FOLIC ACID

4 mg) daily prior to conception and be continued for at least the first 12 weeks of pregnancy.

Administration:

Oral. The tablets should be swallowed with a drink of water.

Gastrointestinal disorders Rare (≥1/10,000 to <1/1,000) Anorexia, nausea, abdominal distension and flatulence Immune system disorders Rare (≥1/10,000 to <1/1,000) Allergic reactions, comprising erythema, rash, pruritus, urticaria, and dyspnoea.

Not known (cannot be estimated from the available data) Anaphylactic reaction Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit /risk balance of the medicinal product.

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Folic acid should not be administered for treatment of pernicious anaemia or undiagnosed megaloblastic anaemia without sufficient amounts of cyanocobalamin (vitamin B12) as folic acid alone will not prevent and may precipitate development of subacute combined degeneration of the spinal cord.

Therefore a full clinical diagnosis should be made before initiating treatment. Women with pre-existing diabetes, obesity, family history of neural tube defects, or previous pregnancy affected by neural tube defect have an increased risk of having a pregnancy affected by a neural tube defect and higher doses should be considered.

Patients with rare hereditary problems of galactose intolerance, the total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

1. Folic acid should not be given alone in the treatment of Addisonian pernicious anaemia and other vitamin B12 deficiency states, as this may precipitate the onset of subacute combined degeneration of the spinal cord. Patients with malignant disease, unless megaloblastic anaemia due to folic acid deficiency.

Should not be taken by people with folate dependant tumours.