Quốc gia: Malta
Ngôn ngữ: Tiếng Anh
Nguồn: Medicines Authority
ATORVASTATIN
Viatris Hellas Ltd 253-255, Mesogion Avenue, 154 51 Neo Psychiko, Athens,, Greece
C10AA05
ATORVASTATIN 10 mg
FILM-COATED TABLET
ATORVASTATIN 10 mg
POM
LIPID MODIFYING AGENTS
Authorised
2005-10-05
Page 1 of 8 PACKAGE LEAFLET PACKAGE LEAFLET: INFORMATION FOR THE USER LIPITOR 10 MG FILM-COATED TABLETS LIPITOR 20 MG FILM-COATED TABLETS LIPITOR 40 MG FILM-COATED TABLETS LIPITOR 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 Lipitor is and what it is used for 2. What you need to know before you take Lipitor 3. How to take Lipitor 4. Possible side effects 5. How to store Lipitor 6. Contents of the pack and other information 1. WHAT LIPITOR IS AND WHAT IT IS USED FOR Lipitor belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines. Lipitor 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, Lipitor 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 LIPITOR DO NOT TAKE LIPITOR − 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 children and not using reliable contraception − if you are pregnant or trying to become pregnant Page 2 of 8 − if you are breast-feeding − if you use th Đọc toàn bộ tài liệu
Page 1 of 25 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Lipitor 10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg atorvastatin (as atorvastatin calcium trihydrate). Excipient(s) with known effect Each Lipitor 10 mg film-coated tablet contains 27.25 mg lactose monohydrate and 0.00004 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. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypercholesterolaemia Lipitor 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. Lipitor 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 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. Page 2 of 25 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The patient should be placed on a standard cholesterol-lowering diet before receiving Lipitor and should continue on this diet during treatment with Lipitor. The dose should be individualised according to baseline LDL-C levels, the goal of therapy, and patient response. The usual starting dose is 10 mg once a day. Adjustment of dose should be made at intervals of 4 weeks or more. The maximum do Đọc toàn bộ tài liệu