Folic Acid Tablets 5mg
Out of date information, search anotherSUMMARY OF PRODUCT CHARACTERISTICS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:
|
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. |
|
Children: |
Folic Acid Tablets 5mg are not recommended for children. |
For prophylaxis in haemolytic states or in renal dialysis:
|
Adults and the elderly: |
5mg daily or even weekly. |
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Children: |
Folic Acid Tablets 5mg are not recommended for children. |
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.
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
See sub-section 4.3 Contraindications
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
• Antiepileptics - if folic acid supplements are given to treat folate deficiency, which can be caused by the use of anti epileptics (phenytoin, phenobarbital and primidone), the serum antiepileptic levels may fall, leading to decreased seizure control in some patients.
• Antibacterials - chloramphenicol and co-trimoxazole may interfere with folate metabolism.
• Sulfasalazine - can reduce the absorption of folic acid.
• Folic acid may interfere with the toxic and therapeutic effects of methotrexate.
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
None known.
4.9
Undesirable effects
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Gastrointestinal disorders Rare (>1/10,000 til< 1/1,000 |
Anorexia, nausea, abdominal distension and flatulence |
|
Immune System disorders Rare (>1/10,000 til <1/1,000) |
Allergic reactions, comprising erythema, rash, pruritus, urticaria, dyspnoea, and anaphylactic reactions (including shock) |
Overdose
No data available.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Folic acid is a member of the vitamin B group. It is used in the treatment and prevention of folate deficiency states.
5.2 Pharmacokinetic properties
Folic acid is absorbed mainly from the proximal part of the small intestine. Folate polyglutamates are considered to be deconjugated to monoglutamates during absorption. Folic acid rapidly appears in the blood, where it is extensively bound to plasma protein. When large amounts are absorbed, a high proportion is metabolised in the liver to other active forms of folate and a proportion is stored as reduced and methylated folate. Large amounts of folate are rapidly excreted in the urine.
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
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
26/02/2012
DATE OF REVISION OF THE TEXT
26/02/2012
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