Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
EZETIMIBE, MICRONIZED, ATORVASTATIN CALCIUM TRIHYDRATE
Merck Sharp and Dohme Limited
C10BA05
EZETIMIBE, MICRONIZED, ATORVASTATIN CALCIUM TRIHYDRATE
10 / 20 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
HMG CoA reductase inhibitors in combination with other lipid modifying agents
Transfer Pending
2014-11-07
PACKAGE LEAFLET: INFORMATION FOR THE USER ATOZET® 10 MG/10 MG FILM-COATED TABLETS ATOZET® 10 MG/20 MG FILM-COATED TABLETS ATOZET® 10 MG/40 MG FILM-COATED TABLETS ATOZET® 10 MG/80 MG FILM-COATED TABLETS EZETIMIBE AND ATORVASTATIN 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 ATOZET is and what it is used for 2. What you need to know before you take ATOZET 3. How to take ATOZET 4. Possible side effects 5. How to store ATOZET 6. Contents of the pack and other information 1. WHAT ATOZET IS AND WHAT IT IS USED FOR ATOZET is a medicine to lower increased levels of cholesterol. ATOZET contains ezetimibe and atorvastatin. ATOZET is used in adults to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, ATOZET raises levels of “good” cholesterol (HDL cholesterol). ATOZET works to reduce your cholesterol in two ways. It reduces the cholesterol absorbed in your digestive tract, as well as 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-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 Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atozet 10mg/20mg Film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg ezetimibe and 20 mg of atorvastatin (as atorvastatin calcium trihydrate). Excipient(s) with known effect: Each 10 mg/20 mg film-coated tablet contains 179 mg of lactose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Capsule-shaped, biconvex, white to off-white, film-coated tablets, size 14.48 mm x 5.79 mm, “333” debossed on one side 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Prevention of Cardiovascular Events_ ATOZET 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_ ATOZET is indicated as adjunctive therapy to diet for use in adults 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)_ ATOZET is indicated as adjunctive therapy to diet for use in adults with HoFH. Patients may also receive adjunctive treatments (e.g., low-density lipoprotein [LDL] apheresis). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _Hypercholesterolaemia and/or Coronary Heart Disease (with ACS History)_ The patient should be on an appropriate lipid lowering diet and should continue on this diet during treatment with ATOZET. The dose range of ATOZET is 10/10 mg/day through 10/80 mg/day. The typical dose is 10/10 mg once a day. The patient’s low-density lipoprotein cholesterol (LDL - C) level, coronary heart disease risk status, and response to current cholesterol-lowering therapy should be considered when starting therapy or adjusting the dose. The dose of ATOZET should Citiți documentul complet