Krajina: Írsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Atorvastatin
Clonmel Healthcare Ltd
C10AA; C10AA05
Atorvastatin
40 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
HMG CoA reductase inhibitors; atorvastatin
Marketed
2016-03-11
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER ATORVASTATIN CLONMEL 10 MG FILM-COATED TABLETS ATORVASTATIN CLONMEL 20 MG FILM-COATED TABLETS ATORVASTATIN CLONMEL 40 MG FILM-COATED TABLETS ATORVASTATIN CLONMEL 80 MG FILM-COATED TABLETS 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Atorvastatin Clonmel is and what it is used for 2. What you need to know before you take Atorvastatin Clonmel 3. How to take Atorvastatin Clonmel 4. Possible side effects 5. How to store Atorvastatin Clonmel 6. Contents of the pack and other information 1. WHAT ATORVASTATIN CLONMEL IS AND WHAT IT IS USED FOR Atorvastatin Clonmel belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines. Atorvastatin Clonmel is used to lower lipids known as cholesterol and triglycerides in the blood when a low fat diet and life style changes on their own have failed. If you are at an increased risk of heart disease, Atorvastatin Clonmel can also be used to reduce such risk even if your cholesterol levels are normal. You should maintain a standard cholesterol lowering diet during treatment. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE ATORVASTATIN CLONMEL DO NOT TAKE ATORVASTATIN CLONMEL • if you are allergic to atorvastatin or any of the other ingredients of this medicine (listed in section 6) • if you have or have ever had a disease which affects the liver • if you have had any unexplained abnormal blood tests for liver function • if you are a woman able to have c Prečítajte si celý dokument
Health Products Regulatory Authority 24 November 2023 CRN00DV3G Page 1 of 18 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atorvastatin Clonmel 40 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg of atorvastatin (as atorvastatin calcium trihydrate). Excipients with known effect Each film-coated tablet contains 39 mg lactose monohydrate. Each film-coated tablet contains 20 mg of atorvastatin (as atorvastatin calcium trihydrate). Excipients with known effect Each film-coated tablet contains 78 mg lactose monohydrate. Each film-coated tablet contains 40 mg of atorvastatin (as atorvastatin calcium trihydrate). Excipients with known effect Each film-coated tablet contains 156 mg lactose monohydrate. Each film-coated tablet contains 80 mg of atorvastatin (as atorvastatin calcium trihydrate). Excipients with known effect Each film-coated tablet contains 312 mg lactose monohydrate. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White to off-white, round, biconvex film-coated tablets, diameter: 10 mm. The _SCORE LINE_ is _NOT INTENDED_ for breaking the tablet. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypercholesterolaemia Atorvastatin Clonmel is indicated as an adjunct to diet for reduction of elevated total cholesterol (total-C), LDL-cholesterol (LDL-C), apolipoprotein B, and triglycerides in adults, adolescents and children aged 10 years or older with primary hypercholesterolaemia including familial hypercholesterolaemia (heterozygous variant) or combined (mixed) hyperlipidaemia (Corresponding to Types Ila and Ilb of the Fredrickson classification) when response to diet and other non-pharmacological measures is inadequate. Atorvastatin Clonmel is also indicated to reduce total-C and LDL-C in adults with homozygous familial hypercholesterolaemia as an adjunct to other lipid-lowering treatments (e.g. LDL apheresis) or if such treatments are unavailable. Prevention of cardiovascular disease Pr Prečítajte si celý dokument