Country: Malta
Bahasa: Inggeris
Sumber: Medicines Authority
ATORVASTATIN
Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland
C10AA05
ATORVASTATIN 20 mg
FILM-COATED TABLET
ATORVASTATIN 20 mg
POM
LIPID MODIFYING AGENTS
Withdrawn
2012-08-01
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ATORVASTATIN ACTAVIS 10 MG FILM-COATED TABLETS ATORVASTATIN ACTAVIS 20 MG FILM-COATED TABLETS ATORVASTATIN ACTAVIS 40 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 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 of the side effects, talk to your doctor or pharmacist. This includes any possibleside effects not listed in this leaflet. IN THIS LEAFLET: 1. What Atorvastatin Actavis is and what it is used for 2. What you need to know before you take Atorvastatin Actavis 3. How to take Atorvastatin Actavis 4. Possible side effects 5. How to store Atorvastatin Actavis 6. Contents of the pakc and other information 1. WHAT ATORVASTATIN ACTAVIS IS AND WHAT IT IS USED FOR Atorvastatin Actavis belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines. Atorvastatin Actavis 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 Actavis 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 ACTAVIS DO NOT TAKE ATORVAST Baca dokumen lengkap
Page 1 of 19 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Atorvastatin Actavis 10 mg film-coated tablets Atorvastatin Actavis 20 mg film-coated tablets Atorvastatin Actavis 40 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg, 20 mg or 40 mg of atorvastatin as atorvastatin calcium. Excipient: For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. 10 mg: White, oval, biconvex film-coated tablets marked with “10 on one side and A on the other”. 20 mg: White, oval, biconvex film-coated tablets marked with “20 on one side and A on the other”. 40 mg: White, oval, biconvex film-coated tablets marked with “40 on one side and A on the other”. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypercholesterolaemia Atorvastatin Actavisis 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 IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. Atorvastatin Actavisis 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 Prevention of cardiovascular events in adult patients estimated to have a high risk for a first cardiovascular event (see section 5.1), as an adjunct to correction of other risk factors. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The Baca dokumen lengkap