Vitamin B Compound Strong Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
BEVITCO/Aneurine Co. Forte Tablets Vitamin B Compound strong Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Aneurine Hydrochloride 5.00 mg
Riboflavine 2.00 mg
Nicotinamide 20.00 mg
Pyridoxine HCl 2.00 mg
Also contains glucose. For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Dark chocolate film-coated, engraved
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment of clinical and subclinical vitamin B deficiency states as manifested by glossitis, stomatitis, cheilosis, the heart manifestations of beriberi, the skin manifestations of pellagra, corneal vascularisation and polyneuritis.
4.2 Posology and method of administration
Adults and children over 3 years: 1 - 2 -tablets three times daily. Elderly: Same dose as for adults.
Children under 3 years: Not recommended
Route of administration: Oral
4.3 Contraindications
Known hypersensitivity to any of the active constituents or to any of the excipients.
4.4 Special warnings and precautions for use
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency of glucose-galactose malabsorption should not take this medicine.
4.5 Interaction with other medicinal products and other forms of interaction
Pyridoxine may increase the peripheral metabolism of levodopa, reducing therapeutic efficacy of the latter drug. Therefore, patients with Parkinson's disease who are receiving treatment with plain levodopa should not take vitamin B6 in doses which greatly exceed the daily requirement. This does not apply when levodopa is combined with a peripheral decarboxylase inhibitor.
4.6 Fertility, pregnancy and lactation
The usual precautions should be observed when administering drugs during pregnancy, especially in the first trimester.
In high doses, pyridoxine may interfere with prolactin release and should only be used with caution in nursing mothers.
Severely thiamine (Vitamin B1) deficient mothers should avoid breast-feeding as toxic methyl-glyoxal is present in milk.
4.7 Effects on ability to drive and use machines
None stated
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.
4.9 Overdose
Excess vitamin B is readily excreted (water soluble), therefore no serious problems are anticipated for vitamin B in this form.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
All the members of the B-Complex group are water soluble.
Riboflavine is an orange-yellow crystalline powder with a slight odour and bitter taste; and is incompatible with alkalis and salts of heavy metals. The other members are all white crystalline powders.
Thiamine has a meat-like odour and bitter taste and is incompatible with oxidising and reducing substances.
Nicotinamide is incompatible with alkalis and mineral acids.
5.2 Pharmacokinetic properties
Thiamine: Rapidly absorbed from GI tract. Widely distributed in most body tissues. Amounts in excess of requirements excreted unchanged or as metabolites.
Riboflavine: Absorbed from GI tract. Bound to plasma proteins. Excess of requirements excreted in urine. Converted in body to flavine mononucleotide and then to flavine adenin di-nucleotide.
Pyridoxine: Converted to and excreted as 4-pyridoxic acid.
Nicotinamide: Rapidly absorbed from the GI tract. Widely distributed in body tissues; has a short half-life.
5.3 Preclinical safety data
Not applicable
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Talc
Magnesium Stearate Stearic Acid
Glucose (Dextrose Monohydrate)
Colloidal Anhydrous Silica Ethanol (96%)
Purified Water Ethylcellulose
Hydroxypropylmethylcelluse 5/6cps Diethylphthalate
Opaspray K-1-9231 Brown (E172)
6.2 Incompatibilities
None stated
6.3 Shelf Life
Containers: 3 years Blister Pack: 2 years
6.4. Special Precautions for Storage
Do not store above 25°C. Store in the original package.
6.5 Nature and contents of container
High density polystyrene with polythene lids and/or polypropylene containers with polypropylene or polythene lids and polyurethane/polythene inserts. Pack size: 100 and 500 tablets
And
Blister pack of PVC/Aluminium foil.
Pack size: 28 tablets
6.6 Special precautions for disposal
Not applicable
7
MARKETING AUTHORISATION HOLDER
Chelonia Healthcare Limited 11 Boumpoulinas Street,
3rd floor, 1060 Nicosia Cyprus
8 MARKETING AUTHORISATION NUMBER(S)
PL 33414/0011
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
30/08/1985 / 31/10/2002
10 DATE OF REVISION OF THE TEXT
October 2014