Source: European Medicines Agency (EU) Revision Year: 2017
Pharmacotherapeutic group: anti-anemic
ATC code: B03AA01
Iron is essential for transport of oxygen (e.g. haemoglobin) and for energy transfer in the body. The content of iron in the body is about 50 mg of Fe2+/kg BW in men and about 38 mg of Fe2+/kg BW in women.
Iron in the ferrous form (Fe2+) is the bioavailable form which can enter the cell metabolism along with the existing heme iron. Complexed mainly with amino acids, iron is transported into the mucosal epithelial cells of the small intestine, mainly in the duodenum and to a lesser extent in the proximal jejunum. There the larger quantity of iron from nonheme food sources is reduced to the ferrous form (Fe2+). The iron derived from Niferex is already in the reduced ferrous form (Fe2+) and hence readily bioavailable for absorption into the cell metabolism.
Iron is necessary to the organism to build up hemoglobin, myoglobin and enzymes containing ferrous. Iron deficiency may be triggered by a higher demand of iron (e.g. during growth and pregnancy), a higher iron loss (e.g. bleeding) or decreased iron intake (e.g. insufficient content of iron in the food). An iron deficiency anemia may occur as a consequence of an iron deficiency.
Niferex is a medicinal product for the treatment of iron deficiency. It contains iron (Fe2+) in a form that the body can easily absorb and utilize. The product is therefore suitable to eliminate symptoms caused by iron deficiency. Like all iron preparations, Niferex has no effects on erythropoiesis or anaemia that is not due to iron deficiency.
See section 4.2 for information on paediatric use.
Niferex, hard capsules contain gastro-resistant granules. The capsule shell dissolves in the stomach and the acid-resistant coated pellets reach subsequently, and in small amounts, the duodenum where they dissolve and release the iron complex.
In patients with depleted iron stores the relative bioavailability is 95% that of an aqueous iron sulphate solution as reference. This is equivalent to a Fe2+ absorption in the range of 15%.
In the blood, iron irons are bound to transferrin and transported to sites where they are needed. Iron is stored as ferritin in the liver, spleen and bone marrow.
Only a small portion (1–2 mg/day) of the iron released by the breakdown of haemoglobin (20–30 mg a day) is excreted in the faeces. Most is re-used by the body, mainly for the synthesis of haemoglobin.
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SmPC.
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