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Folic Acid 5mg Tablets

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Document: leaflet MAH GENERIC_PL 20395-0133 change

Patient Information Leaflet

FOLIC ACID 5mg TABLETS

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 any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

In this leaflet:

1.    What Folic Acid 5mg Tablets is and what they are used for

2.    Before you take Folic Acid 5mg Tablets

3.    How to take Folic Acid 5mg Tablets

4.    Possible side effects

5.    How to store Folic Acid 5mg    Tablets

6.    Further information

1.    WHAT FOLIC ACID 5MG    TABLETS ARE AND WHAT THEY ARE USED FOR

Folic acid is a vitamin used to prevent or treat a deficiency (lack of) folic acid in the body.

Folic Acid 5mg Tablets are used in the treatment and prevention of certain types of anaemia (low red blood cells), e.g. megaloblastic anaemia or pernicious anaemia caused by folate and/or vitamin B12 deficiency. Adequate amounts of vitamin B12 (Hydroxocobalamin) need to be given along with folic acid.

Folic Acid 5mg Tablets are also used when there is deficiency of folic acid, for example when “phenytoin” a drug used for epilepsy (fits) is taken.

2. BEFORE YOU TAKE FOLIC ACID 5MG TABLETS DO NOT take Folic Acid 5mg Tablets if:

•    you know that you are allergic to folic acid or any of the other ingredients of Folic Acid 5mg Tablets (see section 6 of this leaflet).

•    pernicious anaemia (a form of anaemia caused by lack of vitamin B12) or another condition caused by vitamin B12 deficiency.

•    a malignant (cancerous) disease.

Take special care with Folic Acid 5mg Tablets:

If you suffer from other Vitamin B12 deficiency states, you should also be given vitamin B12 in addition to folic acid, as folic acid should never be taken alone in the treatment of Vitamin B12 deficiency states.

Check with your doctor or pharmacist before taking Folic Acid tablets if you have:

•    a folate dependent tumour.

If any of the above conditions apply to you, speak to your doctor before you take these tablets. Taking other medicines

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

•    antiepileptics (to treat epilepsy) such as phenytoin, phenobarbital and primidone

•    antibacterials (to treat infections) such as chloramphenicol and co-trimoxazole

•    sulfasalazine (to treat ulcerative colitis, Crohn’s disease or rheumatoid arthritis)

•    methotrexate (to treat Crohn’s disease, psoriasis or rheumatoid arthritis)

Pregnancy and breast feeding

Ask your doctor or pharmacist for advice before taking any medicine.

You should let your doctor know if you are or think you may be pregnant or are planning to become pregnant, or are breast feeding.

3. HOW TO TAKE FOLIC ACID 5MG TABLETS

Please read the label carefully, it will tell you how many Folic Acid 5mg Tablets to take each day. Folic Acid 5mg Tablets should be swallowed with a glass of water.

Usual dose in adults:

For the treatment of anaemia (low red blood cells): one tablet a day

For the prevention of anaemia (low red blood cells): one tablet every one to seven days

Folic Acid 5mg Tablets are not recommended for use in children.

Your doctor will decide the best dose for you. Always take Folic Acid 5mg Tablets exactly as your doctor has told you. You should take your medicine for as long as your doctor tells you. Check with your doctor or pharmacist if you are not sure.

Your doctor may also give you Hydroxocobalamin by injection.

If you take more Folic Acid 5mg Tablets than you should:

There should be no problem if you accidentally take too much of this medicine. If you are concerned, please speak to your doctor or pharmacist.

If you forget to take your Folic Acid 5mg Tablets:

If you miss a dose, take it as soon as you remember, if it is within a few hours of the normal time. Otherwise, leave out that dose completely and take your next dose at the normal time it is due.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Folic Acid 5mg Tablets can sometimes 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:

Rare (affecting more than 1 in 10,000 but less than 1 in 1,000 patients)

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

   Stomach and gut: loss of appetite, feeling sick, a bloated feeling, wind.

If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

5. HOW TO STORE FOLIC ACID 5MG TABLETS

Keep out of the reach and sight of children.

Do not use Folic Acid 5mg Tablets after the expiry date which is stated on the box. If your medicine is out of date, take it to your pharmacist who will get rid of it safely.

Do not store above 25°C. Store in the original container/package. Protect from light.

6. FURTHER INFORMATION

The active substance in Folic Acid 5mg Tablets is folic acid.

Folic Acid 5mg Tablets also contains calcium hydrogen phosphate, starch, sodium lauryl sulphate, magnesium stearate.

What Folic Acid 5mg Tablets look like and contents of pack

The tablets are plain yellow biconvex tablets.

Folic Acid 5mg Tablets are available in blister packs of 28 tablets or securitainers (plastic bottles) containing 50, 100, 250, 1000 or 5000 tablets (not all pack sizes may be marketed)

Marketing authorization holder

Relonchem Limited, Cheshire House, Gorsey Lane, Widnes, Cheshire, UK, WA8 0RP. Product License Number: PL20395/0133

This leaflet was last revised in November 2014.

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