Iron (III) hydroxide polymaltose complex, folic acid.
Each chewable tablet contains 100 mg of iron as Iron (III)-Hydroxide Polymaltose Complex (IPC) and 0.35 mg of folic acid, cyclamate, flavouring, excip. pro compresso.
Pharmacotherapeutical group: Antianaemicum.
Maltofer Fol chewable tablets is a combination preparation containing iron and folic acid for the treatment of iron deficiency (during lactation).
In Maltofer Fol chewable tablets, the content of folic acid is according to the WHO guidelines. Folic acid is an important vitamin for the development of the unborn child. Folic acid deficiency in the first weeks of pregnancy can lead to malformations in the child.
Iron is an important constituent of haemoglobin, myoglobin, and the enzymes which contain iron. Iron deficiency is particularly frequent during pregnancy and lactation, and manifests itself as chronic fatigue, lack of concentration, irritability, nervousness, headache, loss of appetite, susceptibility to stress and infection, paleness, cracks at the corners of the mouth (rhagades), dry skin, brittle hair and nails.
The iron in Maltofer Fol chewable tablets is present as Iron (III)-Hydroxide Complex, where individual particles are embedded in a carbohydrate polymer (polymaltose). This prevents the iron from causing any harm in the gastrointestinal system. This protection inhibits interactions of the iron with food. Moreover, it ensures the bioavailability of the iron. The structure of IPC is similar to ferritin, the naturally occurring iron storage protein. Due to this similarity, iron is absorbed through natural mechanisms.
IPC has no pro-oxidative properties such as there are with bivalent iron salts.
Treatment of latent and manifest iron deficiency and prevention of iron and folic acid deficiency before, during and after pregnancy (during lactation).
Dosage and duration of therapy are dependent upon the extent of iron deficiency.
Manifest iron deficiency: 1 chewable tablet two to three times daily until a normalisation of the haemoglobin value is achieved. Afterwards the therapy should be continued with 1 chewable tablet daily at least until the end of the pregnancy to replenish the iron stores.
Latent iron deficiency and prevention of iron and folic acid deficiency: 1 chewable tablet daily.
Administration: The daily dosage can be divided into separate doses or can be taken at one time. Maltofer Fol chewable tablets can be chewed or swallowed whole and should be taken during or immediately after a meal.
In cases of overdosage neither intoxication nor iron overload have been reported to date.
Iron overload (e.g. haemochromatosis, haemosiderosis) or disturbances in iron utilisation (e.g. lead anaemia, sidero-achrestic anaemia, thalassaemia) and anaemia not caused by iron deficiency (e.g. haemolytic anaemia). Known intolerance of any of the ingredients.
Notice to diabetics: 0.03 bread units per chewable tablet.
In cases of anaemia due to infections or malignancy, the substituted iron is stored in the reticulo-endothelial system, from which it is mobilised and utilised only after curing the primary disease.
Reproduction studies in animals did not show any foetal risk. Controlled studies in pregnant women after the first trimester have not shown any undesirable effects on mother and neonates. There is no evidence of a risk during the first trimester and a negative influence on the foetus is unlikely. The administration of Maltofer Fol chewable tablets is unlikely to cause undesirable effects to the nursed child.
During pregnancy and lactation Maltofer Fol chewable tablets should be used only after consulting a medical doctor or pharmacist.
The following adverse drug reactions could very rarely be observed after the intake of Maltofer Fol: constipation, diarrhea, nausea, abdominal pain, gastric disorders, indigestion (dyspepsia), vomiting, rash (urticaria, exanthema, pruritus).
A dark colouration of the stool due to iron elimination is of no clinical significance.
Maltofer Fol does not stain dental enamel.
Until now interactions have not been observed. Since the iron is complex-bound, ionic interactions with food components (phytin, oxalates, tannin etc.) and concomitant administration of medicaments (tetracyclines, antacids) are unlikely to occur.
The haemoccult test (selective for Hb) for the detection of occult blood is not impaired and therefore there is no need to interrupt iron therapy.
Below 25°C in the original container.
B03BB51 - folic acid, combinations ; Belongs to the class of folic acid and derivatives. Used in the treatment of anemia.