Flofol

Read all of this information carefully before you start taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Ask your pharmacist if you need more information or advice.
• If you get any side effects, talk to your doctor or pharmacist.

1. What FLOFOL 400 microgram tablets are and what they are used for
Folic Acid is a member of the vitamin B group. It is essential for good health. Folic acid is required for the manufacture of nucleic acids (such as DNA), the genetic material of cells. It is vital for the development and proper function of the central nervous system.

Folic acid 400 microgram tablets are indicated for the prevention of first time neural tube defects in the foetus. The neural tube is part of the nervous system and is located within the spine. Neural tube defects cause stillbirth, neonatal death and severe disabilities such as Spina Bifida. It is for use by women who are planning a pregnancy.

Studies have shown that over 70% of first time neural tube defects such as Spina Bifida can be prevented by taking folic acid (0.4mg) daily.

2. What you need to know before you take FLOFOL 400 microgram tablets
Do not take Folic Acid 400 microgram Tablets

•  If you are allergic to folic acid or any of the other ingredients of this medicine (listed in the label).
•  If you have a deficiency of vitamin B12, possibly caused by pernicious anaemia or a vegetarian diet.

Warning and precautions

Talk to your doctor or pharmacist before taking FLOFOL 400 microgram Tablets

•  If you are under therapy for a folate-dependent tumour.
•  If you have a family history of neural tube defects (NTDs), as you may need a higher dose of folic acid than this product provides.
•  If you suffer from diabetes, as you may need a higher dose of folic acid than this product provides.
•  If you are obese, as you may need a higher dose of folic acid than this product provides.

Other medicines and FLOFOL 400 microgram Tablets

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:

• Anti-epileptics (medicines used to treat epilepsy and fits) such as phenytoin, phenobarbital or primidone. Your doctor may need to change the amount of ant-epileptic 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.
• FLOFOL 400 microgram Tablets with food or drink.

The tablets should be swallowed with water.

• Pregnancy and breast-feeding
  Folic acid is indicated for use during pregnancy and lactation.

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

• Driving and using machines
  There is no information on the effects of Folic Acid 400 microgram Tablets on the ability to drive or use machines. However, no negative effect is anticipated.
• FLOFOL 400 microgram Tablets contain 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 FLOFOL 400 microgram Tablets
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

 The recommended dose is:

Adult females
Women planning a pregnancy should take one tablet (0.4 mg) daily. You should begin taking this product at least 14 weeks before you become pregnant and continue taking it for at least the first 12 weeks of pregnancy.

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

If you have an allergic reaction to Folic Acid 400 microgram Tablets see a doctor straight
away An allergic reaction may include:

•  Any kind of skin rash, flaking skin, boils or sore lips and mouth.
•  Sudden wheezing, fluttering or tightness of the chest or collapse.

Tell your doctor if you get any of these side effects:

• Feeling sick (nausea).
• Being sick (vomiting).
• Upset stomach