Vitamin B Compound Tablets Bpc
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vitamin B Tablets Compound BPC
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains Thiamine Hydrochloride 1.00 mg, Riboflavin 1.00 mg and
Nicotinamide 15.00 mg.
For excipients, see 6.1
3 PHARMACEUTICAL FORM
Tablets
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the prevention of vitamin deficiency.
4.2 Posology and method of administration Dosage
Adults. Elderly and Children over 12 years
One or two tablets daily.
Children under 12 years
Not recommended.
Route of administration: Oral
Contraindications
4.3
Hypersensitivity to thiamine hydrochloride, riboflavin and nicotinamide.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption 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, 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.
4.6 Fertility, Pregnancy and lactation
The active ingredients 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. 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.
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 neuropathies.
4.9 Overdose
Adverse effects are not normally expected from an acute overdose of the water soluble vitamins.
In massive overdosage gastric lavage and emesis may be carried out. Riboflavin is removed by haemo-dialysis but more slowly than normal renal excretion.
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
6.2 Incompatibilities
Incompatible with alkalis and salts of heavy metals.
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:
a) Opaque plastic containers fitted with plastic snap-on closures in pack sizes of 28, 30, 42, 50, 56, 60, 84, 90, 100, 112, 250, 500 and 1,000 tablets.
b) Opaque plastic containers composed of either high density polypropylene or high density polyethylene with a tamper-evident or child-resistant tamper-evident closure composed of high density polyethylene in all pack sizes (28, 30, 42, 50, 56, 60, 84, 90, 100, 112, 250, 500 and 1,000 tablets). Packing inclusion:
standard polyether foam or polyethylene or polypropylene filler.
c) Blister packs of aluminium / opaque PVC subsequently packed in printed cartons in pack sizes of 28, 30, 56, 60, 84, 90 and 112.
6.6 Special precautions for disposal
No special instructions for use/handling.
MARKETING AUTHORISATION HOLDER
7
Crescent Pharma Limited
3&4 Quidhampton Business Units
Polhampton Lane
Overton
Hampshire
RG25 3ED UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 20416/0409
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
17/02/2010
10 DATE OF REVISION OF THE TEXT
15/04/2015