PYRIDOXINE Tablet Ref.[7152] Active ingredients: Pyridoxine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2015  Publisher: Wockhardt UK Ltd, Ash Road North, Wrexham, LL13 9UF, UK

Contraindications

Hypersensitivity to any of the ingredients.

Special warnings and precautions for use

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

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.

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 respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development.

Caution should be exercised when prescribing to pregnant women.

Effects on ability to drive and use machines

None known.

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.

Incompatibilities

None known.

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