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.
Known hypersensitivity to Fegem.
Known hypersensitivity to hydroxybenzoate esters.
Patients with malignant disease, unless megaloblastic anaemia due to Fegem deficiency.
None stated.
Fegem is generally well tolerated, although the following side effects have been reported:
Blood and lymphatic system disorders:
Fegem may worsen the symptoms of co-existing vitamin B12 deficiency and should never be used to treat anaemia without a full investigation of the cause.
Immune system disorders:
Allergic reactions to Fegem have been reported.
Gastrointestinal disorder:
Abdominal distension, flatulence, anorexia and nausea.
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.
Fegem is a drug on which extensive clinical experience has been obtained. Relevant information for the prescriber is provided elsewhere in the Summary of Product Characteristics.
ATC Code: B03B B
After conversion into co-enzyme forms it is concerned in single carbon unit transfers in the synthesis of purines, pyrimidines and methionine.
About 70 - 80 % of a 2 mg oral solution of Fegem is absorbed. Larger doses are probably equally well absorbed. It is distributed into plasma and extracellular fluid. In plasma, folate is bound weakly to albumin (70 %). There is a further high affinity binder for folate but this has a very low capacity and is barely detectable in normal sera. About 70 % of small doses of folate (about 1 mg) are retained and the rest excreted into the urine. With larger doses most is excreted into the urine. With a 5 mg dose of folate, urinary excretion will be complete in about five hours. There is an enterohepatic circulation of folate. The retained folate is taken into cells and reduced by dihydrofolate to tetrahydrofolate. Fegem is a relatively poor substrate for folate reduction, the normal substrate being dihydrofolate.
Fegem itself does not occur in natural materials, it is entirely a pharmacological form of the compound. Once reduced, folate has additional glutamic acid residues added, a folate pentaglutamate being the dominant intracellular analogue. These polyglutamates are the active co-enzymes.
Fegem should not be administered for treatment of pernicious anaemia or undiagnosed megaloblastic anaemia without sufficient amounts of cyanocobalamin (vitamin B12) as Fegem alone will not prevent and may precipitate development of subacute combined degeneration of the spinal cord. Therefore a full clinical diagnosis should be made before initiating treatment.
Folate should not be routinely used in patients receiving coronary stents.
Caution should be exercised when administering Fegem to patients who may have folate dependent tumours.
Fegem is removed by haemodialysis.
Contains methyl- ethyl- and propyl- p-hydroxybenzoates; may cause allergic reactions (possibly delayed).
Contains 0.75 mmol (or 17.4mg) sodium per 20 ml dose, and is therefore essentially 'sodium-free'.
Contains phenylalanine. May be harmful for people with phenylketonuria.
There are no known effects of this preparation on the ability to drive or use machines.
Not applicable.
