Vitamin B6 Tablets 50mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vitamin B6 Tablets 50 mg
2. Qualitative and Quantitative Composition
Pyridoxine Hydrochloride 97% 51.55 mg
3. Pharmaceutical Form
Tablet
Clinical Particulars
4.1. Therapeutic Indications
Prevention and treatment of vitamin B6 deficiency. Deficiency may manifest itself as anaemia, peripheral neuritis, convulsions or lesions of the skin or mucous membranes. Pyridoxine is used in treatment of peripheral neuritis associated with pellagra or isoniazid therapy and anaemia responsive to pyridoxine.
4.2. Posology and Method of Administration
Adults and the elderly
Deficiency states: Half to one tablet up to three times daily (in persons with inadequate diet).
Isoniazid neuritis: One tablet three times daily.
Idiopathic sideroblastic anaemia: Two to eight tablets daily in divided doses. Children: Not recommended.
Route of administration
Oral.
Known hypersensitivity to pyridoxine.
4.4. Special Warnings and Precautions for Use
Long term continuous treatment has been associated with adverse sensory neurological reactions.
4.5. Interactions with other Medicaments and other forms of Interaction
Pyridoxine may reduce the effects of levodopa but this does not occur if a dopa ecarboxylase inhibitor is given. Pyridoxine requirements have been reported to be increased by oral contraceptives, hydrallazine, isoniazid and penicillamine.
4.6. Pregnancy and Lactation
As with all medicines, use in the first three months of pregnancy should be avoided unless advised by a physician; Pyridoxine may interfere with prolactin release so should be used with caution in nursing mothers.
4.7. Effects on Ability to Drive and Use Machines
None.
4.8. Undesirable Effects
Long term continuous treatment has been associated with adverse sensory neurological reactions.
4.9. Overdose
The acute toxicity of pyridoxine hydrochloride is low. Ingestion of large amounts may cause headaches which may be treated symptomatically.
Pharmacological Properties
5.1. Pharmacodynamic Properties
Pyridoxine is a water soluble vitamin involved principally in amino acid metabolism but also in carbohydrate and fat metabolism. It is also required for the forma ion of haemoglobin. Deficiency may lead to peripheral neuritis, lesions of the skin and mucous membranes and in children may affect the CNS.
5.2. Pharmacokinetic Properties
Pyridoxine is readily absorbed from the gastro-intestinal tract following oral administration and is converted to the active forms pyridoxal phosphate and pyridoxamine phosphate. They are stored mainly in the liver where there is oxidation to 4-pyridoxic acid which is excreted in the urine. Pyridoxal crosses the placenta and also appears in breast milk.
5.3. Preclinical Safety Data
No relevant data.
Pharmaceutical Particulars
6.1. List of Excipients
Calcium Phosphate Tribasic
Calcium Sulphate Dihydrate
Sago Starch
Gum Acacia
Potato Starch
Talc
Vegetable Stearic Acid Sodium Lauryl Sulphate Ethyl Cellulose N100
Industrial Methylated Spirit 64 OP (Not detected)
6.2. Incompatibilities
None.
36 months.
6.4.
6.5.
6.6.
7
8.
Special Precautions for Storage
In well-closed containers, protected from light, at not more than 30°C. Nature and Contents of Container
High impact polystyrene white or polystyrene amber co-plastic bottles. Pack size: 100 or 1000 tablets.
Polythene bags enclosed in lever lid tins. Pack size: 10000 tablets.
Beatson Clark amber glass bottles with metal screw caps. Pack size 100 tablets.
Polystyrene tampertainers. Pack size: 100 tablets.
Instruction for Use/Handling None.
MARKETING AUTHORISATION HOLDER
Nutrition Warehouse Limited Samuel Ryder House Townsend Drive Attleborough Fields Nuneaton Warwickshire CV11 6XW United Kingdom
MARKETING AUTHORISATION NUMBER(S)
PL 14010/0008
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
1st October 1999
10. DATE OF (PARTIAL) REVISION OF THE TEXT
October 2003