Pyridoxin

Overdose

a) Symptoms - None reported

b) Treatment - no treatment necessary.

Shelf life

Two years

Contraindications

Hypersensitivity to any of the ingredients.

Incompatibilities

None known

List of excipients

Calcium Hydrogen Phosphate BP

Starch Maize BP

Sodium Lauryl Sulphate BP

Magnesium Stearate BP

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

Pharmaceutical form

Oral tablet

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.

Preclinical safety data

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.

Therapeutic indications

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

Pharmacodynamic properties

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.

Pharmacokinetic properties

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.

Date of revision of the text

23/04/2015

Name of the medicinal product

Pyridoxine 50mg Tablets

Marketing authorisation holder

Wockhardt UK Ltd

Ash Road North

Wrexham

LL13 9UF

UK

Special precautions for storage

Store below 25°C

Protect from light and moisture.

Nature and contents of container

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.

Marketing authorisation number(s)

PL 29831/0181

MA154/02601

Qualitative and quantitative composition

Pyridoxine Hydrochloride 50mg

Special warnings and precautions for use

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

Effects on ability to drive and use machines

None known.

Dosage (Posology) and method of administration

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

Special precautions for disposal and other handling

Not applicable.

Date of first authorisation/renewal of the authorisation

25 June 2007