G

Gabapentin

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

Gabapentin acts on the central nervous system and may cause drowsiness, dizziness or other related symptoms.

Almasilate, gabapentin

Possible decrease in gabapentin absorption due to pH gastrointestinal changes

Aluminium hydroxide, gabapentin

Concomitant use of aluminium hydroxide may decrease the absorption and effect of gabapentin. Separate administration by at least 2-3 hours

Antacids, gabapentin [2] ---> SmPC of [2] of eMC

Coadministration of gabapentin with antacids containing aluminium and magnesium, reduces gabapentin bioavailability up to 24%. It is recommended that gabapentin is taken about two hours following any such antacid administration.

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

Gabapentin is excreted in human milk. Gabapentin should be used in breast-feeding mothers only if the benefits clearly outweigh the risks.

Carbamazepine, gabapentin [2] ---> SmPC of [2] of eMC

There is no interaction between gabapentin and carbamazepine

Cimetidine, gabapentin [2] ---> SmPC of [2] of eMC

A slight decrease in renal excretion of gabapentin observed when co-administered with cimetidine is not expected to be of clinical importance.

Efavirenz [1], gabapentin ---> SmPC of [1] of EMA

Clinically significant interactions are not expected since gabapentin is exclusively eliminated unchanged in the urine

Efavirenz/emtricitabine/tenofovir disoproxil [1], gabapentin ---> SmPC of [1] of EMA

Clinically significant interactions are not expected since gabapentin is exclusively eliminated unchanged in the urine

Gabapentin [1], morphine ---> SmPC of [1] of eMC

Patients should be carefully observed for signs of CNS depression, such as somnolence, and the dose of gabapentin or morphine should be reduced appropriately.

Gabapentin [1], oral contraceptives ---> SmPC of [1] of eMC

Coadministration of gabapentin with oral contraceptives containing norethindrone and/or ethinyl estradiol, does not influence the steady-state pharmacokinetics of either component.

Gabapentin [1], phenobarbital ---> SmPC of [1] of eMC

There is no interaction between gabapentin and phenobarbital

Gabapentin [1], phenytoin ---> SmPC of [1] of eMC

There is no interaction between gabapentin and phenytoin

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

Gabapentin should not be used during pregnancy unless the potential benefit to the mother clearly outweighs the potential risk to the foetus.

Gabapentin [1], probenecide ---> SmPC of [1] of eMC

Renal excretion of gabapentin is unaltered by probenecid.

Gabapentin [1], valproic acid ---> SmPC of [1] of eMC

There is no interaction between gabapentin and valproic acid

Gabapentin, lamotrigine [2] ---> SmPC of [2] of eMC

Co-administration of lamotrigine (OCT2 inhibitor) with renally excreted medicinal products which are substrates of OCT2 may result in increased plasma levels of these drugs.

Gabapentin, levetiracetam [2] ---> SmPC of [2] of EMA

Pre-marketing data from clinical studies conducted indicate that levetiracetam did not influence the serum levels of existing antiepileptic medicinal products and that these antiepileptics did not influence the pharmacokinetics of levetiracetam

Gabapentin, retigabine [2] ---> SmPC of [2] of EMA

Based on these pooled data, retigabine did not cause clinically significant effects on the plasma trough concentrations of this antiepileptic medicinal product

CONTRAINDICATIONS of Gabapentin

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

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

Gadobutrol

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

At clinical doses, no effects on the infant are anticipated due to the small amount excreted in milk and poor absorption from the gut.

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

It should not be used during pregnancy unless the clinical condition of the woman requires use of gadobutrol.

CONTRAINDICATIONS of Gadobutrol

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

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

Gadodiamide

Breast-feeding, gadodiamide

Breast feeding should be discontinued for at least 24 hours

Gadodiamide, pregnancy

Should not be used during pregnancy unless clearly necessary

Gadofosveset (Ablavar)

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

Should not be used during lactation

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

Gadofosveset demonstrated no adverse interaction at clinically relevant concentrations.

Drugs with high protein binding, gadofosveset [2] ---> SmPC of [2] of EMA

An interaction with other plasma protein bound active substances is generally possible

Gadofosveset [1], ibuprofen ---> SmPC of [1] of EMA

Gadofosveset demonstrated no adverse interaction at clinically relevant concentrations.

Gadofosveset [1], naproxen ---> SmPC of [1] of EMA

Gadofosveset demonstrated no adverse interaction at clinically relevant concentrations.

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

Gadofosveset demonstrated no adverse interaction at clinically relevant concentrations.

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

Gadofosveset demonstrated no adverse interaction at clinically relevant concentrations.

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

Should not be used during pregnancy unless clearly necessary

Gadofosveset [1], propranolol ---> SmPC of [1] of EMA

Gadofosveset demonstrated no adverse interaction at clinically relevant concentrations.

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

Gadofosveset demonstrated no adverse interaction at clinically relevant concentrations.

Gadofosveset [1], warfarin ---> SmPC of [1] of EMA

Gadofosveset demonstrated no adverse interaction at clinically relevant concentrations.

CONTRAINDICATIONS of Gadofosveset (Ablavar)

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

https://www.ema.europa.eu/en/documents/product-information/ablavar-epar-product-information_en.pdf 16/09/2011 (withdrawn)

Gadopiclenol (Elucirem)

ACE inhibitors, gadopiclenol [2] ---> SmPC of [2] of EMA

Decrease the efficacy of the mechanisms of cardiovascular compensation for blood pressure disorders. The physician must obtain information before injection of gadopiclenol about the concomitant intake of those medicinal products.

AIIRA, gadopiclenol [2] ---> SmPC of [2] of EMA

Betablockers, gadopiclenol [2] ---> SmPC of [2] of EMA

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

Continuing or discontinuing breast feeding for a period of 24 hours after administration of Elucirem, should be at the discretion of the doctor and breast-feeding mother.

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

Animals studies do not indicate impairment of fertility (see section 5.3).

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

Elucirem should not be used during pregnancy unless the clinical condition of the woman requires use of gadopiclenol.

Gadopiclenol [1], vasoactive substance ---> SmPC of [1] of EMA

CONTRAINDICATIONS of Gadopiclenol (Elucirem)

- 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/elucirem-epar-product-information_en.pdf 14/11/2025

Other trade names: Vueway,

Gadoteridol

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

At clinical doses, no effects on the infant are anticipated due to the small amount excreted in milk and poor absorption from the gut.

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

It should not be used during pregnancy unless the clinical condition of the woman requires use of gadoteridol.

CONTRAINDICATIONS of Gadoteridol

- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to other gadolinium-based contrast.

- In children under 6 months of age.

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

Gadoversetamide (Optimark)

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

Ambulant patients while driving vehicles or operating machinery should take into account that acute dizziness may uncommonly occur

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

Breast-feeding should be discontinued for at least 24 hours after the administration of Optimark

Calcium, gadoversetamide [2] ---> SmPC of [2] of EMA

Optimark has been shown to cause interference in the measurement of serum calcium using the ortho-cresolphthalein complexone (OCP) colorimetric method.

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

Non-clinical data did not reveal special hazards for humans based on conventional studies of reproductive toxicity. Clinical studies on fertility have not been performed

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

Optimark should not be used during pregnancy unless the clinical condition of the woman requires use of gadoversetamide.

CONTRAINDICATIONS of Gadoversetamide (Optimark)

Hypersensitivity to gadoversetamide or to other gadolinium containing products, or to any of the excipients listed in section 6.1.

Optimark is contraindicated

- in patients with severe renal impairment (GFR < 30 ml/min/1.73 m²) and/or acute kidney injury,

- in patients who have had liver transplantation or

- in patients in the perioperative liver transplantation period and

- in neonates up to 4 weeks of age

https://www.ema.europa.eu/en/documents/product-information/optimark-epar-product-information_en.pdf 08/05/2017 (withdrawn)

Gadoxetate

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

At clinical doses, no effects on the infant are anticipated due to the small amount excreted in milk and poor absorption from the gut.

Cefazolin, gadoxetate

Block of hepatic uptake of gadoxetic acid and decreased hepatic contrast

Cefotaxime, gadoxetate

Block of hepatic uptake of gadoxetic acid and decreased hepatic contrast

Ceftriaxone, gadoxetate

Block of hepatic uptake of gadoxetic acid and decreased hepatic contrast

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

It should not be used during pregnancy unless the clinical condition of the woman requires use of gadoxetate.

Gadoxetate [1], strong OATP inhibitors ---> SmPC of [1] of eMC

As transport of gadoxetate to the liver may be mediated by OATP transporters it cannot be excluded that potent OATP inhibitors could cause drug interactions reducing the hepatic contrast effect.

Gadoxetate, rifampicin

Block of hepatic uptake of gadoxetic acid and decreased hepatic contrast

CONTRAINDICATIONS of Gadoxetate

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

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

Galantamine

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

Galantamine has minor or moderate influence on the ability to drive and use machines. Symptoms include dizziness and somnolence, especially during the first weeks after initiation of treatment.

Ambenonium, galantamine [2] ---> SmPC of [2] of eMC

Because of its mechanism of action, galantamine should not be given concomitantly with other cholinomimetics

Amiodarone, galantamine [2] ---> SmPC of [2] of eMC

As expected with cholinomimetics, a pharmacodynamic interaction is possible with medicinal products that significantly reduce the heart rate

Anticholinergics, galantamine [2] ---> SmPC of [2] of eMC

Galantamine has the potential to antagonise the effect of anticholinergic medicinal products. Should anticholinergic medicinal products such as atropine be abruptly stopped there is a potential risk that galantamine's effect could be exacerbated.

Atropine, galantamine [2] ---> SmPC of [2] of eMC

Betablockers, galantamine [2] ---> SmPC of [2] of eMC

As expected with cholinomimetics, a pharmacodynamic interaction is possible with medicinal products that significantly reduce the heart rate

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

Women on galantamine should not breast-feed.

Carteolol, galantamine

Risk of excessive bradycardia (addition of bradycardic effects)

Cholinergic agents, galantamine [2] ---> SmPC of [2] of eMC

Because of its mechanism of action, galantamine should not be given concomitantly with other cholinomimetics

Depolarizing muscle relaxants, galantamine [2] ---> SmPC of [2] of eMC

Galantamine, as a cholinomimetic, is likely to exaggerate succinylcholine-type muscle relaxation during anaesthesia, especially in cases of pseudocholinesterase deficiency.

Digoxin, galantamine [2] ---> SmPC of [2] of eMC

As expected with cholinomimetics, a pharmacodynamic interaction is possible with medicinal products that significantly reduce the heart rate. Therapeutic doses of galantamine 24 mg/day had no effect on the kinetics of digoxin

Donepezil, galantamine [2] ---> SmPC of [2] of eMC

Because of its mechanism of action, galantamine should not be given concomitantly with other cholinomimetics

Drugs inducing bradycardia, galantamine

As expected with cholinomimetics, a pharmacodynamic interaction is possible with medicinal products that significantly reduce the heart rate

Erythromycin, galantamine [2] ---> SmPC of [2] of eMC

The co-administration of galantamine with strong CYP3A4 inhibitors may increase the bioavailability of galantamine and the incidence of cholinergic adverse reactions, predominantly nausea and vomiting.

Fluoxetine, galantamine [2] ---> SmPC of [2] 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.

Foods, galantamine [2] ---> SmPC of [2] of eMC

It is recommended that galantamine be taken with food in order to minimize cholinergic undesirable effects.

Galantamine [1], ketoconazole ---> SmPC of [1] of eMC

Galantamine [1], neostigmine ---> SmPC of [1] of eMC

Because of its mechanism of action, galantamine should not be given concomitantly with other cholinomimetics

Galantamine [1], parasympathomimetics ---> SmPC of [1] of eMC

Because of its mechanism of action, galantamine should not be given concomitantly with other cholinomimetics

Galantamine [1], paroxetine ---> SmPC of [1] of eMC

Galantamine [1], pilocarpine ---> SmPC of [1] of eMC

Because of its mechanism of action, galantamine should not be given concomitantly with systemically administered pilocarpine

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

Caution should be exercised when prescribing to pregnant women.

Galantamine [1], pyridostigmine ---> SmPC of [1] of eMC

Because of its mechanism of action, galantamine should not be given concomitantly with other cholinomimetics

Galantamine [1], quinidine ---> SmPC of [1] of eMC

Galantamine [1], ritonavir ---> SmPC of [1] of eMC

Galantamine [1], rivastigmine ---> SmPC of [1] of eMC

Because of its mechanism of action, galantamine should not be given concomitantly with other cholinomimetics

Galantamine [1], strong CYP2D6 inhibitors ---> SmPC of [1] of eMC

Galantamine [1], strong CYP3A4 inhibitors ---> SmPC of [1] of eMC

Galantamine [1], succinylcholine ---> SmPC of [1] of eMC

Galantamine, as a cholinomimetic, is likely to exaggerate succinylcholine-type muscle relaxation during anaesthesia, especially in cases of pseudocholinesterase deficiency.

Galantamine [1], suxamethonium ---> SmPC of [1] of eMC

Galantamine, as a cholinomimetic, is likely to exaggerate succinylcholine-type muscle relaxation during anaesthesia, especially in cases of pseudocholinesterase deficiency.

Galantamine [1], torsades de pointes inducing drugs ---> SmPC of [1] of eMC

Caution should be taken with medicinal products that have potential to cause torsades de pointes. In such cases an ECG should be considered.

Galantamine [1], warfarin ---> SmPC of [1] of eMC

Therapeutic doses of galantamine 24 mg/day had no effect on the kinetics and prothrombin time of warfarin.

Galantamine, hydroquinidine

Risk excessive bradycardia due to the bradycardic effects of both active ingredients may be additive

Galantamine, memantin [2] ---> SmPC of [2] of EMA

In a clinical study in young healthy subjects, no relevant effect of memantine on the pharmacokinetics of galantamine was observed.

Galantamine, miconazole

Oral miconazole is contraindicated with medicinal products that are metabolised by CYP3A4 and may prolong also the QT interval

Galantamine, olanzapine

Possible antagonism of action

Galantamine, sotalol

Bradycardia-inducing medicinal products enhance the risk of torsades de pointes

CONTRAINDICATIONS of Galantamine

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

- Since no data are available on the use of galantamine in patients with severe hepatic (Child-Pugh score greater than 9) and severe renal (creatinine clearance less than 9 ml/min) impairment, galantamine is contraindicated in these populations. Galantamine is contraindicated in patients who have both significant renal and hepatic dysfunction.

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

Gallium chloride (GalliaPharm)

Breast-feeding, gallium chloride [2] ---> SmPC of [2] of EMA

If the administration is considered necessary, breast-feeding should be interrupted, and the expressed feeds discarded.

Fertility, gallium chloride [2] ---> SmPC of [2] of EMA

Further information concerning the use of a 68Ga-labelled radiopharmaceutical concerning fertility is specified in the Summary of Product Characteristics/package leaflet of the kit for radiopharmaceutical preparation to be radiolabelled.

Gallium chloride [1], medicinal products ---> SmPC of [1] of EMA

No interaction studies of the gallium (68Ga) chloride solution for radiolabelling with other medicinal products have been performed, because it is used for in vitro radiolabelling of medicinal products.

Gallium chloride [1], pregnancy ---> SmPC of [1] of EMA

Only essential investigations should therefore be carried out during pregnancy, when the likely benefit far exceeds the risk incurred by the mother and the foetus.

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

When an administration of radiopharmaceuticals to a woman of childbearing potential is intended, it is important to determine whether or not she is pregnant. Any woman who has missed a period should be assumed to be pregnant until proven otherwise.

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

Radionuclide procedures carried out on pregnant women also involve radiation dose to the foetus.

CONTRAINDICATIONS of Gallium chloride (GalliaPharm)

- Gallium (68Ga) chloride solution should not be administered directly to the patient.

- The use of 68Ga-labelled medicinal products is contraindicated in case of hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

- For information on contraindications to particular 68Ga-labelled radiopharmaceuticals prepared by radiolabelling with gallium (68Ga) chloride solution, refer to the Summary of Product Characteristics/package leaflet of the particular medicinal product to be radiolabelled.

https://www.ema.europa.eu/en/documents/product-information/galliapharm-epar-product-information_en.pdf 22/08/2024

Galcanezumab (Emgality)

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

Galcanezumab may have a minor influence on the ability to drive and use machines. Vertigo may occur following the administration of galcanezumab

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

Human IgG is known to be excreted in breast milk during the first days after birth, which is decreasing to low concentrations soon afterwards; consequently, a risk to breast-fed infants cannot be excluded during this short period.

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

The effect of galcanezumab on human fertility has not been evaluated. Fertility studies in animals do not indicate harmful effects with respect to male and female fertility (see section 5.3).

Galcanezumab [1], interactions ---> SmPC of [1] of EMA

No drug interaction studies were conducted. No pharmacokinetic drug interactions are expected based on the characteristics of galcanezumab.

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

Human immunoglobulin (IgG) is known to cross the placental barrier. As a precautionary measure, it is preferable to avoid the use of galcanezumab during pregnancy.

CONTRAINDICATIONS of Galcanezumab (Emgality)

-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/emgality-epar-product-information_en.pdf 09/10/2025

Galsulfase (Naglazyme)

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

No studies on the effects on the ability to drive and use machines have been performed.

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

It is not known whether galsulfase is excreted in milk, therefore breast-feeding should be stopped during Naglazyme treatment.

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

Reproduction studies have been performed in rats and rabbits at doses up to 3 mg/kg/day and have revealed no evidence of impaired fertility or harm to the embryo or foetus due to Naglazyme.

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

Naglazyme should not be used during pregnancy unless clearly necessary.

CONTRAINDICATIONS of Galsulfase (Naglazyme)

- Severe or life-threatening hypersensitivity to the active substance or to any of the excipients, if hypersensitivity is not controllable.

https://www.ema.europa.eu/en/documents/product-information/naglazyme-epar-product-information_en.pdf 26/04/2022

Ganaxolone (Ztalmy)

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

ZTALMY may cause somnolence, sedation and sedation-related adverse reactions, such as fatigue and ataxia, and other CNS-related events such as dizziness (see section 4.4). Patients should be advised not to drive or use machines (see section 4.8).

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

Concomitant use with CNS depressants (including alcohol) may increase the risk of sedation and somnolence (see section 4.4). Patients should be prohibited from drinking alcohol during treatment.

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

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

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

Enzyme inducing antiepileptics (e.g., carbamazepine, phenytoin, phenobarbital, and primidone) and St. John's Wort may result in similarly lower plasma exposures of ganaxolone.

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

Concomitant use with CNS depressants (including alcohol) may increase the risk of sedation and somnolence (see section 4.4). Patients should be prohibited from drinking alcohol during treatment.

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

The changes in ganaxolone exposures when coadministered with strong, moderate, or weak CYP3A4 inhibitors are not expected to be clinically significant.

Enzyme inducing antiepileptic, ganaxolone [2] ---> SmPC of [2] of EMA

Enzyme inducing antiepileptics (e.g., carbamazepine, phenytoin, phenobarbital, and primidone) and St. John's Wort may result in similarly lower plasma exposures of ganaxolone.

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

There are no human data on the effect of ganaxolone on fertility. Animal studies are insufficient with respect to fertility (see section 5.3).

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

ZTALMY must be taken with or shortly after meals and each dose should be administered with similar types of food, if possible (see section 5.2). Do not mix with food or drinks prior to administration.

Ganaxolone [1], glucuronidation inhibitors ---> SmPC of [1] of EMA

Dose reduction of ganaxolone and/or the UGT inhibitor may be necessary when given in combination.

Ganaxolone [1], itraconazol ---> SmPC of [1] of EMA

Coadministration of ganaxolone with itraconazole, a strong CYP3A4 inhibitor, increased the ganaxolone AUC by 17% in healthy subjects (the Cmax was unchanged).

Ganaxolone [1], moderate CYP3A4 inhibitors ---> SmPC of [1] of EMA

The changes in ganaxolone exposures when coadministered with strong, moderate, or weak CYP3A4 inhibitors are not expected to be clinically significant.

Ganaxolone [1], oral contraceptives ---> SmPC of [1] of EMA

The potential interaction of ganaxolone with oral contraceptives has not been investigated.

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

Enzyme inducing antiepileptics (e.g., carbamazepine, phenytoin, phenobarbital, and primidone) and St. John's Wort may result in similarly lower plasma exposures of ganaxolone.

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

ZTALMY is not recommended during pregnancy and in woman of childbearing potential not using contraception.

Ganaxolone [1], primidone ---> SmPC of [1] of EMA

Enzyme inducing antiepileptics (e.g., carbamazepine, phenytoin, phenobarbital, and primidone) and St. John's Wort may result in similarly lower plasma exposures of ganaxolone.

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

Concomitant use of rifampicin decreased the AUC0-inf of ganaxolone by approximately 57-68%.

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

Enzyme inducing antiepileptics (e.g., carbamazepine, phenytoin, phenobarbital, and primidone) and St. John's Wort may result in similarly lower plasma exposures of ganaxolone.

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

Coadministration with a strong CYP3A4 inducer will decrease ganaxolone exposure.

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

The changes in ganaxolone exposures when coadministered with strong, moderate, or weak CYP3A4 inhibitors are not expected to be clinically significant.

Ganaxolone [1], valproate ---> SmPC of [1] of EMA

Dose reduction of ganaxolone and/or the UGT inhibitor may be necessary when given in combination.

Phenytoin [1], ganaxolone ---> SmPC of [1] of EMA

Enzyme inducing antiepileptics (e.g., carbamazepine, phenytoin, phenobarbital, and primidone) and St. John's Wort may result in similarly lower plasma exposures of ganaxolone.

