Summary of medicine characteristics - PYRIDOXINE 10 MG TABLETS
1 NAME OF THE MEDICINAL PRODUCT
Pyridoxine 10mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Pyridoxine hydrochloride 10 mg equivalent to 8.2 mg pyridoxine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Pyridoxine 10mg tablets are plain white uncoated biconvex tablets.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Pyridoxine is indicated for adults and children over 12 years old in the treatment of isoniazid-induced peripheral neuritis and pyridoxine deficiency states.
4.2 Posology and method of administration
Posology
Adults and children over 12 years old
Isoniazid neuropathy:
Prophylaxis 10mg daily
Treatment 50mg three times daily (Adults)
Treatment 30–50mg two to three times a day (children over 12 years)
Deficiency states:
20–50mg up to three times daily
Elderly
As for adults.
Paediatric population
Little information is available on the use of pyridoxine in children under 12 years.
Doses of 4mg/Kg have been used to treat children with familial pyridoxine resistance.
Method of administration
Oral.
4.3 Contraindications
Hypersensitivity to the pyridoxine or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
If symptoms persist or worsen, seek medical advice. Do not exceed the stated dose.
4.5 Interaction with other medicinal products and other forms of interaction
Pyridoxine antagonises the therapeutic effect of levodopa when it is used
without a dopa-decarboxylase inhibitor.
Larger doses of pyridoxine can cause a reduction in serum phenytoin and
phenobarbitone levels in some patients.
Pyridoxine requirements have been reported to be increased by oral
contraceptives, hydralazine, isoniazid, cycloserine and penicillamine.
4.6 Fertility, pregnancy and lactation
Pregnancy
There are no or limited amount of data from the use of pyridoxine in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3) Pyridoxine is not recommended during the first trimester of pregnancy.
Breastfeeding
There is insufficient information on the excretion of pyridoxine in human milk. A risk to the breastfed child cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from pyridoxine therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Fertility
Animal studies showed that male fertility was affected following administration of high doses of pyridoxine. (see section 5.3) The relevance of these findings for human
fertility is unclear.
4.7 Effects on ability to drive and use machines
Pyridoxine has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
None at recommended dosages. Large daily doses taken over a prolonged
period can cause the development of severe peripheral neuropathy.
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
4.9 Overdose
4.9 OverdoseIngestion of 2–3g may cause headache. No treatment necessary.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pyridoxine is one of three similar compounds that may be referred to as
Vitamin B6. The other two compounds are pyridoxal and pyridoxamine.
Pyridoxine, converted to pyridoxal phosphate, is a co-enzyme for
transamination and is involved in many metabolic processes.
5.2 Pharmacokinetic properties
Pyridoxine is readily absorbed from the gastrointestinal tract following oral administration and is converted to the active forms of pyridoxal phosphate and pyridoxamine phosphate, which are stored in the liver. The principal excretory product is 4-pyridoxic acid, which is formed by the action of hepatic aldehyde oxidase on free pyridoxal. Pyridoxine crosses the placenta and also appears in breast milk.
5.3 Preclinical safety data
5.3 Preclinical safety dataEffects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to its clinical use.
Pyridoxine causes a peripheral sensory neuropathy in embryonic chickens largely consistent with its effects in adult mammals.
The development and function of the male reproductive organs in rats were affected when high doses of pyridoxine were administered.
6.1 List of excipients
Microcrystalline cellulose
Calcium hydrogen phosphate dihydrate
Magnesium stearate
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
2 years
6.4 Special precautions for storage
Do not store above 25°C. Store in the original package.
6.5 Nature and contents of container
Available in polypropylene containers with a low density polyethylene cap containing 28 tablets.
6.6 Special precautions for disposal
6.6 Special precautions for disposalNot applicable.