FOLIC ACID

Posology Adults (including the elderly) In folate deficient megaloblastic anaemia: 5mg daily for 4 months; up to 15mg daily may be necessary for malabsorption states. In drug induced folate deficiency: 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 underlying disease. Prevention of neural tube defects in women known to be at risk: 5mg daily started before conception and continued throughout the first trimester.

Pregnancy:

In established folate deficiency: 5mg daily continued to term. Paediatric population For young children a more suitable dosage form should be used.

In folate deficient megaloblastic anaemia:

Child 1-18 years 5mg daily for 4 months; maintenance 5mg every 1-7 days. 5mg-5mg once daily. Child 12-18 years 5-10mg once daily.

Prophylaxis of folate deficiency in renal dialysis:

Child 1-12 years 250 microgram/kg (max 10mg) once daily. Children 12-18 years 5-10mg once daily. Method of administration For oral administration.

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): Not known: Allergic reactions, comprising erythema, rash, pruritis, urticaria, dyspnoea Anaphylactic reaction 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. Caution should be exercised when administering folic acid to patients who may have folate dependent tumours.

This product 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 defects. This product contains lactose.

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose – galactose malabsorption should not take this medicine. This product contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

1. 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. Folic acid should never be given alone in the treatment of Addisonian pernicious anaemia and other vitamin B12 deficiency states because it may precipitate the onset of subacute combined degeneration of the spinal cord.

Folic acid should not be used in malignant disease unless megaloblastic anaemia owing to folate deficiency is an important complication.