CONTRAINDICATIONS of Ganaxolone (Ztalmy)

- 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/ztalmy-epar-product-information_en.pdf 29/07/2024

Ganciclovir

Abacavir/lamivudine/zidovudine [1], ganciclovir ---> SmPC of [1] of EMA

Concomitant treatment, especially acute therapy, with potentially nephrotoxic or myelosuppressive medicinal products may increase the risk of adverse reactions to zidovudine

Ability to drive, ganciclovir

Seizures, sedation, dizziness and/or confusional states may occur

Adefovir, ganciclovir ---> SmPC of [valganciclovir] of eMC

The renal clearance of ganciclovir may be inhibited due to nephrotoxicity caused by drugs. Concomitant use of valganciclovir with these drugs should be considered only if the potential benefits outweigh the potential risks

Amphotericin B, ganciclovir [2] ---> SmPC of [2] of eMC

Toxicity may be enhanced when valganciclovir is co-administered with, or is given immediately before or after, other drugs that inhibit replication of rapidly dividing cell populations

Amphotericin, ganciclovir [2] ---> SmPC of [2] of eMC

Toxicity may be enhanced when valganciclovir is co-administered with, or is given immediately before or after, other drugs that inhibit replication of rapidly dividing cell populations

Boceprevir, ganciclovir ---> SmPC of [valganciclovir] of eMC

Metabolic and drug transport interactions of valganciclovir or ganciclovir with the antiviral are considered unlikely

Breast-feeding, ganciclovir

Ganciclovir is contraindicated in pregnancy

Cidofovir, ganciclovir [2] ---> SmPC of [2] of eMC

Since ganciclovir is renal excreted, toxicity may be enhanced during coadministration of valganciclovir with drugs that might reduce the renal clearance of ganciclovir: nephrotoxicity and competitive inhibition of active tubular secretion

Dapsone, ganciclovir [2] ---> SmPC of [2] of eMC

Toxicity may be enhanced when valganciclovir is co-administered with, or is given immediately before or after, other drugs that inhibit replication of rapidly dividing cell populations

Darunavir, ganciclovir ---> SmPC of [valganciclovir] of eMC

Metabolic and drug transport interactions of valganciclovir or ganciclovir with the antiviral are considered unlikely

Didanosine [1], ganciclovir ---> SmPC of [1] of eMC

Los pacientes que tomen didanosina en combinación con ganciclovir y valganciclovir deben ser cuidadosamente monitorizados por las toxicidades asociadas a didanosina.

Doxorubicine, ganciclovir [2] ---> SmPC of [2] of eMC

Toxicity may be enhanced when valganciclovir is co-administered with, or is given immediately before or after, other drugs that inhibit replication of rapidly dividing cell populations

Efavirenz, ganciclovir ---> SmPC of [valganciclovir] of eMC

Metabolic and drug transport interactions of valganciclovir or ganciclovir with the antiviral are considered unlikely

Efavirenz/emtricitabine/tenofovir disoproxil [1], ganciclovir ---> SmPC of [1] of EMA

Use of Atripla should be avoided with concurrent or recent use of a nephrotoxic medicinal product.

Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil [1], ganciclovir ---> SmPC of [1] of EMA

Use of emtricitabine/rilpivirine/tenofovir should be avoided with concurrent or recent use of a nephrotoxic medicinal product

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

Co-administration of medicinal products that reduce renal function or compete for active tubular secretion (e.g. cidofovir) may increase serum concentrations of emtricitabine, tenofovir and/or the co-administered medicinal products.

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

Use of Truvada should be avoided with concurrent or recent use of a nephrotoxic medicinal product

Enfuvirtide, ganciclovir ---> SmPC of [valganciclovir] of eMC

Metabolic and drug transport interactions of valganciclovir or ganciclovir with the antiviral are considered unlikely

Etravirine, ganciclovir ---> SmPC of [valganciclovir] of eMC

Metabolic and drug transport interactions of valganciclovir or ganciclovir with the antiviral are considered unlikely

Flucytosine, ganciclovir [2] ---> SmPC of [2] of eMC

Toxicity may be enhanced when valganciclovir is co-administered with, or is given immediately before or after, other drugs that inhibit replication of rapidly dividing cell populations

Foscarnet, ganciclovir [2] ---> SmPC of [2] of eMC

Ganciclovir [1], hydroxyurea ---> SmPC of [1] of eMC

Toxicity may be enhanced when valganciclovir is co-administered with, or is given immediately before or after, other drugs that inhibit replication of rapidly dividing cell populations

Ganciclovir [1], inhibitors of active tubular secretion ---> SmPC of [1] of eMC

Ganciclovir [1], nucleoside analogues ---> SmPC of [1] of eMC

Ganciclovir [1], pentamidine ---> SmPC of [1] of eMC

Toxicity may be enhanced when valganciclovir is co-administered with, or is given immediately before or after, other drugs that inhibit replication of rapidly dividing cell populations

Ganciclovir [1], probenecide ---> SmPC of [1] of eMC

Probenecid given with oral ganciclovir resulted in statistically significantly decreased renal clearance of ganciclovir (20 %) leading to statistically significantly increased exposure (40 %).

Ganciclovir [1], trimethoprim ---> SmPC of [1] of eMC

There is a potential for toxicity to be enhanced since trimethoprim and ganciclovir are known to be myelosuppressive and therefore both drugs should be used concomitantly only if the potential benefits outweigh the risks.

Ganciclovir [1], trimethoprim/sulfamethoxazol ---> SmPC of [1] of eMC

Toxicity may be enhanced when valganciclovir is co-administered with, or is given immediately before or after, other drugs that inhibit replication of rapidly dividing cell populations

Ganciclovir [1], vinblastine ---> SmPC of [1] of eMC

Toxicity may be enhanced when valganciclovir is co-administered with, or is given immediately before or after, other drugs that inhibit replication of rapidly dividing cell populations

Ganciclovir [1], vincristine ---> SmPC of [1] of eMC

Toxicity may be enhanced when valganciclovir is co-administered with, or is given immediately before or after, other drugs that inhibit replication of rapidly dividing cell populations

Ganciclovir, gentamicin

Increased risk of nephrotoxicity. Caution should be exercised.

Ganciclovir, imipenem/cilastatin [2] ---> SmPC of [2] of eMC

Generalized seizures have been reported in patients who received ganciclovir and imipenem/cilastatin. These medicinal products should not be used concomitantly unless the potential benefit outweighs the risks.

Ganciclovir, lamivudine

Co-administration intravenous is not recommended

Ganciclovir, lamivudine/zidovudine [2] ---> SmPC of [2] of EMA

Concomitant treatment, especially acute therapy, with potentially nephrotoxic or myelosuppressive medicinal products may increase the risk of adverse reactions to zidovudine.

Ganciclovir, maraviroc ---> SmPC of [valganciclovir] of eMC

Metabolic and drug transport interactions of valganciclovir or ganciclovir with the antiviral are considered unlikely

Ganciclovir, meglumine and sodium ioxitalamate

The co-administration with other medicinal products with nephrotoxic potential may decrease the renal function and cause a permanent damage

Ganciclovir, mycophenolate mofetil [2] ---> SmPC of [2] of EMA

It is anticipated that co-administration of these agents (which compete for mechanisms of renal tubular secretion) will result in increases in MPAG and ganciclovir concentration.

Ganciclovir, mycophenolate [2] ---> SmPC of [2] of EMA

It is anticipated that co-administration of these agents (which compete for mechanisms of renal tubular secretion) will result in increases in MPAG and ganciclovir concentration.

Ganciclovir, mycophenolic acid [2] ---> SmPC of [2] of eMC

Increased levels of mycophenolic acid glucuronide (MPAG) and ganciclovir may be expected when ganciclovir and mycophenolic acid are coadministered, possibly as a result of competition for the tubular secretion pathway.

Ganciclovir, myelosuppressive agents

Patients treated with ganciclovir and medicinal products with myelosuppressive effects should be closely monitored for signs of toxicity

Ganciclovir, nephrotoxic substances ---> SmPC of [tenofovir disoproxil] of EMA

Use of ganciclovir should be avoided with recent or concurrent use of a nephrotoxic medicinal product

Ganciclovir, netilmicin

The administration concurrent or sequential of netilmicin with other potentially nephrotoxic or neurotoxic drugs may increase the nephrotoxicity and/or neurotoxicity

Ganciclovir, non-nucleoside reverse transcriptase inhibitors ---> SmPC of [valganciclovir] of eMC

Ganciclovir, ospemifene [2] ---> SmPC of [2] of EMA

Ospemifene and its major metabolite, 4-hydroxyospemifene, inhibited organic cation transporter (OCT)1 in vitro at clinically relevant concentrations. Therefore, ospemifene may increase concentrations of medicinal products which are substrates of OCT1

Ganciclovir, pregnancy

Ganciclovir should not be used during pregnancy unless the potential benefit outweighs the potential teratogenic risk to the foetus.

Ganciclovir, protease inhibitors ---> SmPC of [valganciclovir] of eMC

Metabolic and drug transport interactions of valganciclovir or ganciclovir with the antiviral are considered unlikely

Ganciclovir, raltegravir ---> SmPC of [valganciclovir] of eMC

Metabolic and drug transport interactions of valganciclovir or ganciclovir with the antiviral are considered unlikely

Ganciclovir, rilpivirine ---> SmPC of [valganciclovir] of eMC

Metabolic and drug transport interactions of valganciclovir or ganciclovir with the antiviral are considered unlikely

Ganciclovir, safinamide [2] ---> SmPC of [2] of EMA

Safinamide inhibits OCT1 in vitro at clinically relevant portal vein concentrations. Therefore, caution is necessary when safinamide is taken concomitantly with medicinal products that are OCT1 substrates and have a tmax similar to safinamide (2 hours)

Ganciclovir, stavudine ---> SmPC of [valganciclovir] of eMC

No clinically significant interactions were observed when stavudine and oral ganciclovir were given in combination.

Ganciclovir, tacrolimus [2] ---> SmPC of [2] of EMA

Concurrent use of tacrolimus with medicinal products known to have nephrotoxic or neurotoxic effects may increase these effects

Ganciclovir, tafamidis [2] ---> SmPC of [2] of EMA

Tafamidis inhibits the uptake transporters OAT1 and OAT3 (organic anion transporters) and may cause drug-drug interactions at clinically relevant concentrations with substrates of these transporters

Ganciclovir, telaprevir ---> SmPC of [valganciclovir] of eMC

Metabolic and drug transport interactions of valganciclovir or ganciclovir with the antiviral are considered unlikely

Ganciclovir, tenofovir ---> SmPC of [tenofovir disoproxil] of EMA

Use of tenofovir should be avoided with recent or concurrent use of a nephrotoxic medicinal product

Ganciclovir, tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Use of tenofovir should be avoided with recent or concurrent use of a nephrotoxic medicinal product

Ganciclovir, tiopronin

Increased risk of nephrotoxicity. Caution should be exercised

Ganciclovir, zalcitabine

Both active principles have the potential to cause peripheral neuropathy and patients should be monitored for such events

Ganciclovir, zidovudine ---> SmPC of [lamivudine/zidovudine] of EMA

Concomitant treatment, especially acute therapy, with potentially nephrotoxic or myelosuppressive medicinal products may increase the risk of adverse reactions to zidovudine.

Peripheral neuropathy, valganciclovir

Both active principles have the potential to cause peripheral neuropathy and patients should be monitored for such events

Peripheral neuropathy, zalcitabine

Both active principles have the potential to cause peripheral neuropathy and patients should be monitored for such events

Ganirelix (Orgalutran)

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

It is not known whether ganirelix is excreted in breast milk. The use of Orgalutran is contraindicated during pregnancy and breast-feeding

Commonly used medicinal products, ganirelix [2] ---> SmPC of [2] of EMA

The possibility of interactions with commonly used medicinal products, including histamine liberating medicinal products, cannot be excluded.

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

Ganirelix is used to prevent premature LH surges that might otherwise occur in these women during the ovarian stimulation.

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

Ganirelix is used in the treatment of women undergoing controlled ovarian hyperstimulation in assisted reproduction programmes.

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

There are no adequate data from the use of ganirelix in pregnant women. In animals, exposure to ganirelix at the time of implantation resulted in litter resorption. The use of Orgalutran is contraindicated during pregnancy and breast-feeding

CONTRAINDICATIONS of Ganirelix (Orgalutran)

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

- Hypersensitivity to gonadotrophin-releasing hormone (GnRH) or any other GnRH analogue.

- Moderate or severe impairment of renal or hepatic function.

- Pregnancy or breast-feeding

https://www.ema.europa.eu/en/documents/product-information/orgalutran-epar-product-information_en.pdf 18/12/2025

Other trade names: Ganirelix SUN,

Garadacimab (Andembry)

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

Consequently, transfer of IgG antibodies to the newborns through milk may happen during the first few days. Afterwards, garadacimab could be used during breast-feeding if clinically needed.

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

Effect on fertility has not been evaluated in humans. Garadacimab had no effect on male or female fertility in rabbits (see section 5.3).

Garadacimab [1], medicinal products ---> SmPC of [1] of EMA

The use of analgesic, antibacterial, antihistamine, anti-inflammatory and anti-rheumatic medications had no effect on the PK of garadacimab.

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

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

Garadacimab [1], rescue medication ---> SmPC of [1] of EMA

For breakthrough HAE attacks, use of rescue medications such as plasma-derived and recombinant C1-INH or icatibant had no effect on the PK of garadacimab.

CONTRAINDICATIONS of Garadacimab (Andembry)

- 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/andembry-epar-product-information_en.pd 11/03/2025

Gefapixant (Lyfnua)

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

Gefapixant has no or negligible influence on the ability to drive and use machines. In individual cases, dizziness may occur following administration of gefapixant that may influence the ability to drive and use machines.

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

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

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

No human data on the effect of gefapixant on fertility are available. In rats, there was no effect on mating or fertility with gefapixant treatment (see section 5.3).

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

As a precautionary measure, it is preferable to avoid the use of Lyfnua during pregnancy and in women of childbearing potential not using contraception.

CONTRAINDICATIONS of Gefapixant (Lyfnua)

- 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/lyfnua-epar-product-information_en.pdf 14/05/2025

Gefitinib (Iressa)

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

During treatment with gefitinib, asthenia has been reported. Therefore, patients who experience this symptom should be cautious when driving or using machines.

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

Substances that cause significant sustained elevation in gastric pH may reduce gefitinib plasma concentrations and thereby reduce the efficacy of gefitinib.

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

Substances that are inducers of CYP3A4 activity may increase metabolism and decrease gefitinib plasma concentrations and thereby reduce the efficacy of gefitinib. Concomitant medicinal products that induce CYP3A4 should be avoided.

BCRP inhibitors, gefitinib [2] ---> SmPC of [2] of EMA

Gefitinib inhibits the transporter protein BCRP in vitro, but the clinical relevance of this finding is unknown.

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

Gefitinib is contraindicated during breast-feeding and therefore breast-feeding must be discontinued while receiving gefitinib therapy

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

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

Concomitant administration with potent inhibitors of CYP3A4 activity may increase gefitinib plasma concentrations. The increase may be clinically relevant since adverse reactions are related to dose and exposure.

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

The metabolism of gefitinib is via the cytochrome P450 isoenzyme CYP3A4 (predominantly) and via CYP2D6. Substances that inhibit CYP3A4 may decrease the clearance of gefitinib.

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

In vitro studies have shown that gefitinib has limited potential to inhibit CYP2D6 and can increase the exposition of CYP2D6 substrates. Such an increase might potentially be relevant for CYP2D6 substrates with narrow therapeutic index.

Drugs primarily metabolised by CYP2D6, gefitinib

Gefitinib, CYP2D6 inhibitor, may increase the plasma levels of the medicinal product mainly metabolized by CYP2D6, which is relevant if this has a narrow therapeutic index

Flecainide, gefitinib

The CYP2D6 inhibition may increase the plasma levels of flecainide

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

Substances that cause significant sustained elevation in gastric pH may reduce gefitinib plasma concentrations and thereby reduce the efficacy of gefitinib.

Gastrointestinal perforation, gefitinib [2] ---> SmPC of [2] of EMA

Gastrointestinal perforation has been reported in patients taking gefitinib. In most cases this is associated with other known risk factors

Gefitinib [1], H2 antagonists ---> SmPC of [1] of EMA

Substances that cause significant sustained elevation in gastric pH may reduce gefitinib plasma concentrations and thereby reduce the efficacy of gefitinib.

Gefitinib [1], itraconazol ---> SmPC of [1] of EMA

Gefitinib [1], ketoconazole ---> SmPC of [1] of EMA

Gefitinib [1], metoprolol ---> SmPC of [1] of EMA

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

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

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

IRESSA should not be used during pregnancy unless clearly necessary.

Gefitinib [1], protease inhibitors ---> SmPC of [1] of EMA

Gefitinib [1], proton pump inhibitors ---> SmPC of [1] of EMA

Substances that cause significant sustained elevation in gastric pH may reduce gefitinib plasma concentrations and thereby reduce the efficacy of gefitinib.

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

Concomitant administration of gefitinib with ranitidine at a dose that caused sustained elevations in gastric pH ? 5 resulted in a reduced mean gefitinib AUC by 47% in healthy volunteers (see section 4.4 and 5.2).

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

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

Gefitinib [1], strong CYP2D6 inhibitors ---> SmPC of [1] of EMA

There are no data on concomitant treatment with an inhibitor of CYP2D6 but potent inhibitors of this enzyme might cause increased plasma concentrations of gefitinib in CYP2D6 extensive metabolisers by about 2-fold

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

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

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

Gefitinib [1], vinorelbine ---> SmPC of [1] of EMA

Data from phase II clinical trials, where gefitinib and vinorelbine have been used concomitantly, indicate that gefitinib may exacerbate the neutropenic effect of vinorelbine.

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

Gefitinib [1], warfarin ---> SmPC of [1] of EMA

INR elevations and/or bleeding events have been reported in some patients concomitantly taking warfarin

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

Women of childbearing potential must be advised not to get pregnant during therapy.

Gefitinib, lanthanum carbonate

Substances that cause significant sustained elevation in gastric pH may reduce gefitinib plasma concentrations and thereby reduce the efficacy of gefitinib.

Gefitinib, P-glycoprotein and CYP3A4 inhibitors

The P-glycoprotein and CYP3A4 inhibition may increase the plasma concentrations of gefitinib

Gefitinib, riociguat [2] ---> SmPC of [2] of EMA

The class of tyrosine kinase inhibitors was identified as potent inhibitors of CYP1A1, with erlotinib and gefitinib exhibiting the highest inhibitory potency in vitro.

Gefitinib, vemurafenib [2] ---> SmPC of [2] of EMA

In vitro studies have demonstrated that vemurafenib is a substrate of the efflux transporters P-gp and BCRP. It cannot be excluded that vemurafenib pharmacokinetics could be affected by medicines that influence P-gp or BCRP

CONTRAINDICATIONS of Gefitinib (Iressa)

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

- Breast-feeding

https://www.ema.europa.eu/en/documents/product-information/iressa-epar-product-information_en.pdf 17/07/2023

Other trade names: Gefitinib Mylan,

Gemcitabine

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

Patients should be cautioned against driving or operating machinery until it is established that they do not become somnolent.

Bevacizumab [1], gemcitabine ---> SmPC of [1] of EMA

Conclusions on the impact of bevacizumab on gemcitabine pharmacokinetics cannot be drawn.

Bleomycin, gemcitabine

Increased risk of pulmonary toxicity with pulmotoxic substances

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

Breast-feeding must be discontinued during gemcitabine therapy.

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

In a Phase Ib study, there were no significant effects of gemcitabine on the pharmacokinetics of erlotinib nor were there significant effects of erlotinib on the pharmacokinetics of gemcitabine.

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

Gemcitabine should not be used during pregnancy unless clearly necessary. Women should be advised not to become pregnant during treatment with gemcitabine and to warn their attending physician immediately, should this occur after all.

Gemcitabine [1], radiotherapy ---> SmPC of [1] of eMC

Radiation injury has been reported on targeted tissues (e.g. oesophagitis, colitis, and pneumonitis) in association with both concurrent and non-concurrent use of gemcitabine.

Gemcitabine [1], vaccinations with live organism vaccines ---> SmPC of [1] of eMC

Yellow fever and other live attenuated vaccines are not recommended due to the risk of systemic, possibly fatal, disease, particularly in immunosuppressed patients.

Gemcitabine [1], yellow fever vaccine ---> SmPC of [1] of eMC

Yellow fever and other live attenuated vaccines are not recommended due to the risk of systemic, possibly fatal, disease, particularly in immunosuppressed patients.

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

There was no evidence of any PK interaction between pertuzumab and gemcitabine. The PK of pertuzumab in these studies was comparable to those observed in single-agent studies.

CONTRAINDICATIONS of Gemcitabine

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

- Breast-feeding

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

Gemfibrozil

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

In isolated cases dizziness and visual disturbances can occur which may negatively influence driving.

Acenocoumarol [1], gemfibrozil ---> SmPC of [1] of eMC

The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk

Alogliptin/pioglitazone [1], gemfibrozil ---> SmPC of [1] of EMA

Gemfibrozil, CYP2C8 inhibitor, may increase the AUC of pioglitazone. Close monitoring of glycaemic control should be considered

Atorvastatin [1], gemfibrozil ---> SmPC of [1] of eMC

The use of fibrates alone is occasionally associated with muscle related events, including rhabdomyolysis. The risk of these events may be increased with the concomitant use of fibric acid derivatives and atorvastatin.

Atorvastatin, gemfibrozil ---> SmPC of [ezetimibe/atorvastatin] of eMC

The use of fibrates alone is occasionally associated with muscle-related events, including rhabdomyolysis. The risk of these events may be increased with the concomitant use of fibric acid derivatives and atorvastatin.

Bexarotene [1], gemfibrozil ---> SmPC of [1] of EMA

A population analysis of plasma bexarotene concentrations in patients with CTCL indicated that concomitant administration of gemfibrozil resulted in substantial increases in plasma concentrations of bexarotene.

Bile-acid sequestrants, gemfibrozil [2] ---> SmPC of [2] of eMC

Reduced bioavailability of gemfibrozil may result when given simultaneously with resin-granule drugs such as colestipol. Administration of the products 2 hours or more apart is recommended.

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

Gemfibrozil should not be used when breast-feeding.

Colchicine, gemfibrozil

Risk of myopathy and rhabdomyolysis may be increased with concomitant administration of colchicine and gemfibrozil.

Colestipol, gemfibrozil [2] ---> SmPC of [2] of eMC

Reduced bioavailability of gemfibrozil may result when given simultaneously with resin-granule drugs such as colestipol. Administration of the products 2 hours or more apart is recommended.

Dabrafenib [1], gemfibrozil ---> SmPC of [1] of EMA

Dabrafenib is a substrate for the metabolising enzymes CYP2C8. Medicines that are strong inhibitors of CYP2C8 are therefore likely to increase dabrafenib concentrations. Use caution if strong inhibitors are coadministered with dabrafenib.

