sign in sign up
<<
Home , Pyridoxine

Prescribing Information/Insert

BERIN PLUS™ This product is indicated for treatment of B1, B6, and B12 NAME OF THE MEDICINAL PRODUCT deficiencies. It should not be used routinely as a nutritional supplement, or after the deficiencies are corrected. mononitrate (vitamin B1) / Pyridoxine hydrochloride Interactions () / (), 100 mg/ 200 mg/ 200 mcg, film-coated tablet Levodopa QUALITATIVE AND QUANTITATIVE COMPOSITION Product reduces the effects of levodopa but this does not occur if a dopa decarboxylase inhibitor is also given. Each film coated tablet contains the following active ingredients: • Thiamine mononitrate 100 mg BP (vitamin B1) Product reduces the activity of altretamine. • Pyridoxine hydrochloride 200 mg BP (vitamin B6) Phenobarbital, phenytoin • Cyanocobalamin 200 mcg BP (vitamin B12) Product may decrease serum concentrations of phenobarbital and Excipients phenytoin. Accacia (powder) Irradiated, Lactose, Maize starch, Gelatin powder, Hydralazine, , Magnesium stearate, AMB 80W53716/ 80W53095 Orange/ TAB Hydralazine, isoniazid, penicillamine may increase the requirements COAT TC Orange (HPMC based coating materials). for pyridoxine. PHARMACEUTICAL FORM Oral contraceptives Orange bi-convex circular tablets having one face engraved with Serum concentration of vitamin B6, vitamin B12 may be decreased by "BERIN PLUS" along the periphery and the other face plain. use of oral contraceptives. CLINICAL INFORMATION Neomycin, aminosalicylic acid, histamine H2-antagonists, Indications omeprazole, colchicine For the treatment of vitamin B1, B6, B12 deficiency symptoms. Absorption of the product from the gastrointestinal tract may be Dosage and Administration reduced by neomycin, aminosalicylic acid, histamine H2-antagonists, For oral use omeprazole, and colchicine. No interaction is likely when product is Adults given by injection. Usual recommended daily dosage is one tablet three times a day or as Chloramphenicol per doctors advise. Parenteral chloramphenicol may attenuate the effect of this medicinal Children product in anaemia. There are no relevant data available. Loop diuretics Elderly During long-term use of loop diuretics, e.g. furosemide, the excretion There are no relevant data available. of thiamine may be increased resulting in a decrease of the thiamine Renal impairment level in the blood due to reduced tubular reabsorption. There are no relevant data available. and Lactation Hepatic impairment Fertility There are no relevant data available. There are no relevant data available. Contraindications Pregnancy and Lactation Product is contraindicated in: This medicinal product should be applied to pregnant women only if • Hypersensitivity to thiamine mononitrate (film-coated tablets), the potential benefit justifies the potential risk to the fetus. pyridoxine hydrochloride, cyanocobalamin, cobalt or any other Lactation ingredients. This product is distributed into breast milk. The negative effect for Warnings and Precautions the child is thought to be unlikely when therapeutic doses are adhered Contact dermatitis to. A higher dose of vitamin B6 (more than 600 mg daily) may inhibit This medicinal product contains thiamine. Occupational exposure to the production of breast milk in individual cases.It is considered that thiamine has produced contact dermatitis. These sensitized use of this medicinal product is usually compatible with individuals may experience a relapse of dermatitis after subsequent but infant risk cannot be ruled out. exposure (see Section Adverse Reactions). Ability to perform tasks that require judgement, motor or Severe sensory neuropathy cognitive skills Caution should be exercised during the long-term use of this product. There are no relevant data available. It contains pyridoxine. Large doses of pyridoxine are associated with Adverse Reactions the development of severe peripheral neuropathies; the dose at which Data these occur is controversial. Severe sensory neuropathy has been Not relevant for this product. described in patients receiving 2 to 6 g daily of pyridoxine for periods Post Marketing Data of 2 to 40 months. There has, however, been debate as to whether Adverse drug reactions (ADRs) are listed below by MedDRA system smaller doses can produce such effects. Some contend that amounts organ class and by frequency. of pyridoxine below this level are unlikely to produce toxic effects. Frequencies are defined as: However, there have been some case reports with amounts up to Very common ≥1/10 about 500 mg daily and prolonged use of even lower doses (about Common ≥1/100 to <1/10 200 mg daily or less) may also cause sensory peripheral neuropathy Uncommon ≥1/1000 to <1/100 (see Section Adverse Reactions). Rare ≥1/10000 to <1/1000 Patients with folate deficiency Very rare <1/10000 This medicinal product should not be given to patients with suspected Not known (cannot be estimated from the available data). vitamin B12 deficiency without first confirming the diagnosis. Immune system disorders Regular monitoring of the blood is advisable. Use of doses greater Not known: hypersensitivity reactions than 10 micrograms daily may produce a haematological response in Nervous system disorders patients with deficiency; indiscriminate use may mask the Not known: severe peripheral neuropathies (see Section Warnings and precise diagnosis. Precautions) Leber's disease and tobacco amblyopia Skin and subcutaneous tissue disorders This medicinal product should not be used for Leber's disease or Not known: dermatitis (see Section Warnings and Precautions) tobacco amblyopia since these optic neuropathies may degenerate further. Overdosage Long-term use In individual cases, the parenteral injection of large doses of thiamine has led to anaphylactic shocks. A pyridoxine overdose over a long period of time, i.e. more than 2 months and a dose higher than 1 g per day, may lead to neurotoxic effects. Management should be as clinically indicated or as recommended by the national poisons centre, where available. Clinical Pharmacology Pharmacodynamics Pharmacotherapeutic group ATC Code A11DB Mechanism of Action and Pharmacodynamics effects The vitamin B-complex comprises a group of water-soluble factors more or less closely associated in their natural occurrence. It is known that nearly every vitamin of the B-complex forms part of a co-enzyme essential for the metabolism of protein, or fatty acid Pharmacokinetics There are no relevant data available. Clinical Studies There are no relevant data available. Non-clinical information There are no relevant data available. PHARMACEUTICAL INFORMATION Shelf-Life 24 months Storage Store at a cool and dry place (below 25°C). Protect from light and moisture. Nature and Contents of Container 30 Tablets in plastic container. Incompatibilities There are no relevant data available. Use and Handling There are no special requirements for use or handling of this product.

Version Number: NCDS 03 Version Date: 29 March 2017

Manufactured by GlaxoSmithKline Bangladesh Limited, Fouzderhat Industrial Area, Chittagong