国: オランダ
言語: オランダ語
ソース: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
EZETIMIB 10 mg/stuk ; SIMVASTATINE 80 mg/stuk
Vocate Pharmaceuticals SA 150 Gounari street 16674 GLYFADA (GRIEKENLAND)
C10BA02
EZETIMIB 10 mg/stuk ; SIMVASTATINE 80 mg/stuk
Tablet
BUTYLHYDROXYANISOL (E 320) ; CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CITROENZUUR 1-WATER (E 330) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT ; PROPYLGALLAAT (E 310), BUTYLHYDROXYANISOL (E 320) ; CELLULOSE, MICROKRISTALLIJN (E 460) ; CITROENZUUR 1-WATER (E 330) ; CROSCARMELLOSE NATRIUM (E 468) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; LACTOSE 1-WATER ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMLAURILSULFAAT (E 487) ; PROPYLGALLAAT (E 310)
Oraal gebruik
Simvastatin And Ezetimibe
1900-01-01
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT SIMVEZOR 10 MG/10 MG TABLETTEN SIMVEZOR 10 MG/20 MG TABLETTEN SIMVEZOR 10 MG/40 MG TABLETTEN SIMVEZOR 10 MG/80 MG TABLETTEN EZETIMIBE AND SIMVASTATIN READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet (see section 4). WHAT IS IN THIS LEAFLET: 1. What Simvezor is and what it is used for 2. What you need to know before you take Simvezor 3. How to take Simvezor 4. Possible side effects 5. How to store Simvezor 6. Contents of the pack and other information 1. WHAT SIMVEZOR IS AND WHAT IT IS USED FOR Simvezor contains the active substances ezetimibe and simvastatin. Simvezor is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Simvezor raises levels of “good” cholesterol (HDL cholesterol). Simvezor works to reduce your cholesterol in two ways. The active ingredient ezetimibe reduces the cholesterol absorbed in your digestive tract. The active ingredient simvastatin belonging to the class of “statins” inhibits the production of the cholesterol your body makes by itself. Cholesterol is one of several fatty substances found in the bloodstream. Your total cholesterol is made up mainly of LDL and HDL cholesterol. LDL cholesterol is often called “bad” cholesterol because it can build up in the walls of your arteries forming plaque. Eventually this plaque build-up can lead to a narrowing of the arteries. This narrowing can slow or block blood flow to vital organs such as the heart and brai 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Simvezor 10 mg/10 mg tabletten Simvezor 10 mg/20 mg tabletten Simvezor 10 mg/40 mg tabletten Simvezor 10 mg/80 mg tabletten 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg ezetimibe and 10, 20, 40 or 80 mg of simvastatin. Excipient(s) with known effect Each 10/10 mg tablet contains 51 mg of lactose monohydrate. Each 10/20 mg tablet contains 113 mg of lactose monohydrate. Each 10/40 mg tablet contains 236 mg of lactose monohydrate. Each 10/80 mg tablet contains 482 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. 10mg/10mg: White to οff white capsule shaped uncoated tablets debossed with “G” on one side and “321” on other side, approx.8.5 mm in length and 4.25 mm in width. 10mg/20mg: White to οff white capsule shaped uncoated tablets debossed with “G” on one side and “322” on other side, approx.10.7 mm in length and 5.3 mm in width. 10mg/40mg: White to οff white capsule shaped uncoated tablets debossed with “G” on one side and “323” on other side, approx.14.0 mm in length and 6.0 mm in width. 10mg/80mg: White to οff white capsule shaped uncoated tablets debossed with “G” on one side and “324” on other side, approx.17.5 mm in length and 7.5 mm in width. 4 CLINICAL PARTICULARS _4.1_ _ _ _THERAPEUTIC INDICATIONS _ Prevention of Cardiovascular Events Simvezor is indicated to reduce the risk of cardiovascular events (see section 5.1) in patients with coronary heart disease (CHD) and a history of acute coronary syndrome (ACS), either previously treated with a statin or not. Hypercholesterolaemia Simvezor is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate: • patients not appropriately controlled with a statin alone • patients already treated with a statin and ezetimibe Homozyg 完全なドキュメントを読む