Pyridoxine Hydrochloride 50mg Tablets Bp
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Pyridoxine 50mg Tablets BP
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Pyridoxine Hydrochloride BP 50mg
3. PHARMACEUTICAL FORM
Oral tablet
4.1 Therapeutic indications
Pyridoxine Hydrochloride is used for isoniazid-induced peripheral neuritis, idiopathic sideroblastic anaemia and Vitamin B6 deficiency states.
4.2 Posology and method of administration
For isoniazid-inducedperipheral neuritis
Adults: Treatment - 50mg three times daily
Prophylaxis - Not suitable with this dosage form
Children: This presentation is not recommended
For idiopathic sideroblastic anaemia
Adults: 100 to 400mg daily in divided doses
Children: This presentation is not recommended
For deficiency states
Adults: 50 to 150mg daily in divided doses
Children: This presentation is not recommended
Elderly: Dosage requirements appear to be similar to those for young adults
Pyridoxine 50mg Tablets BP
4.3
Contraindications
Hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
If symptoms persist or worsen, seek medical advice. Do not exceed the stated dose.
4.5 Interaction with other medicinal products and other forms of interaction
Many drugs may alter the metabolism or bioavailability of pyridoxine, including isoniazid, penicillamine and oral contraceptives, which may increase the requirements for pyridoxine. Pyridoxine hydrochloride may reduce the effect of levodopa, a drug used in the treatment of Parkinsons Disease unless a dopa decarboxylase inhibitor is also given.
4.6 Pregnancy and lactation
Data on exposed pregnancies indicate no adverse effects of pyridoxine in therapeutic doses on pregnancy or the health of the foetus or newborn child, or during lactation.
Animal studies are insufficient with respects to effects on pregnancy, embiyonal/foetal development, parturition or postnatal development.
Caution should be exercised when prescribing to pregnant women.
4.7 Effects on ability to drive and use machines
None known.
4.8 Undesirable effects
Long term administration of large doses of pyridoxine is associated with the development of severe peripheral neuritis.
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
a) Symptoms - None reported
b) Treatment - no treatment necessary.
5.1 Pharmacodynamic properties
Pyridoxine hydrochloride is Vitamin B6. It is converted to pyridoxal phosphate which is the co-enzyme for a variety of metabolic transformations. It is essential for human nutrition.
5.2 Pharmacokinetic properties
Pyridoxine hydrochloride is absorbed from the gastrointestinal tract and is converted to the active forms pyridoxal phosphate and pyridoxamine phosphate. It crosses the placental barrier and appears in breast milk. It is excreted in the urine as 4-pyridoxic acid.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to those already included in other sections of the Summary of Product Characteristics.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Calcium Hydrogen Phosphate BP Starch Maize BP Sodium Lauryl Sulphate BP Magnesium Stearate BP
Purified Water BP (non-detectable in the final formulation)
6.2 Incompatibilities
None known
6.3 Shelf life
Two years
6.4 Special precautions for storage
Store below 25°C
Protect from light and moisture.
6.5
Nature and contents of container
Packs of 100 or 500 tablets contained in polypropylene securitainers or polyethylene containers.
Strip packs of opaque white or clear PVC film and 20pm aluminium foil of 10 or 14 tablets. Tablets will be packed in multiple strips of 10 tablets resulting in packs of 10, 20, 30, 40, 50, 60, 70, 80, 90 and 100 tablets, or tablets will be packed in multiple strips of 14 tablets resulting in packs of 14, 28, 56, 84 and 112 tablets.
6.6 Instructions for use, handling and disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Wockhardt UK Ltd Ash Road North Wrexham LL13 9UF United Kingdom
8 MARKETING AUTHORISATION NUMBER(S)
PL 29831/0181
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
25/06/2007
10 DATE OF REVISION OF THE TEXT
23/04/2015