Pyridoxine 10mg tablets

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Pyridoxine hydrochloride

Available from:

A A H Pharmaceuticals Ltd

ATC code:

A11HA02

INN (International Name):

Pyridoxine hydrochloride

Dosage:

10mg

Pharmaceutical form:

Oral tablet

Administration route:

Oral

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09060204; GTIN: 5025903084853

Patient Information leaflet

Peel here but do not remove
TOR
GENERICS
Tor Generics Ltd;
Northwood HA6 2TH, UK
READ THE PACKAGE LEAFLET BEFORE USE.
DOSAGE: For oral use. Swallow whole, do not chew.
Use as directed by your doctor.
Do not store above 25°C .
This container is fitted with a tamper evident cap, if damaged
or missing do not use. Replace cap firmly after use.
Please store the tablets in the original container.
DO NOT EXCEED THE STATED DAILY DOSE
Keep out of sight and reach of children.
PL20491/0003
PRODUCT INFORMATION
28 Tablets
10 MG TABLETS
PYRIDOXINE
EXCIPIENTS: microcrystalline cellulose, calcium hydrogen
phosphate dihydrate, magnesium stearate.
Each tablet contains 10 mg pyridoxine hydrochloride
equivalent to 8.2mg pyridoxine.
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PYRIDOXINE 10MG TABLETS
Pyridoxine Hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their signs of illness are the same
as yours.
-
If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
WHAT IS IN THIS LEAFLET
1. WHAT PYRIDOXINE IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PYRIDOXINE
3. HOW TO TAKE PYRIDOXINE
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE PYRIDOXINE
6. CONTENTS OF THE PACK AND OTHER 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.
Pyridoxine Tablets are used to treat damage to the nerves (peripheral
neuritis) caused by isoniazid, a drug used to treat tuberculosis.
Pyridoxine
Tablets are also used to treat low levels of Vitamin B6 in the body.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PYRIDOXINE
TABLETS
DO NOT TAKE P

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
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.
B