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Pharma code 1200

FOLIC ACID 5 mg TABLETS

BEFORE YOU TAKE FOLIC ACID

PACKAGE LEAFLET: INFORMATION FOR THE USER

Read all of this leaflet carefully before you

start taking this medicine.

•    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. Do not pass it on to others. It may harm them, even if their symptoms 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.

DO NOT take Folic Acid and contact your doctor if you:

•    are allergic (hypersensitive) to folic acid or any of the other ingredients of this medicine

•    have pernicious anaemia, a disease where an inability to absorb vitamin B12 prevents the production of red blood cells and can damage the spinal cord or other vitamin B12 deficiency states without adequate amounts of cyanocobalamin.

IN THIS LEAFLET:

1.    What Folic Acid is and what it is used for

2.    Before you take Folic Acid

3.    How to take Folic Acid

4.    Possible side effects

5.    How to store Folic Acid

6. Further information

OWHAT FOLIC ACID IS AND WHAT IT IS USED FOR

•    Folic acid is a dietary supplement

•    Folic acid is used:

•    to treat anaemia (reduction in red blood cells which can make the skin pale and cause weakness or breathlessness) due to folic acid deficiency and as a supplement to folate deficiency

•    during pregnancy to help prevent neural tube defects in the developing foetus. These defects affect the spinal cord or brain development in the foetus and can lead to conditions such as spina bifida.

Take special care with Folic Acid

Tell your doctor before you start to take this

medicine if you:

•    have cancer.

Taking other medicines

Talk to your doctor if you are taking any of the following:

•    phenytoin

•    phenobarbital.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Important information about some of the ingredients of Folic Acid

•    Patients who are intolerant to lactose should note that Folic Acid tablets contain a small amount of lactose. If your doctor has told you that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Pregnancy and breast-feeding

•    If you are pregnant, planning to become pregnant or are breast-feeding, ask your doctor for advice before taking any medicine.

Driving and using machines

•    Folic Acid is not expected to affect your ability to drive or operate machinery.

^3 HOW TO TAKE FOLIC ACID

Always take Folic Acid exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure.

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The tablets should be swallowed preferably with a drink of water.The usual dose is:

•    Adults including the Elderly, and Children over 1 year

Initially 5 mg daily for four months, thereafter the usual maintenance dose is 5 mg every 1-7 days.

The usual dosage during pregnancy is 5 mg daily.

•    Children up to 1 year of age:

500 micrograms per kg of bodyweight daily.

If you take more Folic Acid than you should

If you (or someone else) swallow a lot of the tablets all together, or if you think a child has swallowed any of the tablets, contact your nearest hospital casualty department or your doctor immediately.

Please take this leaflet, any remaining tablets, and the container with you to the hospital or doctor so that they know which tablets were consumed.

If you forget to take Folic Acid

If you forget to take a tablet, take one as soon as you remember, unless it is nearly time to take the next one. DO NOT take a double dose to make up for a forgotten dose.

If you stop taking Folic Acid

DO NOT stop taking your medicine without talking to your doctor first even if you feel better.

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

POSSIBLE SIDE EFFECTS

Like all medicines, Folic Acid can cause side effects, although not everybody gets them.

Stop taking the tablets and tell your doctor immediately or go to the casualty department at your nearest hospital if the following happens:

•    an allergic reaction (swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives).

This is a very serious but rare side effect.

You may need urgent medical attention or hospitalisation.

The following side effects have been reported:

•    loss of appetite

•    feeling sick

•    bloating.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. 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 By reporting side effects you can help provide more information on the safety of this medicine.

HOW TO STORE FOLIC ACID

Keep out of the reach and sight of children.

Do not store above 25°C. Store in the original package.

Do not use Folic Acid after the expiry date that is stated on the outer packaging.The expiry date refers to the last day of that month.

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.

FURTHER INFORMATION

What Folic Acid Tablets contain:

•    The active ingredient is folic acid 5 mg.

•    The other ingredients are lactose, dextrin, maize starch and magnesium stearate.

What Folic Acid Tablets look like and contents of the pack:

•    Folic Acid 5 mg Tablets are yellow biconvex tablets engraved with APS 0406 on one side and are plain on the other side

•    The tablets are available in packs of 7, 10, 14, 21, 28, 30, 56, 60, 84, 90, 100, 110, 112, 120, 150, 160 and 168, 10 x 50 and 1000. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation holder and company responsible for manufacture: TEVA UK Limited, Eastbourne, BN22 9AG. This leaflet was last revised: June 2015 PL 00289/5094R

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