Dasabuvir with ombitasvir/paritaprevir/ritonavir, gemfibrozil ---> SmPC of [dasabuvir] of EMA

Increase in dasabuvir exposure is due to CYP2C8 inhibition and increase in paritaprevir is possibly due to OATP1B1 inhibition by gemfibrozil. Concomitant use is contraindicated

Dasabuvir [1], gemfibrozil ---> SmPC of [1] of EMA

Medicinal products that are strong CYP2C8 inhibitors may increase dasabuvir plasma concentrations and must not be co-administered with dasabuvir

Drugs primarily metabolised by CYP2C8, gemfibrozil [2] ---> SmPC of [2] of eMC

In vivo studies indicate that gemfibrozil is a potent inhibitor of CYP2C8 (an enzyme important for the metabolism of e.g. repaglinide, rosiglitazone and paclitaxel)

Drugs primarily metabolised by CYP2C9, gemfibrozil [2] ---> SmPC of [2] of eMC

In vitro studies have shown that gemfibrozil is a strong inhibitor of CYP2C9 (an enzyme involved in the metabolism of e.g. warfarin and glimepiride)

Drugs with high protein binding, gemfibrozil [2] ---> SmPC of [2] of eMC

Gemfibrozil is highly bound to plasma proteins and there is potential for displacement interactions with other drugs.

Eluxadoline [1], gemfibrozil ---> SmPC of [1] of EMA

Co-administration of OATP1B1 inhibitors with eluxadoline may increase exposure to eluxadoline. Eluxadoline should not be administered concomitantly with such medicinal products

Empagliflozin [1], gemfibrozil ---> SmPC of [1] of EMA

An interaction study with gemfibrozil showed that empagliflozin Cmax increased by 15% and AUC increased by 59% following co-administration. These changes were not considered to be clinically meaningful.

Empagliflozin/linagliptin [1], gemfibrozil ---> SmPC of [1] of EMA

Empagliflozin/metformin [1], gemfibrozil ---> SmPC of [1] of EMA

Enzalutamide [1], gemfibrozil ---> SmPC of [1] of EMA

CYP2C8 plays an important role in the elimination of enzalutamide. A strong CYP2C8 inhibitor increased AUC of enzalutamide. Strong inhibitors of CYP2C8 are to be avoided or used with caution during enzalutamide treatment.

Ezetimibe [1], gemfibrozil ---> SmPC of [1] of eMC

Concomitant ezetimibe and gemfibrozil administration modestly increased total ezetimibe concentrations

Ezetimibe/atorvastatin [1], gemfibrozil ---> SmPC of [1] of eMC

Concomitant fenofibrate/gemfibrozil administration increased total ezetimibe levels approx. 1.5- and 1.7-fold, respectively. Although these increases are not considered clinically significant, coadministration of ATOZET with fibrates is not recommended

Ezetimibe/simvastatine [1], gemfibrozil ---> SmPC of [1] of eMC

Concomitant administration increased total ezetimibe concentrations approximately 1.7-fold. Gemfibrozil increases the AUC of simvastatin acid by 1.9-fold

Fenofibrate/simvastatin [1], gemfibrozil ---> SmPC of [1] of EMA

The risk of myopathy and rhabdomyolysis is significantly increased by concomitant use of gemfibrozil with simvastatin. The co-administration is contraindicated

Flunitrazepam, gemfibrozil

Substances that inhibit hepatic enzymes may enhance the effect of benzodiazepines. Interactions with strong CYP3A4 inhibitors cannot be excluded

Fluvastatin [1], gemfibrozil ---> SmPC of [1] of eMC

An increased risk of myopathy and/or rhabdomyolysis has been observed in patients receiving HMG-CoA reductase inhibitors together with gemfibrozil

Foods, gemfibrozil [2] ---> SmPC of [2] of eMC

As the presence of food alters the bioavailability slightly gemfibrozil should be taken 30 minutes before a meal.

Gemfibrozil [1], glimepiride ---> SmPC of [1] of eMC

In vitro studies have shown that gemfibrozil is a strong inhibitor of CYP2C9 (an enzyme involved in the metabolism of e.g. warfarin and glimepiride)

Gemfibrozil [1], insulin ---> SmPC of [1] of eMC

There have been reports of hypoglycaemic reactions after concomitant use with gemfibrozil and hypoglycaemic agents (oral agents and insulin).Monitoring of glucose levels is recommended.

Gemfibrozil [1], oral anticoagulants ---> SmPC of [1] of eMC

Gemfibrozil may potentiate the effects of oral anticoagulants, which necessitates careful monitoring of the anticoagulant dosing

Gemfibrozil [1], oral antidiabetics ---> SmPC of [1] of eMC

There have been reports of hypoglycaemic reactions after concomitant use with gemfibrozil and hypoglycaemic agents (oral agents and insulin).Monitoring of glucose levels is recommended.

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

Gemfibrozil should not be used during pregnancy unless it is clearly necessary.

Gemfibrozil [1], rosuvastatin ---> SmPC of [1] of eMC

One study indicated that the co-administration of a single rosuvastatin dose to healthy volunteers on gemfibrozil resulted in a 2.2-fold increase in mean C max and a 1.9-fold increase in mean AUC of rosuvastatin.

Gemfibrozil [1], statins ---> SmPC of [1] of eMC

The use of fibrates alone is occasionally associated with myopathy. An increased risk of muscle related adverse events, including rhabdomyolysis, has been reported when fibrates are co-administered with statins.

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

Based on the drug interaction of non-liposomal irinotecan and ketoconazole, co-administration of ONIVYDE with other inhibitors of UGT1A1 may also increase systemic exposure of ONIVYDE.

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

Co-administration of PREVYMIS with medicinal products that are inhibitors of OATP1B1/3 transporters may result in increased letermovir plasma concentrations.

Gemfibrozil, loperamide [2] ---> SmPC of [2] of eMC

In a study a CYP2C8 inhibitor, gemfibrozil, increased loperamide by approximately 2-fold.

Gemfibrozil, lovastatine [2] ---> SmPC of [2] of eMC

An increased risk of myopathy and/or rhabdomyolysis has been observed in patients receiving HMG-CoA reductase inhibitors together with fibrates. The combination should only be used with caution

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

Particular caution is recommended when nateglinide is co-administered with potent inhibitors of CYP2C9, or in patients known to be poor metabolisers for CYP2C9.

Gemfibrozil, OATP1B1 substrates

Gemfibrozil, OATP1B1 inhibitor, may increase the plasma levels of OATP1B1 substrates. The co-administration should be undertaken with caution

Gemfibrozil, ombitasvir/paritaprevir/ritonavir [2] ---> SmPC of [2] of EMA

No interaction expected when gemfibrozil is used in combination with ombitasvir/paritaprevir/ritonavir without dasabuvir. No dose adjustment is necessary.

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

The metabolism of paclitaxel is catalysed, in part, by cytochrome P450 isoenzymes CYP2C8 and CYP3A4. Therefore, caution should be exercised when administering paclitaxel concomitantly with medicines known to inhibit either CYP2C8 or CYP3A4.

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

Co-administration of pioglitazone with gemfibrozil (an inhibitor of CYP2C8) is reported to result in a 3-fold increase in AUC of pioglitazone. A decrease in the dose of pioglitazone may be needed when gemfibrozil is concomitantly administered.

Gemfibrozil, pioglitazone/glimepiride [2] ---> SmPC of [2] of EMA

Gemfibrozil, pioglitazone/metformin [2] ---> SmPC of [2] of EMA

Gemfibrozil, CYP2C8 inhibitor, may increase the AUC of pioglitazone. Close monitoring of glycaemic control should be considered

Gemfibrozil, pravastatine [2] ---> SmPC of [2] of eMC

The use of fibrates alone is occasionally associated with myopathy. The adverse events with pravastatin cannot be excluded; therefore the combined use of pravastatin and fibrates should generally be avoided

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

Gemfibrozil may enhance and/or prolong the hypoglycaemic effect of repaglinide. The concomitant use of gemfibrozil and repaglinide is contraindicated

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

Co-administration of rosiglitazone with gemfibrozil (an inhibitor of CYP2C8) resulted in a twofold increase in rosiglitazone plasma concentrations.

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

In the presence of 600 mg gemfibrozil, twice a day, a strong inhibitor of CYP2C8, exposure to selexipag increased approximately 2-fold. Concomitant administration of Uptravi with strong inhibitors of CYP2C8 (e.g., gemfibrozil) is contraindicated

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

Inhibitors of OATP1B1 may result in mild increases in simeprevir plasma concentrations.

Gemfibrozil, simvastatine [2] ---> SmPC of [2] of eMC

Gemfibrozil increases the AUC of simvastatin acid by 1.9-fold, possibly due to inhibition of the glucuronidation pathway and/or OATP1B1. Concomitant administration with gemfibrozil is contraindicated.

Gemfibrozil, warfarin [2] ---> SmPC of [2] of eMC

Gemfibrozil may potentiate the effects of oral anticoagulants, which necessitates careful monitoring of the anticoagulant dosing

CONTRAINDICATIONS of Gemfibrozil

- Hypersensitivity to the active substance or any of the excipients

- Hepatic impairment.

- Severe renal impairment.

- History of/or pre-existing gall bladder or biliary tract disease, including gallstones

- Concomitant use of repaglinide or simvastatin

- Patients with previous history of photoallergy or phototoxic reaction during treatment with fibrates.

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

Gemtuzumab ozogamicin (Mylotarg)

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

MYLOTARG has moderate influence on the ability to drive and use machines. Patients should be advised they may experience fatigue, dizziness and headache during treatment with MYLOTARG

Breast-feeding, gemtuzumab ozogamicin [2] ---> SmPC of [2] of EMA

Because of the potential for adverse reactions in breast-fed children, women should not breast-feed during treatment with MYLOTARG and for at least 1 month after the final dose

Fertility, gemtuzumab ozogamicin [2] ---> SmPC of [2] of EMA

Male and female fertility may be compromised by treatment with gemtuzumab ozogamicin (see section 5.3). Both men and women should seek advice on fertility preservation before treatment.

Gemtuzumab ozogamicin [1], pregnancy ---> SmPC of [1] of EMA

Pregnant women, or patients becoming pregnant whilst receiving gemtuzumab ozogamicin, or treated male patients as partners of pregnant women, must be apprised of the potential hazard to the foetus.

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

Women of childbearing potential, or partners of females of childbearing potential should be advised to use 2 methods of effective contraception during treatment with MYLOTARG for at least 7 months (females) or 4 months (males) after the last dose.

CONTRAINDICATIONS of Gemtuzumab ozogamicin (Mylotarg)

- 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/mylotarg-epar-product-information_en.pdf 17/09/2025

Gentamicin

Aciclovir, gentamicin

Increased risk of nephrotoxicity. Caution should be exercised.

Adefovir dipivoxil [1], gentamicin ---> SmPC of [1] of EMA

Co-administration of adefovir dipivoxil with intravenous aminoglycosides may increase serum concentrations of either adefovir or the co-administered medicinal product

Agalsidase alfa [1], gentamicin ---> SmPC of [1] of EMA

Agalsidase alfa should not be co-administered with gentamicin since this substance has the potential to inhibit intra-cellular alfa-galactosidase activity.

Agalsidase beta [1], gentamicin ---> SmPC of [1] of EMA

Agalsidase beta should not be administered with gentamicin due to a theoretical risk of inhibition of intra-cellular alfa-galactosidase activity.

Aminoglycoside antibiotics, amphotericin

Concurrent administration of aminoglycoside antibiotics with amphotericin may increase the risk of nephrotoxicity

Aminoglycoside antibiotics, cefalotin

Increased nephrotoxicity has been reported following concomitant parenteral administration of aminoglycoside antibiotics and cephalosporins.

Aminoglycoside antibiotics, clindamycin

Concurrent administration of aminoglycoside antibiotics with clindamycin may increase the risk of nephrotoxicity

Aminoglycoside antibiotics, cytotoxic agents

Concurrent administration of aminoglycoside antibiotics with cytotoxic agents may increase the risk of nephrotoxicity

Aminoglycoside antibiotics, daunorubicin

Concurrent administration of aminoglycoside antibiotics with cytotoxic agents may increase the risk of nephrotoxicity

Aminoglycoside antibiotics, gentamicin [2] ---> SmPC of [2] of eMC

Concurrent administration of gentamicin and other potentially ototoxic or nephrotoxic drugs should be avoided.

Aminoglycoside antibiotics, immunosuppressives

Concurrent administration of aminoglycoside antibiotics with immunosuppresive agents may increase the risk of nephrotoxicity

Aminoglycoside antibiotics, indometacin

Concurrent administration of aminoglycoside antibiotics with indometacin may decrease the renal clearance of antibiotic with risk of toxicity

Aminoglycoside antibiotics, loxapine

Loxapine may mask the ototoxicity symptoms of aminoglycoside antibiotics

Amphotericin B, gentamicin [2] ---> SmPC of [2] of eMC

Amphotericin B is potential enhancer of nephrotoxicity

Amphotericin, gentamicin [2] ---> SmPC of [2] of eMC

Amphotericin is potential enhancer of nephrotoxicity

Bacteriostatic antibiotics, gentamicin

The co-administration of bactericide with bacteriostatic antibiotics should be avoided due to possible antagonist effects

Beta-lactam antibiotics, gentamicin [2] ---> SmPC of [2] of eMC

In vitro admixture of aminoglycosides with beta-lactam antibiotics (penicillins or cephalosporins) may result in significant mutual inactivation.

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

In the absence of gastro-intestinal inflammation, the amount of gentamicin ingested from the milk is unlikely to result in significant blood levels in breast-fed infants.

Buclizine, gentamicin

Buclizine may mask the ototoxicity symptoms of aminoglycoside antibiotics

Calcium chloride, gentamicin

The calcium chloride injection may abolish the neuromuscular blocking of aminoglycoside antibiotic

Capreomycin, gentamicin [2] ---> SmPC of [2] of eMC

Concurrent administration of gentamicin and other potentially ototoxic or nephrotoxic drugs should be avoided.

Cefalotin, gentamicin [2] ---> SmPC of [2] of eMC

Any potential nephrotoxicity of cephalosporins, and in particular cephaloridine, may also be increased in the presence of gentamicin. Consequently, if this combination is used monitoring of kidney function is advised.

Cephalosporins, gentamicin [2] ---> SmPC of [2] of eMC

Cidofovir, gentamicin

Increased risk of nephrotoxicity. Caution should be exercised.

Cisplatin, gentamicin [2] ---> SmPC of [2] of eMC

Cisplatin is potential enhancer of nephrotoxicity

Citrated blood, gentamicin

Massive transfusions of citrated blood may enhance the neuromuscular blockade

Clindamycin, gentamicin [2] ---> SmPC of [2] of eMC

Concurrent administration of gentamicin and other potentially ototoxic or nephrotoxic drugs should be avoided.

Colistin, gentamicin

The administration concurrent or sequential of polypeptide antibiotics with aminoglycoside antibiotics may increase the risk of nephrotoxicity and/or of neuromuscular blockade that can cause respiratory depression or paralysis (apnea)

Curare-type muscle relaxants, gentamicin [2] ---> SmPC of [2] of eMC

Neuromuscular blockade and respiratory paralysis have been reported from administration of aminoglycosides to patients who have received curare-type muscle relaxants during anaesthesia.

Cyclizine, gentamicin

Cyclizine may mask the ototoxicity symptoms of aminoglycoside antibiotics

Cyclosporine [1], gentamicin ---> SmPC of [1] of eMC

Care should be taken when using ciclosporin together with other active substances that exhibit nephrotoxic synergy

Cytotoxic agents, gentamicin [2] ---> SmPC of [2] of eMC

Concurrent administration of gentamicin and other potentially ototoxic or nephrotoxic drugs should be avoided.

Daunorubicin, gentamicin [2] ---> SmPC of [2] of eMC

Concurrent administration of gentamicin and other potentially ototoxic or nephrotoxic drugs should be avoided.

Digoxin [1], gentamicin ---> SmPC of [1] of eMC

Serum levels of digoxin may be increased by concomitant administration of gentamicin

Escin, gentamicin

Concomitant use should be avoided. The nephrotoxicity of aminoglycoside antibiotic may increase.

Ethacrynic acid, gentamicin [2] ---> SmPC of [2] of eMC

Potent diuretics are believed to enhance the risk of ototoxicity

Ether, gentamicin

The neuromuscular blocking properties of aminoglycoside antibiotics are potentiated by ether

Ganciclovir, gentamicin

Increased risk of nephrotoxicity. Caution should be exercised.

Gentamicin [1], immunosuppressives ---> SmPC of [1] of eMC

Concurrent administration of gentamicin and other potentially ototoxic or nephrotoxic drugs should be avoided.

Gentamicin [1], loop diuretics ---> SmPC of [1] of eMC

Potent diuretics are believed to enhance the risk of ototoxicity

Gentamicin [1], penicillins ---> SmPC of [1] of eMC

In vitro admixture of aminoglycosides with beta-lactam antibiotics (penicillins or cephalosporins) may result in significant mutual inactivation.

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

In common with most drugs known to cross the placenta, usage in pregnancy should only be considered in life threatening situations where expected benefits outweigh possible risks.

Gentamicin [1], strong diuretic agents ---> SmPC of [1] of eMC

Potent diuretics are believed to enhance the risk of ototoxicity

Gentamicin, halogenated anaesthetics

Halogenated anaesthetics may potentiate the neuromuscular blockade

Gentamicin, indometacin

Concurrent administration of aminoglycoside antibiotics with indometacin may decrease the renal clearance of antibiotic with risk of toxicity

Gentamicin, iodinated contrast media

Increased risk of nephrotoxicity. Caution should be exercised.

Gentamicin, loxapine

Loxapine may mask the ototoxicity symptoms of aminoglycoside antibiotics

Gentamicin, magnesium

In patients receiving gentamicin, the neuromuscular block effect of magnesium salts may be increased

Gentamicin, meclozine

Meclozine may mask the ototoxicity symptoms of aminoglycoside antibiotics

Gentamicin, methoxyflurane

Concurrent administration of aminoglycoside antibiotics with methoxyflurane may increase the risk of nephrotoxicity. The concurrent administration should be avoided

Gentamicin, metildigoxin

Increased plasma levels of metildigoxin

Gentamicin, muscle relaxants

Concurrent administration of gentamicin with neuromuscular blockers may enhance the neuromuscular blockade

Gentamicin, neostigmine

Antagonist effect

Gentamicin, nephrotoxic substances

Concurrent administration of gentamicin and other potentially ototoxic or nephrotoxic drugs should be avoided.

Gentamicin, opioid analgesics

Concurrent administration of gentamicin with opioid analgesics may be additive with the respiratory depressant effects

Gentamicin, oral anticoagulants ---> SmPC of [imipenem/cilastatin] of eMC

There have been many reports of increases in the anti-coagulant effects of orally administered anti-coagulant agents, including warfarin in patients who are concomitantly receiving antibacterial agents.

Gentamicin, ototoxic agents

Concurrent administration of gentamicin and other potentially ototoxic or nephrotoxic drugs should be avoided.

Gentamicin, pancuronium

The neuromuscular blocking may be deep and prolonged if gentamicin is coadministered during or immediately after surgery with a nondepolarizing muscle relaxant

Gentamicin, pentamidine

Increased risk of nephrotoxicity. Caution should be exercised.

Gentamicin, phenothiazines

Phenothiazines may mask the ototoxicity symptoms of aminoglycoside antibiotics

Gentamicin, piperacillin ---> SmPC of [piperacillin/tazobactam] of eMC

The inactivation of gentamicin by piperacillin has been demonstrated in patients with severe renal impairment.

Gentamicin, piperacillin/tazobactam [2] ---> SmPC of [2] of eMC

The inactivation of gentamicin by piperacillin has been demonstrated in patients with severe renal impairment.

Gentamicin, platinum compounds

Increased risk of nephrotoxicity. Caution should be exercised.

Gentamicin, polymyxin

Gentamicin, polypeptide antibiotics

Gentamicin, pyridostigmine

The aminoglycoside antibiotic agent antagonizes the effects of pyridostigmine

Gentamicin, tacrolimus [2] ---> SmPC of [2] of EMA

Concurrent use of tacrolimus with medicinal products known to have nephrotoxic or neurotoxic effects may increase these effects

Gentamicin, tenofovir disoproxil [2] ---> SmPC of [2] of EMA

Use of tenofovir should be avoided with concurrent or recent use of a nephrotoxic medicinal product

Gentamicin, thioxanthenes

Thioxanthenes may mask the ototoxicity symptoms of aminoglycoside antibiotics

Gentamicin, torasemid [2] ---> SmPC of [2] of eMC

Torasemide, especially at high doses, may potentiate the toxicity of aminoglycoside antibiotics

Gentamicin, trimethobenzamide

Trimethobenzamide may mask the ototoxicity symptoms of aminoglycoside antibiotics

Gentamicin, tubocuranine

The neuromuscular blocking may be deep and prolonged if gentamicin is coadministered during or immediately after surgery with a nondepolarizing muscle relaxant

Gentamicin, vancomycin [2] ---> SmPC of [2] of eMC

Concurrent or sequential systemic or topical use of other potentially neurotoxic or nephrotoxic drugs may potentiate the nephrotoxicity and/or ototoxicity of vancomycin and consequently requires careful monitoring.

Gentamicin, warfarin

Gentamicin potentiates the anticoagulant effect

CONTRAINDICATIONS of Gentamicin

- Gentamicin is contra-indicated in patients with a known allergy to it and other aminoglycosides.

- Evidence exists that gentamicin may cause neuromuscular blockade and is therefore contra-indicated in myasthenia gravis and related conditions.

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

Gilteritinib (Xospata)

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

Gilteritinib has minor influence on the ability to drive and use machines. Dizziness has been reported in patients taking Xospata and should be considered when assessing a patient's ability to drive or use machines

Azithromycin, gilteritinib [2] ---> SmPC of [2] of EMA

Strong inhibitors of CYP3A, P-gp and/or BCRP (e.g., voriconazole, itraconazole, posaconazole, clarithromycin, erythromycin, captopril, carvedilol, ritonavir, azithromycin) can increase gilteritinib plasma concentrations.

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

Caution is advised during co-administration of gilteritinib with substrates of P-gp (e.g., digoxin, dabigatran etexilate), BCRP (e.g., mitoxantrone, methotrexate, rosuvastatin) and OCT1 (e.g., metformin).

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

A risk to breast-fed children cannot be excluded. Breast-feeding should be discontinued during treatment with Xospata and for at least two months after the last dose.

