a) Symptoms - None reported
b) Treatment - no treatment necessary.
Two years
Hypersensitivity to any of the ingredients.
None known
Calcium Hydrogen Phosphate BP
Starch Maize BP
Sodium Lauryl Sulphate BP
Magnesium Stearate BP
Purified Water BP (non-detectable in the final formulation)
Oral tablet
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.
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.
Pyridoxine Hydrochloride is used for isoniazid-induced peripheral neuritis, idiopathic sideroblastic anaemia and Vitamin B6 deficiency states.
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.
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.
23/04/2015
Pyridoxine 50mg Tablets
Wockhardt UK Ltd
Ash Road North
Wrexham
LL13 9UF
UK
Store below 25°C
Protect from light and moisture.
Packs of 100 or 500 tablets contained in polypropylene securitainers or polyethylene containers.
Strip packs of opaque white or clear PVC film and 20μm 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.
PL 29831/0181
MA154/02601
Pyridoxine Hydrochloride 50mg
If symptoms persist or worsen, seek medical advice. Do not exceed the stated dose.
None known.
For isoniazid-induced peripheral 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 |
Not applicable.
25 June 2007
