Land: Storbritannien
Språk: engelska
Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ezetimibe
Teva UK Ltd
C10AX09
Ezetimibe
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 02120000; GTIN: 5017007027638
EZETIMIBE 10 MG TABLETS 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. 1. WHAT EZETIMIBE IS AND WHAT IT IS USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EZETIMIBE 3. HOW TO TAKE EZETIMIBE 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE EZETIMIBE 6. CONTENTS OF THE PACK AND OTHER INFORMATION WHAT EZETIMIBE IS AND WHAT IT IS USED FOR Ezetimibe is a medicine to lower increased levels of cholesterol. Ezetimibe lowers levels of total cholesterol, "bad" cholesterol (LDL cholesterol) and fatty substances called triglycerides in the blood. In addition, Ezetimibe raises levels of "good" cholesterol (HDL cholesterol). Ezetimibe, the active ingredient of Ezetimibe 10 mg Tablets works by reducing the cholesterol absorbed in your digestive tract. Ezetimibe 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 “good” cholesterol because it helps keep the bad cholesterol from building up in the arteries and protects against heart disease. Tr Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ezetimibe 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg ezetimibe. Excipient with known effect: Each tablet contains 35 mg 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, 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 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 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 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 10 mg tablet daily. Ezetimibe can be administered at any time of the day, with or without food. When Ezetimibe 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 CORONARY HEART DISEASE AND ACS EVENT HISTORY _ For incre Läs hela dokumentet