Land: Vereinigtes Königreich
Sprache: Englisch
Quelle: myHealthbox
ezetimibe
Glenmark Pharmaceuticals Europe Limited
C10AX09
ezetimibe
10mg
Tablets
Oral use
Pack sizes: 14, 28, 30, 50, 98 and 100 tablets
POM - Prescription Only Medicine
Glenmark Pharmaceuticals Europe Limited
Other lipid modifying agents
Primary Hypercholesterolaemia Homozygous Familial Hypercholesterolaemia (HoFH) Homozygous Sitosterolaemia (phytosterolaemia)
Authorised
2015-05-22
PACKAGE LEAFLET: INFORMATION FOR THE USER EZETIMIBE 10 MG TABLETS Ezetimibe SAME SIZE ARTWORK LEAFLET SIZE: 120 mm x 450 mm 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. - T h i s m e d i c i n e h a s b e e n 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 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 " g o o d " c h o l e s t e r o l ( H D L cholesterol). Ezetimibe, the active ingredient of Ezetimibe tablets, works by reducing the cholesterol absorbed in your digestive tract. Ezetimibe adds to the cholesterol- lowering effect of statins, a group of m e d i c i n e s t h a t r e d u c e t h e cholesterol your Lesen Sie das vollständige Dokument
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ezetimibe 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg of ezetimibe. Excipient(s) with known effect: Each tablet contains 69.75 mg of lactose monohydrate. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Tablet White to off-white, capsule shaped, approximately 8.0 x 4.0 x 2.6 mm in size, flat, bevelled edged uncoated tablets engraved with ‘G’ on one side and “44” on the other 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 nonfamilial) hypercholesterolaemia in whom a statin is considered inappropriate or is not tolerated. _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 familial sitosterolaemia. A beneficial effect of ezetimibe on cardiovascular morbidity and mortality has not yet been demonstrated. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with ezetimibe. Route of administration is oral. The recommended dose Lesen Sie das vollständige Dokument