Captopril, gilteritinib [2] ---> SmPC of [2] of EMA

Carvedilol, gilteritinib [2] ---> SmPC of [2] of EMA

Cephalexin, gilteritinib [2] ---> SmPC of [2] of EMA

Additionally, the PK of cephalexin were not significantly (Cmax and AUC decreased by less than 10%) affected after once daily administration of gilteritinib (200 mg) for 15 days in patients with FLT3-mutated relapsed or refractory AML.

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

Dabigatran etexilate, gilteritinib [2] ---> SmPC of [2] of EMA

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

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

Escitalopram, gilteritinib [2] ---> SmPC of [2] of EMA

Based on in vitro data, gilteritinib may reduce the effects of medicinal products that target 5HT2B receptor or sigma nonspecific receptor (e.g., escitalopram, fluoxetine, sertraline).

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

There are no data on the effect of gilteritinib on human fertility.

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

Based on in vitro data, gilteritinib may reduce the effects of medicinal products that target 5HT2B receptor or sigma nonspecific receptor (e.g., escitalopram, fluoxetine, sertraline).

Gilteritinib [1], hormonal contraceptives ---> SmPC of [1] of EMA

It is unknown whether gilteritinib may reduce the effectiveness of hormonal contraceptives, and therefore women using hormonal contraceptives should add a barrier method of contraception.

Gilteritinib [1], itraconazol ---> SmPC of [1] of EMA

Gilteritinib [1], men ---> SmPC of [1] of EMA

Males of reproductive potential should be advised to use effective contraception during treatment and for at least 4 months after the last dose of Xospata (see section 4.4).

Gilteritinib [1], metformin ---> SmPC of [1] of EMA

Gilteritinib [1], methotrexate ---> SmPC of [1] of EMA

Gilteritinib [1], midazolam ---> SmPC of [1] of EMA

The PK of midazolam (a sensitive CYP3A4 substrate) were not significantly (Cmax and AUC increased approximately 10%) affected after once-daily administration of gilteritinib (300 mg) for 15 days in patients with FLT3-mutated relapsed or refractory AML.

Gilteritinib [1], mitoxantrone ---> SmPC of [1] of EMA

Gilteritinib [1], OCT1 substrates ---> SmPC of [1] of EMA

Gilteritinib [1], P-glycoprotein substrates ---> SmPC of [1] of EMA

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

Concomitant use of Xospata with strong CYP3A/P-gp inducers (e.g., phenytoin, rifampin and St. John's wort) should be avoided because they can decrease gilteritinib plasma concentrations.

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

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

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

Gilteritinib [1], pregnancy test ---> SmPC of [1] of EMA

Pregnancy testing is recommended for females of reproductive potential seven days prior to initiating Xospata treatment.

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

Concomitant use of Xospata with strong CYP3A/P-gp inducers (e.g., phenytoin, rifampin and St. John's wort) should be avoided because they can decrease gilteritinib plasma concentrations.

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

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

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

Based on in vitro data, gilteritinib may reduce the effects of medicinal products that target 5HT2B receptor or sigma nonspecific receptor (e.g., escitalopram, fluoxetine, sertraline).

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

Concomitant use of Xospata with strong CYP3A/P-gp inducers (e.g., phenytoin, rifampin and St. John's wort) should be avoided because they can decrease gilteritinib plasma concentrations.

Gilteritinib [1], strong CYP3A4 and P-glycoprotein inductors ---> SmPC of [1] of EMA

Concomitant use of Xospata with strong CYP3A/P-gp inducers (e.g., phenytoin, rifampin and St. John's wort) should be avoided because they can decrease gilteritinib plasma concentrations.

Gilteritinib [1], strong CYP3A4 and P-glycoprotein-inhibitors ---> SmPC of [1] of EMA

Caution is required when prescribing gilteritinib with medicines that are strong inhibitors of CYP3A and/or P-gp because they can increase gilteritinib exposure. Alternative medicines that do not strongly inhibit CYP3A and/or P-gp should be considered.

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

Co-administration of CYP3A/P-gp inducers may lead to decreased gilteritinib exposure and consequently a risk for lack of efficacy. Therefore, concomitant use of gilteritinib with strong CYP3A4/P-gp inducers should be avoided

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

Gilteritinib [1], strong P-gp inductors ---> SmPC of [1] of EMA

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

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

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

Women of childbearing potential are recommended to use effective contraception (methods that result in less than 1% pregnancy rates) during and up to 6 months after treatment.

CONTRAINDICATIONS of Gilteritinib (Xospata)

- 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/xospata-epar-product-information_en.pdf 15/04/2024

Ginseng

Antidiabetics, ginseng

Ginseng may impair the blood glucose levels.

Breast-feeding, ginseng

This drug should not be used during pregnancy and breastfeeding because there is no experience

Coumarin anticoagulants, ginseng

The co-administration of ginseng with anti-coagulant effect of coumarin drugs may potentiate the anti-coagulant effect

Digoxin, ginseng

It has been reported increased digoxin levels

Ginseng, insulin

Ginseng may impair the blood glucose levels.

Ginseng, monoamine oxidase inhibitors

Ginseng may enhance the effect of MAO inhibitors (hypertensive crisis, tremor, insomnia, headaches, mania)

Ginseng, pregnancy

This drug should not be used during pregnancy and breastfeeding because there is no experience

Ginseng, trandolapril

Ginseng may antagonize the antihypertensive effect of trandolapril.

Ginseng, warfarin

The co-administration of ginseng with anti-coagulant effect of coumarin drugs may potentiate the anti-coagulant effect

Givosiran (Givlaari)

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

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

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

1.3-fold increase in Cmax and 3.1-fold increase in AUC0-inf of caffeine

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

2.0-fold increase in Cmax and 2.4-fold increase in AUC0-inf of dextromethorphan

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

Caution is recommended during the use of medicinal products that are substrates of CYP1A2 or CYP2D6 while on treatment with Givlaari as this medicinal product may increase or prolong their therapeutic effect or alter their adverse event profiles.

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

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

There are no data on the effects of givosiran on human fertility. No impact on male or female fertility was detected in animal studies (see section 5.3).

Givosiran [1], losartan ---> SmPC of [1] of EMA

No effect on the exposure of losartan

Givosiran [1], midazolam ---> SmPC of [1] of EMA

1.2-fold increase in Cmax and 1.5-fold increase in AUC0-inf of midazolam

Givosiran [1], omeprazole ---> SmPC of [1] of EMA

1.1-fold increase in Cmax and 1.6-fold increase in AUC0-inf of omeprazole

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

The use of this medicinal product could be considered during pregnancy taking into account the expected health benefit for the woman and potential risks to the foetus.

CONTRAINDICATIONS of Givosiran (Givlaari)

- Severe hypersensitivity (e.g. anaphylaxis) to the active substance or to any excipients listed in section 6.1.

https://www.ema.europa.eu/en/documents/product-information/givlaari-epar-product-information_en.pdf 08/05/2025

Glasdegib (Daurismo)

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

Patients experiencing fatigue or other symptoms (e.g., muscle cramps, pain, nausea) affecting the ability to react normally while taking Daurismo should exercise caution when driving or operating machines.

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

Concomitant administration of glasdegib with acid-reducing agents (including PPIs, H2-receptor antagonists, and locally acting antacids) is permitted.

BCRP substrates with narrow therapeutic range, glasdegib [2] ---> SmPC of [2] of EMA

Narrow therapeutic index substrates of P-gp (e.g., digoxin) or BCRP should be used with caution in combination with glasdegib.

Boceprevir, glasdegib [2] ---> SmPC of [2] of EMA

Caution should be used when administering concomitantly with strong CYP3A4 inhibitors as an increase in glasdegib plasma concentration may occur.

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

Concomitant use of Daurismo with moderate CYP3A4 inducers should be avoided. If concomitant use of moderate CYP3A4 inducers cannot be avoided, the dose of Daurismo should be increased as tolerated

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

Given the potential for serious adverse reactions in breast-feeding children from glasdegib, breast-feeding is not recommended during treatment with Daurismo and for at least one week after the last dose

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

Concomitant use with strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, enzalutamide, mitotane, phenytoin and St. John's Wort) should be avoided, as this is likely to decrease glasdegib plasma concentrations.

Cobicistat, glasdegib [2] ---> SmPC of [2] of EMA

Caution should be used when administering concomitantly with strong CYP3A4 inhibitors as an increase in glasdegib plasma concentration may occur.

Conivaptan, glasdegib [2] ---> SmPC of [2] of EMA

Caution should be used when administering concomitantly with strong CYP3A4 inhibitors as an increase in glasdegib plasma concentration may occur.

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

Narrow therapeutic index substrates of P-gp (e.g., digoxin) or BCRP should be used with caution in combination with glasdegib.

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

Concomitant use of Daurismo with moderate CYP3A4 inducers should be avoided. If concomitant use of moderate CYP3A4 inducers cannot be avoided, the dose of Daurismo should be increased as tolerated

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

Etravirine, glasdegib [2] ---> SmPC of [2] of EMA

Concomitant use of Daurismo with moderate CYP3A4 inducers should be avoided. If concomitant use of moderate CYP3A4 inducers cannot be avoided, the dose of Daurismo should be increased as tolerated

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

Glasdegib has the potential to impair reproductive function in males. Based on its mechanism of action, Daurismo may impair female fertility

Glasdegib [1], grapefruit ---> SmPC of [1] of EMA

Caution should be used when administering concomitantly with strong CYP3A4 inhibitors as an increase in glasdegib plasma concentration may occur.

Glasdegib [1], grapefruit juice ---> SmPC of [1] of EMA

Caution should be used when administering concomitantly with strong CYP3A4 inhibitors as an increase in glasdegib plasma concentration may occur.

Glasdegib [1], H2 antagonists ---> SmPC of [1] of EMA

Concomitant administration of glasdegib with acid-reducing agents (including PPIs, H2-receptor antagonists, and locally acting antacids) is permitted.

Glasdegib [1], itraconazol ---> SmPC of [1] of EMA

Caution should be used when administering concomitantly with strong CYP3A4 inhibitors as an increase in glasdegib plasma concentration may occur.

Glasdegib [1], ketoconazole ---> SmPC of [1] of EMA

Caution should be used when administering concomitantly with strong CYP3A4 inhibitors as an increase in glasdegib plasma concentration may occur.

Glasdegib [1], MATE1 inhibitors ---> SmPC of [1] of EMA

In vitro studies indicated that glasdegib may have the potential to inhibit (MATE)1 and MATE2K at clinically relevant concentrations.

Glasdegib [1], men ---> SmPC of [1] of EMA

Glasdegib may be present in semen. Male patients should not donate semen during treatment with Daurismo and for at least 30 days after the last dose.

Glasdegib [1], men ---> SmPC of [1] of EMA

Male patients with female partners should be advised of the potential risk of exposure through semen and to always use effective contraception, including a condom (with spermicide, if available),

Glasdegib [1], mitotane ---> SmPC of [1] of EMA

Glasdegib [1], modafinil ---> SmPC of [1] of EMA

Concomitant use of Daurismo with moderate CYP3A4 inducers should be avoided. If concomitant use of moderate CYP3A4 inducers cannot be avoided, the dose of Daurismo should be increased as tolerated

Glasdegib [1], moderate CYP3A4 inductors ---> SmPC of [1] of EMA

Concomitant use of Daurismo with moderate CYP3A4 inducers should be avoided. If concomitant use of moderate CYP3A4 inducers cannot be avoided, the dose of Daurismo should be increased as tolerated

Glasdegib [1], nafcillin ---> SmPC of [1] of EMA

Concomitant use of Daurismo with moderate CYP3A4 inducers should be avoided. If concomitant use of moderate CYP3A4 inducers cannot be avoided, the dose of Daurismo should be increased as tolerated

Glasdegib [1], P-glycoprotein substrates with small therapeutic index ---> SmPC of [1] of EMA

Narrow therapeutic index substrates of P-gp (e.g., digoxin) or BCRP should be used with caution in combination with glasdegib.

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

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

Caution should be used when administering concomitantly with strong CYP3A4 inhibitors as an increase in glasdegib plasma concentration may occur.

Glasdegib [1], potent CYP3A4 inhibitors that prolong the QT interval ---> SmPC of [1] of EMA

For medicinal products that have known QT prolonging effects and/or strong CYP3A4 inhibitor potential, alternatives should be considered.

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

Glasdegib can cause foetal harm when administered to a pregnant woman. Daurismo should not be used during pregnancy and in women of childbearing potential not using contraception

Glasdegib [1], proton pump inhibitors ---> SmPC of [1] of EMA

Concomitant administration of glasdegib with acid-reducing agents (including PPIs, H2-receptor antagonists, and locally acting antacids) is permitted.

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

Glasdegib may prolong QT interval. Therefore, the concomitant use of glasdegib with other medicinal products known to prolong QT interval or induce Torsades de Pointes should be carefully considered

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

Concomitant administration of glasdegib with acid-reducing agents (including PPIs, H2-receptor antagonists, and locally acting antacids) is permitted.

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

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

Caution should be used when administering concomitantly with strong CYP3A4 inhibitors as an increase in glasdegib plasma concentration may occur.

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

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

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

Caution should be used when administering concomitantly with strong CYP3A4 inhibitors as an increase in glasdegib plasma concentration may occur.

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

Caution should be used when administering concomitantly with strong CYP3A4 inhibitors as an increase in glasdegib plasma concentration may occur.

Glasdegib [1], torsades de pointes inducing drugs ---> SmPC of [1] of EMA

Glasdegib may prolong QT interval. Therefore, the concomitant use of glasdegib with other medicinal products known to prolong QT interval or induce Torsades de Pointes should be carefully considered

Glasdegib [1], troleandomycin ---> SmPC of [1] of EMA

Caution should be used when administering concomitantly with strong CYP3A4 inhibitors as an increase in glasdegib plasma concentration may occur.

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

Caution should be used when administering concomitantly with strong CYP3A4 inhibitors as an increase in glasdegib plasma concentration may occur.

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

If Daurismo is used in women of childbearing potential, they should be advised to avoid becoming pregnant. The pregnancy status of female patients of childbearing potential should be verified prior to initiating treatment.

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

Women of childbearing potential who are receiving this medicinal product should always use effective contraception during treatment with Daurismo and for at least 30 days after the last dose.

CONTRAINDICATIONS of Glasdegib (Daurismo)

- 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/daurismo-epar-product-infomartion_en.pdf 27/08/2024

Glatiramer

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

Caution should be exercised when glatiramer is administered to a nursing mother.

Corticosteroids, glatiramer [2] ---> SmPC of [2] of eMC

An increased incidence of injection site reactions has been seen in glatiramer patients receiving concurrent administration of corticosteroids.

Dimethyl fumarate [1], glatiramer ---> SmPC of [1] of EMA

Commonly used medicinal products in patients with multiple sclerosis were clinically tested for potential interactions with dimethyl fumarate and did not alter the pharmacokinetic profile of dimethyl fumarate.

Drugs with high protein binding, glatiramer [2] ---> SmPC of [2] of eMC

As glatiramer has, theoretically, the potential to affect the distribution of protein bound substances, concomitant use of such medicinal products should be monitored carefully.

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

Glatiramer is contraindicated during pregnancy.

Glatiramer, natalizumab [2] ---> SmPC of [2] of EMA

Natalizumab is contraindicated in combination with glatiramer acetate

CONTRAINDICATIONS of Glatiramer

Copaxone is contraindicated under the following conditions:

- Hypersensitivity to glatiramer acetate or mannitol.

- Pregnant women

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

Glecaprevir/pibrentasvir (Maviret)

Atazanavir, glecaprevir/pibrentasvir [2] ---> SmPC of [2] of EMA

Co-administration of Maviret with atazanavir-containing products is contraindicated due to the risk of ALT elevations

Atazanavir/cobicistat [1], glecaprevir/pibrentasvir ---> SmPC of [1] of EMA

Co-administration of EVOTAZ with glecaprevir/pibrentasvir fixed dose combination is contraindicated because of the potential increase in the risk of ALT elevations due to a significant increase in glecaprevir and pibrentasvir plasma concentrations

Atorvastatin, glecaprevir/pibrentasvir [2] ---> SmPC of [2] of EMA

Co-administration with atorvastatin and simvastatin is contraindicated

BCRP inhibitors, glecaprevir/pibrentasvir [2] ---> SmPC of [2] of EMA

Co-administration of Maviret with medicinal products that inhibit P-gp and BCRP may slow elimination of glecaprevir and pibrentasvir and thereby increase plasma exposure of the antivirals.

BCRP substrates, glecaprevir/pibrentasvir [2] ---> SmPC of [2] of EMA

Co-administration with Maviret may increase plasma concentrations of medicinal products that are substrates of P-gp (e.g. dabigatran etexilate, digoxin), BCRP, or OATP1B1/3 (e.g. atorvastatin, lovastatin, pravastatin, rosuvastatin, simvastatin).

Bictegravir/emtricitabine/tenofovir alafenamide [1], glecaprevir/pibrentasvir ---> SmPC of [1] of EMA

Therefore, caution is recommended when bictegravir is combined with medicinal products known to inhibit P-gp and/or BCRP (e.g. macrolides, ciclosporin, verapamil, dronedarone, glecaprevir/pibrentasvir)

Breast-feeding, glecaprevir/pibrentasvir [2] ---> SmPC of [2] of EMA

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

Carbamazepine, glecaprevir/pibrentasvir [2] ---> SmPC of [2] of EMA

Medicinal products that are strong P-gp and CYP3A inducers could significantly decrease glecaprevir or pibrentasvir plasma levels and may lead to reduced therapeutic effect of Maviret or loss of virologic response. Co-administration is contraindicated

Cobicistat, glecaprevir/pibrentasvir [2] ---> SmPC of [2] of EMA

Co-administration of Maviret with medicinal products that inhibit P-gp and BCRP may slow elimination of glecaprevir and pibrentasvir and thereby increase plasma exposure of the antivirals.

Crizotinib, glecaprevir/pibrentasvir [2] ---> SmPC of [2] of EMA

Co-administration of Maviret with medicinal products that are moderate inducers P-gp/CYP3A may decrease glecaprevir and pibrentasvir plasma concentrations. Co-administration of moderate inducers is not recommended

Cyclosporine, glecaprevir/pibrentasvir [2] ---> SmPC of [2] of EMA

Maviret is not recommended for use in patients requiring stable ciclosporin doses > 100 mg per day.

CYP3A4 substrates, glecaprevir/pibrentasvir [2] ---> SmPC of [2] of EMA

Clinically significant increases in exposure were not observed for sensitive substrates of CYP3A (midazolam, felodipine) or UGT1A1 (raltegravir) when administered with Maviret.

Dabigatran etexilate, glecaprevir/pibrentasvir [2] ---> SmPC of [2] of EMA

The concomitant use of dabigatran etexilate with the fixed-dose combination of the P-gp inhibitors glecaprevir/pibrentasvir has been shown to increase exposure of dabigatran and may increase the risk of bleeding.

Dabigatran etexilate, glecaprevir/pibrentasvir [2] ---> SmPC of [2] of EMA

Co-administration with Maviret may increase plasma concentrations of medicinal products that are substrates of P-gp. Co-administration is contraindicated

Darunavir, glecaprevir/pibrentasvir [2] ---> SmPC of [2] of EMA

Medicinal products that inhibit OATP1B1/3 (e.g. elvitegravir, ciclosporin, darunavir, lopinavir) increase systemic concentrations of glecaprevir. Co-administration with darunavir is not recommended.

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

It is not recommended to co-administer REZOLSTA with glecaprevir/pibrentasvir.

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

Based on theoretical considerations DRV/COBI may increase the exposure to glecaprevir and pibrentasvir. (P-gp, BCRP and/or OATP1B1/3 inhibition) It is not recommended to co-administer Symtuza with glecaprevir/pibrentasvir.

Darunavir/ritonavir, glecaprevir/pibrentasvir [2] ---> SmPC of [2] of EMA

Medicinal products that inhibit OATP1B1/3 (e.g. elvitegravir, ciclosporin, darunavir, lopinavir) increase systemic concentrations of glecaprevir. Co-administration with darunavir is not recommended.

Digoxin, glecaprevir/pibrentasvir [2] ---> SmPC of [2] of EMA

Inhibition of P-gp. Caution and therapeutic concentration monitoring of digoxin is recommended.

Doravirine [1], glecaprevir/pibrentasvir ---> SmPC of [1] of EMA

No dose adjustment is required.

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

No dose adjustment is required.

Dronedarone, glecaprevir/pibrentasvir [2] ---> SmPC of [2] of EMA

Co-administration of Maviret with medicinal products that inhibit P-gp and BCRP may slow elimination of glecaprevir and pibrentasvir and thereby increase plasma exposure of the antivirals.

Efavirenz, glecaprevir/pibrentasvir [2] ---> SmPC of [2] of EMA

Co-administration with efavirenz may lead to reduced therapeutic effect of Maviret and is not recommended.

Elvitegravir, glecaprevir/pibrentasvir [2] ---> SmPC of [2] of EMA

Medicinal products that inhibit OATP1B1/3 (e.g. elvitegravir, ciclosporin, darunavir, lopinavir) increase systemic concentrations of glecaprevir.

Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide, glecaprevir/pibrentasvir [2] ---> SmPC of [2] of EMA

No dose adjustment is required.

Eslicarbazepine, glecaprevir/pibrentasvir [2] ---> SmPC of [2] of EMA

Ethinyl estradiol, glecaprevir/pibrentasvir [2] ---> SmPC of [2] of EMA

Co-administration of Maviret with ethinyloestradiol-containing products is contraindicated due to the risk of ALT elevations

Ethinyl estradiol/levonorgestrel, glecaprevir/pibrentasvir [2] ---> SmPC of [2] of EMA

No dose adjustment is required with levonorgestrel, norethindrone or norgestimate as contraceptive progestagen.

Felodipine, glecaprevir/pibrentasvir [2] ---> SmPC of [2] of EMA

Clinically significant increases in exposure were not observed for sensitive substrates of CYP3A (midazolam, felodipine) or UGT1A1 (raltegravir) when administered with Maviret.

Fenofibrate/simvastatin [1], glecaprevir/pibrentasvir ---> SmPC of [1] of EMA

Contraindicated with Cholib

Fertility, glecaprevir/pibrentasvir [2] ---> SmPC of [2] of EMA

Animal studies do not indicate harmful effects of glecaprevir or pibrentasvir on fertility at exposures higher than the exposures in humans at the recommended dose (see section 5.3).

