Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Lithium carbonate 400mg
Clinect NZ Pty Limited
Lithium carbonate 400 mg
400 mg
Modified release tablet
Active: Lithium carbonate 400mg Excipient: Acacia Glyceryl palmito-stearate Magnesium stearate Maize starch Mannitol Sodium laurilsulfate Sodium starch glycolate
Blister pack, 100 tablets
Prescription
Prescription
Chemetall GmbH
Package - Contents - Shelf Life: Blister pack, - 100 tablets - 36 months from date of manufacture stored at or below 25°C
1969-12-31
CONSUMER MEDICINE INFORMATION PRIADEL ® 400 MG PROLONGED RELEASE TABLETS LITHIUM CARBONATE WHAT IS IN THIS LEAFLET This leaflet answers some common questions about PRIADEL. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking PRIADEL against the benefits he/she expects it will have for you. If you have any concerns about taking this medicine, ask your doctor or pharmacist. Keep this leaflet with the medicine. You may need to read it again. WHAT PRIADEL IS USED FOR PRIADEL is used for the treatment of mania and hypomania, recurrent bipolar depression, and prophylactic treatment of recurrent affective disorders. Lithium carbonate provides a source of lithium, which competes with sodium at various sites in the body. BEFORE YOU TAKE PRIADEL Do not take PRIADEL if: • you have an allergy to PRIADEL or any of the ingredients listed at the end of this leaflet • you have problems passing urine or have an impairment of kidney function • you have an impairment of heart function • you are on a low sodium diet or have a condition associated with low sodium levels, such as Addison’s disease • You are breastfeeding. Tell your doctor if: • you have any other medical conditions • you are taking lithium in any other form • you are pregnant, or intend to become pregnant or to breastfeed. Lithium may be harmful to the foetus and newborn baby, so PRIADEL should not be used during pregnancy unless considered essential. Lithium is secreted into breast milk, so PRIADEL should not be used during breastfeeding. Your doctor might arrange for blood tests and other health checks to be carried out prior to and during treatment with PRIADEL. Treatment with PRIADEL tablets requires regular monitoring of serum lithium levels. Your doctor will arrange for the necessary blood tests to be carried out. Frequent blood tests are required at the start of treatment. The period between Read the complete document
NEW ZEALAND DATA SHEET 1. PRIADEL PROLONGED RELEASE TABLETS 400 MG Priadel prolonged release tablets 400 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 400 mg lithium carbonate. For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Prolonged release tablets. White circular, bi-convex tablets engraved PRIADEL on one side, scored on the other side. Each tablet contains 400 mg Lithium Carbonate Ph Eur in a controlled release dosage form. PRIADEL tablets are scored; therefore they can be divided accurately to provide dosage adjustments of 200 mg. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. Treatment of mania and hypomania. 2. Lithium may also be tried in the treatment of some patients with recurrent bipolar depression, for which treatment with other antidepressants has been unsuccessful. 3. Prophylactic treatment of recurrent affective disorders. 4.2 DOSAGE AND METHOD OF ADMINISTRATION _DOSE _ 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 (70 kg) an initial dose of 1-3 tablets (400-1,200 mg) 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. PRIADEL tablets should be taken with food, as this causes less nausea than on an empty stomach. The tablets should not be crushed, chewed or swallowed with hot liquids. When changing from other lithium preparations, serum lithium levels should first be checked, then PRIADEL therapy commenced 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 five day Read the complete document