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Vitamin B6 Tablets 50mg

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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