Vitamin B6 Tablets 20mg
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