País: Irlanda
Idioma: inglés
Fuente: HPRA (Health Products Regulatory Authority)
ATORVASTATIN CALCIUM TRIHYDRATE
Ranbaxy Ireland Limited
C10AA05
ATORVASTATIN CALCIUM TRIHYDRATE
20 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
HMG CoA reductase inhibitors
Transfer Pending
2012-09-07
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT ATORVASTATIN 10 MG FILM-COATED TABLETS ATORVASTATIN 20 MG FILM-COATED TABLETS ATORVASTATIN 40 MG FILM-COATED TABLETS ATORVASTATIN 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 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 is and what it is used for 2. What you need to know before you take Atorvastatin 3. How to take Atorvastatin 4. Possible side effects 5. How to store Atorvastatin 6. Contents of the pack and other information. 1. WHAT ATORVASTATIN IS AND WHAT IT IS USED FOR Atorvastatin belongs to a group of medicines known as statins, which are lipid (fat) regulating medicines. Atorvastatin 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 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 DO NOT TAKE ATORVASTATIN: • if you are allergic to atorvastatin or to any similar medicines used to lower blood lipids Leer el documento completo
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atorvastatin 20mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20mg of atorvastatin as atorvastatin calcium trihydrate. Excipient with known effect: Contains 76.7 mg lactose monohydrate, 5.6 mg sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. White to off white, film-coated oval tablets about 6.6 mm wide and about 12.1 mm long, embossed with ‘A31’ on one side and plain on 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 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 patient should be placed on a standard cholesterol-lowering diet before receiving atorvastatin and should continue on this diet during treatment with atorvastatin. The dose should be Leer el documento completo