Страна: ЮАР
Язык: английский
Источник: South African Health Products Regulatory Authority (SAHPRA)
Organon South Africa (Pty) Ltd
See ingredients
TABLET
EACH TABLET CONTAINS EZETIMIBE 10,0 mg
Registered
2006-06-03
Page 1 of 10 PATIENT INFORMATION LEAFLET SCHEDULING STATUS EZETROL ® 10 MG TABLETS EZETIMIBE CONTAINS SUGAR (LACTOSE MONOHYDRATE): EACH TABLET CONTAINS 55,0 MG OF LACTOSE MONOHYDRATE. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING EZETROL − Keep this leaflet. You may need to read it again. − If you have further questions, please ask your doctor, pharmacist, nurse or other healthcare provider. − EZETROL has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. WHAT IS IN THIS LEAFLET 1. What EZETROL is and what it is used for 2. What you need to know before you take EZETROL 3. How to take EZETROL 4. Possible side effects 5. How to store EZETROL 6. Contents of the pack and other information 1. WHAT EZETROL IS AND WHAT IT IS USED FOR EZETROL is a cholesterol-lowering medicine. It works by decreasing the absorption of S4 Page 2 of 10 cholesterol in the small intestine. EZETROL reduces elevated total-cholesterol and LDL (bad) cholesterol. EZETROL may be taken with other cholesterol-lowering medicines known as statins or alone, in addition to diet. EZETROL is for patients whose cholesterol levels are too high and when diet alone cannot lower these levels adequately. For patients with heart disease, EZETROL combined with cholesterol-lowering medicines called statins reduces the risk of heart attack, stroke, surgery to increase heart blood flow or hospitalisation for chest pain. Your doctor has prescribed EZETROL to reduce the amount of cholesterol and triglycerides in your blood. Cholesterol is one of several fatty substances found in the bloodstream. Your total cholesterol is made up mainly of LDL and HDL cholesterol. Triglycerides are another form of fat in your blood that may increase your risk for heart disease. HOW CAN HIGH CHOLESTEROL BE TREATED? High cholesterol can be treated in two main ways: LIFESTYLE CHANGES – including a cholesterol-lowering diet, increased physical activity and weight Прочитать полный документ
Page 1 of 18 SCHEDULING STATUS 1 NAME OF THE MEDICINE EZETROL ® 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each EZETROL10 mg tablet contains 10 mg of ezetimibe. EZETROL contains sugar (55,0 mg of lactose monohydrate per tablet). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM White to off-white capsule-shaped tablets, debossed with “414” on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PRIMARY HYPERCHOLESTEROLAEMIA EZETROL, 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) and low- density lipoprotein cholesterol (LDL-C), in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia. REDUCTION IN RISK OF CARDIOVASCULAR EVENTS EZETROL is indicated to reduce the risk of cardiovascular events 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. S4 Page 2 of 18 HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLAEMIA (HOFH) EZETROL, administered with a statin, is indicated for the reduction of elevated total-C and LDL-C levels in patients with HoFH. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The patient should be on an appropriate lipid-lowering diet and weight loss program where indicated and should continue on this diet during treatment with EZETROL. POSOLOGY USE IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLAEMIA The recommended dose of EZETROL is 10 mg once daily, used alone, with a statin or with fenofibrate. EZETROL can be administered at any time of the day, with or without food. USE IN PATIENTS WITH CORONARY HEART DISEASE AND ACS EVENT HISTORY 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. SPECIAL POPULATIONS USE IN PATIENTS WITH RENAL IMPAIR Прочитать полный документ