FOLIC ACID

In folate-deficient megaloblastic anaemia Adults, children over age of 1 year and elderly. Initially 5 mg daily for 4 months or until a haematopoietic response has been obtained. Up to 15 mg may be recommended in malabsorption states.

Maintenance dose - one 5 mg tablet every 1 - 7 days depending on the underlying disease. For prophylaxis in chronic haemolytic states or in renal dialysis. 5 mg daily or even weekly, depending on the diet and the rate of haemolysis. Children up to 1 year of age 500 microgram per kg of body weight daily.

Oral administration.

Folic acid is generally well tolerated although the following side effects have been reported: Gastroin testinal disorder s Rare (≥1/10,000 to <1/1,000) Anorexia, nausea, abdominal distension and flatulence Immune system disorder s Rare (≥1/10,000 to <1/1,000) Allergic reactions, comprising erythema, rash, pruritus, urticaria, dyspnoea, and anaphylactic reactions (including shock).

Anaphylactic reaction Blood and lymphat ic system disorder Folic acid may worsen the symptoms of co- existing vitamin B12 deficiency and 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.

It is important to establish which deficiency is present and the underlying cause before commencing treatment. 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. Therefore a full clinical diagnosis should be made before initiating treatment.

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

• 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. • Known hypersensitivity to the active ingredient or any of the excipients.