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.

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.

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 respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women.

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 reportedb) 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 BPStarch Maize BPSodium Lauryl Sulphate BP Magnesium Stearate BPPurified 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