproic acid

Due to increased risk of haemorrhage, concomitant use of urokinase and active substances that affect platelet function should be avoided

           CONTRAINDICATIONS of Urokinase

           - Hypersensitivity to the active substance or to any of the excipients

           - Active clinically relevant bleeding

           - Aneurysm and arteriovenous malformation

           - Intracranial neoplasm or other neoplasm with risk of haemorrhage

           - Decreased blood coagulation (haemorrhagic diathesis, concomitant therapy with anticoagulants, spontaneous fibrinolysis) and severe thrombocytopenia

           - Severe uncontrolled arterial hypertension (systolic > 200 mmHg, diastolic > 100 mmHg; grade III or IV hypertensive retinopathy)

           - Acute pancreatitis, pericarditis, bacterial endocarditis, sepsis

           - Recent cerebrovascular accident (e.g. within 2 months)

           - Recent trauma including cardiopulmonary resuscitation, thoracic surgery or neurosurgery (e.g. within 2 months)

           - Recent major surgery until primary wound healing, recent organ biopsy, lumbar puncture, translumbal aortography (e.g. within 10 days)

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

Ursodeoxycholic acid

Aluminium hydroxide, ursodeoxycholic acid [2] ---> SmPC of [2] of eMC

Ursodeoxycholic acid should not be coadministered with antacids containing aluminium, because they bind the acid in the gut and inhibit its absorption and efficacy. It must be taken at least 2 hours before or after ursodeoxycholic acid

Aluminium oxide, ursodeoxycholic acid [2] ---> SmPC of [2] of eMC

Ursodeoxycholic acid should not be coadministered with antacids containing aluminium, because they bind the acid in the gut and inhibit its absorption and efficacy. It must be taken at least 2 hours before or after ursodeoxycholic acid

Bile-acid sequestrants, ursodeoxycholic acid

Possible inhibition of the ursodeoxycholic acid absorption. The resins must be taken at least 2 hours before or after of the ursodeoxycholic acid

Breast-feeding, ursodeoxycholic acid [2] ---> SmPC of [2] of eMC

Ursodeoxycholic acid should not be taken during lactation. If treatment is necessary, the infant should be weaned.

Calcium acetate [1], ursodeoxycholic acid ---> SmPC of [1] of eMC

The co-administration may decrease the absorption of ursodeoxycholic acid. It is recommended to administer the two substances at least 2 hours apart.

Cholestyramine, ursodeoxycholic acid [2] ---> SmPC of [2] of eMC

Ursodeoxycholic acid should not be coadministered with colestyramine, because it binds ursodeoxycholic acid in the gut and thereby inhibits its absorption and efficacy. It must be taken at least 2 hours before or after ursodeoxycholic acid

Ciprofloxacin, ursodeoxycholic acid [2] ---> SmPC of [2] of eMC

In isolated cases ursodeoxycholic acid can reduce the absorption of ciprofloxacin.

Clofibrate, ursodeoxycholic acid [2] ---> SmPC of [2] of eMC

Blood cholesterol lowering agents such as clofibrate may increase biliary lithiasis, which is a counter -effect to ursodeoxycholic acid used for dissolution of gallstones.

Colestipol, ursodeoxycholic acid [2] ---> SmPC of [2] of eMC

Ursodeoxycholic acid should not be coadministered with colestipol, because it binds ursodeoxycholic acid in the gut and thereby inhibits its absorption and efficacy. It must be taken at least 2 hours before or after ursodeoxycholic acid

Cyclosporine, ursodeoxycholic acid [2] ---> SmPC of [2] of eMC

Ursodeoxycholic acid can increase the absorption of ciclosporin from the intestine.

Dapsone, ursodeoxycholic acid [2] ---> SmPC of [2] of eMC

An interaction with a reduction of the therapeutic effect of dapsone was reported.

Drugs primarily metabolised by CYP3A4, ursodeoxycholic acid

Ursodeoxycholic acid, CYP3A4 inductor, may decrease the plasma concentrations of the medicinal products mainly metabolized by CYP3A4

Estrogens, ursodeoxycholic acid [2] ---> SmPC of [2] of eMC

Oestrogenic hormones may increase biliary lithiasis, which is a counter -effect to ursodeoxycholic acid used for dissolution of gallstones.

Lipid-lowering agents, ursodeoxycholic acid [2] ---> SmPC of [2] of eMC

Blood cholesterol lowering agents such as clofibrate may increase biliary lithiasis, which is a counter -effect to ursodeoxycholic acid used for dissolution of gallstones.

Magaldrate, ursodeoxycholic acid

The co-administration may decrease the absorption of ursodeoxycholic acid. It is recommended to administer the two substances at least 2 hours apart.

Nitrendipine, ursodeoxycholic acid [2] ---> SmPC of [2] of eMC

Ursodeoxycholic acid has been shown to reduce the plasma peak concentrations (Cmax) and the area under the curve (AUC) of the calcium antagonist nitrendipine.

Oral contraceptives, ursodeoxycholic acid

Ursodeoxycholic acid adversely interacts with oral contraceptives. Therefore, an alternative, effective and safe method of contraception should be used during treatment

Pregnancy, ursodeoxycholic acid [2] ---> SmPC of [2] of eMC

Ursodeoxycholic acid must not be used during pregnancy unless clearly necessary.

Sucralfate, ursodeoxycholic acid

Concomitant administration of sucralfate may reduce the bioavailability of ursodeoxycholic acid. The bioavailability may be restored by separating the administration from sucralfate by 2 hours.

