Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nicotinamide; Riboflavin; Thiamine hydrochloride
Sigma Pharmaceuticals Plc
Nicotinamide; Riboflavin; Thiamine hydrochloride
15mg ; 1mg ; 1mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 09060207
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vitamin B Compound Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Nicotinamide 15.0 mg Thiamine Hydrochloride 1.0 mg Riboflavin 1.0 mg. Excipient with known effect: Each tablet contains lactose 122.0 mg For the full list of excipients see section 6.1 3 PHARMACEUTICAL FORM Tablet. Plain yellow, uncoated round tablet 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prophylaxis of Vitamin B deficiencies; as a nutritional supplement in the elderly; and as an aid to convalescence after illness or surgery. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oral administration. Adults, the elderly and children over 12 years: One to three tablets daily. Not recommended for children under 12 years of age. 4.3 CONTRAINDICATIONS Known hypersensitivity to any of the ingredients present. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE These tablets are not suitable for the treatment of symptomatic Vitamin B complex deficiencies. Patients with rare hereditary problems of galactose intolerance, the LAPP lactase deficiency or glucose-galactose malabsorption should not take this medicine. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None known. 4.6 FERTILITY, PREGNANCY AND LACTATION Widespread use over the years has not shown any problems when used during pregnancy and breastfeeding. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES No or negligible influence. 4.8 UNDESIRABLE EFFECTS None known. REPORTING OF SUSPECTED ADVERSE REACTIONS: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. 4.9 OVERDOSE If large amounts are ingested accidentally, treat symptomatically. 5 PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES A11E A – Vitamin B-Complex, Plain Thiami Lees het volledige document