国: イスラエル
言語: 英語
ソース: Ministry of Health
SIMVASTATIN
TEVA ISRAEL LTD
C10AA01
TABLETS
SIMVASTATIN 10 MG
PER OS
Required
TEVA PHARMACEUTICAL WORKS PRIVATE LIMITED COMPANY, HUNGARY
SIMVASTATIN
SIMVASTATIN
Coronary Heart Disease : In patients with coronary heart disease and hypercholesterolemia Simvastatin-teva is indicated to: - Reduce the risk of total mortality by reducing coronary death - Reduce the risk of non-fatal myocardial infarction - Reduce the risk for undergoing myocardial revascularization procedures.- Reduce the risk of stroke and transient ischemic attacks (TIA). Hyperlipidemia: Simvastatin-teva is indicated as an adjunct to diet to reduce elevated TOTAL-C LDL-C Apo B and TG and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Frederickson Types IIa and IIb) Simvastatin-teva therefore lowers the LDL-C/HDL-C and the total-C/HDL-C ratios.Homozygous familial hypercholesterolemia: Simvastatin-teva is also indicated as an adjunct to diet and other non-dietary measures in reducing elevated total cholesterol LDL-cholesterol and apolipoprotein B in patients with homozygous familial hypercholesterolemia when response to these measures is inadequate. Hypertriglyceridemia (Fredrickson type IV hyperlipidemia). Simvastatin-teva is indicated for the treatment of patients with primary dysbetalipoproteinemia (Fredrickson type III hyperlipidemia).
2020-11-30
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a doctor's prescription only SIMVASTATIN TEVA 10 MG SIMVASTATIN TEVA 20 MG SIMVASTATIN TEVA 40 MG SIMVASTATIN TEVA 80 MG TABLETS COMPOSITION: Each tablet of Simvastatin Teva 10 mg contains: Simvastatin 10 mg Each tablet of Simvastatin Teva 20 mg contains: Simvastatin 20 mg Each tablet of Simvastatin Teva 40 mg contains: Simvastatin 40 mg Each tablet of Simvastatin Teva 80 mg contains: Simvastatin 80 mg For information regarding inactive ingredients and allergens in the preparation see section 6 - “Additional information” and section 2 - “Important information about some ingredients of the medicine”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have additional questions, refer to the doctor or the pharmacist. This medicine has been prescribed for treatment of your illness. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. Do not use in children and adolescents under the age of 20. 1. WHAT IS THE MEDICINE INTENDED FOR? In patients with coronary heart disease and hypercholesterolemia, Simvastatin Teva reduces: • The overall mortality risk by lowering mortality from heart disease. • The risk of a non-fatal heart attack. • The risk of invasive procedures to restore blood flow to the heart (such as balloon dilation or bypass surgery). • The risk of stroke and Transient Ischemic Attack - TIA. Simvastatin Teva is indicated for lowering the levels of LDL and other fatty substances in the blood and raising HDL blood levels in patients with hyperlipidemia (high level of fats in the blood). THERAPEUTIC CLASS: Statins, HMG-CoA reductase enzyme inhibitors. HOW DOES SIMVASTATIN TEVA WORK: Simvastatin Teva contains the active ingredient simvastatin. Simvastatin Teva is used to lower blood levels of total cholesterol, levels of the “bad” cholestero 完全なドキュメントを読む
Page 1 of 23 Simvastatin-Teva-10mg-20mg-40mg-80mg-tabs-KK-12-2021 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Simvastatin Teva 10 mg Simvastatin Teva 20 mg Simvastatin Teva 40 mg Simvastatin Teva 80 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Simvastatin Teva 10 mg: Each tablet contains 10 mg simvastatin. Excipients with known effect: Each tablet contains 70.65 mg lactose monohydrate. Simvastatin Teva 20 mg: Each tablet contains 20 mg simvastatin. Excipients with known effect: Each tablet contains 141.30 mg lactose monohydrate. Simvastatin Teva 40 mg: Each tablet contains 40 mg simvastatin. Excipients with known effect: Each tablet contains 282.60 mg lactose monohydrate. Simvastatin Teva 80 mg: Each tablet contains 80 mg simvastatin. Excipients with known effect: Each tablet contains 565.24 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets Simvastatin Teva 10 mg: Light pink oval-shaped film-coated tablet with a breakline on one side. Simvastatin Teva 20 mg: Tan oval-shaped film-coated tablet with a breakline on one side. Simvastatin Teva 40 mg: Pink oval-shaped film-coated tablet with a breakline on one side. Simvastatin Teva 80 mg: Page 2 of 23 Simvastatin-Teva-10mg-20mg-40mg-80mg-tabs-KK-12-2021 Brick-red oval-shaped film-coated tablet with a breakline on one side. Tablet can be divided into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Coronary Heart Disease: In patients with coronary heart disease and hypercholesterolemia Simvastatin Teva is indicated to: Reduce the risk of total mortality by reducing coronary death; Reduce the risk of non-fatal myocardial infarction; Reduce the risk for undergoing myocardial revascularization procedures. Reduce the risk of stroke and transient ischemic attacks (TIA). Hyperlipidemia: Simvastatin Teva is indicated as an adjunct to diet to reduce elevated TOTAL-C LDL- C Apo B and TG and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous 完全なドキュメントを読む