Fluvastatin, glecaprevir/pibrentasvir [2] ---> SmPC of [2] of EMA

Interactions with fluvastatin and pitavastatin are likely and caution is recommended during the combination. A low dose of the statin is recommended at the initiation of the DAA treatment.

Foods, glecaprevir/pibrentasvir [2] ---> SmPC of [2] of EMA

Take the tablets with food.

Glecaprevir/pibrentasvir [1], inhibit the bile salt export pump ---> SmPC of [1] of EMA

Both glecaprevir and pibrentasvir inhibit the bile salt export pump (BSEP) in vitro.

Glecaprevir/pibrentasvir [1], itraconazol ---> SmPC of [1] of EMA

Co-administration of Maviret with medicinal products that inhibit P-gp and BCRP may slow elimination of glecaprevir and pibrentasvir and thereby increase plasma exposure of the antivirals.

Glecaprevir/pibrentasvir [1], ketoconazole ---> SmPC of [1] of EMA

Co-administration of Maviret with medicinal products that inhibit P-gp and BCRP may slow elimination of glecaprevir and pibrentasvir and thereby increase plasma exposure of the antivirals.

Glecaprevir/pibrentasvir [1], lopinavir ---> SmPC of [1] of EMA

Medicinal products that inhibit OATP1B1/3 (e.g. elvitegravir, ciclosporin, darunavir, lopinavir) increase systemic concentrations of glecaprevir.

Glecaprevir/pibrentasvir [1], losartan ---> SmPC of [1] of EMA

No dose adjustment is required.

Glecaprevir/pibrentasvir [1], lovastatine ---> SmPC of [1] of EMA

Co-administration is not recommended. If used, lovastatin should not exceed a dose of 20 mg/day and patients should be monitored.

Glecaprevir/pibrentasvir [1], lumacaftor ---> SmPC of [1] of EMA

Glecaprevir/pibrentasvir [1], midazolam ---> SmPC of [1] of EMA

Clinically significant increases in exposure were not observed for sensitive substrates of CYP3A (midazolam, felodipine) or UGT1A1 (raltegravir) when administered with Maviret.

Glecaprevir/pibrentasvir [1], moderate CYP3A4 inductors ---> SmPC of [1] of EMA

Glecaprevir/pibrentasvir [1], OATP1B1 inhibitors ---> SmPC of [1] of EMA

Medicinal products that inhibit OATP1B1/3 (e.g. elvitegravir, ciclosporin, darunavir, lopinavir) increase systemic concentrations of glecaprevir.

Glecaprevir/pibrentasvir [1], OATP1B1 substrates ---> SmPC of [1] of EMA

Glecaprevir/pibrentasvir [1], omeprazole ---> SmPC of [1] of EMA

No dose adjustment is required.

Glecaprevir/pibrentasvir [1], oxcarbazepine ---> SmPC of [1] of EMA

Glecaprevir/pibrentasvir [1], P-glycoprotein substrates ---> SmPC of [1] of EMA

Glecaprevir/pibrentasvir [1], P-gp inhibitors ---> SmPC of [1] of EMA

Co-administration of Maviret with medicinal products that inhibit P-gp and BCRP may slow elimination of glecaprevir and pibrentasvir and thereby increase plasma exposure of the antivirals.

Glecaprevir/pibrentasvir [1], phenobarbital ---> SmPC of [1] of EMA

Glecaprevir/pibrentasvir [1], phenytoin ---> SmPC of [1] of EMA

Glecaprevir/pibrentasvir [1], pitavastatin ---> SmPC of [1] of EMA

Interactions with fluvastatin and pitavastatin are likely and caution is recommended during the combination. A low dose of the statin is recommended at the initiation of the DAA treatment.

Glecaprevir/pibrentasvir [1], pravastatine ---> SmPC of [1] of EMA

Caution is recommended. Pravastatin dose should not exceed 20 mg per day and rosuvastatin dose should not exceed 5 mg per day.

Glecaprevir/pibrentasvir [1], pregnancy ---> SmPC of [1] of EMA

As a precautionary measure, Maviret use is not recommended in pregnancy.

Glecaprevir/pibrentasvir [1], primidone ---> SmPC of [1] of EMA

Glecaprevir/pibrentasvir [1], raltegravir ---> SmPC of [1] of EMA

Clinically significant increases in exposure were not observed for sensitive substrates of CYP3A (midazolam, felodipine) or UGT1A1 (raltegravir) when administered with Maviret. No dose adjustment is required.

Glecaprevir/pibrentasvir [1], rifampicin ---> SmPC of [1] of EMA

Glecaprevir/pibrentasvir [1], ritonavir ---> SmPC of [1] of EMA

Co-administration of Maviret with medicinal products that inhibit P-gp and BCRP may slow elimination of glecaprevir and pibrentasvir and thereby increase plasma exposure of the antivirals.

Glecaprevir/pibrentasvir [1], rosuvastatin ---> SmPC of [1] of EMA

Caution is recommended. Pravastatin dose should not exceed 20 mg per day and rosuvastatin dose should not exceed 5 mg per day.

Glecaprevir/pibrentasvir [1], simvastatine ---> SmPC of [1] of EMA

Co-administration with atorvastatin and simvastatin is contraindicated

Glecaprevir/pibrentasvir [1], sofosbuvir ---> SmPC of [1] of EMA

No dose adjustment is required.

Glecaprevir/pibrentasvir [1], St. John's wort ---> SmPC of [1] of EMA

Glecaprevir/pibrentasvir [1], strong CYP3A4 and P-glycoprotein inductors ---> SmPC of [1] of EMA

Glecaprevir/pibrentasvir [1], tacrolimus ---> SmPC of [1] of EMA

Increase of tacrolimus exposure is expected. Therefore, a therapeutic drug monitoring of tacrolimus is recommended and a dose adjustment of tacrolimus made accordingly

Glecaprevir/pibrentasvir [1], UGT1A1 substrates ---> SmPC of [1] of EMA

Clinically significant increases in exposure were not observed for sensitive substrates of CYP3A (midazolam, felodipine) or UGT1A1 (raltegravir) when administered with Maviret.

Glecaprevir/pibrentasvir [1], valsartan ---> SmPC of [1] of EMA

No dose adjustment is required.

Glecaprevir/pibrentasvir [1], vitamin K antagonists ---> SmPC of [1] of EMA

As liver function may change during treatment with Maviret, a close monitoring of International Normalised Ratio (INR) values is recommended.

Glecaprevir/pibrentasvir, lopinavir/ritonavir [2] ---> SmPC of [2] of EMA

Concomitant administration of glecaprevir/pibrentasvir and Kaletra is not recommended due to an increased risk of ALT elevations associated with increased glecaprevir exposure.

Glecaprevir/pibrentasvir, nirmatrelvir/ritonavir [2] ---> SmPC of [2] of EMA

Serum levels may be increased due to P-gp, BCRP and OATP1B inhibition by ritonavir. Coadministration is not recommended due to an increased risk of ALT elevations associated with increased glecaprevir exposure

Glecaprevir/pibrentasvir, pravastatine/fenofibrate [2] ---> SmPC of [2] of EMA

Concomitant use of pravastatin and glecaprevir/pibrentasvir may increase the plasma concentration of pravastatin and may lead to an increase of dose-dependent adverse events including myopathy risk.

CONTRAINDICATIONS of Glecaprevir/pibrentasvir (Maviret)

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

- Patients with severe hepatic impairment (Child-Pugh C) (see sections 4.2, 4.4, and 5.2).

- Concomitant use with atazanavir containing products, atorvastatin, simvastatin, dabigatran etexilate, ethinyl oestradiol-containing products, strong P-gp and CYP3A inducers (e.g., rifampicin, carbamazepine, St. John's wort (Hypericum perforatum), phenobarbital, phenytoin, and primidone) (see section 4.5).

https://www.ema.europa.eu/en/documents/product-information/maviret-epar-product-information_en.pdf 02/03/2023

Glibenclamide (Amglidia)

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

AMGLIDIA has moderate influence on the ability to drive and use machines since glibenclamide may increase the risk of hypoglycaemia.

ACE inhibitors, glibenclamide [2] ---> SmPC of [2] of EMA

Potentiation of the blood-glucose lowering

Acenocoumarol, glibenclamide

The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk

Acetazolamide, glibenclamide [2] ---> SmPC of [2] of EMA

Weakening of the blood-glucose- lowering effect

Adrenaline, glibenclamide [2] ---> SmPC of [2] of EMA

Weakening of the blood-glucose- lowering effect

Alcohol, glibenclamide

Disulfiram-like reactions have occurred very rarely following the concomitant use of alcohol and glibenclamide.

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

Both acute and chronic alcohol intake, or excessive alcohol ingestion by people who drink occasionally, may attenuate the hypoglycaemic effect of glibenclamide or dangerously potentiate it by delaying its metabolic inactivation.

Allopurinol, glibenclamide

The co-administration may enhance the hypoglycemic effect

Anabolic steroids, glibenclamide [2] ---> SmPC of [2] of EMA

The co-administration may enhance the hypoglycemic effect

Androgens, glibenclamide

The co-administration may potentiate the blood-glucose-lowering effect and, thus, in some instances hypoglycaemia

Antiadrenergics, glibenclamide

The co-administration may enhance the hypoglycemic effect

Azapropazone, glibenclamide

The co-administration may potentiate the blood-glucose-lowering effect and, thus, in some instances hypoglycaemia

Barbiturates, glibenclamide

Weakening of the blood-glucose-lowering effect

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

Weakening of the blood-glucose-lowering effect

Benzocaine, glibenclamide

The co-administration may weaken the hypoglycemic effect

Betablockers, glibenclamide [2] ---> SmPC of [2] of EMA

Under the influence of sympatholytic medicinal products, the signs of adrenergic counter-regulation to hypoglycaemia may be reduced or absent.

Bezafibrate, glibenclamide

The co-administration may enhance the hypoglycemic effect

Biguanides, glibenclamide [2] ---> SmPC of [2] of EMA

The co-administration may enhance the hypoglycemic effect

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

Increase liver enzymes. Incorrect control of plasma glucose

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

Breast-feeding seems to be compatible, but as a precautious measure monitoring of the fully breast-fed infant's blood sugar level is advisable.

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

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

Calcium antagonists, glibenclamide [2] ---> SmPC of [2] of EMA

Weakening of the blood-glucose-lowering effect

Chloramphenicol, glibenclamide [2] ---> SmPC of [2] of EMA

Potentiation of the blood-glucose lowering

Chlorpromazine, glibenclamide

The co-administration may weaken the hypoglycemic effect

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

Weakening of the blood-glucose-lowering effect

Ciprofloxacin, glibenclamide

The co-administration may increase the effect of glibenclamide (hypoglycemia)

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

Potentiation of the blood-glucose lowering

Clonidine, glibenclamide [2] ---> SmPC of [2] of EMA

Potentiation or weakening of the blood-glucose lowering. Signs of adrenergic counterregulation to hypoglycaemia may be reduced or absent Incorrect control of plasma glucose

Colesevelam [1], glibenclamide ---> SmPC of [1] of EMA

Co-administration of colesevelam and glyburide caused a decrease in the AUC0-inf and Cmax of glyburide. No interaction was observed when colesevelam was administered 4 hours after glyburide.

Colesevelam, glibenclamide [2] ---> SmPC of [2] of EMA

Colesevelam binds to glibenclamide and reduces glibenclamide absorption from the gastrointestinal tract. No interaction was observed when glibenclamide was taken at least 4 hours before colesevelam.

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

Weakening of the blood-glucose-lowering effect

Cotrimoxazole, glibenclamide [2] ---> SmPC of [2] of EMA

Potentiation of the blood-glucose lowering effect

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

Potentiate or weaken the effect of coumarin derivatives. Incorrect dose of coumarin derivatives administered

Cyclophosphamide, glibenclamide [2] ---> SmPC of [2] of EMA

Potentiation of the blood-glucose lowering

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

Glibenclamide may increase ciclosporin plasma concentration and potentially lead to its increased toxicity.

CYP2C9 inductors, glibenclamide

The CYP2C9 induction may decrease the plasma concentrations of glibenclamide, which has a narrow therapeutic margin

CYP2C9 inhibitors, glibenclamide

The CYP2C9 inhibition may increase the plasma concentrations of glibenclamide, which has a narrow therapeutic margin

Desmopressin, glibenclamide

The co-administration may shorten the antidiuretic effect

Diazoxide, glibenclamide [2] ---> SmPC of [2] of EMA

Weakening of the blood-glucose-lowering effect

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

Potentiation of the blood-glucose lowering

Diuretics, glibenclamide [2] ---> SmPC of [2] of EMA

Weakening of the blood-glucose-lowering effect

Estrogens, glibenclamide [2] ---> SmPC of [2] of EMA

Weakening of the blood-glucose-lowering effect

Ethionamide, glibenclamide

The co-administration may enhance the hypoglycemic effect

Fenfluramine, glibenclamide [2] ---> SmPC of [2] of EMA

Potentiation of the blood-glucose lowering

Fenyramidol, glibenclamide [2] ---> SmPC of [2] of EMA

Potentiation of the blood-glucose lowering

Fibrates, glibenclamide [2] ---> SmPC of [2] of EMA

Potentiation of the blood-glucose lowering

Fluconazole [1], glibenclamide ---> SmPC of [1] of eMC

Fluconazole has been shown to prolong the serum half-life of concomitantly administered oral sulfonylureas in healthy volunteers. Frequent monitoring of blood glucose is recommended during coadministration.

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

Potentiation of the blood-glucose lowering

Fluvastatin [1], glibenclamide ---> SmPC of [1] of eMC

Patients on concomitant therapy with glibenclamide (glyburide) and fluvastatin should continue to be monitored appropriately when their fluvastatin dose is increased to 80 mg per day.

Fosphenytoin [1], glibenclamide ---> SmPC of [1] of eMC

CYP2C9 inhibition may increase plasma phenytoin concentrations. Phenytoin may increase serum glucose levels and therefore adjustment for insulin or oral antidiabetic agents may be necessary.

Gestagens, glibenclamide

The co-administration may weaken the hypoglycemic effect

Glibenclamide [1], glucagon ---> SmPC of [1] of EMA

Weakening of the blood-glucose-lowering effect

Glibenclamide [1], guanethidine ---> SmPC of [1] of EMA

Potentiation of the blood-glucose lowering. Signs of adrenergic counterregulation to hypoglycaemia may be reduced or absent Incorrect control of plasma glucose

Glibenclamide [1], H2 antagonists ---> SmPC of [1] of EMA

Potentiation or weakening of the blood- glucose lowering effect. Incorrect control of plasma glucose

Glibenclamide [1], heparin ---> SmPC of [1] of EMA

Potentiation of the blood-glucose lowering

Glibenclamide [1], ifosfamide ---> SmPC of [1] of EMA

Potentiation of the blood-glucose lowering

Glibenclamide [1], IMAOs ---> SmPC of [1] of EMA

Potentiation of the blood-glucose lowering

Glibenclamide [1], insulin ---> SmPC of [1] of EMA

Potentiation of the blood-glucose lowering

Glibenclamide [1], isoniazid ---> SmPC of [1] of EMA

Weakening of the blood-glucose- lowering effect

Glibenclamide [1], laxatives ---> SmPC of [1] of EMA

Large doses of laxatives, Weakening of the blood-glucose lowering effect

Glibenclamide [1], miconazole ---> SmPC of [1] of EMA

Potentiation of the blood-glucose lowering

Glibenclamide [1], nicotinic acid ---> SmPC of [1] of EMA

Weakening of the blood-glucose lowering effect

Glibenclamide [1], NSAID ---> SmPC of [1] of EMA

Highly protein-bound medicinal products, which may also potentiate the hypoglycaemic action of glibenclamide due to glibenclamide displacement from plasma proteins

Glibenclamide [1], oral anticoagulants ---> SmPC of [1] of EMA

Highly protein-bound medicinal products, which may also potentiate the hypoglycaemic action of glibenclamide due to glibenclamide displacement from plasma proteins

Glibenclamide [1], oral antidiabetics ---> SmPC of [1] of EMA

Potentiation of the blood-glucose lowering

Glibenclamide [1], oxyphenbutazone ---> SmPC of [1] of EMA

Potentiation of the blood-sugar-lowering effect

Glibenclamide [1], pentoxifylline ---> SmPC of [1] of EMA

Potentiation of the blood-sugar-lowering effect

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

Weakening of the blood-glucose-lowering effect

Glibenclamide [1], phosphamides ---> SmPC of [1] of EMA

Potentiation of the blood-glucose lowering

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

The use of glibenclamide during the first trimester does not seem to cause an increase in congenital malformations. With respect to the second and third trimester published data did not find fetotoxic effects.

Glibenclamide [1], probenecide ---> SmPC of [1] of EMA

Potentiation of the blood-sugar-lowering effect

Glibenclamide [1], progestagens ---> SmPC of [1] of EMA

Weakening of the blood-glucose-lowering effect

Glibenclamide [1], reserpine ---> SmPC of [1] of EMA

Potentiation or weakening of the blood-glucose lowering. Signs of adrenergic counterregulation to hypoglycaemia may be reduced or absent Incorrect control of plasma glucose

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

Weakening of the blood-glucose-lowering effect

Glibenclamide [1], salicylates ---> SmPC of [1] of EMA

Highly protein-bound medicinal products, which may also potentiate the hypoglycaemic action of glibenclamide due to glibenclamide displacement from plasma proteins

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

Potentiation of the blood-glucose lowering with Long-acting sulphonamides.

Glibenclamide [1], sympatholytic drug ---> SmPC of [1] of EMA

Under the influence of sympatholytic medicinal products, the signs of adrenergic counter-regulation to hypoglycaemia may be reduced or absent.

Glibenclamide [1], sympathomimetics ---> SmPC of [1] of EMA

Weakening of the blood-glucose lowering effect

Glibenclamide [1], testosterone ---> SmPC of [1] of EMA

The co-administration may enhance the hypoglycemic effect

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

Potentiation of the blood-glucose lowering

Glibenclamide [1], tritoqualine ---> SmPC of [1] of EMA

Potentiation of the blood-glucose lowering

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

Women of childbearing potential planning a pregnancy should be switched from oral glibenclamide to insulin. Glibenclamide should not be given during pregnancy.

Glibenclamide, glucocorticoids

The co-administration may weaken the hypoglycemic effect

Glibenclamide, glutethimide

The co-administration may weaken the hypoglycemic effect

Glibenclamide, hydantoins

The co-administration may weaken the hypoglycemic effect

Glibenclamide, indometacin

The co-administration may weaken the hypoglycemic effect

Glibenclamide, interferon

Caution should be used when administering interferon with medicines mainly metabolised by hepatic cytochrome P450 and have a narrow therapeutic window

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

Clinical pharmacology studies have shown that the pharmacokinetics of levofloxacin were not affected to any clinically relevant extent when levofloxacin was administered together with glibenclamide

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

In clinical studies linagliptin had no clinically relevant effect on the pharmacokinetics of glibenclamide

Glibenclamide, linagliptin/metformin [2] ---> SmPC of [2] of EMA

Co-administration of multiple oral doses of 5 mg linagliptin and a single oral dose of 1.75 mg glibenclamide (glyburide) resulted in clinically not relevant reduction of 14% of both AUC and Cmax of glibenclamide.

Glibenclamide, lithium

The co-administration may weaken the hypoglycemic effect

Glibenclamide, lornoxicam

Increased risk of hypoglycaemia

Glibenclamide, magnesium hydroxide [2] ---> SmPC of [2] of eMC

The co-administration of magnesium hydroxide may increase the absorption of antidiabetic agents. Separate administration by 2-3 hours

Glibenclamide, male sex hormones

The co-administration may enhance the hypoglycemic effect

Glibenclamide, metformin

The co-administration may enhance the hypoglycemic effect

Glibenclamide, metformin/saxagliptin/dapagliflozin [2] ---> SmPC of [2] of EMA

In studies conducted in healthy subjects, neither the pharmacokinetics of saxagliptin nor its major metabolite were meaningfully altered

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

Decreased bioavailability of glibenclamide

Glibenclamide, moxifloxacin [2] ---> SmPC of [2] of eMC

No clinically relevant interaction was observed between moxifloxacin and glibenclamide.

Glibenclamide, nicotinates

The co-administration may weaken the hypoglycemic effect

Glibenclamide, ofloxacin [2] ---> SmPC of [2] of eMC

Ofloxacin may cause a slight increase in serum concentrations of glibenclamide administered concurrently; patients treated with this combination should be closely monitored.

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

Olaparib is an inhibitor of OATP1B1. It cannot be excluded that olaparib may increase the exposure to substrates of OATP1B1

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

No clinically significant interactions were observed

Glibenclamide, para-aminosalicylic acid

The co-administration may enhance the hypoglycemic effect

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.

Glibenclamide, pentamidine

The co-administration may cause severe hyperglycemia or hypoglycemia

Glibenclamide, perhexiline

The co-administration may enhance the hypoglycemic effect

Glibenclamide, phenylbutazone

The co-administration may enhance the hypoglycemic effect

Glibenclamide, phenytoin ---> SmPC of [fosphenytoin] of eMC

CYP2C9 inhibition may increase plasma phenytoin concentrations

Glibenclamide, pyrazolones

The co-administration may enhance the hypoglycemic effect

Glibenclamide, quinolones ---> SmPC of [levofloxacin] of EMA

As with all quinolones, disturbances in blood glucose, including both hypoglycaemia and hyperglycaemia have been reported, usually in diabetic patients receiving concomitant treatment with an oral hypoglycaemic agent (e.g. glibenclamide) or with insulin.

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

Safinamide may transiently inhibit BCRP in vitro. No precautions are necessary when safinamide is taken with medicinal products that are BCRP substrates (e.g., pitavastatin, pravastatin, ciprofloxacin, methotrexate, topotecan, diclofenac or glyburide).

