Patient leaflet - Pyridoxine Hydrochloride 50 mg film-coated tablets

1. What Pyridoxine tablets are and what they are used for 2. What you need to know before you take Pyridoxine

tablets

3. How to take Pyridoxine tablets
4. Possible side effects
5. How to store Pyridoxine tablets
6. Contents of the pack and other information
1. What Pyridoxine tablets are and what they are used for

Pyridoxine hydrochloride 50 mg film-coated tablets are further referred in this leaflet as Pyridoxine tablets.

The active ingredient of Pyridoxine tablets is pyridoxine hydrochloride, which is Vitamin B6.

Pyridoxine tablets are used to treat low levels of Vitamin B6 in the body and in the treatment of idiopathic sideroblastic anaemia where the red cells in the blood do not form properly.

Pyridoxine tablets can also be used to treat damage to the nerves (peripheral neuritis) caused by isoniazid, a medicine used to treat tuberculosis.

2. What you need to know before you take Pyridoxine tablets

Do not take Pyridoxine tablets:

If you are allergic to pyridoxine hydrochloride or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before taking Pyridoxine tablets if:

the patient is a child. Pyridoxine tablets are not recommended
for children.
Other medicines and Pyridoxine tablets
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, have recently taken or might take 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 following (or any other medicines):
- levodopa, a medicine used in the treatment of
  Parkinson’s disease
- isoniazid, used to treat tuberculosis
- oral contraceptives
- penicillamine, used to treat arthritis and other
  conditions.

If you have any doubts about whether you should take this medicine, then discuss them with your doctor before taking Pyridoxine tablets.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

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

3. How to take Pyridoxine tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Unless you are 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 mg to 150 mg daily in divided doses.

For the treatment of idiopathic sideroblastic anaemia

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

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

The usual adult dose is 50 mg 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.

If you forget to take Pyridoxine tablets

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.

Do not take a double dose to make up for a forgotten tablet.

If you stop taking 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.

If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines this medicine can cause side effects, 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 Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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

5. How to store Pyridoxine tablets

Keep this medicine out of the sight and reach of children.

Do not take this medicine after the expiry date which is stated on the blister and carton after ‘EXP’. The expiry date refers to the last day of that month.

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

This medicinal product does not require any special temperature storage conditions. Store in the original package in order to protect from light.

Do not throw away any medicines via

wastewater or household waste.

Ask your pharmacist how to throw away

medicines you no longer use.

These measures will help to protect the

environment.

6. Contents of the pack and other information

What Pyridoxine tablets contain

The active substance is pyridoxine hydrochloride. Each film-coated tablet contains 50 mg pyridoxine hydrochloride.

The other ingredients are:

Core tablet: microcrystalline cellulose, sodium starch glycolate (Type A), colloidal anhydrous silica, magnesium stearate. Film-coating: hypromellose, macrogol, talc, titanium dioxide.

What Pyridoxine tablets look like and contents of the pack

Pyridoxine tablet is a white to off white, circular, biconvex, film coated tablet with break line on one side and plain on other side.

Pack sizes: 10, 14, 20, 28, 30, 40, 50, 56, 60, 70, 80, 84, 90, 100 and 112 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Waymade PLC

Sovereign House

Miles Gray Road

Basildon, Essex, SS14 3FR

United Kingdom

Manufacturer: