Summary of Product Characteristics (SmPC) - Pyridoxine Hydrochloride 50 mg tablets
1 NAME OF THE MEDICINAL PRODUCT
Pyridoxine Hydrochloride 50mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Pyridoxine Hydrochloride 50mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral tablet
White to off-white, capsule shaped, uncoated tablets, having break line on one side and ‘U26’ debossed on the other side.
Length: 11.00 mm approx
Width: 5.00 mm approx
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Pyridoxine Hydrochloride is indicated for adults in the treatment of isoniazid-induced peripheral neuritis, idiopathic sideroblastic anaemia and Vitamin B6 deficiency states.
4.2 Posology and method of administration
Posology
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 Pyridoxine hydrochloride 50mg tablets.
Method of administration
Oral
4.3 Contraindications
Hypersensitivity to the active substance 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
Many drugs may alter the metabolism or bioavailability of pyridoxine hydrochloride, including isoniazid, penicillamine and oral contraceptives, which may increase the requirements for pyridoxine hydrochloride. 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.
4.6 Fertility, pregnancy and lactation
Data on exposed pregnancies indicate no adverse effects of pyridoxine hydrochloride 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.
4.7 Effects on ability to drive and use machines
Pyridoxine hydrochloride 50mg tablets have no known influence on the ability to drive and use machines.
4.8 Undesirable effects
Long term administration of large doses of pyridoxine hydrochloride 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.
4.9 Overdose
- a) Symptoms - None reported
- b) Treatment - no treatment necessary.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
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.
5.2 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.
5.3 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.
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 50mg 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/ 0334
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
10/09/2026
10 DATE OF REVISION OF THE TEXT
10/09/2026