País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
PITAVASTATIN CALCIUM
Kowa Pharmaceutical Europe Co. Ltd
PITAVASTATIN CALCIUM
2 Base Milligrams
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Withdrawn
2013-02-04
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alipza 2mg film-coated tablets. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains pitavastatin calcium equivalent to 2mg pitavastatin. Excipient(s) include 126.17mg Lactose monohydrate. For a full list of excipients see Section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Round white film-coated tablets embossed ‘KC’ on one face and ‘2’on the reverse. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Alipza is indicated for the reduction of elevated total cholesterol (TC) and LDL-C, in adult patients with primary hypercholesterolaemia, including heterozygous familial hypercholesterolaemia, and combined (mixed) dyslipidaemia, when response to diet and other non-pharmacological measures is inadequate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral use only and should be swallowed whole. Alipza can be taken at any time of the day with or without food. It is desirable that the patient takes the tablet at the same time each day. Statin therapy is generally more effective in the evening due to the circadian rhythm of lipid metabolism. Patients should be on a cholesterol lowering diet before treatment. It is important that patients continue dietary control during treatment. Adults: The usual starting dose is 1mg once daily. Adjustment of dose should be made at intervals of 4 weeks or more. Doses should be individualized according to LDL-C Levels, the goal of therapy and patient response. Most Patients will require a 2mg dose (see Section 5.1). The Maximum daily dose is 4mg. Elderly: No dosage adjustment is required (see Sections 5.1 and 5.2). Paediatric use: Pitavastatin should not be used in children aged below 18 years because safety and efficacy has not been established. No data Leia o documento completo