Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2022 Publisher: Sandoz Limited, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, United Kingdom
Ezetimibe, co-administered with an HMG-CoA reductase inhibitor (statin) is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia who are not appropriately controlled with a statin alone.
Ezetimibe monotherapy is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia in whom a statin is considered inappropriate or is not tolerated.
Ezetimibe is indicated to reduce the risk of cardiovascular events (see section 5.1) in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS) when added to ongoing statin therapy or initiated concomitantly with a statin.
Ezetimibe co-administered with a statin, is indicated as adjunctive therapy to diet for use in patients with HoFH. Patients may also receive adjunctive treatments (e.g. LDL apheresis).
The patient should be on an appropriate lipid lowering diet and should continue on this diet during treatment with Ezetimibe.
Route of administration is oral. The recommended dose is one Ezetimibe 10 mg tablet daily. Ezetimibe can be administered at any time of the day, with or without food.
When Ezetimibe is added to a statin, either the indicated usual initial dose of that particular statin or the already established higher statin dose should be continued. In this setting, the dosage instructions for that particular statin should be consulted.
For incremental cardiovascular event reduction in patients with coronary heart disease and ACS event history, Ezetimibe 10 mg may be administered with a statin with proven cardiovascular benefit.
Dosing of Ezetimibe should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant.
No dosage adjustment is required for elderly patients (see section 5.2).
Initiation of treatment must be performed under review of a specialist.
Children and adolescents ≥6 years: The safety and efficacy of ezetimibe in children aged 6 to 17 years has not been established. Current available data are described in sections 4.4, 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
When Ezetimibe is administered with a statin, the dosage instructions for the statin, in children should be consulted.
Children <6 years: The safety and efficacy of Ezetimibe in children aged <6 years has not been established. No data are available.
No dosage adjustment is required in patients with mild hepatic impairment (Child-Pugh score 5 to 6).
Treatment with Ezetimibe is not recommended in patients with moderate (Child-Pugh score 7 to 9) or severe (Child-Pugh score>9) liver dysfunction (see sections 4.4 and 5.2).
No dosage adjustment is required for renal impaired patients (see section 5.2).
In clinical studies, administration of ezetimibe, 50 mg/day, to 15 healthy subjects for up to 14 days, or 40 mg/day to 18 patients with primary hypercholesterolaemia for up to 56 days, was generally well tolerated.
In animals, no toxicity was observed after single oral doses of 5,000 mg/kg of ezetimibe in rats and mice and 3,000 mg/kg in dogs.
A few cases of overdose with ezetimibe have been reported: most have not been associated with adverse experiences. Reported adverse experiences have not been serious. In the event of an overdose, symptomatic and supportive measures should be employed.
3 years.
Bottles: After first opening: 9 months. Do not store above 25°C.
Blisters: Store in the original package in order to protect from moisture.
Bottles: Keep the container tightly closed in order to protect from moisture.
For storage conditions after first opening of the medicinal product, see section 6.3.
Alu/Alu blister: 7, 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98, 100 and 100 (hospital pack) tablets.
White HDPE container closed with white, tamper-evident polypropylene screw cap with mounted LDPE capsule with silica gel: 100 tablets and 250 tablets (for hospital use and dose dispensing pharmacies only).
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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