Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ROSUVASTATIN
PCO Manufacturing
40mg Milligram
Coated Tablets
2005-06-07
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Crestor 40mg Film-coated Tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 40mg of Rosuvastatin (as rosuvastatin calcium). Excipients: Lactose monohydrate For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet _Product imported from Italy and the UK:_ Pink coloured, oval shaped film-coated tablet with ‘ZD4522’ engraved on one side and ‘40’ on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Primary hypercholesterolaemia (type IIa including heterozygous familial hypercholesterolaemia) or mixed dyslipidaemia (type IIb) as an adjunct to diet when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate. Homozygous familial hypercholesterolaemia as an adjunct to diet and other lipid lowering treatments (e.g. LDL apheresis) or if such treatments are not appropriate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Before treatment initiation the patient should be placed on a standard cholesterol-lowering diet that should continue during treatment. The dose should be individualised according to the goal of therapy and patient response, using current consensus guidelines. The recommended start dose is 5mg or 10 mg orally once daily in both statin naïve or patients switched from another HMG CoA reductase inhibitor. The choice of start dose should take into account the individual patient’s cholesterol level and future cardiovascular risk as well as the potential risk for adverse reactions (see below). A dose adjustment to the next level can be made after 4 weeks, if necessary _(see Section 5.1 Pharmacodynamic_ _properties). In _light of the increased reporting rate of adverse reactions with the 40 Read the complete document