Pyridoxine 50mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Pyridoxine hydrochloride

Available from:

Zanza Specials International Ltd

ATC code:

A11HA02

INN (International Name):

Pyridoxine hydrochloride

Dosage:

50mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09060204; GTIN: 5060033710920 5060033710838

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 those you may have bought yourself without a
prescription.
Please check wit

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Pyridoxine 50mg Tablets BP
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pyridoxine Hydrochloride BP 50mg
3.
PHARMACEUTICAL FORM
Oral tablet
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
Pyridoxine 50mg Tablets BP
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 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
None known.
4.