מדינה: אירלנד
שפה: אנגלית
מקור: HPRA (Health Products Regulatory Authority)
Ezetimibe
Key Pharmaceuticals Ltd
C10AX; C10AX09
Ezetimibe
10 milligram(s)
Tablet
Product subject to prescription which may be renewed (B)
Other lipid modifying agents; ezetimibe
Marketed
2018-02-09
PACKAGE LEAFLET EZETIMIBE 10 MG TABLETS KEY PHARMACEUTICALS LTD. PL 34424/0005 PA 0343/001/001 VERSION NO. – 08 (SEPTEMBER 2020)_MM PAGE 1 OF 7 Package leaflet: Information for the user EZETIMIBE 10 MG TABLETS ezetimibe Your medicine is called Ezetimibe 10 mg Tablets, but it will be referred to as Ezetimibe tablets or Ezetimibe throughout this leaflet. 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 side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. WHAT EZETIMIBE TABLETS ARE AND WHAT THEY ARE USED FOR 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE EZETIMIBE TABLETS 3. HOW TO TAKE EZETIMIBE TABLETS 4. POSSIBLE SIDE EFFECTS 5. HOW TO STORE EZETIMIBE TABLETS 6. CONTENTS OF THE PACK AND OTHER INFORMATION 1. WHAT EZETIMIBE TABLETS ARE AND WHAT THEY ARE USED FOR Ezetimibe tablets are a medicine to lower increased levels of cholesterol. Ezetimibe tablets lowers levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Ezetimibe tablets raise levels of "good" cholesterol (HDL cholesterol). Ezetimibe, the active ingredient of Ezetimibe tablets, works by reducing the cholesterol absorbed in your digestive tract. Ezetimibe tablets add 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 arter קרא את המסמך השלם
Health Products Regulatory Authority 22 September 2020 CRN009VJ7 Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ezetimibe 10mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10mg of ezetimibe. Each tablet contains less than 1 mmol (23mg) of sodium in the form of croscarmellose sodium, sodium lauryl sulphate and sodium stearyl fumerate, that is to say that each tablet is essentially sodium free. Excipient(s) with known effect Each tablet contains 44.50 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White to off – white, capsule shaped, flat bevelled edged, uncoated tablets debossed with ‘EZE’ on one side and plain on other side, approximately 8.2mm in length and 4.1mm 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). Homozygous Sitosterolaemia (Phytosterolaemia) Ezetimibe is indicated as adjunctive therapy to diet for use in patients with homozygous f קרא את המסמך השלם