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Folic Acid Tablets Bp 0.4mg

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PATIENT INFORMATION LEAFLET

Folic Acid Tablets BP 0.4mg One a day

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 your pharmacist. This medicine has been prescribed only 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.

In this leaflet

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

2.    What you need to know before you take Folic Acid

3.    How to take Folic Acid

4.    Possible side effects

5.    How to store Folic Acid

6.    Contents of the pack and other information


1. WHAT FOLIC ACID IS AND WHAT IT IS USED FOR


The name of your medicine is Folic Acid Tablets BP 0.4mg. Folic Acid is a member of the Vitamin B group. It is essential for good health and is present in fresh and processed food.

You should use this medicine if you are trying to become pregnant and also during the first three months of your pregnancy.

You should also use this medicine when you know you are pregnant or think you are pregnant and continue to use it during the first three months of your pregnancy.

Folic acid is necessary for the development and growth of healthy cells and tissues. It is vital for the development and proper function of the central nervous system.

Folic Acid is used to help prevent babies being born with Neural Tube Defects such as Spina Bifida.

The neural tube is part of the nervous system and is located within the spine. The baby’s neural tube develops during the early stages of pregnancy and it is at this particular critical stage that neural tube defects such as spina bifida can occur.

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOLIC ACID


Do not take Folic Acid and tell your doctor if you:

•    are allergic (hypersensitive) to folic acid or any other ingredients in this product. Signs of an allergic reaction include a rash, itching or shortness of breath

•    suffer from untreated ‘pernicious anaemia’ or vitamin B12 (cobalamin) deficiency

•    suffer from a malignant disease (cancer or tumour)

•    are receiving treatment for a folate-dependant tumour

Talk to your doctor or pharmacist before taking Folic Acid if:

•    you have been told by your doctor that you have an intolerance to some sugars.

Taking other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

In particular, tell your doctor if you are taking any of the following:

•    Antiepileptics (medicines used to treat epilepsy and fits) such as phenytoin, phenobarbital or primidone. Your doctor may need to change the amount of antiepileptic medicine you are taking, because folic acid tablets may reduce the effect of these medicines.

•    Antibacterials (used to treat infections) e.g. chloramphenicol and co-trimoxazole

•    Sulfasalazine, an anti-inflammatory drug used for the treatment of arthritis or inflammatory bowel disease, including ulcerative colitis or Crohn’s disease

•    Methotrexate, a disease modifying anti rheumatic drug used to treat severe active rheumatoid arthritis, severe psoriasis and certain types of cancer.

Pregnancy and Breast-feeding

This medicine is to be used before you become pregnant and during the first 12 weeks of your pregnancy. If you think you are pregnant you should start taking Folic Acid. Folic acid is needed for the development of your baby’s spine and brain in the early weeks of pregnancy.

Driving and using machines

Folic acid is not likely to affect you being able to drive or use machines.

Important information about some of the ingredients in Folic Acid Tablets BP 0.4mg

This medicine contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

3. HOW TO TAKE FOLIC ACID


Take this medicine as your doctor or pharmacist has told you. Look on the label and ask the doctor or pharmacist if you are not sure.

Taking this medicine

The tablets should be swallowed with water.

Each tablet contains 0.4mg (400pg) of folic acid.

Women who are planning or trying to become pregnant:

Take one tablet (0.4mg) daily

You should begin taking this product before you become pregnant and continue taking it for at least the first 12 weeks of pregnancy. If you think you are pregnant you should start taking this product.

If you take more Folic Acid than you should

If you, or anyone else, have taken too many tablets you should contact your doctor or go to a hospital straight away.

If you forget to take Folic Acid

If you forget to take a dose take it as soon as you remember it. If it is nearly time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

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

4.


POSSIBLE SIDE EFFECTS


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

Tell your doctor if you notice any of the following side effects, they get worse or you notice any not listed:

As can happen with any medicine, a few people may develop an allergic reaction. If you experience any of the following, seek medical help immediately:

•    itchy/red skin, rash, swelling of the face, lips, tongue or throat or difficulty breathing or swallowing, shock (cold sweaty skin, weak pulse, dry mouth, dilated pupils).

The side effects that some patients have had with Folic Acid Tablets are:

•    Stomach and intestines: loss of appetite, feeling sick, bloating of the stomach, flatulence (wind). 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.

5.    HOW TO STORE FOLIC ACID


Do not use the tablets after the expiry date printed on the pack.

KEEP OUT OF THE SIGHT AND REACH OF CHILDREN

Store the tablets below 25oC in a dry place, away from direct light.

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 CONTENTS OF THE PACK AND OTHER INFORMATION

What Folic Acid contains

The active ingredient is folic acid. Each tablet contains 0.4mg (400pg) of folic acid.

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

What Folic Acid looks like and contents of the pack

Folic acid tablets 0.4mg are pale yellow, circular tablets.

It comes in pack sizes of 28, 56, 84, 90, 98 and 100 tablets.

Marketing Authorisation Holder and Manufacturer

Athlone Pharmaceuticals Limited, Ballymurray, Co. Roscommon, Ireland

Distributed by

Kent Pharmaceuticals Limited, Wotton Road, Ashford, Kent, TN23 6LL, U.K.

PL 30464/0027

This leaflet was last revised in November 2013.