Maltofer Fol Tablets
Each chewable tablet contains 100 mg of iron as iron (iii) hydroxide polymaltose complex (IPC) and 0.35 mg Folic Acid, cyclamate, aromatic agents, excipient for compression.
Maltofer Fol chewable tablets are a combination preparation containing iron and folic acid for the treatment of iron deficiency and the prevention of iron and folic acid deficiency before, during and after pregnancy (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 malformation in the child.
Iron is an important constituent of hemoglobin, 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, and 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 exists as iron (iii) hydroxide complex, where individual particles are embedded into a carbohydrate polymer (polymaltose). This prevents the iron from causing any harm in the gastro-intestinal system. This protection inhibits interactions of the iron with food. Moreover, it ensures the bio-availability of the iron.
The structure of Iron Polymaltose Complex is similar to ferritin, the naturally occurring iron storage protein. Due to this similarity, iron is absorbed through natural mechanisms. Iron Polymaltose Complex 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.
The daily dose 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 case of immediate iron need (low Hb, concomitant EPO treatment etc.), parenteral iron preparations should be used for iron substitution so that the iron is more rapidly available.
Iron overload (e.g. haemochromatosis, haemosiderosis) or disturbances in iron utilization (e.g. lead anemia, sideroacrestic anemia, thalasaemia) and anemia not caused by iron deficiency (e.g. haemolytic anemia).
Special Warnings and Special Precautions for Use
Notice to diabetics: 0.04 bread units per chewable tablet.
In cases of anemia due to infections or malignancy, the substituted iron is stored in the reticulo-endothelial system, from which it is mobilized and utilized only after curing the primary disease.
Maltofer Fol Interaction with other medicaments and other forms of Interactions
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.
Pregnancy and Lactation
Pregnancy Category A
Reproduction studies in animals did not show any foetal risk. Controlled studies in pregnant women after the first trimester have not show 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 undesireable effects to the nursed child. During pregnancy and lactation Maltofer chewable tablets should be used only after consulting a medical doctor or pharmacist.
Occasionally gasto-intestinal irritations such as a sensation of replation, pressure in the epigastric region, nausea, obstipation or diarrhea can occur. A dark coloration of the stool due to iron is of no clinical significance. Maltofer Fol chewable tablets do not cause teeth staining.
In case of over dosage neither intoxication nor iron overload have been reported to the date.