FOLIC ACID

Posology Adults In folate deficient megaloblastic anaemia: 5mg daily for 4 months. Up to 15mg daily may be necessary for malabsorption states. For prophylaxis in chronic haemolytic states or in renal dialysis: 5mg every 1-7 days depending on diet and underlying disease.

In drug induced folate deficiency: 5mg daily.

Paediatric population Over 1 year:

As adult dose. Up to 1 year: 500μg/kg daily. Method of administration For oral use.

Folic acid is generally well tolerated although the following side effects have been reported: System organ class Frequency Adverse event Blood and lymphatic system disorders Not known (cannot be estimated from the available data) Worsening of symptoms of co-existing vitamin B12 deficiency* Immune system disorders Rare (≥1/10,000 to 1<1,000) Allergic reactions comprising erythema, rash, pruritus, urticaria, dyspnoea and anaphylactic reaction (including shock) Gastrointestinal disorders Rare (≥1/10,000 to 1<1,000) Anorexia, nausea, abdominal distension, flatulence *Folic acid should never be used to treat anaemia without a full investigation of the cause.

Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

Patients with vitamin B12 deficiency should not be treated with folic acid unless administered with adequate amounts of hydroxocobalamin, as it can mask the condition but the subacute irreversible damage to the nervous system will continue.

The deficiency can be due to undiagnosed megaloblastic anaemia including in infancy, pernicious anaemia or macrocytic anaemia of unknown aethiology or other cause of cobalamin deficiency, including lifelong vegetarians. Folate should not be routinely used in patients receiving coronary stents.

Caution should be exercised when administering folic acid to patients who may have folate dependent tumours. Folic acid is removed by haemodialysis. This medicine is not intended for healthy pregnant women where lower doses are recommended, but for pregnant women with folic acid deficiency or women at risk for the reoccurrence of neural tube defect.

This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.

1. Should not be given alone in Addisonian anaemia or other vitamin B12 deficiency states because it may precipitate the onset of subacute combined degeneration of the spinal cord. Do not use in malignant disease unless megaloblastic anaemia due to folate deficiency is an important complication.

Long-term folate therapy is contraindicated in any patient with untreated cobalamin deficiency. This can be untreated pernicious anaemia or other cause of cobalamin deficiency, including lifelong vegetarians. In elderly people, a cobalamin absorption test should be done before long-term folate therapy.

Folate given to such patients for 3 months or longer has precipitated cobalamin neuropathy. No harm results from short courses of folate.