Nazione: Malta
Lingua: inglese
Fonte: Malta Medicines Authority
ezetimibe 10 mg
Sandoz Limited
C10AX09
ezetimibe
tablet
Authorised
2014-01-23
Page 1 of 7 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. 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 levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, this medicine raises levels of "good" cholesterol (HDL cholesterol). It is used for patients who cannot control their cholesterol levels by diet alone. You should stay on a cholesterol-lowering diet while taking this medicine. This medicine works by reducing the cholesterol absorbed in your digestive tract. It does not help you lose weight. Ezetimibe adds to the cholesterol-lowering effect of statins, a group of medicines that reduce the cholesterol your body makes by itself. Ezetimibe is used in addition to diet if you have: a raised cholesterol level in your blood (primary hypercholesterolaemia [heterozygous familial and non-familial]) This medicine can be taken - together with a statin, when your cholesterol level is not well controlled with a stati Leggi il documento completo
Page 1 of 14 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: 68 mg lactose monohydrate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet White to almost white, oval tablets (7.4 mm x 4.1 mm) with debossing “10” on one side and “EZT” 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 non-familial) 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. Page 2 of 14 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 is one Ezetimibe 10 mg tablet daily. Ezetimibe can be administered at any time of Leggi il documento completo