Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
EZETIMIBE SIMVASTATIN
MSD-SP Limited
10/80 Milligram
Tablets
2004-12-03
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Inegy 10 mg / 80 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg ezetimibe and 80 mg of simvastatin. Excipient(s): Each 10/80 mg tablet contains 535.8 mg of lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White to off-white capsule-shaped tablets with code “315” on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _HYPERCHOLESTEROLAEMIA_ INEGY is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non- familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate: • patients not appropriately controlled with a statin alone • patients already treated with a statin and ezetimibe INEGY contains ezetimibe and simvastatin. Simvastatin (20-40 mg) has been shown to reduce the frequency of cardiovascular events (see section 5.1). A beneficial effect of INEGY or ezetimibe on cardiovascular morbidity and mortality has not yet been demonstrated. _HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLAEMIA (HOFH)_ INEGY is indicated as adjunctive therapy to diet for use in patients with HoFH. Patients may also receive adjunctive treatments (e.g., low-density lipoprotein [LDL] apheresis). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _HYPERCHOLESTEROLAEMIA_ The patient should be on an appropriate lipid -lowering diet and should continue on this diet during treatment with INEGY. Route of administration is oral. The dosage range of INEGY is 10/10 mg/day through 10/80 mg/day in the evening. All dosages may not be available in all member states. The typical dose is 10/20 mg/day or 10/40 mg/day given as a single dose in the evening. The 10/80-mg dose is only reco Prečítajte si celý dokument