Vitamin B Compound Strong Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vitamin B Compound Strong Tablets BPC.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Thiamine HCI 5 mg, Riboflavin 2 mg, Nicotinamide 20 mg and Pyridoxine HC1 2 mg
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Brown, sugar coated deep convex tablets.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Recommended clinical indication
For the treatment of mild chronic vitamin deficiency.
4.2 Posology and method of administration
Dosage
Adults, elderly and children over 12 years: 1 - 2 tablets three times daily. Children under 12 years: Not recommended
Route of administration: Oral
4.3 Contraindications
Hypersensitivity, to thiamine hydrochloride, riboflavin, pyridoxine hydrochloride and nicotinamide.
Patients with rare hereditary problems of galactose or fructose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
4.4 Special warnings and precautions for use
None.
4.5 Interaction with other medicinal products and other forms of interaction
Alcohol impairs the intestinal absorption of riboflavin. With the concurrent use of antidepressants, tricyclic or phenothiazines, with riboflavin, the requirements of the latter may increase.
Probenecid decreases the gastrointestinal absorption of riboflavin.
Diagnostic interference usually results from large doses.
1. Urinary catecholamine concentration measurement by fluorimetric method, riboflavin interferes by producing fluorescent substances thus falsely elevating the results.
2. Urobilinogen determination using Ehrlich’s reagent, riboflavin may produce false-positive results.
Concurrent use of chloramphenicol, cycloserine, ethionamide, hydralazine, isoniazid, penicillamine or immunosuppressants with pyridoxin may cause anaemia or peripheral neuritis by acting as pyridoxin antagonists or increasing the renal excretion of pyridoxin. Requirements of pyridoxin may be increased in patients receiving these medications.
Concomitant administration of oestrogens may increase the requirements of pyridoxin.
Concurrent use of levodopa with pyridoxine is not recommended since levodopa’s antiparkinsonian effects are reversed by as little as 5 mg of oral pyridoxin; this problem does not occur with carbidopa-levodopa combination.
Fertility, Pregnancy and lactation
4.6
The vitamins cross the placental barrier and are excreted in the breast milk.
Problems in humans during pregnancy and lactation have not been documented with intake of normal daily requirements. However ingestion of large quantities during pregnancy may lead to pyridoxine dependency syndrome in the neonate. As with all medication careful consideration should be given prior to administration during the first trimester of pregnancy.
4.7 Effects on ability to drive and use machines
None reported
4.8 Undesirable effects
Adverse effects are rare. Hypersensitivity reactions such as skin rash, itching or wheezing may occur but usually following parenteral administration.
Large doses may cause discolouration of urine. Long-term administration of large doses may cause peripheral neuropatbies.
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
Adverse effects are not normally expected from an acute overdose of the water-soluble vitamins contained in this preparation.
5.1 Pharmacodynamic properties
Thiamine combines with adenosine triphosphate (ATP) to form a coenzyme, thiamine pyrophosphate (thiamine diphosphate cocarboxylase) which is necessary for carbohydrate metabolism.
Riboflavin is converted to two coenzymes, flavine mononucleotide (FMN) and flavine adenine dinucleotide (FAD) which are necessary for normal tissue respiration. Riboflavin is also required for the activation of pyridoxine and may be involved in maintaining erythrocyte integrity.
Nicotinamide is a component of two coenzymes, nicotinamide adenine dinucleotide (NAD) and nicotinamide adenine dinucleotide phosphate (NADP) which are necessary for lipid metabolism, tissue respiration and glycogenolysis.
5.2 Pharmacokinetic properties
Thiamine hydrochloride, riboflavin and nicotinamide are well absorbed from the gastrointestinal tract mainly the duodenum and jejunum.
Absorption of large doses are limited. Alcohol inhibits the absorption of these vitamins.
The vitamins are widely distributed to most body tissues and appear in breast milk. Excess beyond daily requirements are excreted via urine as unchanged or as metabolites. Biotransformation of vitamins occur in the liver.
5.3 Preclinical safety data
Not applicable
6.1 List of excipients
Lactose
Maize Starch
Pregelatinised Starch
Magnesium Stearate
Coating components
Shellac
Gelatin
Sucrose
Nipasept Sodium (containing E215, E217 and E219)
Kaolin
Talc
Titanium Dioxide (E171)
Opalux Brown (containing sucrose, El 72, E216, E218 and E211)
6.2 Incompatibilities
None.
6.3 Shelf life
36 months
6.4 Special precautions for storage
Keep out of the reach and sight of children. Store in container provided and protect from heat, light and moisture.
6.5
Nature and contents of container
The product is packed in opaque plastic containers fitted with snap-on plastic closures in pack sizes of 28, 30, 42, 50, 56, 60, 84, 90, 100, 112, 250, 500 and 1000 tablets.
Blister packs of aluminium/opaque PVC in pack sizes of 28, 30,56, 60, 84, 90 and 112.
6.6 Special precautions for disposal
No special instructions for use/handling.
7 MARKETING AUTHORISATION HOLDER
Crescent Pharma Limited
3&4 Quidhampton Business Units
Polhampton Lane
Overton
Hampshire
RG25 3ED
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 20416/0410
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
17/02/2010
10 DATE OF REVISION OF THE TEXT
26/07/2016