Country: Malta
Language: English
Source: Medicines Authority
CALCIUM PANTOTHENATE, ASCORBIC ACID, COLECALCIFEROL, DL, ALFA, TOCOPHERYL ACETATE, NICOTINAMIDE, THIAMINE MONONITRATE, PYRIDOXINE HYDROCHLORIDE, RETINOL PALMITATE, RIBOFLAVIN
Wallace Manufacturing Chemists Limited 51-53 Stert Street, Abingdon, OX14 3JF, United Kingdom
A11BA
CALCIUM PANTOTHENATE 5 mg ASCORBIC ACID 40 mg COLECALCIFEROL 500 IU DL-ALFA-TOCOPHERYL ACETATE 2 IU NICOTINAMIDE 20 mg THIAMINE MONONITRATE 2.5 mg PYRIDOXINE HYDROCHLORIDE 1 mg RETINOL PALMITATE 5000 IU RIBOFLAVIN 2.5 mg
SOFT CAPSULE
CALCIUM PANTOTHENATE 5 mg ASCORBIC ACID 40 mg COLECALCIFEROL 500 IU DL-ALFA-TOCOPHERYL ACETATE 2 IU NICOTINAMIDE 20 mg THIAMINE MONONITRATE 2.5 mg PYRIDOXINE HYDROCHLORIDE 1 mg RETINOL PALMITATE 5000 IU RIBOFLAVIN 2.5 mg
OTC
VITAMINS
Withdrawn
2006-04-13
Concavit Capsules Each Capsule contains: - Vitamin A BP 5000.00 iu Calciferol BP 500.00 iu Ascorbic Acid BP 40.00 mg Thiamine Mononitrate BP 2.50 mg Riboflavine BP 2.50 mg Pyridoxine Hydrochloride BP 1.00 mg Nicotinamide BP 20.00 mg Calcium Pantothenate BP 5.00 mg dl- α -Tocopheryl Acetate BP 2.00 iu In addition the capsules also contain: Soya Bean Oil, Fat mixture, Soya Lecithin, Gelatin, Glycerin, Sorbitol, Hydroxybenzoates (Ethyl and Propyl), Ponceau 4R (E124) and water. Concavit capsules are available in packs of 25 and 100. Concavit is an oral vitamin supplement. The product licence holder is Wallace Manufacturing Chemists Ltd., 52 Queen Anne Street, London W1M 9LA, England and the capsules are manufactured by Cardinal Health, Frankland Road, Blagrove Estate, Swindon, Wiltshire SN5 8YS, England. Concavit is intended as a multiple vitamin supplement in situations of special dietary need. It is not intended for the correction of specific vitamin deficiencies. BEFORE YOU USE CONCAVIT Do not use Concavit to treat vitamin deficiencies caused by inability to absorb the vitamin(s) orally. Do not use Concavit if: • You are hypersensitive to any of the ingredients • You have a history of high levels of Vitamins A or D • You have bone tumours • You have elevated blood calcium levels. • You have abnormal metabolic sensitivity to vitamin D Do not take Vitamin A supplements if you are pregnant or likely to become pregnant except on the advice of your doctor or antenatal clinic. PRECAUTIONS FOR THE USE OF CONCAVIT Do not exceed the stated dose. INTERACTIONS WITH OTHER MEDICINE Concavit may react with other medicines you are taking. Concavit contains a range of Vitamins and each can affect and in turn be affected by other medicines you are ta Read the complete document
Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1. TRADE NAME OF THE MEDICINAL PRODUCT Concavit Capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ _Each Capsule contains: - _ Vitamin A BP 5000.00 iu Calciferol BP 500.00 iu Ascorbic Acid BP 40.00 mg Thiamine Mononitrate BP 2.50 mg Riboflavine BP 2.50 mg Pyridoxine Hydrochloride BP 1.00 mg Nicotinamide BP 20.00 mg Calcium Pantothenate BP 5.00 mg dl- -Tocopheryl Acetate BP 2.00 iu 3. PHARMACEUTICAL FORM Soft Gelatine Capsules CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS As a supplement of multiple vitamins in situations of special dietary need. Not suitable for the correction of specific vitamin deficiencies. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Adults, The Elderly and Children - 1 capsule daily 4.3. CONTRA-INDICATIONS • Oral administration in the treatment of deficiency state in malabsorption syndromes. • Hypersensitivity to any of the ingredients. • History of hypervitaminoses A or D. • Sarcoidosis • Hypercalcaemia • Abnormal metabolic sensitivity to Vitamin D. • Do not take Vitamin A supplements if you are pregnant or likely to become pregnant except on the advice of a doctor or antenatal clinic. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE There are serious risks of developing hypercalcaemia when calcium salts or thiazides are co- administered. Serum calcium, phosphate, alkaline phosphatase, liver function tests and magnesium should be monitored when indicated. Page 2 of 4 Absorption of Vitamin A is reduced in cystic fibrosis, hepatic diseases, pancreatic dysfunction and in patients with intestinal infections. The use of Vitamin A in renal diseases requires extreme caution. 4.5. INTERACTIONS WITH OTHER MEDICAMENTS AND Read the complete document