Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
ATORVASTATIN
Teva Pharma B.V.
40 Milligram
Film Coated Tablet
2010-08-27
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Atorvastatin 40 mg Film -coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film -coated tablet contains 40 mg of atorvastatin (as atorvastatin calcium). _Excipients_ Each 40 mg film -coated tablet contains 243.36 mg of lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film -coated tablet. White to off -white, capsule-shaped, film-coated tablet, debossed with "93" on one side and "7312" on the other side of the tablet. 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 and 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 non -pharmacological 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. The dose should be individualised acco Läs hela dokumentet