Negara: Inggris
Bahasa: Inggris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nicotinamide; Pyridoxine hydrochloride; Riboflavin; Thiamine hydrochloride
NorthStar Healthcare Unlimited Company
Nicotinamide; Pyridoxine hydrochloride; Riboflavin; Thiamine hydrochloride
20mg ; 2mg ; 2mg ; 5mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 09060207; GTIN: 5051089990299
PKD22001 Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Vitamin B Compound Strong Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 20mg Nicotinamide, 2mg Pyridoxine Hydrochloride, 2mg Riboflavine and 4.85mg Thiamine Mononitrate. Excipient with known effect: lactose. For the full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Film-coated tablet (Tablets) Brown coloured, circular, film coated tablets with debossed ‘BP’ on one side and ‘2’ on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of clinical and sub-clinical vitamin B deficiency states (manifestations of which include glossitis, stomatitis, cheilosis, the heart manifestations of beriberi, the skin manifestations of pellagra, corneal vascularisation and polyneuritis). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology Adults (including elderly) and children over 3 years: One to two tablets three times daily. _Paediatric population_ Should not be used in children under 3 years. Method of administration For oral administration. 4.3 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 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 Pyridoxine may increase the peripheral metabolism of levodopa, reducing therapeutic efficacy of the latter drug. Therefore, patients with Parkinson's disease who are receiving treatment with plain levodopa should not take vitamin B 6 in doses which greatly exceed the daily requirement. This does not apply when levodopa is combined with a peripheral decarboxylase inhibitor. 4.6 FERTILITY, PREGNANCY AND LACTATION PREGNANCY: There is limited amount of data from the use of the product in pregnant women. Animal studies are insufficient with respect to repro Baca dokumen lengkapnya