Maltofer Fol

Known hypersensitivity to Maltofer Fol.

Known hypersensitivity to hydroxybenzoate esters.

Patients with malignant disease, unless megaloblastic anaemia due to Maltofer Fol deficiency.

Maltofer Fol should not be administered for treatment of pernicious anaemia or undiagnosed megaloblastic anaemia without sufficient amounts of cyanocobalamin (vitamin B₁₂) as Maltofer Fol 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 Maltofer Fol to patients who may have folate dependent tumours.

Maltofer Fol 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.

Maltofer Fol is generally well tolerated, although the following side effects have been reported:

Blood and lymphatic system disorders:

Maltofer Fol 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 Maltofer Fol 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.

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.

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 Maltofer Fol 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. Maltofer Fol is a relatively poor substrate for folate reduction, the normal substrate being dihydrofolate.

Maltofer Fol 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.

• R52.1 – Chronic intractable pain
• R52.2 – Other chronic pain
• R52.9 – Unspecified pain

None stated.

Not applicable.