Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Ezetimibe; Simvastatin
McDermott Laboratories Ltd., T/A Gerard Laboratories
C10BA; C10BA02
Ezetimibe; Simvastatin
10mg/20 milligram(s)
Tablet
Oral use
Blister of 14, 28, 3, 98 and 100 tablets, perforated blister of 14 x 1, 28 x 1, 30 x 1 and 90 x 1 tablets.
Product subject to prescription which may be renewed (B)
McDermott Laboratories Ltd t/a Gerard Laboratories, Mylan Hungary, Generics
Reductase inhibitors in combination with other lipid modifying agents
HMG CoA reductase inhibitors in combination with other lipid modifying agents; simvastatin and ezetimibe
It is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familiar and non-familiar) hypercholesterolaemia or mixed hyperlipidaemia, and in patient with HoFH
Also available in bottle containing: 30, 100, 250 and 500 tablets
Not marketed
2015-05-22
41 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT EZETIMIBE/SIMVASTATIN 10 MG/20 MG TABLETS EZETIMIBE/SIMVASTATIN 10 MG/40 MG TABLETS EZETIMIBE/SIMVASTATIN 10 MG/80 MG TABLETS _ _ _ _ ezetimibe and simvastatin 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/Simvastatin is and what it is used for 2. What you need to know before you take Ezetimibe/Simvastatin 3. How to take Ezetimibe/Simvastatin 4. Possible side effects 5. How to store Ezetimibe/Simvastatin 6. Contents of the pack and other information 1. WHAT EZETIMIBE/SIMVASTATIN IS AND WHAT IT IS USED FOR Ezetimibe/Simvastatin contains two active substances ezetimibe and simvastatin. Ezetimibe/Simvastatin is a medicine used to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Ezetimibe/Simvastatin raises levels of “good” cholesterol (HDL cholesterol). Ezetimibe/Simvastatin works to reduce your cholesterol in two ways. The active ingredient ezetimibe reduces the cholesterol absorbed in your digestive tract. The active ingredient simvastatin, belonging to the class of “statins,” inhibits the production of 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- Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 21 August 2023 CRN00DL0Q Page 1 of 26 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ezetimibe/Simvastatin 10mg/20mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg of ezetimibe and 20 mg of simvastatin. Excipient with known effect Each 10 mg/20 mg tablet contains 147.71 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet. White to off-white, oval, biconvex tablet approximately 11 mm long and 6.5 mm in width, debossed with M on one side of the tablet and ES2 on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prevention of Cardiovascular Events Ezetimibe/Simvastatin 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), either previously treated with a statin or not. Hypercholesterolaemia Ezetimibe/Simvastatin is indicated as adjunctive therapy to diet for use in patients with primary (heterozygous familial and non-familial) hypercholesterolaemia or mixed hyperlipidaemia where use of a combination product is appropriate: • patients not appropriately controlled with a statin alone • patients already treated with a statin and ezetimibe Homozygous Familial Hypercholesterolaemia (HoFH) Ezetimibe/Simvastatin is indicated as adjunctive therapy to diet for use in patients with HoFH. Patients may also receive adjunctive treatments (e.g. low-density lipoprotein [LDL] apheresis). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Hypercholesterolaemia The patient should be on an appropriate lipid-lowering diet and should continue on this diet during treatment with Ezetimibe/Simvastatin. The dosage range of Ezetimibe/Simvastatin is 10 mg/10 mg/day through 10 mg/80 mg/day in the evening. All dosages may not be available in all member states. The typical dose is 10 mg/20 mg/day or 10 mg/40 mg/day given as a single dose in the evening. The 10 mg/80 mg dose i Olvassa el a teljes dokumentumot