           CONTRAINDICATIONS of Ursodeoxycholic acid

           Ursofalk 250 mg hard capsules should not be used in patients with:

           - Acute inflammation of the gall bladder or biliary tract

           - occlusion of the biliary tract (occlusion of the common bile duct or a cystic duct)

           - frequent episodes of biliary colic

           - radio]opaque calcified gallstones

           - impaired contractility of the gall bladder

           - hypersensitivity to bile acids or any excipient of the formulation

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

Ustekinumab (Stelara)

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

The effect of the most frequently used concomitant medicinal products in patients with psoriasis on pharmacokinetics of ustekinumab was explored. There were no indications of an interaction with these concomitantly administered medicinal products.

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

The effect of the most frequently used concomitant medicinal products in patients with psoriasis on pharmacokinetics of ustekinumab was explored. There were no indications of an interaction with these concomitantly administered medicinal products.

Azathioprine, ustekinumab [2] ---> SmPC of [2] of EMA

The pharmacokinetics of ustekinumab was not impacted by concomitant use of MTX, NSAIDs, 6-mercaptopurine, azathioprine and oral corticosteroids in patients with psoriatic arthritis, Crohn's disease or ulcerative colitis

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

A decision on whether to discontinue breast-feeding during treatment and up to 15 weeks after treatment or to discontinue therapy with STELARA must be made taking into account the benefit of breast-feeding to the child and the benefit of STELARA

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

The pharmacokinetics of ustekinumab was not impacted by concomitant use of MTX, NSAIDs, 6-mercaptopurine, azathioprine and oral corticosteroids in patients with psoriatic arthritis, Crohn's disease or ulcerative colitis

CYP450 substrates, ustekinumab [2] ---> SmPC of [2] of EMA

The results of an in vitro study do not suggest the need for dose adjustments in patients who are receiving concomitant CYP450 substrates (see section 5.2).

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

The effect of ustekinumab on human fertility has not been evaluated (see section 5.3).

Ibuprofen, ustekinumab [2] ---> SmPC of [2] of EMA

The effect of the most frequently used concomitant medicinal products in patients with psoriasis on pharmacokinetics of ustekinumab was explored. There were no indications of an interaction with these concomitantly administered medicinal products.

Immunosuppressives, ustekinumab [2] ---> SmPC of [2] of EMA

Caution should be exercised when considering concomitant use of other immunosuppressants and ustekinumab or when transitioning from other immunosuppressive biologics

Immunotherapy, ustekinumab [2] ---> SmPC of [2] of EMA

STELARA has not been evaluated in patients who have undergone allergy immunotherapy. It is not known whether STELARA may affect allergy immunotherapy.

Levothyroxine, ustekinumab [2] ---> SmPC of [2] of EMA

The effect of the most frequently used concomitant medicinal products in patients with psoriasis on pharmacokinetics of ustekinumab was explored. There were no indications of an interaction with these concomitantly administered medicinal products.

Mercaptopurine, ustekinumab [2] ---> SmPC of [2] of EMA

The pharmacokinetics of ustekinumab was not impacted by concomitant use of MTX, NSAIDs, 6-mercaptopurine, azathioprine and oral corticosteroids in patients with psoriatic arthritis, Crohn's disease or ulcerative colitis

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

The effect of the most frequently used concomitant medicinal products in patients with psoriasis on pharmacokinetics of ustekinumab was explored. There were no indications of an interaction with these concomitantly administered medicinal products.

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

The pharmacokinetics of ustekinumab was not impacted by concomitant use of MTX, NSAIDs, 6-mercaptopurine, azathioprine and oral corticosteroids in patients with psoriatic arthritis, Crohn's disease or ulcerative colitis

NSAID, ustekinumab [2] ---> SmPC of [2] of EMA

The pharmacokinetics of ustekinumab was not impacted by concomitant use of MTX, NSAIDs, 6-mercaptopurine, azathioprine and oral corticosteroids in patients with psoriatic arthritis, Crohn's disease or ulcerative colitis

Paracetamol, ustekinumab [2] ---> SmPC of [2] of EMA

The effect of the most frequently used concomitant medicinal products in patients with psoriasis on pharmacokinetics of ustekinumab was explored. There were no indications of an interaction with these concomitantly administered medicinal products.

Pregnancy, ustekinumab [2] ---> SmPC of [2] of EMA

As a precautionary measure, it is preferable to avoid the use of STELARA in pregnancy.

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

Patients receiving ustekinumab may receive concurrent inactivated or non-live vaccinations.

Ustekinumab [1], vaccinations with live organism vaccines ---> SmPC of [1] of EMA

It is recommended that live viral or live bacterial vaccines (such as Bacillus of Calmette and Guérin (BCG)) should not be given concurrently with ustekinumab.

Ustekinumab [1], vaccinations with live organism vaccines ---> SmPC of [1] of EMA

Administration of live vaccines (such as the BCG vaccine) to infants exposed in utero to ustekinumab is not recommended for six months following birth or until ustekinumab infant serum levels are undetectable

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

Women of childbearing potential should use effective methods of contraception during treatment and for at least 15 weeks after treatment.

            CONTRAINDICATIONS of Ustekinumab (Stelara)             

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

            - Clinically important, active infection (e.g. active tuberculosis)     

            https://www.ema.europa.eu/en/documents/product-information/stelara-epar-product-information_en.pdf 14/04/2025 

Other trade names: Absimky, Eksunbi, Fymskina, Imuldosa, Otulfi, Pyzchiva, Steqeyma, Uzpruvo, Wezenla, Yesintek,