País: Nova Zelândia
Língua: inglês
Origem: Medsafe (Medicines Safety Authority)
Lithium carbonate 250mg; ; Lithium carbonate 250mg
Viatris Limited
Lithium carbonate 250 mg
250 mg
Film coated tablet
Active: Lithium carbonate 250mg Excipient: Carnauba wax Clear film coat 5544 Lactose monohydrate Magnesium stearate Maize starch Povidone Sodium starch glycolate Active: Lithium carbonate 250mg Excipient: Carnauba wax Diethyl phthalate Ethanol Hypromellose E-15 Lactose monohydrate Magnesium stearate Maize starch Povidone Purified water Sodium starch glycolate
Bottle, plastic, HDPE, 500 tablets
Prescription
Prescription
FMC Corporation
Package - Contents - Shelf Life: Bottle, plastic, HDPE - 500 tablets - 36 months from date of manufacture stored at or below 25°C
1988-09-26
Page 1 of 4 NEW ZEALAND CONSUMER MEDICINE INFORMATION LITHICARB FC _LITHIUM CARBONATE TABLETS, FILM-COATED 250 MG AND 400MG _ _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about LITHICARB FC. It does not contain all the information available on this medicine. 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 using LITHICARB FC against the benefits expected it will have for you. If you have any concerns about using this medicine, ask your doctor or pharmacist. Keep this leaflet. You may want to read it again. WHAT LITHICARB FC IS USED FOR AND HOW IT WORKS Your LITHICARB FC tablets contain the active ingredient lithium carbonate. Lithium carbonate provides a source of lithium ions, which compete with sodium ions at various sites in the body. LITHICARB FC is used to treat patients with mental conditions (e.g. over-activity and mood changes) and recurring bipolar disorder. LITHICARB FC is also used in the prevention of mood problems. Your doctor may, however, prescribe LITHICARB FC for another reason. Ask your doctor if you have any questions about why LITHICARB FC has been prescribed for you. There is no evidence that LITHICARB FC is addictive. LITHICARB FC is available on prescription from your doctor. BEFORE YOU TAKE LITHICARB FC _WHEN YOU MUST NOT TAKE _ _IT _ DO NOT TAKE LITHICARB FC IF: • YOU ARE ALLERGIC TO LITHIUM CARBONATE OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET Symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing, swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin. • YOU HAVE A HEART OR KIDNEY PROBLEM • YOU HAVE LOW ACTIVITY OF THE ADRENAL GLAND (EG ADDISON’S DISEASE) • YOU HAVE AN UNDERACTIVE THYROID GLAND • IF YOU HAVE LOW LEVELS OF SODIUM IN YOUR BODY (EG IF YOU ARE DEHYDRATED OR ON A LOW SALT DIET) • IF YOU ARE PREGNANT OR BREASTFEEDING • IF YOU INTEND TO BECO Leia o documento completo
Page 1 of 10 NEW ZEALAND DATA SHEET LITHICARB FC 1. PRODUCT NAME LITHICARB FC 250 mg and 400 mg, film coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film coated tablet contains 250 mg or 400 mg of lithium carbonate. LITHICARB FC tablets contain lactose. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM LITHICARB 250 mg tablets are clear film coated, white biconvex tablets, 11.1 mm diameter, imprinted “LC” breakline over “250” on one side. LITHICARB 400 mg tablets are clear film coated, white biconvex tablets, 12.7 mm diameter, imprinted “LC” breakline over “400” on one side. LITHICARB FC tablets are scored, therefore they can be divided accurately to provide dosage adjustments as small as 125 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 _ _DOSE AND METHOD OF ADMINISTRATION _ DOSE A simple treatment schedule has been evolved which, except for some minor variations, should be followed whether using LITHICARB FC 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 400-1,200 mg of LITHICARB FC 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, chewed or swallowed with hot liquids. When changing from other lithium preparations serum lithium levels should first be checked, then LITHICARB FC therapy commenced at a daily dose as close as possible to the Page 2 of 10 dose of the other form of lithium. As bioavailability varies from product to product (particularly with regard to retard or slow release Leia o documento completo