Country: New Zealand
Lingwa: Ingliż
Sors: Medsafe (Medicines Safety Authority)
Simvastatin 80mg
AFT Pharmaceuticals Ltd
Simvastatin 80 mg
80 mg
Film coated tablet
Active: Simvastatin 80mg Excipient: Butylated hydroxyanisole Hyprolose Hypromellose Lactose Magnesium stearate Microcrystalline cellulose Pregelatinised maize starch Purified talc Purified water Titanium dioxide
Blister pack, PVC/PE/PVdC/Al foil (30 tablets), 30 tablets
Prescription
Prescription
Zhejiang Hisun Pharmaceutical Co. Ltd
Package - Contents - Shelf Life: Blister pack, PVC/PE/PVdC/Al foil (30 tablets) - 30 tablets - 36 months from date of manufacture stored at or below 25°C
2006-02-08
NEW ZEALAND DATA SHEET Page 1 of 18 1 SIMSTATIN TABLETS SimStatin 5mg tablets SimStatin 10mg tablets SimStatin 20mg tablets SimStatin 40mg tablets SimStatin 80mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 5mg tablet contains simvastatin 5mg Each 10mg tablet contains simvastatin 10mg Each 20mg tablet contains simvastatin 20mg Each 40mg tablet contains simvastatin 40mg Each 80mg tablet contains simvastatin 80mg Excipients with known effect Butylated hydroxyanisole For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM SimStatin 5mg tablets are a yellow, oblong, biconvex, filmcoated tablet, scored and debossed with “5” on one side and debossed “SVT” on the other. SimStatin 10mg tablets are a white oblong, biconvex, filmcoated tablet, scored and debossed with “10” on one side and debossed “SVT” on the other. SimStatin 20mg tablets are a white oblong, biconvex, filmcoated tablet, scored and debossed with “20” on one side and debossed “SVT” on the other. SimStatin 40mg tablets are a white oblong, biconvex, filmcoated tablet, scored and debossed with “40” on one side and debossed “SVT” on the other. SimStatin 80mg tablets are a white oblong, biconvex, filmcoated tablet, debossed with “80” and “SVT” on the other. 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 hyperlipidemia but with a total cholesterol of > 3.5 mmol/L), ie., patients with diabetes, history of stroke or other cerebrovascular disease, peripheral vessel disease, or with existing CHD, SimStatin is indicated to: NEW ZEALAND DATA SHEET Page 2 of 18 • 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 revascularization procedures; • Reduce the risk of major coronary events (a composite of non-fatal myocardial infarction or CHD deaths); • R Aqra d-dokument sħiħ