দেশ: আয়ার্লণ্ড
ভাষা: ইংরেজি
সূত্র: HPRA (Health Products Regulatory Authority)
Ezetimibe; Atorvastatin calcium trihydrate
Zentiva k.s.
C10BA05
Ezetimibe; Atorvastatin calcium trihydrate
Film-coated tablet
atorvastatin and ezetimibe
Not marketed
2024-02-23
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ATORVASTATIN/EZETIMIBE 10 MG/10 MG FILM-COATED TABLETS ATORVASTATIN/EZETIMIBE 10 MG/20 MG FILM-COATED TABLETS ATORVASTATIN/EZETIMIBE 10 MG/40 MG FILM-COATED TABLETS ATORVASTATIN/EZETIMIBE 10 MG/80 MG FILM-COATED TABLETS atorvastatin/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. See section 4. WHAT IS IN THIS LEAFLET 1. What Atorvastatin/Ezetimibe is and what it is used for 2. What you need to know before you take Atorvastatin/Ezetimibe 3. How to take Atorvastatin/Ezetimibe 4. Possible side effects 5. How to store Atorvastatin/Ezetimibe 6. Contents of the pack and other information 1. WHAT ATORVASTATIN/EZETIMIBE IS AND WHAT IT IS USED FOR Atorvastatin/Ezetimibe is a medicine to lower increased levels of cholesterol. Atorvastatin/Ezetimibe contains ezetimibe and atorvastatin. Atorvastatin/Ezetimibe is used in adults to lower levels of total cholesterol, “bad” cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. In addition, Atorvastatin/Ezetimibe raises levels of “good” cholesterol (HDL cholesterol). Atorvastatin/Ezetimibe 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 plaq সম্পূর্ণ নথি পড়ুন
Health Products Regulatory Authority 11 March 2024 CRN00D5D5 Page 1 of 22 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atorvastatin/Ezetimibe 10 mg/40 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg ezetimibe and 40 mg atorvastatin (as atorvastatin calcium trihydrate). Excipient(s) with known effect: Each 10 mg/40 mg film-coated tablet contains 234.71 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White to off white, capsule shaped with the dimensions of approximately 16 mm x 6 mm, biconvex, film-coated tablets with one side debossed "4T" and plain on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Prevention of Cardiovascular Events_ Atorvastatin/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), either previously treated with a statin or not. _Hypercholesterolaemia_ Atorvastatin/Ezetimibe 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)_ Atorvastatin/Ezetimibe 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 ezetimibe/atorvastatin. The dose range of ezetimibe/atorvastatin is 10/10 mg/day through 10/80 mg/day. The typical dose is 10/10 সম্পূর্ণ নথি পড়ুন