EZETIMIBE MEVON TABLET 10 MG [SIN16441P]

Product Info

EZETIMIBE MEVON TABLET 10 MG

[SIN16441P]

4.1. Therapeutic indications

Primary Hypercholesterolaemia
Ezetimibe MEVON co-administered with an HMG-CoA reductase inhibitor (statin) or alone, is indicated as adjunctive therapy to diet for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C) and apolipoprotein B (Apo B) in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia.

Homozygous Familial Hypercholesterolaemia (HoFH)
Ezetimibe MEVON co-administered with atorvastatin or simvastatin, is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH, as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable.

Homozygous Sitosterolaemia (Phytosterolaemia)
Ezetimibe MEVON is indicated as adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolaemia.

4.2. Posology and method of administration

Posology
The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with Ezetimibe MEVON.

The recommended dose is one Ezetimibe MEVON 10 mg tablet daily.
When Ezetimibe MEVON 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.

Co-administration with bile acid sequestrants
Dosing of Ezetimibe MEVON should occur either ≥ 2 hours before or ≥ 4 hours after administration of a bile acid sequestrant.

Elderly
No dosage adjustment is required for elderly patients (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population
Initiation of treatment must be performed under review of a specialist.

Children and adolescents ≥ 10 years: No dosage adjustment is required.

Children < 10 years: Treatment with ezetimibe is not recommended.

Hepatic impairment
No dosage adjustment is required in patients with mild hepatic impairment (Child-Pugh score 5 to 6). Treatment with Ezetimibe MEVON 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 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Renal impairment
Monotherapy
In patients with renal impairment, no dosage adjustment of ezetimibe is necessary (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Combination therapy with simvastatin
In patients with mild renal impairment (estimated GFR ≥60 mL/min/1.73 m²), no dosage adjustment of ezetimibe or simvastatin is necessary. In patients with chronic kidney disease and estimated glomerular filtration rate <60 mL/min/1.73m², the dose of ezetimibe is 10 mg and the dose of simvastatin is 20 mg once a day in the evening. In such patients, the use of higher doses of simvastatin should be closely monitored.

Method of administration
Route of administration is oral. Ezetimibe MEVON can be administered at any time of the day, with or without food.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
When Ezetimibe MEVON is co-administered with a statin, please refer to the SmPC for that particular medicinal product.

Therapy with Ezetimibe MEVON co-administered with a statin is contraindicated during pregnancy and lactation.

Ezetimibe MEVON co-administered with a statin is contraindicated in patients with active liver disease or unexplained persistent elevations in serum transaminases.