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Folic Acid 5mg Tablets

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Document: leaflet MAH GENERIC_PL 20416-0290 change

Patient Information Leaflet

Folic Acid 5 mg Tablets

This medicine will be called Folic Acid Tablets in this leaflet.

Read all of this leaflet carefully before you start taking this medicine

•    Keep this leaflet. You may need to read it again.

•    This medicine is only for you. Do not give it to anyone else to take. It may harm them, even if their symptoms are the same as yours.

•    If you have any further questions, please ask your doctor or pharmacist.

•    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 Tablets are and what they are used for

2.    Before you take Folic Acid Tablets

3.    How to take Folic Acid Tablets

4.    Possible side effects

5.    How to store Folic Acid Tablets

6.    Further information

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

These tablets contain the active ingredient, folic acid. Folic acid is the chemical name for Vitamin B9. It is necessary for the normal production of blood cells.

Folic Acid Tablets are used for the treatment of certain types of anaemia. They are also used to help prevent the breakdown of red blood cells which can occur as a result of renal (kidney) dialysis or certain other conditions.

2. Before you take Folic Acid Tablets Some people must not take these tablets. Talk to your doctor if:

• You know you are allergic to folic acid or to any of the other ingredients (these are listed in section 6)

• You are suffering from pernicious anaemia or any other vitamin B12 deficiency unless you have already been treated with a drug called hydroxocobalamin

•    You have cancer.

You must be especially careful if:

• You have an intolerance to some sugars. These tablets contain small amounts of lactose and sucrose.

If any of the conditions above apply to you, please discuss your treatment with your doctor before taking this medicine.

Taking other medicines

Folic Acid Tablets can affect, or be affected by, some other medicines you may be taking. Make sure your doctor knows if you are taking any of the following:

•    Medicines for epilepsy e.g. carbamazepine, phenytoin, primidone, sodium valproate or phenobarbital (The dose of these drugs may need to be adjusted)

• Sulfasalazine, used to treat some inflammatory conditions including rheumatoid arthritis, Crohn's disease or ulcerative colitis

•    Triamterene, a diuretic used to treat raised blood pressure and oedema

•    Methotrexate, a cancer drug which can also be used to treat psoriasis

•    Trimethoprim, an antibiotic

•    Aspirin

•    Drugs containing lithium, used to treat depression.

Always tell your doctor or pharmacist about all the medicines you are taking including other vitamin supplements. This means medicines you have bought yourself as well as those you have on prescription from your doctor.

Pregnancy and breastfeeding

Women are frequently recommended to take folic acid when they are trying for a baby, and during the first few months of pregnancy, however, you should check with your doctor before taking any drugs if you are pregnant or breastfeeding.

Driving and using machinery

Folic Acid Tablets should not affect your ability to drive or operate machinery.

Other special warnings

•    Alcohol may reduce folic acid levels

•    If you need a general anaesthetic make sure your doctor or dentist is aware you are taking Folic Acid.

3. How to take Folic Acid Tablets

The tablets should be swallowed with a drink of water.

The doctor will decide what dose of tablets you need to take. Always take the tablets exactly as the doctor has told you. The dose will be on the pharmacist's label. If you are not sure, ask your doctor or pharmacist. Carry on taking them for as long as you have been told unless you have any problems. In that case, check with your doctor.

The usual doses are as follows:

Adults, the elderly and children over 1 year of age:

The usual dose is 1 tablet daily for up to 4 months. After that your doctor may reduce the dose to 1 tablet every few days. In rare cases some people may need to take up to 3 tablets daily.

If you take more tablets than you should

If you have taken more tablets than you should, speak to your doctor or pharmacist straightaway. Take your tablets or the pack with you so they know what you have taken.

If you forget to take a dose of Folic Acid Tablets

If you miss a dose don't worry. Miss this dose and carry on with the normal routine.

4. 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 if you experience the following rare effects (may affect less than 1 in 1,000 people):

• Allergic reactions which can include itchy red skin, rash, hives, breathlessness, swelling of the face, lips, tongue or throat, difficulty breathing, dizziness, shock.

Other rare effects which have been reported are:

• Nausea (feeling sick), loss of appetite

•    Bloated or swollen stomach or abdomen, wind.

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

5. How to store Folic Acid Tablets

Keep out of the sight and reach of children.

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

Containers: Do not store above 25C. Keep the container tightly closed.

Do not use the tablets after the expiry date shown on the carton or label.

If you stop taking the tablets, please take any left over back to your pharmacist to be destroyed.

Ingredients

Each tablet contains 5 mg of the active ingredient, folic acid. The other ingredients are lactose, pregelatinised maize starch, sucrose and stearic acid.

What the medicine looks like

The tablets are round and yellow with no markings. They are supplied to your pharmacist in packs of 28, 56, 100,

500 or 1000 tablets. Not all pack sizes may be available.

Product licence holder and manufacturer

The Product Licence holder is Crescent Pharma Ltd, Units 3 & 4, Quidhampton Business Units, Polhampton Lane, Overton, Hampshire, RG25 3ED.

Manufactured by Surepharm Services Ltd., Bretby, Burton upon Trent, Staffs, DE15 0YZ, UK.

Product Licence Number: PL 20416//0290

Date of revision: October 2014.

If you would like the leaflet in a different format, please contact the licence holder at the above address.

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