Maa: Irlanti
Kieli: englanti
Lähde: HPRA (Health Products Regulatory Authority)
PRAVASTATIN SODIUM
WPR Healthcare Limited
PRAVASTATIN SODIUM
20 Milligram
Tablets
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pravastatin Sodium 20 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains Pravastatin sodium 20mg. Excipient: Also contain lactose anhydrous. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet _Product imported from the Netherlands:_ Yellow, round, biconvex tablets with '93' on one side and ‘7201’ on the other side 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 immunosuppressive 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 Tablets, 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 is administered orally once daily preferably in the evening with or without food. _Hypercholesterolaemia_ The recommended dose range is 10-40 mg once daily. The Lue koko asiakirja