Pays: Nouvelle-Zélande
Langue: anglais
Source: Medsafe (Medicines Safety Authority)
Simvastatin 10mg; ; ; ;
Teva Pharma (New Zealand) Limited
Simvastatin 10 mg
10 mg
Film coated tablet
Active: Simvastatin 10mg Excipient: Butylated hydroxyanisole Hyprolose Hypromellose Lactose Magnesium stearate Microcrystalline cellulose Pregelatinised maize starch Purified talc Purified water Titanium dioxide
Blister pack, PVC/PE/PVDC, 30 tablets
Prescription
Prescription
Biocon Limited
Patients at High Risk of Coronary Heart Disease (CHD) or with existing CHD. In patients at high risk of CHD (with or without hyperlipidaemia but with a total cholesterol of >3.5 mmol/L), i.e. patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing CHD, simvastatin is indicated to: · Reduce the risk of total mortality by reducing CHD deaths. · Reduce the risk of major vascular events (a composite of non-fatal myocardial infarction, CHD death, stroke, or revascularisation procedures. · Reduce the risk of stroke. · Reduce the need for coronary revascularisation procedures (including coronary artery bypass grafting and percutaneous transluminal coronary angioplasty). · Reduce the need for peripheral and other non-coronary revascularisation procedures. · Reduce the risk of hospitalisation for angina pectoris. In patients with diabetes, simvastatin reduces the risk of developing peripheral macrovascular complications (a composite of peripheral revascularisation procedures, lower limb amputations, or leg ulcers. In hypercholesterolaemic patients with coronary heart disease, simvastatin slows the progress of coronary atherosclerosis, including reducing the development of new lesions and new total occlusions.
Package - Contents - Shelf Life: Blister pack, PVC/PE/PVDC - 30 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PE/PVDC - 90 tablets - 36 months from date of manufacture stored at or below 25°C
2008-07-31
CONSUMER MEDICINE INFORMATION ARROW - SIMVA SIMVASTATIN 10 MG, 20 MG, 40 MG AND 80 MG TABLETS WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ARROW - SIMVA. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking ARROW - SIMVA against the benefits he/she expects it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. YOU MAY NEED TO READ IT AGAIN. WHAT ARROW - SIMVA IS USED FOR ARROW - SIMVA helps lower high cholesterol and triglyceride levels. Your doctor has prescribed ARROW - SIMVA to reduce the health risks associated with coronary heart disease (CHD). If you have CHD, diabetes, history of stroke or other vessel disease (regardless of the amount of cholesterol in your blood), ARROW - SIMVA: • can prolong your life by reducing the risk of heart attack or stroke • reduces the need for surgery to increase blood flow to the legs and major organs such as the heart • reduces the need for hospitalisation for chest pain (also known as angina). CHOLESTEROL Everyone has cholesterol and triglycerides in their blood. They are the types of blood fat needed by the body for building cell walls, making bile acids (which help to digest food) and certain hormones, and other functions. There are different types of cholesterol, for example, low-density lipoprotein (LDL) and high- density lipoprotein (HDL) cholesterol. LDL cholesterol is the 'bad' cholesterol that can block your blood vessels. HDL cholesterol is the 'good' cholesterol that is thought to remove the bad cholesterol from the blood vessels. Your body makes cholesterol, but it also comes from food. Normally, the body balances the cholesterol it makes with the cholesterol it gets from food. This means if more cholesterol comes from food, less is made by the body. However, if you eat a diet high in Lire le document complet
Version 1.0 1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Arrow – Simva 10, film coated tablets, 10 mg Arrow - Simva 20, film coated tablets, 20 mg Arrow - Simva 40, film coated tablets, 40 mg Arrow - Simva 80, film coated tablets, 80 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains simvastatin 10 mg, 20 mg, 40 mg or 80 mg. Excipient with known effect: lactose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Arrow - Simva 10: White oblong biconvex film coated tablet, score line and “10” on one side and “SVT” on the reverse side. Arrow - Simva 20: White oblong biconvex film coated tablet, score line and “20” on one side and “SVT” on the reverse side. Arrow - Simva 40: White oblong biconvex film coated tablet, score line and “40” on one side and “SVT” on the reverse side. Arrow - Simva 80: White oblong biconvex film coated tablet, score line and “80” on one side and “SVT” on the reverse side. The tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _PATIENTS AT HIGH RISK OF CORONARY HEART DISEASE (CHD) OR WITH EXISTING CHD _ In patients at high risk of CHD (with or without hyperlipidaemia but with a total cholesterol of >3.5 mmol/L), i.e. patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing CHD, simvastatin is indicated to: • Reduce the risk of total mortality by reducing CHD deaths; • Reduce the risk of major vascular events (a composite of non-fatal myocardial infarction, CHD death, stroke, or revascularisation procedures; • Reduce the risk of major coronary events (a composite of non-fatal myocardial infarction or CHD deaths); • Reduce the risk of stroke; • Reduce the need for coronary revascularisation procedures (including coronary artery bypass grafting and percutaneous transluminal coronary angioplasty); • Reduce the need for peripheral and other non-coronary revascularisation procedures; • Reduce the risk of hospitalis Lire le document complet