Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
EZETIMIBE
Generics (UK) Limited
C10AX09
EZETIMIBE
10 Milligram
Tablets
Product subject to prescription which may be renewed (B)
ezetimibe
Marketed
2014-07-25
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT EZETIMIBE 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 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 1. WHAT EZETIMIBE IS AND WHAT IT IS USED FOR Ezetimibe contains the active substance ezetimibe. Ezetimibe is a medicine used 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). 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. Triglycerides are another form of fat in your blood that may increase your risk for heart disease. Ezetimibe works by reducing the cholesterol absorbed in your digestive tract. Ezetimibe does not help you lose weight. Ezetimibe adds to the cholesterol-lowering effect of statins, Lestu allt skjalið
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(s) with known effect: Lactose monohydrate. Each tablet contains 62 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White to off white capsule shaped, bevelled edge tablet debossed with ‘M’ on one side of the tablet and ‘EE1’ on the other side, approximately 8.2 mm in length and 4.1 mm in width. 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 patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with Ezetimibe. The recommended dose is one Ezetimibe 10 mg tablet daily. 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 continue Lestu allt skjalið