Krajina: Malta
Jazyk: angličtina
Zdroj: Medicines Authority
ATORVASTATIN
TAD Pharma GmbH Heinz-Lohmann-Strasse 5, 27472 Cuxhaven, Germany
C10AA05
ATORVASTATIN 20 mg
FILM-COATED TABLET
ATORVASTATIN 20 mg
POM
LIPID MODIFYING AGENTS
Authorised
2012-03-14
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ATORVASTATIN TAD 10 MG FILM-COATED TABLETS ATORVASTATIN TAD 20 MG FILM-COATED TABLETS ATORVASTATIN TAD 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 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 TAD is and what it is used for 2. What you need to know before you take Atorvastatin TAD 3. How to take Atorvastatin TAD 4. Possible side effects 5. How to store Atorvastatin TAD 6. Contents of the pack and other information 1. WHAT ATORVASTATIN TAD IS AND WHAT IT IS USED FOR Atorvastatin TAD belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines. Atorvastatin TAD 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 TAD 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 TAD DO NOT TAKE ATORVASTATIN TAD - if you are allergic to atorvastatin or to any similar medicines used to lower blood lipids or to 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 children and not using reliable contraception - if you are p Prečítajte si celý dokument
Page 1 of 22 1. NAME OF THE MEDICINAL PRODUCT Atorvastatin TAD 10 mg film-coated tablets Atorvastatin TAD 20 mg film-coated tablets Atorvastatin TAD 40 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _Atorvastatin TAD 10 mg film-coated tablets _ Each film-coated tablet contains 10 mg atorvastatin as atorvastatin calcium. _Atorvastatin TAD 20 mg film-coated tablets _ Each film-coated tablet contains 20 mg atorvastatin as atorvastatin calcium. _Atorvastatin TAD 40 mg film-coated tablets _ Each film-coated tablet contains 40 mg atorvastatin as atorvastatin calcium. Excipient with known effect: 10 mg film- coated tablets 20 mg film- coated tablets 40 mg film- coated tablets Lactose monohydrate (mg/tablet) 56.9 113.8 227.6 For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet 10 mg tablets: White, round, slightly convex, bevel-edged, with diameter 6 mm. 20 mg tablets: White, round, slightly convex, bevel-edged, with diameter 8 mm. 40 mg tablets: White, round, slightly convex, bevel-edged, with diameter 10 mm. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypercholesterolaemia Atorvastatin TAD 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 IIa and IIb of the Fredrickson classification) when response to diet and other nonpharmacological measures is inadequate. Atorvastatin TAD 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 Page 2 of 22 Prevention of cardiovascular events in adult patients estimated to have a high risk for a first cardiovascula Prečítajte si celý dokument