Iron (III) hydroxide Polymaltose Complex equivalent to Elemental Iron………...100mg Folic Acid.........….……0.35mg

The iron (III) hydroxide polymaltose complex (IPC) is a water-soluble iron oxide, macromolecular complex of polynuclear iron (III) hydroxide and partially hydrolyzed dextrin (polymaltose). The polynuclear iron (III) hydroxide cores are superficially surrounded by a number of non-covalently bound polymaltose molecules resulting in an overall complex molecular mass of approximately 52,300 Daltons. This molecule is so large that diffusion through the membrane of the mucosa is about 40 times smaller than the one for the hexaquo-iron (II) unity. The complex is stable and does not cause release of ionic iron under physiological conditions. The iron in the polynuclear “cores” is bound in a similar structure as in the case of physiologically occurring ferritin. Due to these chemical and pharmacological properties, IPC is suitable for oral iron substitution. MALCIFER-F is rapidly absorbed with a high rate of iron utilization and produces an effective increase in haemoglobin. Folic acid is necessary for the normal production of red blood cells, including maturation of megaloblasts into normoblasts, due to its non-ionic property. · MALCIFER-F does not irritate gastric mucosa · It has palatable taste · Trigger a shift rise in haemoglobin · No interaction with food or medicines · Free from radical formation · Safest among all iron preparations · Does not cause teeth staining

MALCIFER-F is indicated for: 1. Treatment and prevention of all kinds of iron deficiencies 2. Iron deficiency anaemia. 3. Prophylactic therapy of iron deficiency 4. To cover the recommended daily dietary allowances (RDA) 5. During pregnancy, lactation and adolescents. 6. Women capable of bearing children, and adults.

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. MALCIFER-F tablets can be chewed or swallowed whole and should be taken during or immediately after meal. In case of manifested iron deficiency, the therapy takes about 3-5 months until a normalization of the hemoglobin value is achieved. Afterwards the therapy should be continued for several weeks with a dosage such as described for latent iron deficiency to replenish the iron stores.

MALCIFER-F is contraindicated in the following conditions: · Iron overload (e.g. haemochromatosis, haemosiderosis) or disturbances in iron utilization (e.g. lead anaemia, sideroacrestic anaemia, thalassaemia) · Anaemias not caused by iron deficiency (e.g. haemolytic anaemia or in case of megaloblastic anaemia due to vitamin deficiency anaemia) · Hypersensitivity to Iron polymaltose or Folic Acid.

In case of anaemia due to infection or malignancy, the substituted iron is stored in the reticulo-endothelial system from which it is mobilized and utilized only after correcting the primary disease.

Until now interactions have not been observed. Since iron is complex-bound, ionic interactions with foodstuff component (phytin, exalates, tannin, etc) and concomitant administration of medicament (tetracycline, antacids) are unlikely to occur. MALCIFER-F does not cause teeth staining. The haemoccult-test (selective for haemoglobin) for the detection of occult blood is not impaired and therefore, iron therapy must not be interrupted.

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 the possibility of a negative influence of the foetus is unlikely to occur. Mother’s milk contains iron bound to lactoferrin. It is not known how much iron from the complex is passed into mother’s milk. The administration of MALCIFER-F is unlikely to cause undesirable effects to the nursed child. During pregnancy and lactation, MALCIFER-F tablets and syrup should be used on the prescription.

Occasionally gastrointestinal irritation such as sensation of repletion, pressure in the epigastric region, nausea, constipation or diarrhoea can occur. A dark coloration of the stool is of no clinical significance.

In case of overdosage, neither intoxication nor iron overload has been reported upto date.

· Store in a cool dry place · Protect from heat, sunlight and moisture · Keep all medicines out of the reach of children

MALCIFER-F tablets 100mg is available in blister pack of 10’s

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