Страна: Мальта
мова: англійська
Джерело: Medicines Authority
EZETIMIBE
Teva Pharma B.V. Swensweg 5, 2031 GA Haarlem, Netherlands
C10AX09
EZETIMIBE 10 mg
TABLET
EZETIMIBE 10 mg
POM
LIPID MODIFYING AGENTS
Withdrawn
2016-05-04
1 PACKAGE LEAFLET 2 PACKAGE LEAFLET: INFORMATION FOR THE USER EZETIMIBE TEVA 10 MG TABLETS ezetimibe 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 Teva is and what it is used for 2. What you need to know before you take Ezetimibe Teva 3. How to take Ezetimibe Teva 4. Possible side effects 5. How to store Ezetimibe Teva 6. Contents of the pack and other information 1. WHAT EZETIMIBE TEVA IS AND WHAT IT IS USED FOR Ezetimibe Teva is a medicine to lower increased levels of cholesterol Ezetimibe Teva lowers levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Ezetimibe Teva raises levels of "good" cholesterol (HDL cholesterol). Ezetimibe, the active ingredient of Ezetimibe Teva works by reducing the cholesterol absorbed in your digestive tract. Ezetimibe Teva adds to the cholesterol-lowering effect of statins, a group of medicines that reduce 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 brain. This blocking of blood flow can result in a heart attack or stroke HDL cholesterol is often called “go Прочитайте повний документ
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Ezetimibe Teva 10 mg Tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg of ezetimibe. Excipient with known effect: Each tablet contains 35 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. 8.2 mm x 4.1 mm white, biconvex, capsule shaped tablets, with debossed “10” on one side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Primary Hypercholesterolaemia Ezetimibe Teva, co-administered with an HMG-CoA reductase inhibitor (statin) is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia who are not appropriately controlled with a statin alone. Ezetimibe Teva monotherapy is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia in whom a statin is considered inappropriate or is not tolerated. Prevention of Cardiovascular Events Ezetimibe 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) when added to ongoing statin therapy or initiated concomitantly with a statin. Homozygous Familial Hypercholesterolaemia (HoFH) Ezetimibe Teva co-administered with a statin, is indicated as adjunctive therapy to diet for use in patients with HoFH. Patients may also receive adjunctive treatments (e.g. LDL apheresis). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is one Ezetimibe Teva 10 mg tablet daily. Ezetimibe Teva can be administered at any time of the day, with or without food. 3 When Ezetimibe Teva is added to a statin, either the indicated usual initial dose of that particular statin or the already established higher statin dose should be continued. In this setting, the dosage instructions for that particular statin should be consulted. _USE IN PATIENTS WITH Прочитайте повний документ