Pyridoxine

Pyridoxine 50mg Tablets

Pyridoxine Hydrochloride 50mg

Oral tablet

Pyridoxine Hydrochloride is used for isoniazid-induced peripheral neuritis, idiopathic sideroblastic anaemia and Vitamin B₆ deficiency states.

For isoniazid-induced peripheral neuritis

For idiopathic sideroblastic anaemia

For deficiency states

Hypersensitivity to any of the ingredients.

If symptoms persist or worsen, seek medical advice. Do not exceed the stated dose.

None known.

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.

a) Symptoms - None reported

b) Treatment - no treatment necessary.

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.

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.

Calcium Hydrogen Phosphate BP

Starch Maize BP

Sodium Lauryl Sulphate BP

Magnesium Stearate BP

Purified Water BP (non-detectable in the final formulation)

None known

Two years

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.

Not applicable.

Wockhardt UK Ltd

Ash Road North

Wrexham

LL13 9UF

UK

PL 29831/0181

MA154/02601

25 June 2007

23/04/2015