Pyridoxine 50mg Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

PYRIDOXINE HYDROCHLORIDE

Available from:

Wockhardt UK Limited Ash Road North, Wrexham, LL13 9UF, United Kingdom

ATC code:

A11HA02

INN (International Name):

PYRIDOXINE HYDROCHLORIDE 50 mg

Pharmaceutical form:

TABLET

Composition:

PYRIDOXINE HYDROCHLORIDE 50 mg

Prescription type:

OTC

Therapeutic area:

VITAMINS

Authorization status:

Withdrawn

Authorization date:

2006-08-23

Patient Information leaflet

PACKAGE LEAFLET 
INFORMATION FOR THE USER
PYRIDOXINE 50MG TABLETS
PYRIDOXINE HYDROCHLORIDE
READ ALL OF THIS LEAFLET CAREFULLY 
BEFORE YOU START USING 
THIS MEDICINE.
- Keep this leaflet.  You may need to 
read it again.
- If you have further questions, 
please ask your doctor or 
pharmacist.
- This medicine has been prescribed 
for you personally and you should 
not pass it on to others. It may 
harm them, even if their symptoms 
are the same as yours.
The name of your medicine is Pyridoxine 50mg Tablets. In the 
rest of this leaflet it is called Pyridoxine Tablets.
IN THIS LEAFLET: 
1. What Pyridoxine Tablets are and what they are used for
2. Before you take Pyridoxine Tablets
3. How to take Pyridoxine Tablets
4. Possible side effects
5. How to store Pyridoxine Tablets
6. Further information
1. WHAT PYRIDOXINE TABLETS ARE AND 
WHAT THEY ARE USED FOR
The active ingredient in Pyridoxine Tablets is pyridoxine 
hydrochloride, which is Vitamin B6.
It is used to treat low levels of Vitamin B6 in the body and in 
the treatment of a condition called idiopathic sideroblastic 
anaemia where the red cells in the blood do not form properly.  
Pyridoxine can also be used to treat damage to the nerves 
(peripheral neuritis) caused by isoniazid, a drug used to treat 
tuberculosis. 
2. BEFORE YOU TAKE PYRIDOXINE TABLETS
DO NOT TAKE PYRIDOXINE TABLETS IF:
•  you are allergic to pyridoxine hydrochloride or any of the

other ingredients of Pyridoxine Tablets (see list under ‘What 
Pyridoxine Tablets contain’ in section 6)
If the above statement applies to you, you should not take 
Pyridoxine Tablets
TALK TO YOUR DOCTOR BEFORE TAKING PYRIDOXINE TABLETS IF:
•  the patient is a child. PYRIDOXINE TABLETS ARE NOT 
RECOMMENDED FOR CHILDREN.
TAKING OTHER MEDICINES
Taking another medicine while you are taking Pyridoxine 
Tablets can affect how it or the other medicine works. Please 
inform your doctor or pharmacist if you are taking or have 
recently taken any other medicines, including t

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT

Pyridoxine 50mg Tablets  

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Pyridoxine Hydrochloride 50mg 

3. 
PHARMACEUTICAL FORM 

Oral tablet 

4 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

Pyridoxine Hydrochloride is used for isoniazid-induced peripheral
neuritis, 
idiopathic sideroblastic anaemia and Vitamin B
6
 deficiency states. 

4.2 
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 

4.3 
CONTRAINDICATIONS 

Hypersensitivity to any of the ingredients. 

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 

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.  

4.6 
PREGNANCY AND LACTATION  _  _

Data on exposed pregnancies indicate no adverse effects of
pyridoxine in 
therapeutic doses on pre