Pyridoxine hydrochloride 50 mg Film-coated Tablets

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

Posology

Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.

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.

Pregnancy

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.

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 or search for MHRA Yellow Card in the Google Play or Apple App Store.

a) Symptoms - None reported

b) Treatment - no treatment necessary.

Pharmacotherapeutic group: Other plain vitamin preparations, ATC code: A11HA02

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.

core tablet

Microcrystalline cellulose

Sodium starch glycolate, Type A

Colloidal anhydrous silica

Magnesium Stearate

film-coating

Hypromellose

Macrogol

Talc

Titanium dioxide

Not applicable.

2 years

This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light.

ALU-PVC/PVDC blister.

Pack sizes: 10, 14, 20, 28, 30, 40, 50, 56, 60, 70, 80, 84, 90, 100 and 112 tablets.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.