Summary of Product Characteristics (SmPC) - Folic Acid tablets 5 mg
1 NAME OF THE MEDICINAL PRODUCT
Folic Acid Tablets 5mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains folic acid BP 5mg.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
For the treatment and prophylaxis of megaloblastic anaemia or pernicious anaemia, administered with adequate amounts of hydroxocobalamin, and for the treatment and prophylaxis of folic acid deficiency e.g. caused by the administration of phenytoin.
4.2 Posology and method of administration
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.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
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.
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.
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’.
4.5 Interaction with other medicinal products and other forms of interaction
Sulfasalazine and triamterene also inhibit absorption.
Concurrent administration with colestyramine may interfere with folic acid absorption. Patients on prolonged colestyramine therapy should take folic acid 1
hour before or 4 to 6 hours after receiving colestyramine.
Antibiotics may interfere with the microbiological assay for serum and erythrocyte folic acid concentrations and may cause falsely low results.
Antibacterials, chloramphenicol and co-trimoxazole, may interfere with folate metabolism. Trimethoprim or sulphonamides, alone or in combination as co-trimoxazole, may reduce the effect of folic acid and this may be serious in patients with megaloblastic anaemia.
Folate supplements enhance the efficacy of lithium therapy. Methotrexate and trimethoprim are specific anti-folates and the folate deficiency
caused by their prolonged use cannot be treated by Folic Acid Tablets 5mg. Folinic acid should be used.
Nitrous oxide anaesthesia may cause an acute folic acid deficiency.
Both ethanol and aspirin increase folic elimination.
Serum levels of anticonvulsant drugs (phenytoin, phenobarbital, primidone) may
be reduced by administration of folate and therefore patients should be carefully
monitored by the physician and the anticonvulsant drug dose adjusted as necessary.
Fluorouracil toxicity may occur in patients taking folic acid and this combination
should be avoided.
Edible clay or antacids containing aluminium or magnesium may reduce folic acid absorption. Patients should be advised to take antacids at least two hours after administration of folic acid.
Folic acid may reduce intestinal absorption of zinc (of particular importance in pregnancy).
4.6 Fertility, pregnancy and lactation
Pregnancy
Folic acid deficiency during pregnancy may lead to the appearance of foetal malformations. Imbalance in folate requiring trophoblast cells may also lead to detachment of the placenta.
Very high doses of folic acid have been shown to cause foetal abnormalities in rats; however, harmful effects in the human foetus, mother or the pregnancy have not been reported following ingestion of folic acid.
Breast-feeding
Folic acid is excreted in breast milk. 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
None known.
4.8 Undesirable effects
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. 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 cases of acute overdosage appear to have been reported, but even extremely high doses are unlikely to cause harm to patients. No special procedures or antidote are likely to be needed.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: folic acid and derivatives, ATC Code: B03BB01.
Folic acid is a member of the vitamin B group which is reduced in the body to tetrahydrofolate, a co-enzyme active in several metabolic processes and produces a haemopoietic response in nutritional megaloblastic anaemias (but see warning in Section 4.4 regarding need for concomitant use of hydroxycobalamin).
Folic acid is rapidly absorbed and widely distributed in body tissues. It is used in the treatment and prevention of folate deficiency states.
5.2 Pharmacokinetic properties
Absorption – folic acid is rapidly absorbed from the gastrointestinal tract, mainly from the proximal part of the small intestine. Dietary folates are stated to have about half the bioavailability of crystalline folic acid. The naturally occurring folate polyglutamates are largely deconjugated and reduced by dihydrofolate reductase in the intestine to form 5-methyltetrahydrofolate (5MTHF). Folic acid given therapeutically enters the portal circulation largely unchanged, since it is a poor substrate for reduction by dihydrofolate reductases.
Distribution – via portal circulation. 5MTHF from naturally occurring folate is extensively plasma bound. The principal storage site of folate is in the liver; it is also actively concentrated in the CSF. Folate is distributed into breast milk.
Metabolism – therapeutically given folic acid is converted into the metabolically active form 5MTHF in the plasma and liver. There is an enterohepatic circulation for folate.
Elimination – Folate metabolites are eliminated in the urine and folate in excess of body requirements is excreted unchanged in the urine. Folic acid is removed by haemodialysis.
5.3 Preclinical safety data
There are no preclinical safety data of relevance to the prescriber.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Dicalcium phosphate, starch, sodium lauryl sulphate and magnesium stearate.
6.2 Incompatibilities
None known.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Store in a cool dry place. Protect from light.
6.5 Nature and contents of container
Securitainers, pack sizes 50 and 100 tablets. Opaque screw-cap plastic containers, pack sizes 250 and 500 tablets. Polybag-lined lever lid tins, pack sizes 1,000 and 5,000 tablets.
6.6 Special precautions for disposal
Not applicable.
7 MARKETING AUTHORISATION HOLDER
Ennogen IP Ltd
Unit G4, Riverside Industrial Estate,
Riverside Way,
Dartford,
DA1 5BS,
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 55612/0124
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
18/06/1992
10 DATE OF REVISION OF THE TEXT
04/06/2026