Quốc gia: Malaysia
Ngôn ngữ: Tiếng Anh
Nguồn: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
EZETIMIBE
NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.
EZETIMIBE
30 Tablets; 60 Tablets; 100 Tablets
LEK PHARMACEUTICALS D.D.
LETIMBLE TABLETS Ezetimibe (10 mg) 1 _Consumer Medication Information Leaflet (RiMUP) _ WHAT IS IN THIS LEAFLET 1. What LETIMBLE is used for 2. How LETIMBLE works 3. Before you take LETIMBLE 4. How to take LETIMBLE 5. While you are taking LETIMBLE 6. Side effects 7. Storage and disposal of LETIMBLE 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision Please read this information carefully before you start to take your medicine, even if you have just refilled your prescription. Some of the information may have changed. You should also read any information provided with other medicines you are currently taking. Remember that your doctor has prescribed this medicine only for you. Never give it to anyone else. WHAT LETIMBLE IS USED FOR LETIMBLE (ezetimibe) is a tablet that contains 10 mg of ezetimibe as the active ingredient. • LETIMBLE is a cholesterol- lowering medicine. • LETIMBLE is for patients whose cholesterol levels are too high and when diet alone cannot lower these levels adequately. • LETIMBLE reduces elevated total-cholesterol, LDL (bad) cholesterol and triglycerides and increases HDL (good) cholesterol. • LETIMBLE may be taken with other cholesterol-lowering medicines known as statins or alone, in addition to diet. • LETIMBLE may be taken with fenofibrate, another cholesterol-lowering medicine, in addition to diet. • For patients with heart disease, LETIMBLE combined with cholesterol-lowering medicines called statins reduces the risk of heart attack, stroke, surgery to increase blood flow or hospitalization for chest pain. If you have sitosterolemia, your doctor has prescribed LETIMBLE to lower the level of plant sterols in your blood. Sitosterolemia is a hereditary illness that increases the levels of plant sterols in your blood. HOW LETIMBLE WORKS • LETIMBLE works by decreasing the absorption of cholesterol in the small intestine. Statins and fenofibrate lower cholesterol in a different way; they work in the liver. • LETIMBLE adds to the cholestero Đọc toàn bộ tài liệu
1 PACKAGE INSERT 1. NAME OF THE MEDICINAL PRODUCT Letimble 10 mg Tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg of ezetimibe. Excipient(s) with known effect: 67.50 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White to almost white, oval tablets with debossing “10” on one side and “EZT” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Primary hypercholesterolaemia _ Ezetimibe, administered alone, or with an HMG-CoA reductase inhibitor (statin), is indicated as adjunctive therapy to diet in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia. Ezetimibe, administered in combination with fenofibrate, is indicated as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, Apo B and non-HDL-C in patients with mixed hyperlipidemia. _Prevention of Cardiovascular Events _ Ezetimibe, administered with a statin, is indicated to reduce the risk of cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, or need for revascularization), in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS). _Homozygous Familial Hypercholesterolaemia (HoFH)_ Ezetimibe, administered with a statin, is indicated for patients with HoFH. Patients may also receive adjunctive treatments (e.g. LDL apheresis)._ _ _Homozygous Sitosterolaemia (Phytosterolaemia) _ Ezetimibe is indicated 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. _Use in Patients with Primary Hypercholesterolaemia _ The recommended dose of ezetimibe is 10 mg once daily, used alone, with a statin or with fenofibrate. Ezetimibe can be administered at any time of t Đọc toàn bộ tài liệu