Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Lithium carbonate
Sanofi-Aventis Ireland Limited T/A SANOFI
N05AN; N05AN01
Lithium carbonate
400 milligram(s)
Prolonged-release tablet
Product subject to prescription which may not be renewed (A)
Lithium; lithium
Marketed
1978-04-01
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Priadel 400mg Prolonged-release Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 400 mg lithium carbonate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Prolonged-release tablet White, circular, bi-convex tablets engraved PRIADEL on one side and a scoreline on the other. The tablets can be divided into equal halves. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. In the management of acute manic or hypomanic episodes. 2. In the management of episodes of recurrent depressive disorders where treatment with other antidepressants has been unsuccessful. 3. In the prophylaxis against bipolar affective disorders. 4. Control of aggressive behaviour or intentional self harm. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosage must be individualized depending on serum lithium levels and clinical response. The dosage necessary to maintain serum lithium levels within the therapeutic range varies from patient to patient. The minimum effective dose should be sought and maintained. A simple treatment schedule has been evolved which except for some minor variations should be followed whether using Priadel therapeutically or prophylactically. The minor variations to this schedule depend on the elements of the illness being treated and these are described later. 1. In patients of average weight (70kg) an initial dose of 400-1,200mg of Priadel may be given as a single daily dose in the morning or on retiring. Alternatively, the dose may be divided and given morning and evening. The tablets should not be crushed or chewed. When changing for other lithium preparations serum lithium levels should first be checked, then Priadel therapy started at a daily dose as close as possible to the dose of the other form of lithium. As bioavailability varies from product to product (particularly with regard to retard or slow release preparations) a change of product should be regarded as initiation of new treatment. 2. Four to a max Read the complete document