Pays: Malte
Langue: anglais
Source: Medicines Authority
EZETIMIBE, SIMVASTATIN
Teva B.V. Swensweg 5, 2031 GA Haarlem, Netherlands
C10BA02
EZETIMIBE 10 mg SIMVASTATIN 40 mg
TABLET
EZETIMIBE 10 mg SIMVASTATIN 40 mg
POM
LIPID MODIFYING AGENTS
Withdrawn
2017-03-14
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT EZETIMIBE/SIMVASTATIN TEVA 10 MG/20 MG TABLETS EZETIMIBE/SIMVASTATIN TEVA 10 MG/40 MG TABLETS EZETIMIBE/SIMVASTATIN TEVA 10 MG/80 MG TABLETS 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 Ezetimibe/simvastatin Teva is and what it is used for 2. What you need to know before you take Ezetimibe/simvastatin Teva 3. How to take Ezetimibe/simvastatin Teva 4. Possible side effects 5. How to store Ezetimibe/simvastatin Teva 6. Contents of the pack and other information 1. WHAT EZETIMIBE/SIMVASTATIN TEVA IS AND WHAT IT IS USED FOR Ezetimibe/simvastatin Teva contains the active substances ezetimibe and simvastatin. Ezetimibe/simvastatin Teva is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Ezetimibe/simvastatin Teva raises levels of “good” cholesterol (HDL cholesterol). Ezetimibe/simvastatin Teva 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 Lire le document complet
Page 1 of 33 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Ezetimibe/simvastatin Teva 10 mg/20 mg tablets Ezetimibe/simvastatin Teva 10 mg/40 mg tablets Ezetimibe/simvastatin Teva 10 mg/80 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg ezetimibe and 20 mg simvastatin Each tablet contains 10 mg ezetimibe and 40 mg simvastatin Each tablet contains 10 mg ezetimibe and 80 mg simvastatin Excipient with known effect: Ezetimibe/simvastatin Teva 10 mg/20 mg tablets contains 126.450 mg lactose monohydrate Ezetimibe/simvastatin Teva 10 mg/40 mg tablets contains 262.900 mg lactose monohydrate Ezetimibe/simvastatin Teva 10 mg/80 mg tablets contains 535.800 mg lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablets Ezetimibe/simvastatin Teva 10 mg/20 mg tablets: White to off-white capsule shaped tablets. Debossed with “E10” on one side of the tablet and with “S20” on the other side Ezetimibe/simvastatin Teva 10 mg/40 mg tablets: White to off-white capsule shaped tablets. Debossed with “E10” on one side of the tablet and with “S40” on the other side Ezetimibe/simvastatin Teva 10 mg/80 mg tablets: White to off-white capsule shaped tablets. Debossed with “E10” on one side of the tablet and with “S80” on the other side 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of Cardiovascular Events Ezetimibe/simvastatin Teva 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 Page 2 of 33 Ezetimibe/simvastatin Teva 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 Lire le document complet