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Folic Acid 5mg Tablets

Active Ingredient:
folic acid
Company:  
Wockhardt UK Ltd See contact details
About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL) HCP Med Info
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 09 Jul 2018
{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 29831/0097.

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Folic Acid 5mg Tablets

Package leaflet: Information for the user

Folic Acid 5mg Tablets

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
  • 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 only. Do not pass it on to others. It may harm them, even if their signs of illness 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.

What is in this leaflet:

1. What Folic Acid Tablets are and what they are used for
2. What you need to know 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. Contents of the pack and other information

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

The name of your medicine is Folic Acid Tablets, which contains folic acid, a vitamin essential in the production and maintenance of new cells.

Folic Acid Tablets are used in the treatment and prevention of:

  • anaemia due to a lack of folic acid in adults and children
  • anaemia in pregnancy
  • anaemia, as a side effect from treatment with certain medicines
  • anaemia due to damaged red blood cells
  • anaemia in patients on kidney dialysis.

Folic acid Tablets can also be given to some women before and during pregnancy to prevent spina bifida (an abnormality of the spine) in babies, which can be caused by deficiency of this vitamin.

2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE FOLIC ACID TABLETS
Do not take Folic Acid Tablets:
  • if you are allergic to folic acid or to any of the other ingredients of this medicine (listed in section 6).
  • if you have cancer (unless you have anaemia due to a deficiency of folic acid)

Warnings and precautions

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

  • if you are undergoing haemodialysis due to kidney failure
  • if you are receiving a coronary stent (a tube that is inserted in the artery that leads to the heart, in order to stop blockages)
  • if you suffer from pernicious anaemia (a disorder preventing the absorption of vitamin B12) or could be suffering from a lack of vitamin B12
  • if you have a tumour. Care needs to be taken in patients with certain tumours.

Other medicines and Folic Acid Tablets

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

The following medicines can affect or be affected by treatment with Folic Acid Tablets:

  • phenytoin, phenobarbital and primidone (used to control epileptic fits)
  • Fluorouracil, a drug used to treat certain tumours
  • antibiotics. Some antibiotics (trimethoprim and sulphonamides, sometimes combined as co-trimoxazole) reduce the effect of folic acid. All antibiotics can interfere with folic acid blood test results
  • Some indigestion remedies (edible clay and antacids containing aluminium or magnesium). Allow at least a two hour gap between taking your Folic Acid Tablets and indigestion remedies
  • Preparations containing zinc such as vitamins or food supplements (this may be important in pregnancy)
  • sulfasalazine, used to treat the inflammatory bowel conditions ulcerative colitis and Crohn's disease
  • cholestyramine, used to reduce cholesterol levels in the blood

Pregnancy and breast-feeding

This medicine can be taken in pregnancy to treat anaemia.

If you are breast feeding please speak with your doctor before taking this medicine.

Driving and using machinery

This medicine should not affect your ability to drive a car or operate machinery.

Folic Acid Tablets 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 TABLETS

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

Your doctor will decide the right dose for you; this will be on the pharmacist’s label. Check this carefully, it will tell you how much of this medicine to take and how often to take it. This medicine should be swallowed. Unless told otherwise, take your tablet with water.

The recommended doses are as follows:

Anaemia

Adults and children over 1 year:

One tablet a day for the treatment of anaemia or one tablet everyone to seven days for the prevention of anaemia (depending on diet and underlying disease).

Children less than 1 year of age:

500 micrograms per kilogram of body weight daily.

Prevention of spina bifida:

One tablet a day, starting before conception and continuing for the first three months of pregnancy.

If you take more Folic Acid Tablets than you should

If you (or anybody else, including a child), takes more Folic Acid Tablets than you should, it is unlikely that this medicine will cause any harm. If you are at all concerned contact your doctor. Always take the carton and this leaflet with you.

If you forget to take Folic Acid Tablets

If you forget 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 at all. Do not take a double dose to make up for a forgotten dose.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

As can happen with any medicine, a few people may develop an allergic reaction (hypersensitivity) or a severe allergic reaction (anaphylactic 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; dizziness; weakness and/or fainting).

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

  • loss of appetite (anorexia)
  • feeling sick
  • bloating of the stomach
  • flatulence (wind)
  • worsening of the symptoms of vitamin B12 deficiency. Folic acid should never be used to treat anaemia without a full investigation of the cause.

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 FOLIC ACID TABLETS

Keep out the sight and reach of children.

Do not store above 25°C. Store in the original container in order to protect from light.

Do not take after the expiry date on the container (bottle label or carton) or if the tablets show signs of ‘going off’ such as discolouration. The expiry date refers to the last day of the month.

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 protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Folic Acid Tablets contain

The active substance is folic acid. The tablet comes in one strength, 5mg.

The other ingredients are: lactose, maize starch, acacia spray-dried, magnesium stearate and stearic acid.

What Folic Acid Tablets look like and contents of the pack

Folic Acid Tablets are plain yellow, biconvex tablets with a breakline on one face and CP on the reverse.

Folic Acid Tablets are available in:

  • polypropylene or polyethylene tablet containers containing 100, 500 or 1,000 tablets
  • glass bottles containing 100, 500 or 1,000 tablets
  • blister packs containing 28 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Wockhardt UK Ltd
Ash Road North
Wrexham
LL13 9UF
UK

Manufacturer:

CP Pharmaceuticals Ltd
Ash Road North
Wrexham
LL13 9UF
UK

Other formats:

To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

0800 198 5000 (UK Only).

Please be ready to give the following information:

Product name Reference number

Folic Acid 5mg Tablets 29831/0097

This is a service provided by the Royal National Institute of Blind People.

This leaflet was last revised in 05/2018.

107289/4

11001908

Wockhardt UK Ltd
Company image
Address
Ash Road North, Wrexham Industrial Estate, Wrexham, LL13 9UF
WWW
www.wockhardt.co.uk
Telephone
+44 (0)1978 661 261
Fax
+44 (0)1978 661 702
Medical Information e-mail
[email protected]