VITAMIN B COMPOUND STRONG TABLETS BPC - summary of medicine characteristics

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

Brown, sugar coated deep convex tablets.

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.

4.6 Fertility, Pregnancy and lactation

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 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 PHARMACOLOGICAL PROPERTIES

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 PHARMACEUTICAL PARTICULARS

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.

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 THEAUTHORISATION

17/02/2010