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Vitamin B6 Tablets 20mg

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SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Vitamin B6 Tablets 20 mg

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Pyridoxine Hydrochloride B.P. 20 mg

3.    PHARMACEUTICAL FORM

Tablet

4.    CLINICAL PARTICULARS

4.1    Therapeutic indications

Prevention and treatment of vitamin B6 deficiency.

4.2 Posology and method of administration

Adults

One to three tablets daily with food.

Route of administration Oral.

4.3 Contraindications

None.

4.4


Special warnings and precautions for use

4.5 Interactions with other medicinal products and other forms of interaction

Vitamin B6 may reduce the effects of levodopa.

4.6. Pregnancy and lactation

None.

4.7    Effects on ability to drive and use machines

None.

4.8    Undesirable effects

None.

4.9    Overdose

Not known.

5.    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 formation 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

5.3. Preclinical safety data

No relevant data.

6.    PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Sago Starch

Calcium Phosphate Tribasic Calcium Sulphate Dihydrate Potato Starch Vegetable Fatty Acid Talc

Gum Acacia Ethyl Cellulose N100

Industrial Methylated Spirit 64 OP (Not detected)

6.2 Incompatibilities

None.

6.3. Shelf life

36 months.

6.4 Special precautions for storage

In a cool place protected from light.

6.5 Nature and contents of container

Injection moulded high density polyethylene container with security cap.


Pack size: 100 tablets.

Polythene bags enclosed in lever lid tin. Pack size: 1000 tablets.

Beatson Clark amber glass bottle with metal screw cap. Pack size 100 tablets.

6.6 Instruction for use and handling and disposal

None.

7 MARKETING AUTHORISATION HOLDER

Health & Diet Food Company Limited

Samuel Ryder House

Townsend Drive

Attleborough Fields

Nuneaton

Warwickshire

CV11 6XW

8. MARKETING AUTHORISATION NUMBER

PL 14010/0007

9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION

1st October 1999

10. DATE OF REVISION OF THE TEXT

17th December 1999