VITAMIN B COMPOUND TABLETS BPC - summary of medicine characteristics

1 NAME OF THE MEDICINAL PRODUCT

Vitamin B Compound Tablets BPC

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Nicotinamide 15.0 mg

Thiamine Hydrochloride 1.0 mg

Riboflavin 1.0 mg

Excipient(s) with known effect

Lactose

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

Posology

Adults, the elderly and children over 12 years: One to three tablets daily.

Children under 12 years: This product is not recommended for use in children under 12 years.

Method of administration

For oral administration.

4.3 Contraindications

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use

These tablets are not suitable for the treatment of symptomatic Vitamin B complex deficiencies.

This product contains lactose. Patients with rare hereditary problems of galactose intolerance, total 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

Vitamin B Compound Tablets BPC has no or negligible influence on the ability to drive and use machines

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9 Overdose

If large amounts are ingested accidentally, treat symptomatically.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Vitamin B-complex, plain, ATC code: A11EA.

Thiamine is phosphorylated in the body and acts as a co-enzyme in carbohydrate metabolism. Riboflavin is also phosphorylated to give co-enzymes in the respiratory chain and oxidative phosphorylation. Nicotinamide is also active in the respiratory chain. Symptomatic nutritional vitamin B deficiency commonly involves these three vitamins.

5.2 Pharmacokinetic properties

The three vitamins are all well absorbed from the gastro-intestinal tract and are widely distributed in the body tissues. Thiamine and Riboflavin are not stored in the body and are excreted mainly in the urine. Nicotinamide is also widely distributed and has a short half-life. It is excreted mainly as metabolites.

5.3 Preclinical safety data

No data of relevance which is additional to that already included in other sections of the SPC.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Lactose

Potato starch

Stearic acid

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years

6.4 Special precautions for storage

Do not store above 25°C. Store in the original container. Keep the container tightly closed.

6.5 Nature and contents of container

PP or HDPE tablet containers.

Pack sizes 28, 100 & 1000 tablets.

6.6 Special precautions for disposal Not applicable.

7 MARKETING AUTHORISATION HOLDER

Ennogen Healthcare Limited

Unit G4, Riverside Industrial Estate,

Riverside Way,

Dartford DA1 5BS

UK