Země: Malta
Jazyk: angličtina
Zdroj: Medicines Authority
ATORVASTATIN CALCIUM, TRIHYDRATE
Basics GmbH Hemmelrather Weg 201 51377 Leverkusen, Germany
C10AA05
ATORVASTATIN CALCIUM TRIHYDRATE 60 mg
FILM-COATED TABLET
ATORVASTATIN CALCIUM TRIHYDRATE 60 mg
POM
LIPID MODIFYING AGENTS
Withdrawn
2015-03-18
Page 1 of 8 PACKAGE LEAFLET: INFORMATION FOR THE USER ATORVASTATIN BASICS 30 MG FILM-COATED TABLETS ATORVASTATIN BASICS 60 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 Basics is and what it is used for 2. What you need to know before you take Atorvastatin Basics 3. How to take Atorvastatin Basics 4. Possible side effects 5. How to store Atorvastatin Basics 6. Contents of the pack and other information. 1. WHAT ATORVASTATIN BASICS IS AND WHAT IT IS USED FOR Atorvastatin Basics belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines. Atorvastatin Basics 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 Basics 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 BASICS DO NOT TAKE ATORVASTATIN BASICS: • if you are allergic to atorvastatin or to any similar medicines used to lower blood lipids 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 Přečtěte si celý dokument
Page 1 of 24 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Atorvastatin Basics 60 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 60mg atorvastatin (as atorvastatin calcium trihydrate). Excipient: Each tablet contains 196.83 mg lactose monohydrate For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. White to off white, elliptical tablets debossed ‘AS 60’ on one side and plain on the other side 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypercholesterolaemia Atorvastatin 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 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 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 patient should be placed on a standard cholesterol-lowering diet before receiving Atorvastatin and should continue on this diet during treatment with Atorvastatin. Page 2 of 24 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 dose is 80 mg once a day. _Primary hypercholesterolaemia Přečtěte si celý dokument