Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Organon Pharma (Ireland) Limited, 2 Dublin Landings, North Wall Quay North Dock, D01 V4A3, Dublin 1, Ireland
Ezetrol 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.
Ezetrol 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.
Ezetrol 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.
Ezetrol 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).
Ezetrol is indicated as adjunctive therapy to diet for use in patients with homozygous familial sitosterolaemia.
The patient should be on an appropriate lipid‑lowering diet and should continue on this diet during treatment with Ezetrol.
Route of administration is oral. The recommended dose is one Ezetrol 10 mg tablet daily. Ezetrol can be administered at any time of the day, with or without food.
When Ezetrol 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, Ezetrol 10 mg may be administered with a statin with proven cardiovascular benefit.
Dosing of Ezetrol 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.
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 Ezetrol is administered with a statin, the dosage instructions for the statin in children should be consulted.
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 Ezetrol 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 renally 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 5000 mg/kg of ezetimibe in rats and mice and 3000 mg/kg in dogs.
A few cases of overdosage with Ezetrol 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.
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Blisters: Store in the original package in order to protect from moisture.
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Unit Dose peelable blisters of clear polychlorotrifluoroethylene/PVC sealed to vinyl coated aluminium backed with paper and polyester in packs of 7, 10, 14, 20, 28, 30, 50, 98, 100, or 300 tablets.
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