Folic Acid Tablets 5mg
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Folic Acid Tablets 5mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains folic acid BP 5mg.
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
For the treatment of anaemias:
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Adults and the elderly: |
5mg daily for up to 4 months, with adequate amounts of hydroxocobalamin by injection. Up to 15mg daily in malabsorption states. |
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Children: |
Folic Acid Tablets 5mg are not recommended for children. |
For prophylaxis in haemolytic states or in renal dialysis:
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Adults and the elderly: |
5mg daily or even weekly. |
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Children: |
Folic Acid Tablets 5mg are not recommended for children. |
Method of administration: oral
4.3 Contraindications
Known hypersensitivity to folic acid or any of the other excipients.
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.
Caution should be exercised when administering folic acid to patients who may have folate dependant tumours.
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. Sulphasalazine and triamterene also inhibit absorption.
Antibacterials, chloramphenicol and co-trimoxazole, may interfere with folate metabolism.
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 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
This strength of tablet is not suitable for pregnant or nursing mothers.
4.7 Effects on ability to drive and use machines
No effect on concentration and co-ordination.
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4.8 |
Undesirable effects | |
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Gastrointestinal disorders |
Anorexia, nausea, abdominal distension | |
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Rare (>1/10,000 til <1/1,000) |
and flatulence |
Immune System disorders Allergic reactions, comprising erythema,
Rare (>1/10,000 til <1/1,000) rash, pruritus, urticaria, dyspnoea, and
anaphylactic reactions (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 Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
4.9 Overdose
There are no specific symptoms of overdosage and similarly no emergency treatment or antidotes, metabolisation and excretion can be rapid.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
ATC Code: B03B B01 folic acid and derivatives.
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 Pharma Limited Unit G4,
Riverside Industrial Estate,
Riverside Way,
Dartford DA1 5BS UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 40147/0037
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
18/06/1992
10 DATE OF REVISION OF THE TEXT
15/07/2015