Riik: Iirimaa
keel: inglise
Allikas: HPRA (Health Products Regulatory Authority)
PRAVASTATIN SODIUM
Ranbaxy (UK) Limited
PRAVASTATIN SODIUM
40 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Withdrawn
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT BellPrav 40 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 40 mg Pravastatin Sodium. Also includes lactose. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Dark yellow to yellow coloured mottled, circular, biconvex tablets debossed with “P3” on one side and a breakline on the other side. The tablet can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS HYPERCHOLESTEROLEMIA Treatment of primary hypercholesterolemia or mixed dyslipidaemia, as an adjunct to diet, when response to diet and other non-pharmacological treatments (e.g. exercise, weight reduction) is inadequate. PRIMARY PREVENTION Reduction of cardiovascular mortality and morbidity in patients with moderate or severe hypercholesterolemia and at high risk of a first cardiovascular event, as an adjunct to diet (see section 5.1). SECONDARY PREVENTION Reduction of cardiovascular mortality and morbidity in patients with a history of myocardial infarction or unstable angina pectoris and with either normal or increased cholesterol levels, as an adjunct to correction of other risk factors (see section 5.1). POST TRANSPLANTATION Reduction of post transplantation hyperlipidaemia in patients receiving immunosupressive therapy following solid organ transplantation (see sections 4.2, 4.5 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Prior to initiating Pravastatin Tablets1, secondary causes of hypercholesterolaemia should be excluded and patients should be placed on a standard lipid-lowering diet which should be continued during treatment. Pravastatin Tablets1 is administered orally once daily preferably in the evening with or without food. HYPERCHOLESTEROLEMIA The recommended dose range is Lugege kogu dokumenti