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Pyridoxine Hydrochloride 50mg Tablets Bp

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PACKAGE LEAFLET INFORMATION FOR THE USER

Pyridoxine 50mg Tablets Pyridoxine Hydrochloride


following (or any other medication):

•    levodopa, a drug used in the treatment of Parkinson’s disease

•    isoniazid, used to treat tuberculosis

•    oral contraceptives

•    penicillamine, used to treat arthritis and other conditions.


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 with your doctor if you are taking any of the


If you have any doubts about whether you should take this medicine then discuss matters with your doctor before taking it.

Pregnancy and breast-feeding

You should let your doctor know if you are pregnant or wish to become pregnant, or wish to breast-feed, whilst taking these tablets.

Driving and operating machines

Pyridoxine Tablets do not affect the ability to drive or operate machinery.


3. HOW TO TAKE PYRIDOXINE TABLETS

Your doctor will decide the dose which is best for you. Always follow your doctor's instructions completely and also follow any special instructions or warnings which appear on the label which the pharmacist has put on the package. Contact your doctor if your symptoms worsen or do not improve. If you do not understand, or are in any doubt, ask your doctor or pharmacist.

Unless instructed differently, take your tablets with a glass of water.

For the treatment of low levels of Vitamin B6 in the body

The usual dose in adults is 50 to 150mg daily in divided doses.

For the treatment of idiopathic sideroblastic anaemia

The usual adult dose is 100 to 400mg daily in divided doses.

For the treatment of nerve damage (peripheral neuritis) caused by isoniazid

The usual adult dose is 50mg three times a day.

Elderly

If you are elderly you will require similar doses to those given above.


Children

Pyridoxine Tablets are not recommended for use in children.

If you take more Pyridoxine Tablets than you should

If you accidentally take too many tablets contact your doctor or pharmacist or nearest hospital casualty department. Take this leaflet and any remaining tablets with you to show the doctor or pharmacist.


If you miss a dose of PyridoxineTablets

If you forget to take a dose, take another as soon as you remember. If it is almost time for your next dose, then do not take the missed dose at all. Do not take a double dose to make up for a forgotten tablet.

Stopping Pyridoxine Tablets

You should continue to take Pyridoxine Tablets for as long as your doctor tells you to. Do not stop taking the medicine without talking to your doctor first.


103437/4


pg 1/2

ARTWORK CHECK BOX


Process

Black


PRODUCT:

Pyridoxine 50mg Tablets - 28 Tabs

CUSTOMER :

Wockhardt UK

FP CODE:

FP2043

PLANT LOCATION :

Daman (Bhimpore)

DIMENSIONS :

(w)210 x (h)290mm

PHARMACODE No. :

2403

SAP CODE No. :

218422

TEXT FONT SIZE :

9.5 pt.

FILE NAME :

Pyridoxine 50mg_Leaflet_103437-4.ai

SOFTWARE :

Adobe Illustrator CS5

TYPEFACES:

Helvetica Neue Regular / Helvetica 75 Bold

ARTWORK (DETAILS) RECEIVED ON :

24th & 25th March, 2015

PROOF REVISION :

R 1st PDF sent on - 7TH APRIL 2015

CHANGE CONTROL : Version changes due to change in:

□ Size/Layout Ef Regulatory Non-Regulatory Changes in detail: ♦ Regulatory text amends_

♦    Pharmcode re-positioned at 8mm from the cutting edge

♦    Removed pre-printed neutral code_

♦    New single wing Wockhardt logo_


Product name

Reference number

Pyridoxine 50mg Tablets

29831/0181


4. POSSIBLE SIDE EFFECTS

Like many medicines Pyridoxine Tablets may cause side effects in some patients, although not everybody gets them.

If you take large doses of Pyridoxine Tablets for a long time you may develop problems with your nerves (peripheral neuritis). One of the symptoms of peripheral neuritis can be pins and needles.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting systems listed below:

United Kingdom:

Yellow Card Scheme

Website: www.mhra.gov.uk/yellowcard

Malta:

ADR Reporting, Website: www.medicinesauthority.gov.mt/adrportal

By reporting side effects you can help provide more information on the safety of this medicine.

Contents of the pack

Pyridoxine Tablets are available in strip packs of 28 tablets.

Marketing Authorisation Holder: Wockhardt UK Ltd,

Ash Road North, Wrexham, LL13 9UF, UK.

Manufacturer: CP Pharmaceuticals Ltd,

Ash Road North, Wrexham,

LL13 9UF, UK.

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information:

This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in 03/2015

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5. HOW TO STORE PYRIDOXINE TABLETS

Keep out of the reach and sight of children.

Do not take this medicine if the expiry date on the label has passed. The expiry date refers to the last day of that month.

Pyridoxine Tablets should not be taken if they show signs of deterioration.

Store below 25°C.

Store in the original container or package in order to protect from light and moisture. Do not transfer the tablets to another container.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.


6. FURTHER INFORMATION

What Pyridoxine Tablets contain

The active ingredient in Pyridoxine Tablets is pyridoxine

hydrochloride.


The other ingredients are calcium hydrogen phosphate, maize starch, sodium lauryl sulphate, magnesium stearate and    103437/4

purified water.    218422


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