Kraj: Irlandia
Język: angielski
Źródło: HPRA (Health Products Regulatory Authority)
ATORVASTATIN CALCIUM
IPS Healthcare Limited
10 Milligram
Film Coated Tablet
2010-10-08
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Lipitor 10 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10 mg atorvastatin as atorvastatin calcium trihydrate. Excipient: includes lactose monohydrate. _For a full list of excipients, see section 6.1_ 3 PHARMACEUTICAL FORM Film-coated tablets _Product imported from the United Kingdom:_ White, elliptical tablets debossed ‘10’ on one side and ‘PD 155’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hypercholesterolaemia Lipitor is indicated as an adjunct to diet for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides in adults 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 (eg. LDL apheresis) or if such treatments are unavailable. Lipitor also raises HDL-cholesterol and lowers the LDL/HDL and total cholesterol/HDL ratios. 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 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 usual starting dose is 10 mg once a day. Doses should be individualised according to baseline Przeczytaj cały dokument