Šalis: Airija
kalba: anglų
Šaltinis: HPRA (Health Products Regulatory Authority)
EZETIMIBE
MSD-SP Limited
10mg Milligram
Tablets
2003-07-25
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ezetrol 10 mg Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg of ezetimibe. Excipient(s): Each tablet contains 55 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 debossed with “414” on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _PRIMARY HYPERCHOLESTEROLAEMIA_ 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. _HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLAEMIA (HOFH)_ 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). _HOMOZYGOUS SITOSTEROLAEMIA (PHYTOSTEROLAEMIA)_ Ezetrol is indicated as adjunctive therapy to diet for use in patients with homozygous familial sitosterolaemia. A beneficial effect of Ezetrol on cardiovascular morbidity and mortality has not yet been demonstrated. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION 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. IRISH MEDICINES BOARD ______ Perskaitykite visą dokumentą