Vitamin B Compound Tablets Bpc
SUMMARY OF PRODUCT 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.
For excipients see 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
For oral administration.
Adults, the elderly and children over 12 years: One to three tablets daily.
Not recommended for children under 12 years of age.
4.3 Contraindications
Known hypersensitivity to any of the ingredients present.
4.4 Special warnings and precautions for use
These tablets are not suitable for the treatment of symptomatic Vitamin B complex deficiencies.
Patients with rare hereditary problems of galactose intolerance, the LAPP lactase deficiency or glucose-galactose malabsorption should not take this medicine.
4.5 Interactions with other medicinal products and other forms of interaction
None known.
4.6 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
No or negligible influence.
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.
4.9 Overdose
If large amounts are ingested accidentally, treat symptomatically.
5.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
5.1
AllE 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
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.
Shelf life
6.3
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 Instruction for use, handling and disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Dalkeith Laboratories Ltd
2 Park Street
Woburn
Bedfordshire
MK17 9PG
United Kingdom
8. MARKETING AUTHORISATION NUMBER
PL 17496/0002
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION 13/10/2005
10 DATE OF REVISION OF THE TEXT
23/12/2014