Glibenclamide, sirolimus

No clinically significant pharmacokinetic interaction was observed

Glibenclamide, strong CYP2C9 inductors

The strong CYP2C9 induction may decrease the plasma concentrations of glibenclamide, which has a narrow therapeutic margin

Glibenclamide, strong CYP2C9 inhibitors

The strong CYP2C9 inhibition may increase the plasma concentrations of glibenclamide, which has a narrow therapeutic margin

Glibenclamide, sulfinpyrazone

The co-administration may enhance the hypoglycemic effect

Glibenclamide, thiazides

The co-administration may weaken the hypoglycemic effect

Glibenclamide, thyroid hormones

The co-administration may weaken the hypoglycemic effect

Glibenclamide, thyroid stimulating agents

The co-administration may weaken the hypoglycemic effect

Glibenclamide, trandolapril/verapamil [2] ---> SmPC of [2] of eMC

Verapamil may increase the plasma concentrations of glibenclamide thus increasing risk of toxicity

Glibenclamide, tricyclic antidepressant

The co-administration may weaken the hypoglycemic effect

Glibenclamide, trofosfamide

The co-administration may enhance the hypoglycemic effect

Glibenclamide, valsartan [2] ---> SmPC of [2] of eMC

In drug interaction studies with valsartan, no interactions of clinical significance have been found with valsartan and glibenclamide

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

The pharmacokinetics of vardenafil (20 mg) was not affected by co-administration with glibenclamide

Glibenclamide, verapamil ---> SmPC of [trandolapril/verapamil] of eMC

Verapamil may increase the plasma concentrations of glibenclamide thus increasing risk of toxicity

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

In vitro, vismodegib is an inhibitor of OATP1B1. It cannot be excluded that vismodegib may increase the exposure to substrates of OATP1B1. In particular, caution should be exercised if vismodegib is administered in combination with any statin.

CONTRAINDICATIONS of Glibenclamide (Amglidia)

This medicinal product is contraindicated in the following cases:

- hypersensitivity to the active substance, other sulphonylureas or sulphonamides or to any of the excipients listed in section 6.1;

- in patients with ketoacidosis, continuous intravenous insulin injection and intravenous infusion of physiologic saline remains the benchmark treatment.

- in patients with porphyria;

- in patients taking bosentan (see section 4.5)

- in patients with severe renal impairment

- in patients with severe hepatic impairment

https://www.ema.europa.eu/en/documents/product-information/amglidia-epar-product-information_en.pdf. 25/09/2023

Gliclazide

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

Patients should be informed that their concentration may be affected if their diabetes is not satisfactorily controlled, especially at the beginning of treatment

Acarbose, gliclazide [2] ---> SmPC of [2] of eMC

Potentiation of the blood glucose lowering effect and thus, in some instances, hypoglycaemia may occur when other antidiabetic agents are taken

ACE inhibitors, gliclazide [2] ---> SmPC of [2] of eMC

Potentiation of the blood glucose lowering effect and thus, in some instances, hypoglycaemia may occur when angiotensin converting enzyme inhibitors are taken

Alcohol, gliclazide [2] ---> SmPC of [2] of eMC

Alcohol increases the hypoglycaemic reaction (by inhibiting compensatory reactions) that can lead to the onset of hypoglycaemic coma. Avoid alcohol or medicines containing alcohol.

Anticoagulants, gliclazide [2] ---> SmPC of [2] of eMC

Sulphonylureas may lead to potentiation of anticoagulation during concurrent treatment. Adjustment of the anticoagulant may be necessary.

Betablockers, gliclazide [2] ---> SmPC of [2] of eMC

Potentiation of the blood glucose lowering effect and thus, in some instances, hypoglycaemia may occur when beta-blockers are taken

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

Given the risk of neonatal hypoglycaemia, the product is contra-indicated in breast-feeding mothers.

Captopril, gliclazide [2] ---> SmPC of [2] of eMC

Potentiation of the blood glucose lowering effect and thus, in some instances, hypoglycaemia may occur when angiotensin converting enzyme inhibitors are taken

Chlorpromazine, gliclazide [2] ---> SmPC of [2] of eMC

High doses (>100 mg per day of chlorpromazine) increase blood glucose levels (reduced insulin release).

Clarithromycin, gliclazide [2] ---> SmPC of [2] of eMC

Potentiation of the blood glucose lowering effect and thus, in some instances, hypoglycaemia may occur when clarithromycin is taken

Danazol, gliclazide [2] ---> SmPC of [2] of eMC

Danazol has diabetogenic effect and may cause an increase in blood glucose levels. Combination is not recommended

Dihydropyrimidine dehydrogenase inhibitors 4, gliclazide [2] ---> SmPC of [2] of eMC

Potentiation of the blood glucose lowering effect and thus, in some instances, hypoglycaemia may occur when other antidiabetic agents are taken

Enalapril, gliclazide [2] ---> SmPC of [2] of eMC

Potentiation of the blood glucose lowering effect and thus, in some instances, hypoglycaemia may occur when angiotensin converting enzyme inhibitors are taken

Fluconazole, gliclazide [2] ---> SmPC of [2] of eMC

Potentiation of the blood glucose lowering effect and thus, in some instances, hypoglycaemia may occur when fluconazole is taken

Gliclazide [1], GLP-1 receptor agonists ---> SmPC of [1] of eMC

Potentiation of the blood glucose lowering effect and thus, in some instances, hypoglycaemia may occur when other antidiabetic agents are taken

Gliclazide [1], glucocorticoids ---> SmPC of [1] of eMC

Glucocorticoids (systemic and local route) increase in blood glucose levels with possible ketosis (reduced tolerance to carbohydrates due to glucocorticoids).

Gliclazide [1], H2 antagonists ---> SmPC of [1] of eMC

Potentiation of the blood glucose lowering effect and thus, in some instances, hypoglycaemia may occur when H2-receptor antagonists are taken

Gliclazide [1], IMAOs ---> SmPC of [1] of eMC

Potentiation of the blood glucose lowering effect and thus, in some instances, hypoglycaemia may occur when MAOIs are taken

Gliclazide [1], insulin ---> SmPC of [1] of eMC

Potentiation of the blood glucose lowering effect and thus, in some instances, hypoglycaemia may occur when other antidiabetic agents are taken

Gliclazide [1], metformin ---> SmPC of [1] of eMC

Potentiation of the blood glucose lowering effect and thus, in some instances, hypoglycaemia may occur when other antidiabetic agents are taken

Gliclazide [1], miconazole ---> SmPC of [1] of eMC

Miconazole (systemic route, oromucosal gel) increases the hypoglycaemic effect with possible onset of hypoglycaemic symptoms, or even coma. Contra-indicated combination

Gliclazide [1], NSAID ---> SmPC of [1] of eMC

Potentiation of the blood glucose lowering effect and thus, in some instances, hypoglycaemia may occur when nonsteroidal anti-inflammatory agents are taken

Gliclazide [1], oral antidiabetics ---> SmPC of [1] of eMC

Potentiation of the blood glucose lowering effect and thus, in some instances, hypoglycaemia may occur when other antidiabetic agents are taken

Gliclazide [1], phenylbutazone ---> SmPC of [1] of eMC

Phenylbutazone (systemic route) increases the hypoglycaemic effect of sulphonylureas (displaces their binding to plasma proteins and/or reduces their elimination). Combination is not recommended

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

Oral hypoglycaemic agents are not suitable, insulin is the drug of first choice for treatment of diabetes during pregnancy.

Gliclazide [1], ritodrine ---> SmPC of [1] of eMC

The administration of gliclazide and i.v. ritodrine increases the blood glucose levels due to beta-2 agonist effects

Gliclazide [1], salbutamol ---> SmPC of [1] of eMC

The administration of gliclazide and i.v. salbutamol increases the blood glucose levels due to beta-2 agonist effects

Gliclazide [1], sulfonylureas ---> SmPC of [1] of eMC

Sulphonylureas may lead to potentiation of anticoagulation during concurrent treatment. Adjustment of the anticoagulant may be necessary.

Gliclazide [1], sulphonamides ---> SmPC of [1] of eMC

Potentiation of the blood glucose lowering effect and thus, in some instances, hypoglycaemia may occur when sulphonamides are taken

Gliclazide [1], terbutaline ---> SmPC of [1] of eMC

The administration of gliclazide and i.v. terbutaline increases the blood glucose levels due to beta-2 agonist effects

Gliclazide [1], tetracosactide ---> SmPC of [1] of eMC

Tetracosactide increases in blood glucose levels with possible ketosis (reduced tolerance to carbohydrates due to glucocorticoids).

Gliclazide [1], thiazolidinediones ---> SmPC of [1] of eMC

Potentiation of the blood glucose lowering effect and thus, in some instances, hypoglycaemia may occur when other antidiabetic agents are taken

Gliclazide [1], warfarin ---> SmPC of [1] of eMC

Sulphonylureas may lead to potentiation of anticoagulation during concurrent treatment. Adjustment of the anticoagulant may be necessary.

Gliclazide, phenothiazines

The co-administration may weaken the hypoglycemic effect

Gliclazide, rifampicin

Rifampicin, enzymatic inductor, may increase the metabolism of gliclazide and decrease its plasma levels and effect

Gliclazide, sympathomimetics

The co-administration may weaken the hypoglycemic effect

Oral antidiabetics, pregnancy ---> SmPC of [gliclazide] of eMC

Oral hypoglycaemic agents are not suitable, insulin is the drug of first choice for treatment of diabetes during pregnancy.

Sulfonylureas, warfarin ---> SmPC of [gliclazide] of eMC

Sulphonylureas may lead to potentiation of anticoagulation during concurrent treatment. Adjustment of the anticoagulant may be necessary.

CONTRAINDICATIONS of Gliclazide

- Hypersensitivity to gliclazide or to any of the excipients listed in section 6.1, other sulphonylureas, sulphonamides,

- Type 1 diabetes,

- Diabetic pre-coma and coma, diabetic keto-acidosis,

- Severe renal or hepatic insufficiency: in these cases the use of insulin is recommended,

- Treatment with miconazole

- Lactation

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

Glimepiride

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

The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or, for example, as a result of visual impairment.

ACE inhibitors, glimepiride [2] ---> SmPC of [2] of eMC

Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia

Acetazolamide, glimepiride [2] ---> SmPC of [2] of eMC

Weakening of the blood-glucose-lowering effect and possible hyperglycaemia

Adrenaline, glimepiride [2] ---> SmPC of [2] of eMC

Weakening of the blood-glucose-lowering effect and possible hyperglycaemia

Alcohol, glimepiride [2] ---> SmPC of [2] of eMC

Alcohol intake may potentiate or weaken the hypoglycaemic action of glimepiride in an unpredictable fashion.

Allopurinol, glimepiride [2] ---> SmPC of [2] of eMC

Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia

Anabolic steroids, glimepiride

The co-administration may enhance the hypoglycemic effect

Anabolic steroids, glimepiride [2] ---> SmPC of [2] of eMC

Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia

Antiadrenergics, glimepiride [2] ---> SmPC of [2] of eMC

Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia

Azapropazone, glimepiride [2] ---> SmPC of [2] of eMC

The co-administration may potentiate the blood-glucose-lowering effect and, thus, in some instances hypoglycaemia

Barbiturates, glimepiride [2] ---> SmPC of [2] of eMC

Weakening of the blood-glucose-lowering effect and possible hyperglycaemia

Bendroflumethiazide, glimepiride [2] ---> SmPC of [2] of eMC

Weakening of the blood-glucose-lowering effect and possible hyperglycaemia

Betablockers, glimepiride [2] ---> SmPC of [2] of eMC

The combination may lead to either potentiation or weakening of the blood glucose lowering effect. Under the influence of sympatholytic medicinal products the signs of adrenergic counter-regulation to hypoglycaemia may be reduced or absent.

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

Breast-feeding is advised against during treatment with glimepiride.

Chloramphenicol, glimepiride [2] ---> SmPC of [2] of eMC

Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia

Chlorpromazine, glimepiride [2] ---> SmPC of [2] of eMC

Weakening of the blood-glucose-lowering effect and possible hyperglycaemia

Clarithromycin, glimepiride [2] ---> SmPC of [2] of eMC

Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia

Clonidine, glimepiride [2] ---> SmPC of [2] of eMC

Colesevelam, glimepiride [2] ---> SmPC of [2] of eMC

Colesevelam binds to glimepiride and reduces glimepiride absorption from the gastro-intestinal tract. Glimepiride should be administered at least 4 hours prior to colesevelam.

Coumarin anticoagulants, glimepiride [2] ---> SmPC of [2] of eMC

Glimepiride may either potentiate or weaken the effects of coumarin derivatives.

Cyclophosphamide, glimepiride [2] ---> SmPC of [2] of eMC

Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia

Dasabuvir with ombitasvir/paritaprevir/ritonavir, glimepiride ---> SmPC of [ombitasvir/paritaprevir/ritonavir] of

Ombitasvir/paritaprevir/ritonavir administered with or without dasabuvir did not affect the exposures of the CYP2C9 substrate, warfarin. Other CYP2C9 substrates are not expected to require dose adjustments.

Deflazacort, glimepiride [2] ---> SmPC of [2] of eMC

Weakening of the blood-glucose-lowering effect and possible hyperglycaemia

Diazoxide, glimepiride [2] ---> SmPC of [2] of eMC

Weakening of the blood-glucose-lowering effect and possible hyperglycaemia

Disopyramide, glimepiride [2] ---> SmPC of [2] of eMC

Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia

Estrogens, glimepiride [2] ---> SmPC of [2] of eMC

Weakening of the blood-glucose-lowering effect and possible hyperglycaemia

Fenfluramine, glimepiride [2] ---> SmPC of [2] of eMC

Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia

Fibrates, glimepiride [2] ---> SmPC of [2] of eMC

Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia

Fluconazole, glimepiride [2] ---> SmPC of [2] of eMC

Results from an in vivo interaction study reported in literature show that glimepiride AUC is increased approximately 2-fold by fluconazole, one of the most potent CYP2C9 inhibitors.

Fluoxetine, glimepiride [2] ---> SmPC of [2] of eMC

Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia

Foods, glimepiride [2] ---> SmPC of [2] of eMC

Glimepiride must be taken shortly before or during a meal.

Gemfibrozil [1], glimepiride ---> SmPC of [1] of eMC

In vitro studies have shown that gemfibrozil is a strong inhibitor of CYP2C9 (an enzyme involved in the metabolism of e.g. warfarin and glimepiride)

Gestagens, glimepiride [2] ---> SmPC of [2] of eMC

Weakening of the blood-glucose-lowering effect and possible hyperglycaemia

Glimepiride [1], glucagon ---> SmPC of [1] of eMC

Weakening of the blood-glucose-lowering effect and possible hyperglycaemia

Glimepiride [1], glucocorticoids ---> SmPC of [1] of eMC

Weakening of the blood-glucose-lowering effect and possible hyperglycaemia

Glimepiride [1], H2 antagonists ---> SmPC of [1] of eMC

The combination may lead to either potentiation or weakening of the blood glucose lowering effect

Glimepiride [1], ifosfamide ---> SmPC of [1] of eMC

Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia

Glimepiride [1], IMAOs ---> SmPC of [1] of eMC

Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia

Glimepiride [1], insulin ---> SmPC of [1] of eMC

Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia

Glimepiride [1], laxatives ---> SmPC of [1] of eMC

Weakening of the blood-glucose-lowering effect and possible hyperglycaemia with long-term use laxative

Glimepiride [1], loop diuretics ---> SmPC of [1] of eMC

Weakening of the blood-glucose-lowering effect and possible hyperglycaemia

Glimepiride [1], male sex hormones ---> SmPC of [1] of eMC

Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia

Glimepiride [1], metformin ---> SmPC of [1] of eMC

Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia

Glimepiride [1], miconazole ---> SmPC of [1] of eMC

Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia

Glimepiride [1], natriuretic agents ---> SmPC of [1] of eMC

Weakening of the blood-glucose-lowering effect and possible hyperglycaemia

Glimepiride [1], nicotinates ---> SmPC of [1] of eMC

Weakening of the blood-glucose-lowering effect and possible hyperglycaemia

Glimepiride [1], nicotinic acid ---> SmPC of [1] of eMC

Weakening of the blood-glucose-lowering effect and possible hyperglycaemia with nicotinic acid at high doses

Glimepiride [1], oral antidiabetics ---> SmPC of [1] of eMC

Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia

Glimepiride [1], oxyphenbutazone ---> SmPC of [1] of eMC

Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia

Glimepiride [1], para-aminosalicylic acid ---> SmPC of [1] of eMC

Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia

Glimepiride [1], pentoxifylline ---> SmPC of [1] of eMC

Potentiation of the blood-sugar-lowering effect with pentoxifylline (high dose parenteral)

Glimepiride [1], phenothiazines ---> SmPC of [1] of eMC

Weakening of the blood-glucose-lowering effect and possible hyperglycaemia

Glimepiride [1], phenylbutazone ---> SmPC of [1] of eMC

Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia

Glimepiride [1], phenytoin ---> SmPC of [1] of eMC

Weakening of the blood-glucose-lowering effect and possible hyperglycaemia

Glimepiride [1], potassium-sparing diuretics ---> SmPC of [1] of eMC

Weakening of the blood-glucose-lowering effect and possible hyperglycaemia

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

Glimepiride should not be used during the whole pregnancy.

Glimepiride [1], probenecide ---> SmPC of [1] of eMC

Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia

Glimepiride [1], quinolones ---> SmPC of [1] of eMC

Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia

Glimepiride [1], reserpine ---> SmPC of [1] of eMC

Glimepiride [1], rifampicin ---> SmPC of [1] of eMC

Glimepiride is metabolized by cytochrome P450 2C9 (CYP2C9). Its metabolism is known to be influenced by concomitant administration of CYP2C9 inducers (e.g. rifampicin). Weakening of the blood-glucose-lowering effect and possible hyperglycaemia

Glimepiride [1], salicylates ---> SmPC of [1] of eMC

Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia

Glimepiride [1], strong CYP2C9 inductors ---> SmPC of [1] of eMC

Glimepiride is metabolized by cytochrome P450 2C9 (CYP2C9). Its metabolism is known to be influenced by concomitant administration of CYP2C9 inducers (e.g. rifampicin)

Glimepiride [1], strong CYP2C9 inhibitors ---> SmPC of [1] of eMC

Glimepiride is metabolized by cytochrome P450 2C9 (CYP2C9). Its metabolism is known to be influenced by concomitant administration of CYP2C9 inhibitors (e.g. fluconazole).

Glimepiride [1], sulfinpyrazone ---> SmPC of [1] of eMC

Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia

Glimepiride [1], sympathomimetics ---> SmPC of [1] of eMC

Weakening of the blood-glucose-lowering effect and possible hyperglycaemia

Glimepiride [1], testosterone ---> SmPC of [1] of eMC

Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia

Glimepiride [1], tetracyclines ---> SmPC of [1] of eMC

Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia

Glimepiride [1], thiazides ---> SmPC of [1] of eMC

Weakening of the blood-glucose-lowering effect and possible hyperglycaemia

Glimepiride [1], thyroid hormones ---> SmPC of [1] of eMC

Weakening of the blood-glucose-lowering effect and possible hyperglycaemia

Glimepiride [1], thyroid stimulating agents ---> SmPC of [1] of eMC

Weakening of the blood-glucose-lowering effect and possible hyperglycaemia

Glimepiride [1], thyroid stimulators ---> SmPC of [1] of eMC

Weakening of the blood-glucose-lowering effect and possible hyperglycaemia

Glimepiride [1], tritoqualine ---> SmPC of [1] of eMC

Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia

Glimepiride [1], trofosfamide ---> SmPC of [1] of eMC

Potentiation of the blood-sugar-lowering effect and possible hypoglycaemia

Glimepiride, ombitasvir/paritaprevir/ritonavir [2] ---> SmPC of [2] of EMA

CONTRAINDICATIONS of Glimepiride

Glimepiride is contraindicated in patients with the following conditions:

- hypersensitivity to glimepiride, other sulfonylureas or sulfonamides or to any of the excipients

- insulin dependent diabetes,

- diabetic coma,

- ketoacidosis,

- severe renal or hepatic function disorders. In case of severe renal or hepatic function disorders, a changeover to insulin is required.

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

Glofitamab (Columvi)

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

Patients experiencing symptoms of neurological adverse events and/or CRS (pyrexia, tachycardia, hypotension, chills, hypoxia) should be advised not to drive or use machines until symptoms resolve (see sections 4.4 and 4.8).

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

Women should be advised to discontinue breast-feeding during treatment with Columvi and for 2 months after the final dose of Columvi.

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

On initiation of Columvi therapy, patients being treated with CYP450 substrates with a narrow therapeutic index should be monitored.

CYP450 substrates with narrow therapeutic index, glofitamab [2] ---> SmPC of [2] of EMA

On initiation of Columvi therapy, patients being treated with CYP450 substrates with a narrow therapeutic index should be monitored.

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

No interactions with Columvi are expected via the cytochrome P450 enzymes, other metabolizing enzymes or transporters.

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

No human data on fertility are available. No fertility assessments in animals have been performed to evaluate the effect of glofitamab on fertility (see section 5.3).

Glofitamab [1], initial release of cytokines ---> SmPC of [1] of EMA

The initial release of cytokines associated with the start of Columvi treatment could suppress CYP450 enzymes.

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

Columvi is not recommended during pregnancy and in women of childbearing potential not using contraception. Female patients receiving Columvi should be advised of the potential harm to the foetus.

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

Immunisation with live vaccines is not recommended during Columvi therapy

Glofitamab [1], warfarin ---> SmPC of [1] of EMA

On initiation of Columvi therapy, patients being treated with CYP450 substrates with a narrow therapeutic index should be monitored.

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

Female patients of childbearing potential must use highly effective contraceptive methods during treatment with Columvi and for at least 2 months following the last dose of Columvi.

CONTRAINDICATIONS of Glofitamab (Columvi)

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

- For specific contraindications on obinutuzumab, please refer to the obinutuzumab prescribing information.

https://www.ema.europa.eu/en/documents/product-information/columvi-epar-product-information_en.pdf 26/03/2025

Glucagon (Baqsimi)

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

The patient's ability to concentrate and react may be impaired as a result of hypoglycaemia which may persist for a brief period after receiving treatment.

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

After diagnostic procedures hypoglycaemia has been reported infrequently.

Acenocoumarol [1], glucagon ---> SmPC of [1] of eMC

The co-administration may enhance the anticoagulant effect of acenocoumarol and increase the bleeding risk

Betablockers, glucagon [2] ---> SmPC of [2] of EMA

Glucagon treatment results in catecholamine release from the adrenal glands, and concomitant use of beta-blockers could result in unopposed alpha-adrenergic stimulation and consequently, a greater increase in blood pressure

Betablockers, glucagon [2] ---> SmPC of [2] of EMA

Patients taking beta-blockers might be expected to have a greater increase in both pulse and blood pressure, an increase of which will be transient because of glucagon's short half-life.

