Țară: Malta
Limbă: engleză
Sursă: Medicines Authority
Viatris Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
C10AA05
ATORVASTATIN 10 mg
FILM-COATED TABLET
ATORVASTATIN 10 mg
POM
LIPID MODIFYING AGENTS
Authorised
2012-08-03
1 PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER ATORVASTATIN VIATRIS 10 MG FILM-COATED TABLETS ATORVASTATIN VIATRIS 20 MG FILM-COATED TABLETS ATORVASTATIN VIATRIS 40 MG FILM-COATED TABLETS ATORVASTATIN VIATRIS 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 Viatris is and what it is used for 2. What you need to know before you take Atorvastatin Viatris 3. How to take Atorvastatin Viatris 4. Possible side effects 5. How to store Atorvastatin Viatris 6. Contents of the pack and other information 1. WHAT ATORVASTATIN VIATRIS IS AND WHAT IT IS USED FOR Atorvastatin Viatris belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines. Atorvastatin Viatris 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 Viatris 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 VIATRIS DO NOT TAKE ATORVASTATIN VIATRIS − 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 Citiți documentul complet
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Atorvastatin Viatris 10 mg film-coated tablets Atorvastatin Viatris 20 mg film-coated tablets Atorvastatin Viatris 40 mg film-coated tablets Atorvastatin Viatris 80 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg atorvastatin (as atorvastatin calcium trihydrate). Each film-coated tablet contains 20 mg atorvastatin (as atorvastatin calcium trihydrate). Each film-coated tablet contains 40 mg atorvastatin (as atorvastatin calcium trihydrate). Each film-coated tablet contains 80 mg atorvastatin (as atorvastatin calcium trihydrate). Excipient(s) with known effect Each Atorvastatin Viatris 10 mg film-coated tablet contains 27.25 mg lactose monohydrate and 0.00004 mg benzoic acid. Each Atorvastatin Viatris 20 mg film-coated tablet contains 54.50 mg lactose monohydrate and 0.00008 mg benzoic acid. Each Atorvastatin Viatris 40 mg film-coated tablet contains 109.00 mg lactose monohydrate and 0.00016 mg benzoic acid. Each Atorvastatin Viatris 80 mg film-coated tablet contains 218.00 mg lactose monohydrate and 0.00032 mg benzoic acid. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White round, 5.6 mm, film-coated tablets debossed "10" on one side and "ATV" on the other. White round, 7.1 mm, film-coated tablets debossed "20" on one side and "ATV" on the other. White round, 9.5 mm, film-coated tablets debossed "40" on one side and "ATV" on the other. White round, 11.9 mm, film-coated tablets debossed "80" on one side and "ATV" on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypercholesterolaemia Atorvastatin Viatris 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) Citiți documentul complet