Quốc gia: Nam Phi
Ngôn ngữ: Tiếng Anh
Nguồn: South African Health Products Regulatory Authority (SAHPRA)
Organon South Africa (Pty) Ltd
See ingredients
TABLET
EACH TABLET CONTAINS EZETIMIBE 10,0 mg SIMVASTATIN 80,0 mg
Registered
2006-11-08
Page 1 of 12 PATIENT INFORMATION LEAFLET SCHEDULING STATUS INEGY ® 10/10 Tablet INEGY ® 10/20 Tablet INEGY ® 10/40 Tablet INEGY ® 10/80 Tablet • ezetimibe and simvastatin INEGY contains sugar (lactose monohydrate): Each 10/10 mg Tablet contains 58,2 mg of lactose monohydrate. Each 10/20 mg Tablet contains 126,5 mg of lactose monohydrate. Each 10/40 mg Tablet contains 262,9 mg of lactose monohydrate. Each 10/80 mg Tablet contains 535,8 mg of lactose monohydrate. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING INEGY • 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. • You should also read any information provided with other medicines you are currently taking. • INEGY 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 INEGY is and what it is used for S4 Page 2 of 12 2. What you need to know before you take INEGY 3. How to take INEGY 4. Possible side effects 5. How to store INEGY 6. Contents of the pack and other information 1. WHAT INEGY IS AND WHAT IT IS USED FOR WHAT INEGY IS USED FOR INEGY is a medicine used to lower levels of total cholesterol, LDL cholesterol, and fatty substances called triglycerides in the blood. In addition, INEGY raises levels of HDL cholesterol. It is used for patients who cannot control their cholesterol levels by diet alone. You should stay on a cholesterol-lowering diet while taking INEGY. If you have heart disease, INEGY reduces the risk of heart attack, stroke, surgery to increase heart blood flow or hospitalisation for chest pain. HOW DOES INEGY WORK? INEGY works to reduce your cholesterol in two ways. It reduces the cholesterol absorbed in your digestive tract, as well as the cholesterol your body makes by itself. INEGY does not help you lose weight. Your doctor has prescribed INEGY to reduce the amount of cholester Đọc toàn bộ tài liệu
Page 1 of 30 SCHEDULING STATUS 1 NAME OF THE MEDICINE INEGY ® 10/10 Tablet INEGY ® 10/20 Tablet INEGY ® 10/40 Tablet INEGY ® 10/80 Tablet 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each INEGY 10/10 Tablet contains ezetimibe 10 mg and simvastatin 10 mg. Each INEGY 10/20 Tablet contains ezetimibe 10 mg and simvastatin 20 mg. Each INEGY 10/40 Tablet contains ezetimibe 10 mg and simvastatin 40 mg. Each INEGY 10/80 Tablet contains ezetimibe 10 mg and simvastatin 80 mg. INEGY contains sugar (lactose monohydrate): Each 10/10 mg Tablet contains 58,2 mg of lactose monohydrate. Each 10/20 mg Tablet contains 126,5 mg of lactose monohydrate. Each 10/40 mg Tablet contains 262,9 mg of lactose monohydrate. Each 10/80 mg Tablet contains 535,8 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM INEGY 10/10: white to off-white, capsule shaped, biconvex compressed tablets debossed with 311 on one side and plain on the other side. S4 Page 2 of 30 INEGY 10/20: white to off-white, capsule shaped, biconvex compressed tablets debossed with 312 on one side and plain on the other side. INEGY 10/40: white to off-white, capsule shaped, biconvex compressed tablets debossed with 313 on one side and plain on the other side. INEGY 10/80: white to off-white, capsule shaped, biconvex compressed tablets debossed with 315 on one side and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS REDUCTION IN THE RISK OF CARDIOVASCULAR EVENTS INEGY is indicated to reduce the risk of cardiovascular events in patients with coronary artery heart disease (CHD) and a history of acute coronary syndrome (ACS), either previously treated with a statin or not. Benefits have been shown for this group of patients when their LDL-C was above 1,2 mmol/L. No statistically significant benefit was demonstrated for risk reduction of stroke, hospitalisation for unstable angina pectoris and for coronary artery revascularisation procedures. _ _ PRIMARY HYPERCHOLESTEROLAEMIA INEGY is indicated as adjuncti Đọc toàn bộ tài liệu