Summary of Product Characteristics (SmPC) - Vitamin B Compound tablets
1 NAME OF THE MEDICINAL PRODUCT
Vitamin B Compound Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains
Nicotinamide 15.0 mg
Thiamine Hydrochloride 1.0 mg
Riboflavin 1.0 mg.
Excipient with known effect:
Lactose 122 mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Tablet.
Plain yellow, uncoated biconvex 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
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.
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
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
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.
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
There are no preclinical data of relevance to the prescriber which are additional to those already included in other sections of the SmPC.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Lactose
Potato Starch
Stearic Acid
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
18 months in plastic containers.
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
Crescent Pharma Limited
Key House
Sarum Hill
Basingstoke
RG21 8SR
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 20416/0281
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
14/01/2025
10 DATE OF REVISION OF THE TEXT
21/05/2026