Summary of Product Characteristics (SmPC) - Pyridoxine Hydrochloride 10 mg tablets

1 NAME OF THE MEDICINAL PRODUCT

Pyridoxine Hydrochloride 10mg Tablets

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Pyridoxine Hydrochloride 10mg

For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Oral tablet

White to off white, circular, flat face, bevelled edges, uncoated tablets having break line on one side and plain on other side.

Diameter: 7.00mm approx.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Pyridoxine Hydrochloride 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 to 50mg up to three times daily

Elderly

As for adults.

Paediatric population

Little information is available on the use of pyridoxine hydrochloride in children under 12 years.

Doses of 4mg/Kg have been used to treat children with familial pyridoxine hydrochloride resistance.

Method of administration

Oral.

4.3 Contraindications

Hypersensitivity to the pyridoxine hydrochloride 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.

This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, i.e. essentially ‘sodium-free’.

4.5 Interaction with other medicinal products and other forms of interaction

Pyridoxine hydrochloride antagonises the therapeutic effect of levodopa when it is used without a dopa-decarboxylase inhibitor.

Larger doses of pyridoxine hydrochloride can cause a reduction in serum phenytoin and phenobarbitone levels in some patients.

Pyridoxine hydrochloride 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

hydrochloride in pregnant women. Studies in animals have shown

reproductive toxicity (see section 5.3) Pyridoxine hydrochloride is not recommended during the first trimester of pregnancy.

Breastfeeding

There is insufficient information on the excretion of pyridoxine hydrochloride 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 hydrochloride 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 hydrochloride. (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 hydrochloride 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 Store.

4.9 Overdose

Ingestion of 2-3g may cause headache. No treatment necessary.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Other plain Vitamin preparations

ATC Code: A11HA02

Pyridoxine hydrochloride is one of three similar compounds that may be referred to as Vitamin B6. The other two compounds are pyridoxal and pyridoxamine. Pyridoxine hydrochloride, converted to pyridoxal phosphate, is a co-enzyme for transamination and is involved in many metabolic processes.

5.2 Pharmacokinetic properties

Pyridoxine hydrochloride 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 hydrochloride crosses the placenta and also appears in breast milk.

5.3 Preclinical safety data

Effects 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 hydrochloride 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 hydrochloride were administered.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

cellulose microcrystalline

colloidal anhydrous silica

sodium starch glycolate

anhydrous citric acid

magnesium stearate

6.2 Incompatibilities

Not applicable

6.3 Shelf life

24 months

6.4 Special precautions for storage

Do not store above 30°C.

6.5 Nature and contents of container

Pyridoxine Hydrochloride 10mg tablets are available in amber colour PVC/PE/PVDC-Aluminium blister pack of 28 tablets

6.6 Special precautions for disposal

Not applicable.

7 MARKETING AUTHORISATION HOLDER

Macleods Pharma UK Limited

Wynyard Park House,

Wynyard Avenue, Wynyard,

Billingham, TS22 5TB

United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 34771/0333

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

10/09/2026

10 DATE OF REVISION OF THE TEXT