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

Baqsimi can be used during breast-feeding. As glucagon is degraded in the digestive tract and cannot be absorbed in its intact form, it will not exert any metabolic effect in the child.

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

As glucagon is degraded in the digestive tract and cannot be absorbed in its intact form, it will not exert any metabolic effect in the child.

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

No fertility studies have been conducted with glucagon nasal powder. Studies in rats have shown that glucagon does not cause impaired fertility.

Glibenclamide [1], glucagon ---> SmPC of [1] of EMA

Weakening of the blood-glucose-lowering effect

Glimepiride [1], glucagon ---> SmPC of [1] of eMC

Weakening of the blood-glucose-lowering effect and possible hyperglycaemia

Gliquidone, glucagon

Hyperglycemic reactions may occur as expression of weakening effect of gliquidone with gliquidone is co-administered with glucagon

Glucagon [1], indometacin ---> SmPC of [1] of EMA

When used with indometacin, glucagon may lose its ability to raise blood glucose or may even produce hypoglycaemia.

Glucagon [1], insulin ---> SmPC of [1] of EMA

Insulin reacts antagonistically towards glucagon

Glucagon [1], phenindione ---> SmPC of [1] of eMC

Glucagon potentiates the effect of phenindione

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

Baqsimi can be used during pregnancy. Glucagon does not cross the human placenta barrier.

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

The use of glucagon has been reported in pregnant women with diabetes and no harmful effects are known with respect to the course of pregnancy and the health of the unborn and the neonate.

Glucagon [1], warfarin ---> SmPC of [1] of EMA

Glucagon may increase the anticoagulant effect of warfarin.

Glucagon, insulin glargin [2] ---> SmPC of [2] of EMA

Reduced blood-glucose-lowering effect

Glucagon, insulin glargine/lixisenatide [2] ---> SmPC of [2] of EMA

This substance may reduce the blood-glucose-lowering effect.

Glucagon, insulin glulisin [2] ---> SmPC of [2] of EMA

Possible decrease in blood-glucose-lowering activity

Glucagon, pioglitazone/glimepiride [2] ---> SmPC of [2] of EMA

Weakening of the blood-glucose-lowering effect and, thus raised blood glucose levels may occur

Glucagon, secretin

Decreased secretin effect

Glucagon, somatorelin [2] ---> SmPC of [2] of eMC

Concomitant use of somatorelin and substances influencing the release of growth hormone should be avoided.

Glucagon, sulfonylureas

Weakening of the blood-glucose-lowering effect and, thus raised blood glucose levels may occur

CONTRAINDICATIONS of Glucagon (Baqsimi)

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

- Phaeocromocytoma.

https://www.ema.europa.eu/en/documents/product-information/baqsimi-epar-product-information_en.pdf 15/09/2025

Other trade names: GlucaGen Hypokit, Ogluo,

Glucarpidase (Voraxaze)

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

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

Folic acid analogues, glucarpidase [2] ---> SmPC of [2] of EMA

Glucarpidase may also reduce the concentrations of other folate analogs or folate analog metabolic inhibitors.

Folinic acid, glucarpidase [2] ---> SmPC of [2] of EMA

Glucarpidase can decrease folinic acid concentration, which may decrease the effect of folinic acid rescue unless it is dosed as recommended

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

Glucarpidase should only be given to a pregnant woman if clearly needed.

CONTRAINDICATIONS of Glucarpidase (Voraxaze)

- 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/voraxaze-epar-product-information_en.pdf 12/02/2024

Glucosamine

Ability to drive, glucosamine

Dizziness or drowsiness may occur

Acenocoumarol, glucosamine

The co-administration may enhance the effect of coumarin anticoagulant

Breast-feeding, glucosamine

The use of glucosamine during breast-feeding is not recommended

Coumarin anticoagulants, glucosamine

The co-administration may enhance the effect of coumarin anticoagulant

Glucosamine, pregnancy

Glucosamine should not be used during pregnancy

Glucosamine, warfarin

The co-administration may enhance the effect of coumarin anticoagulant

Glucose anhydrous

Breast-feeding, glucose anhydrous

It should be used with caution during breastfeeding

Glucose anhydrous, pregnancy

It should be used with caution during pregnancy. Intravenous glucose may result in considerable foetal insulin production, with an associated risk of rebound hypoglycaemia in the new-born.

CONTRAINDICATIONS of Glucose anhydrous

- The intravenous use of strongly hypertonic solutions of glucose is contraindicated in patients with anuria, intracranial or intraspinal haemorrhage, or delirium

tremens if the patient is already dehydrated.

- Known sensitivity to corn or corn products, hyperglycaemic coma, or ischaemic stroke.

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

Glycerin

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

All medicines, should be avoided if possible during lactation, and should only be used under a doctor's instruction.

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

All medicines, should be avoided if possible during pregnancy, and should only be used under a doctor's instruction.

CONTRAINDICATIONS of Glycerin

Contraindicated in patients with known hypersensitivity to glycerol. Contraindicated in diabetics.

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

Glycerol phenylbutyrate (Ravicti)

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

RAVICTI may have major influence on the ability to drive and use machines given that treatment with glycerol phenylbutyrate may cause dizziness or headaches. Patients should not drive or use machines whilst experiencing these side effects.

Ammonia levels, glycerol phenylbutyrate [2] ---> SmPC of [2] of EMA

Other medicinal products such as corticosteroids, valproic acid, haloperidol and probenecid may have the potential to affect ammonia levels

Apple sauce, glycerol phenylbutyrate [2] ---> SmPC of [2] of EMA

Compatibility studies have demonstrated glycerol phenylbutyrate chemical and physical in-use stability with the following foods and nutritional supplements: apple sauce, ketchup, squash puree

Breast-feeding, glycerol phenylbutyrate [2] ---> SmPC of [2] of EMA

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

Celecoxib, glycerol phenylbutyrate [2] ---> SmPC of [2] of EMA

The effects of glycerol phenylbutyrate on cytochrome P450 (CYP) 2C9 isoenzyme and potential for interaction with celecoxib has been studied in humans with no evidence of an interaction observed.

Contraceptives, glycerol phenylbutyrate [2] ---> SmPC of [2] of EMA

Effective contraceptive measures must be taken by women of child-bearing potential

Corticosteroids, glycerol phenylbutyrate [2] ---> SmPC of [2] of EMA

Use of corticosteroids may cause the breakdown of body protein and increase plasma ammonia levels. Monitor ammonia levels closely when corticosteroids and glycerol phenylbutyrate are used concomitantly.

CYP2D6 substrates, glycerol phenylbutyrate [2] ---> SmPC of [2] of EMA

A potential effect on CYP2D6 isoenzyme cannot be excluded and caution is advised for patients who receive medicinal products that are CYP2D6 substrates.

Cytochrome P450, glycerol phenylbutyrate [2] ---> SmPC of [2] of EMA

Effects of glycerol phenylbutyrate on other CYP isoenzymes have not been studied in humans and cannot be excluded.

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

The potential for interaction of glycerol phenylbutyrate as a CYP3A4 inducer and those products predominantly metabolised by the CYP3A4 pathway is possible.

Fertility, glycerol phenylbutyrate [2] ---> SmPC of [2] of EMA

Glycerol phenylbutyrate had no effect on fertility or reproductive function in male and female rats (see section 5.3). There are no data for human fertility.

Glycerol phenylbutyrate [1], haloperidol ---> SmPC of [1] of EMA

Hyperammonemia may be induced by haloperidol and by valproic acid. Monitor ammonia levels closely when use of valproic acid or haloperidol is necessary in urea cycle disorders (UCDs) patients.

Glycerol phenylbutyrate [1], ketchup ---> SmPC of [1] of EMA

Compatibility studies have demonstrated glycerol phenylbutyrate chemical and physical in-use stability with the following foods and nutritional supplements: apple sauce, ketchup, squash puree

Glycerol phenylbutyrate [1], lipase inhibitors ---> SmPC of [1] of EMA

Concomitant use of medicinal products known to inhibit lipase should be given with caution as glycerol phenylbutyrate is hydrolysed by digestive lipase into phenylbutyrate acid and glycerol.

Glycerol phenylbutyrate [1], lipase inhibitors ---> SmPC of [1] of EMA

This may be associated with increased risk of medicinal product interactions with lipase inhibitors and with lipase contained in pancreatic enzyme replacement therapies.

Glycerol phenylbutyrate [1], midazolam ---> SmPC of [1] of EMA

In vivo exposure to glycerol phenylbutyrate has resulted in decreased systemic exposure to midazolam of approximately 32%, suggesting that steady-state dosing of glycerol phenylbutyrate results in CYP3A4 induction.

Glycerol phenylbutyrate [1], pregnancy ---> SmPC of [1] of EMA

RAVICTI should not be used during pregnancy and in women of childbearing potential not using contraception unless the clinical condition of the woman requires treatment with glycerol phenylbutyrate

Glycerol phenylbutyrate [1], probenecide ---> SmPC of [1] of EMA

Probenecid may inhibit the renal excretion of metabolites of glycerol phenylbutyrate including phenylacetylglutamine (PAGN).

Glycerol phenylbutyrate [1], squash puree ---> SmPC of [1] of EMA

Compatibility studies have demonstrated glycerol phenylbutyrate chemical and physical in-use stability with the following foods and nutritional supplements: apple sauce, ketchup, squash puree

Glycerol phenylbutyrate [1], valproic acid ---> SmPC of [1] of EMA

Hyperammonemia may be induced by haloperidol and by valproic acid. Monitor ammonia levels closely when use of valproic acid or haloperidol is necessary in urea cycle disorders (UCDs) patients.

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

The use of RAVICTI in women of childbearing potential must be accompanied by the use of effective contraception (see section 4.4).

CONTRAINDICATIONS of Glycerol phenylbutyrate (Ravicti)

- Hypersensitivity to the active substance.

- Treatment of acute hyperammonaemia.

https://www.ema.europa.eu/en/documents/product-information/ravicti-epar-product-information_en.pdf 23/02/2024

Glycopyrronium (Enurev Breezhaler)

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

The co-administration of glycopyrronium with other anticholinergic-containing medicinal products has not been studied and is therefore not recommended.

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

The use of glycopyrronium by breast-feeding women should only be considered if the expected benefit to the woman is greater than any possible risk to the infant

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

No clinically relevant drug interaction is expected when glycopyrronium is co-administered with cimetidine or other inhibitors of organic cation transport.

Dopamine antagonists, glycopyrronium

Mutual weakening of effect on gastrointestinal motility

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

Reproduction studies and other data in animals do not indicate a concern regarding fertility in either males or females (see section 5.3).

Glucocorticoids, glycopyrronium

Additional increase in the intraocular pressure

Glycopyrronium [1], indacaterol ---> SmPC of [1] of EMA

Concomitant administration of glycopyrronium and orally inhaled indacaterol, a beta2-adrenergic agonist, under steady-state conditions of both active substances did not affect the pharmacokinetics of either medicinal product.

Glycopyrronium [1], methylxanthine ---> SmPC of [1] of EMA

Enurev Breezhaler has been used concomitantly with other medicinal products commonly used in the treatment of COPD without clinical evidence of drug interactions.

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

Glycopyrronium should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the foetus.

Glycopyrronium [1], steroids ---> SmPC of [1] of EMA

Enurev Breezhaler has been used concomitantly with other medicinal products commonly used in the treatment of COPD without clinical evidence of drug interactions.

Glycopyrronium [1], sympathomimetic bronchodilator ---> SmPC of [1] of EMA

Enurev Breezhaler has been used concomitantly with other medicinal products commonly used in the treatment of COPD without clinical evidence of drug interactions.

Glycopyrronium, metoclopramide

Mutual weakening of effect on gastrointestinal motility

CONTRAINDICATIONS of Glycopyrronium (Enurev Breezhaler)

- 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/enurev-breezhaler-epar-product-information_en.pdf 06/08/2025

Other trade names: Seebri Breezhaler, Sialanar, Tovanor Breezhaler,

Glycopyrronium/formoterol (Bevespi Aerosphere)

Ability to drive, glycopyrronium/formoterol [2] ---> SmPC of [2] of EMA

Bevespi Aerosphere has no or negligible influence on the ability to drive and use machines. However dizziness and nausea are common side effects which should be taken into account when driving or using machines.

Adrenergic bronchodilators, glycopyrronium/formoterol [2] ---> SmPC of [2] of EMA

Studies indicate no clinical evidence of interactions when used concomitantly with other COPD medicinal products including short-acting beta2-adrenergic bronchodilators, methylxanthines, and oral and inhaled steroids.

Anticholinergics, glycopyrronium/formoterol [2] ---> SmPC of [2] of EMA

Co-administration of Bevespi Aerosphere with other anticholinergic and/or long-acting beta2-adrenergic agonist containing medicinal products has not been studied and is not recommended

Beta-adrenergic agonists, betablockers ---> SmPC of [glycopyrronium/formoterol] of EMA

Beta-adrenergic blockers (including eye drops) can weaken or inhibit the effect of beta2-adrenergic agonists, such as formoterol.

Breast-feeding, glycopyrronium/formoterol [2] ---> SmPC of [2] of EMA

Administration of Bevespi Aerosphere to women who are breast-feeding should only be considered if the expected benefit to the mother is greater than any possible risk to the infant

Cimetidine, glycopyrronium/formoterol [2] ---> SmPC of [2] of EMA

The effect of cimetidine on inhaled glycopyrronium disposition showed a limited increase in its total systemic exposure (AUC0-t) by 22% and a slight decrease in renal clearance by 23% due to co-administration of cimetidine.

Corticosteroids, glycopyrronium/formoterol [2] ---> SmPC of [2] of EMA

Concomitant treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible initial hypokalaemic effect of beta2-adrenergic agonists, therefore, caution is advised in their concomitant use

Fertility, glycopyrronium/formoterol [2] ---> SmPC of [2] of EMA

Glycopyrronium did not cause any adverse effects on fertility in rats. It is unlikely that Bevespi Aerosphere administered at the recommended dose will affect fertility in humans.

Glycopyrronium/formoterol [1], non-potassium-sparing diuretics ---> SmPC of [1] of EMA

Glycopyrronium/formoterol [1], pregnancy ---> SmPC of [1] of EMA

Bevespi Aerosphere should only be used during pregnancy if the expected benefits outweigh the potential risks.

Glycopyrronium/formoterol [1], QT interval prolonging drugs ---> SmPC of [1] of EMA

Bevespi Aerosphere should be administered with caution to patients being treated with medicinal products known to prolong the QTc interval

Glycopyrronium/formoterol [1], renal excretion ---> SmPC of [1] of EMA

Since glycopyrronium is eliminated mainly by the renal route, interactions could potentially occur with medicinal products affecting renal excretion mechanisms.

Glycopyrronium/formoterol [1], xanthines ---> SmPC of [1] of EMA

CONTRAINDICATIONS of Glycopyrronium/formoterol (Bevespi Aerosphere)

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

https://www.ema.europa.eu/en/documents/product-information/bevespi-aerosphere-epar-product-information_en.pdf 28/02/2024

Glycopyrronium/indacaterol/mometasone (Zimbus Breezhaler)

Antimuscarinic agents, glycopyrronium/indacaterol/mometasone [2] ---> SmPC of [2] of EMA

The co-administration of this medicinal product with other medicinal products containing long-acting muscarinic antagonists has not been studied and is not recommended as it may potentiate adverse reactions

Beta-adrenergic receptor blockers, glycopyrronium/indacaterol/mometasone [2] ---> SmPC of [2] of EMA

Beta-adrenergic blockers may weaken or antagonise the effect of beta2-adrenergic agonists. Therefore, this medicinal product should not be given together with beta-adrenergic blockers unless there are compelling reasons for their use.

Beta2-adrenergic agonists, beta-adrenergic receptor blockers ---> SmPC of [glycopyrronium/indacaterol/mometasone] of EMA

Beta2-adrenergic agonists, glycopyrronium/indacaterol/mometasone [2] ---> SmPC of [2] of EMA

The co-administration of this medicinal product with other medicinal products containing long-acting beta2-adrenergic agonists has not been studied and is not recommended as it may potentiate adverse reactions

Breast-feeding, glycopyrronium/indacaterol/mometasone [2] ---> SmPC of [2] of EMA

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

Cimetidine, glycopyrronium/indacaterol/mometasone [2] ---> SmPC of [2] of EMA

No clinically relevant drug interaction is expected when glycopyrronium is co-administered with cimetidine or other inhibitors of the organic cation transport.

Cobicistat, glycopyrronium/indacaterol/mometasone [2] ---> SmPC of [2] of EMA

However, there may be a potential for increased systemic exposure to mometasone furoate when strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, nelfinavir, ritonavir, cobicistat) are co-administered.

Corticosteroids, glycopyrronium/indacaterol/mometasone [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

Corticosteroids, hypokalemia ---> SmPC of [glycopyrronium/indacaterol/mometasone] of EMA

Concomitant hypokalaemic treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists

Fertility, glycopyrronium/indacaterol/mometasone [2] ---> SmPC of [2] of EMA

Reproduction studies and other data in animals did not indicate a concern regarding fertility in either males or females.

Glycopyrronium/indacaterol/mometasone [1], IMAOs ---> SmPC of [1] of EMA

This medicinal product should be administered with caution to patients being treated with monoamine oxidase inhibitors, as any effect of these on the QT interval may be potentiated.

Glycopyrronium/indacaterol/mometasone [1], itraconazol ---> SmPC of [1] of EMA

Glycopyrronium/indacaterol/mometasone [1], ketoconazole ---> SmPC of [1] of EMA

Glycopyrronium/indacaterol/mometasone [1], nelfinavir ---> SmPC of [1] of EMA

Glycopyrronium/indacaterol/mometasone [1], OCT inhibitors ---> SmPC of [1] of EMA

No clinically relevant drug interaction is expected when glycopyrronium is co-administered with cimetidine or other inhibitors of the organic cation transport.

Glycopyrronium/indacaterol/mometasone [1], P-gp inhibitors ---> SmPC of [1] of EMA

Due to the very low plasma concentration achieved after inhaled dosing, clinically significant interactions with mometasone furoate are unlikely.

Glycopyrronium/indacaterol/mometasone [1], potassium-sparing diuretics ---> SmPC of [1] of EMA

Concomitant hypokalaemic treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists

Glycopyrronium/indacaterol/mometasone [1], QT interval prolonging drugs ---> SmPC of [1] of EMA

Medicinal products known to prolong the QT interval may increase the risk of ventricular arrhythmia

Glycopyrronium/indacaterol/mometasone [1], ritonavir ---> SmPC of [1] of EMA

Glycopyrronium/indacaterol/mometasone [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA

Due to the very low plasma concentration achieved after inhaled dosing, clinically significant interactions with mometasone furoate are unlikely.

Glycopyrronium/indacaterol/mometasone [1], strong CYP3A4 inhibitors ---> SmPC of [1] of EMA

Glycopyrronium/indacaterol/mometasone [1], tricyclic antidepressant ---> SmPC of [1] of EMA

This medicinal product should be administered with caution to patients being treated with tricyclic antidepressants, as any effect of these on the QT interval may be potentiated.

Glycopyrronium/indacaterol/mometasone [1], xanthines ---> SmPC of [1] of EMA

Concomitant hypokalaemic treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists

Glycopyrronium/indacaterol/mometasone, pregnancy [2] ---> SmPC of [2] of EMA

This medicinal product should only be used during pregnancy if the expected benefit to the patient justifies the potential risk to the foetus.

Hypokalemia, potassium-sparing diuretics ---> SmPC of [glycopyrronium/indacaterol/mometasone] of EMA

Concomitant hypokalaemic treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists

Hypokalemia, xanthines ---> SmPC of [glycopyrronium/indacaterol/mometasone] of EMA

Concomitant hypokalaemic treatment with methylxanthine derivatives, steroids, or non-potassium-sparing diuretics may potentiate the possible hypokalaemic effect of beta2-adrenergic agonists

CONTRAINDICATIONS of Glycopyrronium/indacaterol/mometasone (Zimbus Breezhaler)

- 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/zimbus-breezhaler-epar-product-information_en.pdf 06/09/2024

Golimumab (Simponi)

Abatacept, golimumab [2] ---> SmPC of [2] of EMA

The combination of golimumab with other biological therapeutics used to treat the same conditions as golimumab, including anakinra and abatacept is not recommended (see section 4.4).

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

Simponi has minor influence on the ability to ride bicycles, drive and use machines. Dizziness may however occur following administration of Simponi (see section 4.8).

Anakinra, golimumab [2] ---> SmPC of [2] of EMA

The combination of golimumab with other biological therapeutics used to treat the same conditions as golimumab, including anakinra and abatacept is not recommended (see section 4.4).

Biological medicinal products, golimumab [2] ---> SmPC of [2] of EMA

The combination of golimumab with other biological therapeutics used to treat the same conditions as golimumab, including anakinra and abatacept is not recommended (see section 4.4).

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

Human immunoglobulins are excreted in milk, women must not breast feed during and for at least 6 months after golimumab treatment.

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

A fertility study in mice, using an analogous antibody that selectively inhibits the functional activity of mouse TNF alfa, showed no relevant effects on fertility (see section 5.3).

Golimumab [1], immunosuppressives ---> SmPC of [1] of EMA

Serious infections have occurred in patients on concomitant immunosuppressive therapy that, in addition to their underlying disease, could predispose them to infections.

Golimumab [1], infliximab ---> SmPC of [1] of EMA

Caution should be exercised when using any TNF-antagonist in COPD patients, as well as in patients with an increased risk of malignancy due to heavy smoking.

Golimumab [1], methotrexate ---> SmPC of [1] of EMA

Although concomitant use of MTX results in higher steady-state trough concentrations of golimumab in patients with RA, PsA or AS, the data do not suggest the need for dose adjustment of either golimumab or MTX (see section 5.2).

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

The available clinical experience is limited. Golimumab should only be used during pregnancy if clearly needed.

Golimumab [1], therapeutic infectious agents ---> SmPC of [1] of EMA

Therapeutic infectious agents should not be given concurrently with golimumab (see section 4.4).

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

Patients treated with golimumab may receive concurrent vaccinations, except for live vaccines

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

Live vaccines should not be given concurrently with golimumab (see sections 4.4 and 4.6).

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

Women of childbearing potential must use adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last golimumab treatment.

