4.1. Therapeutic indications

Folic Acid is a component of the B group of vitamins and is necessary for the normal production and maturation of red blood cells.

1. 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.

2. For the prophylaxis of drug induced folate deficiency e.g. caused by administration of phenytoin, phenobarbital and primidone. (See section 4.5).

3. For the prophylaxis against folate deficiency in chronic haemolytic states or in renal dialysis.

4. For the prevention of neural tube defects for woman planning a pregnancy and known to be at risk. (See section 4.6).

4.2. Posology and method of administration

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.

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.

4.3. Contraindications

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 folic acid or any of the excipients listed in section 6.1.

4.4. Special warnings and precautions for use

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 defect.

Folic Acid Tablets contain lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Folic Acid Tablets contain sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

4.5. Interaction with other medicinal products and other forms of interaction

There is a specific interaction between phenytoin and folate such that chronic phenytoin use produces folate deficiency. Correction of the folate deficiency reduces plasma phenytoin with potential loss of seizure control. Similar but less marked relationship exist with all anti-convulsant treatments including sodium valproate, carbamazepine and the barbiturates (including phenobarbital and primidone). Sulphasalazine and triamterene also inhibit absorption.

Antibacterials - chloramphenicol and co-trimoxazole, may interfere with folate metabolism.

Folate supplements enhance the efficacy of lithium therapy.

Folic acid may interfere with the toxic and therapeutic effects of methotrexate. Methotrexate and trimethoprim are specific anti-folates and the folate deficiency caused by their prolonged use cannot be treated by Folic Acid Tablets BP.

Folinic acid should be used.

Nitrous oxide anaesthesia may cause an acute folic acid deficiency.

Both ethanol and aspirin increase folic elimination.

4.6. Fertility, pregnancy and lactation

Pregnancy

There are no known hazards to the use of folic acid in pregnancy, supplements of folic acid are often beneficial.

Non-drug - induced folic acid deficiency, or abnormal folate metabolism, is related to the occurrence of birth defects and some neural tube defects.

Interference with folic acid metabolism or folate deficiency induced by drugs such as anticonvulsants and some antineoplastics early in pregnancy results in congenital anomalies. Lack of the vitamin or its metabolites may also be responsible for some cases of spontaneous abortion and intrauterine growth retardation.

Breast-feeding

Folic acid is actively excreted in human breast milk. Accumulation of folate in milk takes precedence over maternal folate needs. Levels of folic acid are relatively low in colostrum but as lactation proceeds, concentrations of the vitamin rise. No adverse effects have been observed in breast fed infants whose mothers were receiving folic acid.

4.7. Effects on ability to drive and use machines

No effect on concentration and co-ordination.

4.8. Undesirable effects

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, dyspnoea and Anaphylactic reaction (including shock)

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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

4.9. Overdose

No special procedures or antidote are likely to be needed.