Each yellow uncoated tablet contains 5mg folic acid
Folic acid is a component of the B group of vitamins and is necessary for the normal production and maturation of red blood cells
- For the treatment of folate-deficient megaloblastic anaemia due to malnutrition, malabsorption syndromes (such as coeliac disease or sprue) and increased utilisation as in pregnancy. It should not be used alone in undiagnosed megaloblastic anaemia including in infancy, pernicious anaemia or macrocytic anaemia of unknown aetiology, unless administered with adequate amounts of hydroxocobalamin.
- For the prophylaxis of drug induced folate deficiency e.g., caused by administration of phenytoin, phenobarbital and primidone. (See section 4.5).
- For the prophylaxis against folate deficiency in chronic haemolytic states or in renal dialysis.
- For the prevention of neural tube defects for woman planning a pregnancy and known to be at risk
Posology and method of administration
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.
In established folate deficiency: 5mg daily continued to term.
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.
In haemolytic anaemia; metabolic disorders:
Child 1-12 years 2.5mg-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.
- Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
- 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 B12deficiency 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.
Special warnings and precautions for use
- Patients with vitamin B12deficiency 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 monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose – galactose malabsorption should not take this medicine
No special procedures or antidote are likely to be needed.
Special precautions for storage
Store below 25°C in a dry place.
Protect from light.
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