CONTRAINDICATIONS of Golimumab (Simponi)

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

- Active tuberculosis (TB) or other severe infections such as sepsis, and opportunistic infections

- Moderate or severe heart failure (NYHA class III/IV)

https://www.ema.europa.eu/en/documents/product-information/simponi-epar-product-information_en.pdf 30/01/2026

Goserelin

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

The use of goserelin during breast-feeding is not recommended.

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

Goserelin should not be used during pregnancy since concurrent use of LHRH agonists is associated with a theoretical risk of abortion or foetal abnormality.

CONTRAINDICATIONS of Goserelin

- Known severe hypersensitivity to the active substance or to any of the excipients of this product.

- Pregnancy and lactation

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

Gozetotide (Locametz)

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

Locametz is not indicated for use in females. There are no data on the effects of gallium (68Ga) gozetotide on the breast-fed newborn/infant or on milk production. Lactation studies have not been conducted in animals with gallium (68Ga) gozetotide.

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

There are no data on the effect of gallium (68Ga) gozetotide on human fertility.

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

All radiopharmaceuticals, including gallium (68Ga) gozetotide, have the potential to cause foetal harm.

CONTRAINDICATIONS of Gozetotide (Locametz)

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

https://www.ema.europa.eu/en/documents/product-information/locametz-epar-product-information_en.pdf 16/04/2025

Granisetron (Sancuso)

5-HT3 receptor antagonists, antiarrhythmics ---> SmPC of [granisetron] of EMA

5-HT3 receptor antagonists, such as granisetron, may be associated with arrhythmias or ECG abnormalities. This potentially may have clinical significance in patients who are being treated with antiarrhythmics or beta-blockers.

5-HT3 receptor antagonists, betablockers ---> SmPC of [granisetron] of EMA

5-HT3 receptor antagonists, buprenorphine ---> SmPC of [granisetron] of EMA

For serotonergic medicinal products (e.g. SSRIs and SNRIs, buprenorphine, opioids or other serotonergic medicinal products), there have been reports of serotonin syndrome following concomitant use of 5-HT3 antagonists and other serotonergic medicines

5-HT3 receptor antagonists, opiates ---> SmPC of [granisetron] of EMA

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.

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

5-HT3 receptor antagonists, SNRIs ---> SmPC of [granisetron] of EMA

5-HT3 receptor antagonists, SSRI ---> SmPC of [granisetron] of EMA

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

The effect of SANCUSO on the ability to drive or operate machinery has not been studied.

Anti-ulcer medicinal product, granisetron [2] ---> SmPC of [2] of EMA

In studies in healthy subjects, no evidence of any interaction has been indicated between granisetron and anti-ulcer medicinal products (cimetidine)

Aprepitant [1], granisetron ---> SmPC of [1] of EMA

In clinical interaction studies, aprepitant did not have clinically important effects on the pharmacokinetics of granisetron

Benzodiazepines, granisetron [2] ---> SmPC of [2] of EMA

In studies in healthy subjects, no evidence of any interaction has been indicated between granisetron and benzodiazepines (lorazepam), neuroleptics (haloperidol) or anti-ulcer medicinal products (cimetidine).

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

It is unknown whether granisetron or its metabolites are excreted in human milk. Breast-feeding should be discontinued during treatment with SANCUSO.

Busulfan [1], granisetron ---> SmPC of [1] of EMA

No interaction was observed when busulfan was combined with 5 HT3 antiemetics such as ondansetron or granisetron.

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

In studies in healthy subjects, no evidence of any interaction has been indicated between granisetron and anti-ulcer medicinal products (cimetidine)

CYP1A1 inductors, granisetron [2] ---> SmPC of [2] of EMA

As granisetron is metabolised by hepatic cytochrome P450 drug-metabolising enzymes (CYP1A1 and CYP3A4), inducers of these enzymes may change the clearance and, hence, the half-life of granisetron.

CYP1A1 inhibitors, granisetron [2] ---> SmPC of [2] of EMA

As granisetron is metabolised by hepatic cytochrome P450 drug-metabolising enzymes (CYP1A1 and CYP3A4), inhibitors of these enzymes may change the clearance and, hence, the half-life of granisetron.

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

In vitro studies using human microsomes indicate that granisetron neither stimulates nor inhibits the cytochrome P450 enzyme system.

Emetogenic cancer therapies, granisetron [2] ---> SmPC of [2] of EMA

No clinically relevant drug interactions between SANCUSO and emetogenic cancer chemotherapies have been seen. Furthermore, no interaction has been observed between granisetron and emetogenic cancer therapies.

Exposure to sunlight, granisetron [2] ---> SmPC of [2] of EMA

Granisetron may be affected by direct natural or artificial sunlight. Patients must be advised to cover the transdermal patch application site, if there is a risk of exposure to sunlight throughout the period of wear and for 10 days following its removal

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

There are no data on the effect of granisetron on human fertility.

Granisetron [1], ketoconazole ---> SmPC of [1] of EMA

In vitro studies have shown that ketoconazole may inhibit the metabolism of granisetron via the cytochrome P450 3A isoenzyme family. The clinical significance of this is unknown.

Granisetron [1], neuroleptics ---> SmPC of [1] of EMA

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

In human subjects, hepatic enzyme induction by phenobarbital has led to an increase in total plasma clearance (approximately 25%) following intravenous administration of granisetron.

Granisetron [1], phenylephrine ---> SmPC of [1] of eMC

Granisetron could potentiate the vasopressive action of phenylephrine.

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

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

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

As granisetron is metabolised by hepatic cytochrome P450 drug-metabolising enzymes (CYP1A1 and CYP3A4), inducers of these enzymes may change the clearance and, hence, the half-life of granisetron.

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

As granisetron is metabolised by hepatic cytochrome P450 drug-metabolising enzymes (CYP1A1 and CYP3A4), inhibitors of these enzymes may change the clearance and, hence, the half-life of granisetron.

Granisetron, oxaliplatin [2] ---> SmPC of [2] of eMC

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

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.

Granisetron, primidone [2] ---> SmPC of [2] of eMC

Primidone therapy may lead to altered pharmacokinetics in concomitantly administered drugs, whose metabolism may be increased and lead to lowered plasma levels and/or a shorter half-life.

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

Co-administration of VANFLYTA with other medicinal products that prolong the QT interval may further increase the incidence of QT prolongation. Caution should be used when co-administering medicinal products that prolong the QT interval with VANFLYTA

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

Clinically relevant drug-drug interactions with co-medications which are significantly cleared by CYP1A1-mediated biotransformation cannot be ruled out.

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

In a population study using the intravenous route, the co-administration of granisetron, ondansetron, morphine or corticosteroids did not appear to have a significant effect on the pharmacokinetics of total topotecan (active and inactive form).

CONTRAINDICATIONS of Granisetron (Sancuso)

- Hypersensitivity to the active substance, to other 5-HT3 receptor antagonists or to any of the excipients listed in section 6.1.

https://www.ema.europa.eu/en/documents/product-information/sancuso-epar-product-information_en.pdf 02/12/2024

Other trade names: Granisetron Accord, Granisetron Actavis, Granisetron G.E.S., Granisetron Kabi, Granisetron Normon, Granisetron Sandoz, Kytril,

Guaifenesin

Antitussives, guaifenesin [2] ---> SmPC of [2] of eMC

Expectorants such as guaifenesin should not be combined with cough suppressants in the treatment of cough since the combination is illogical and patients may be exposed to unnecessary adverse effects.

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

It is not certain whether guaifenesin is excreted in breast milk.

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

This product, like most medicines, should not be used during pregnancy unless the potential benefit of treatment to the mother outweighs the possible risks to the developing fetus.

Guaifenesin, muscle relaxants

Increased effect of muscle relaxant

Guaifenesin, sedatives

Increased sedative effect

CONTRAINDICATIONS of Guaifenesin

- This product is contraindicated in individuals with known hypersensitivity to the active substance or to any of the excipients.

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

Guanfacin (Intuniv)

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

Guanfacine may have a moderate to severe influence on the ability to drive and use machines. Guanfacine can cause dizziness and somnolence.

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

Caution should be used when Intuniv is administered concomitantly with CNS depressant medicinal products due to the potential for additive pharmacodynamic effects such as sedation and somnolence.

Amisulpride, guanfacin

Concomitant use of amisulpride with drugs inducing bradycardia is not recommended

Antihypertensives, guanfacin [2] ---> SmPC of [2] of EMA

Caution should be used when Intuniv is administered concomitantly with antihypertensive medicinal products, due to the potential for additive pharmacodynamic effects such as hypotension and syncope.

Aprepitant, guanfacin [2] ---> SmPC of [2] of EMA

Co-administration of Intuniv with moderate and strong CYP3A4/5 inhibitors elevates plasma guanfacine concentrations and increases the risk of adverse reactions such as hypotension, bradycardia, and sedation.

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

Atenolol, guanfacin

Bradycardia, delayed conduction of cardiac stimulus

Atenolol/chlortalidone, guanfacin

Enhanced antihypertensive effect and bradycardia

Atenolol/nifedipine, guanfacin

Bradycardia, delayed conduction of cardiac stimulus

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

Caution should be used when Intuniv is administered concomitantly with CNS depressant medicinal products due to the potential for additive pharmacodynamic effects such as sedation and somnolence.

Benzodiazepines, guanfacin [2] ---> SmPC of [2] of EMA

Caution should be used when Intuniv is administered concomitantly with CNS depressant medicinal products due to the potential for additive pharmacodynamic effects such as sedation and somnolence.

Betablockers, guanfacin

The combination may enhance the hypotensive effect and decrease the central sympathetic tonus (reduction of heart rate and cardiac output, vasodilation)

Bisoprolol [1], guanfacin ---> SmPC of [1] of eMC

Concomitant use of centrally-acting antihypertensive and bisoprolol may worsen heart failure by a decrease in the central sympathetic tonus (reduction of heart rate and cardiac output, vasodilation)

BMI, guanfacin [2] ---> SmPC of [2] of EMA

Children and adolescents treated with guanfacine may show an increase in their BMI. Therefore, monitoring of height, weight and BMI should be done prior to initiation of therapy and then every 3 months for the first year,

Boceprevir, guanfacin [2] ---> SmPC of [2] of EMA

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

There was a significant decrease in the rate and extent of guanfacine exposure when co-administered with rifampin, a CYP3A4 inducer. Other CYP3A4 inducers may have a comparable effect

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

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

Buprenorphine, guanfacin

The combination increases the central nervous system depression

Buprenorphine/naloxone [1], guanfacin ---> SmPC of [1] of EMA

The combination increases the central nervous system depression

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

There was a significant decrease in the rate and extent of guanfacine exposure when co-administered with rifampin, a CYP3A4 inducer. Other CYP3A4 inducers may have a comparable effect

Carteolol, guanfacin

Sudden withdrawal of central antihypertensive should be avoided if possible.

Carvedilol [1], guanfacin ---> SmPC of [1] of eMC

Concomitant treatment of carvedilol with guanfacine can lead to additional decrease in heart rate. A monitoring of vital signs is recommended.

Celiprolol, guanfacin

The co-administration may increase the hypotensive effect and the negative chronotropic and dromotropic effect

Chloramphenicol, guanfacin [2] ---> SmPC of [2] of EMA

Ciprofloxacin, guanfacin [2] ---> SmPC of [2] of EMA

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

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

Caution should be used when Intuniv is administered concomitantly with CNS depressant medicinal products due to the potential for additive pharmacodynamic effects such as sedation and somnolence.

Crizotinib [1], guanfacin ---> SmPC of [1] of EMA

Bradycardia has been reported during clinical studies; therefore, use crizotinib with caution due to the risk of excessive bradycardia when used in combination with other bradycardic agents

Diltiazem, guanfacin [2] ---> SmPC of [2] of EMA

Dose titration, guanfacin [2] ---> SmPC of [2] of EMA

During dose titration, weekly monitoring for signs and symptoms of somnolence and sedation, hypotension and bradycardia should be performed.

Doxepin, guanfacin

The co-administration may weaken the hypotensive effect

Drugs inducing bradycardia, guanfacin [2] ---> SmPC of [2] of EMA

Guanfacine should be prescribed with caution in patients with risk factors for torsade de pointes (e.g., heart block, bradycardia, hypokalaemia) or patients who are taking medicinal products known to prolong the QT interval.

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

Intuniv can increase plasma concentrations of concomitantly administered medicinal products that are metabolised via CYP3A4/5

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

There was a significant decrease in the rate and extent of guanfacine exposure when co-administered with rifampin, a CYP3A4 inducer. Other CYP3A4 inducers may have a comparable effect

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

Esmolol, guanfacin

Enhancement of the hypotensive and bradycardic effect

Etravirine, guanfacin [2] ---> SmPC of [2] of EMA

There was a significant decrease in the rate and extent of guanfacine exposure when co-administered with rifampin, a CYP3A4 inducer. Other CYP3A4 inducers may have a comparable effect

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

There are no or limited amount of data regarding effect on fertility from the use of guanfacine in humans. Animal studies indicate an effect on male fertility (see section 5.3).

Fluconazole, guanfacin [2] ---> SmPC of [2] of EMA

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

Intuniv should not be administered with high fat meals due to increased exposure, as it has been shown that high fat meals have a significant effect on the absorption of guanfacine.

Fosamprenavir, guanfacin [2] ---> SmPC of [2] of EMA

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

Guanfacin [1], hostility ---> SmPC of [1] of EMA

Aggressive behaviour or hostility has been reported in clinical trials and in the post-marketing experience of guanfacine. Patients treated with guanfacine should be monitored for the appearance of aggressive behaviour or hostility.

Guanfacin [1], hypnotics ---> SmPC of [1] of EMA

Caution should be used when Intuniv is administered concomitantly with CNS depressant medicinal products due to the potential for additive pharmacodynamic effects such as sedation and somnolence.

Guanfacin [1], hypokalemia ---> SmPC of [1] of EMA

Guanfacin [1], imatinib ---> SmPC of [1] of EMA

Guanfacin [1], indinavir ---> SmPC of [1] of EMA

Guanfacin [1], itraconazol ---> SmPC of [1] of EMA

Guanfacin [1], ketoconazole ---> SmPC of [1] of EMA

Guanfacin [1], lisdexamfetamine ---> SmPC of [1] of EMA

In a drug interaction study, administration of Intuniv in combination with lisdexamfetamine dimesylate induced a 19% increase in guanfacine maximum plasma concentrations, whereas exposure (AUC) was increased by 7%.

Guanfacin [1], MATE1 substrates ---> SmPC of [1] of EMA

Guanfacine is an in vitro inhibitor of MATE1 and the clinical relevance of MATE1 inhibition cannot be excluded. Co-administration of guanfacine with MATE1 substrates may result in increases in the plasma concentrations of these medicinal products.

Guanfacin [1], metformin ---> SmPC of [1] of EMA

Guanfacine may be an inhibitor of OCT1 at maximal portal vein concentrations. Concomitant administration of guanfacine with OCT1 substrates with a similar Tmax (e.g., metformin) may result in increases in Cmax of these medicinal products.

Guanfacin [1], methylphenidate ---> SmPC of [1] of EMA

In a drug interaction study, neither Intuniv nor Osmotic Release Oral System (OROS)-methylphenidate HCl extended-release were found to affect the pharmacokinetics of the other medicinal products when taken in combination.

Guanfacin [1], modafinil ---> SmPC of [1] of EMA

There was a significant decrease in the rate and extent of guanfacine exposure when co-administered with rifampin, a CYP3A4 inducer. Other CYP3A4 inducers may have a comparable effect

Guanfacin [1], moderate CYP3A4 inhibitors ---> SmPC of [1] of EMA

Guanfacin [1], neuroleptics ---> SmPC of [1] of EMA

Caution should be used when Intuniv is administered concomitantly with CNS depressant medicinal products due to the potential for additive pharmacodynamic effects such as sedation and somnolence.

Guanfacin [1], nevirapine ---> SmPC of [1] of EMA

There was a significant decrease in the rate and extent of guanfacine exposure when co-administered with rifampin, a CYP3A4 inducer. Other CYP3A4 inducers may have a comparable effect

Guanfacin [1], OCT1 inhibitors ---> SmPC of [1] of EMA

Guanfacine is an in vitro substrate of OCT1. Potential drug interactions with drugs that inhibit OCT1 cannot be excluded.

Guanfacin [1], OCT1 substrates ---> SmPC of [1] of EMA

Guanfacin [1], oxcarbazepine ---> SmPC of [1] of EMA

There was a significant decrease in the rate and extent of guanfacine exposure when co-administered with rifampin, a CYP3A4 inducer. Other CYP3A4 inducers may have a comparable effect

Guanfacin [1], pharmacodynamic effect ---> SmPC of [1] of EMA

The pharmacodynamic effect of guanfacine can have an additive effect when taken with other products known to cause sedation, hypotension or QT prolongation (see section 4.4).

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

There was a significant decrease in the rate and extent of guanfacine exposure when co-administered with rifampin, a CYP3A4 inducer. Other CYP3A4 inducers may have a comparable effect

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

There was a significant decrease in the rate and extent of guanfacine exposure when co-administered with rifampin, a CYP3A4 inducer. Other CYP3A4 inducers may have a comparable effect

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

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

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

Guanfacin [1], primidone ---> SmPC of [1] of EMA

There was a significant decrease in the rate and extent of guanfacine exposure when co-administered with rifampin, a CYP3A4 inducer. Other CYP3A4 inducers may have a comparable effect

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

Guanfacine causes a decrease in heart rate. Given the effect of guanfacine on heart rate, the concomitant use of guanfacine with QT prolonging medicinal products is generally not recommended (see section 4.4).

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

There was a significant decrease in the rate and extent of guanfacine exposure when co-administered with rifampin, a CYP3A4 inducer. Other CYP3A4 inducers may have a comparable effect

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

There was a significant decrease in the rate and extent of guanfacine exposure when co-administered with rifampin, a CYP3A4 inducer. Other CYP3A4 inducers may have a comparable effect

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

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

Guanfacin [1], sedatives ---> SmPC of [1] of EMA

The pharmacodynamic effect of Intuniv can have an additive effect when taken with other products known to cause sedation, hypotension or QT prolongation

Guanfacin [1], somnolence ---> SmPC of [1] of EMA

Guanfacine may cause somnolence and sedation predominantly at the start of treatment and could typically last for 2-3 weeks and longer in some cases.

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

There was a significant decrease in the rate and extent of guanfacine exposure when co-administered with rifampin, a CYP3A4 inducer. Other CYP3A4 inducers may have a comparable effect

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

There was a significant decrease in the rate and extent of guanfacine exposure when co-administered with rifampin, a CYP3A4 inducer. Other CYP3A4 inducers may have a comparable effect

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

Guanfacin [1], syncope ---> SmPC of [1] of EMA

Guanfacine can cause syncope, hypotension and bradycardia. Syncope may involve risks of falls or accidents, which could result in serious harm (see sections 4.8 and 4.7).

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

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

Guanfacin [1], torsades de pointes inducing drugs ---> SmPC of [1] of EMA

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

Co-administration of Intuniv and valproic acid can result in increased concentrations of valproic acid. Guanfacine and valproic acid are metabolised by glucuronidation, possibly resulting in competitive inhibition.

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

Guanfacin, hydroquinidine

Concomitant use of hydroquinidine and bradycardiac agents increases the risk of heart rhythm disorders (torsades de pointes)

Guanfacin, metoprolol

The co-administration may cause pronounced decrease of cardiac frequency and conduction

Guanfacin, midazolam [2] ---> SmPC of [2] of EMA

The co-administration of midazolam with other sedative/hypnotic agents and CNS depressants, including alcohol, is likely to result in enhanced sedation and respiratory depression.

Guanfacin, nebivolol [2] ---> SmPC of [2] of eMC

Concomitant use of nebivolol with centrally acting antihypertensive drugs may worsen heart failure by a decrease in the central sympathetic tonus (reduction of heart rate and cardiac output, vasodilation)

Guanfacin, penbutolol

The combination may enhance the hypotensive effect and decrease the central sympathetic tonus (reduction of heart rate and cardiac output, vasodilation)

Guanfacin, pindolol

Concomitant use of pindolol and guanfacine may cause strong decrease in the heart rate or delay in conduction

Guanfacin, pindolol/clopamide

Concomitant use of pindolol/clopamide and guanfacin may further decrease the heart frequency

Guanfacin, propranolol

The co-administration may prolong the atrioventricular conduction time and cause additive effects resulting in hypotension, and/or marked bradycardia

Guanfacin, sotalol

Bradycardia-inducing medicinal products enhance the risk of torsades de pointes

Guanfacin, sulpiride [2] ---> SmPC of [2] of eMC

The combination of sulpiride with bradycardia-inducing medications is not recommended

Guanfacin, talinolol

Strong decrease in the heart rate or delay in conduction

Guanfacin, tetrazepam

The co-administration may mutually enhance the CNS depressant effects

Guanfacin, tiapride

Tiapride should not be combined with drugs that prolong the QT interval. These drugs (with the exception of anti-infectious) should be discontinued, if possible, if they induce torsades de pointes

CONTRAINDICATIONS of Guanfacin (Intuniv)

- 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/intuniv-epar-product-information_en.pdf 10/06/2024

Guselkumab (Tremfya)

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

A decision should be made whether to discontinue breast-feeding or to abstain from Tremfya therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

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

There is no need for dose adjustment when co-administering guselkumab and CYP450 substrates.

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

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

Guselkumab [1], immunosuppressives ---> SmPC of [1] of EMA

In psoriasis studies, the safety and efficacy of guselkumab in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated.

Guselkumab [1], midazolam ---> SmPC of [1] of EMA

In a Phase 1 study in subjects with moderate to severe plaque psoriasis, changes in systemic exposures (Cmax and AUCinf) of midazolam, S-warfarin, omeprazole, dextromethorphan, and caffeine after a single dose of guselkumab were not clinically relevant

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

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

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

Before live viral or live bacterial vaccination, treatment should be withheld for at least 12 weeks after the last dose and can be resumed at least 2 weeks after vaccination.

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

Live vaccines should not be used concurrently in patients treated with guselkumab. No data are available on the response to live or inactive vaccines.

Guselkumab [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 12 weeks after treatment.

CONTRAINDICATIONS of Guselkumab (Tremfya)

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

- Clinically important active infections (e.g., active tuberculosis, see section 4.4).

https://www.ema.europa.eu/en/documents/product-information/tremfya-epar-product-information_en.pdf 16/09/2024

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