Summary of Product Characteristics (SmPC) - Vitamin B Compound tablets BPC
1 NAME OF THE MEDICINAL PRODUCT
Vitamin B Compound Tablets BPC
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Nicotinamide 15.0 mg, Thiamine Hydrochloride 1.0 mg and Riboflavin 1.0 mg.
Excipients with known effect: Lactose 122 mg
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.
Not recommended for children under 12 years of age.
Method of administration
For oral use.
4.3 Contraindications
Known hypersensitivity to the active substances 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 medicine 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.
The usual precautions should be observed when administering drugs during pregnancy, especially in the first trimester.
4.7 Effects on ability to drive and use machines
Vitamin B Compound Tablets have no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
Toxic effects are unlikely since any excess vitamin B is excreted.
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
Excess vitamin B is readily excreted, therefore no serious problems are anticipated for the administration of vitamin B in this form. If large amounts are ingested accidentally, treat symptomatically.
5.1 Pharmacodynamic properties
A11E A – Vitamin B-Complex, Plain
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.
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, carbohydrate or fatty acid.
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5.2 Pharmacokinetic properties
Nicotinamide is readily absorbed from the GI tract following oral administration and is widely distributed in the body tissues. Small amounts of nicotinamide are excreted unchanged in urine following therapeutic doses, however, the amount excreted unchanged is increased with larger doses.
Riboflavine is absorbed from the GI tract and in the circulation is bound to plasma proteins. Although widely distributed, little is stored in the body, and amounts in excess of requirements are excreted in the urine.
Thiamine is absorbed from the GI tract and is widely distributed to most body tissues. It is not stored to any appreciable extent in the body and amounts in excess of requirements are excreted in the urine as unchanged thiamine or 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. Not all pack sizes may be marketed.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Kent Pharma UK Limited,
2nd Floor, Connect 38,
1 Dover Place, Ashford,
Kent, England, TN23 1FB
8 MARKETING AUTHORISATION NUMBER(S)
PL 51463/0131
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
13/10/2005
10 DATE OF REVISION OF THE TEXT
30/09/2025