Description
Release form
Chewable tablets.
Packing
90pcs.
Pharmacological action
Ferrum Lek – antianemic drug.
The molecular weight of the complex is so great – about 50 kDa – that its diffusion through the gastrointestinal mucosa is 40 times slower than diffusion of ferrous iron. The complex is stable and does not release iron ions under physiological conditions. The iron of the multinuclear active zones of the complex is bound into a structure similar to that of the natural compound of iron, ferritin. Due to this similarity, the iron of this complex is absorbed only by active absorption. Iron binding proteins located on the surface of the intestinal epithelium, absorb iron (III) from the complex through competitive exchange of ligands. Absorbed iron is mainly deposited in the liver, where it binds to ferritin. Later in the bone marrow, it is included in hemoglobin.
The iron (III) complex polymaltose hydroxide does not have the prooxidant properties inherent in iron (II) salts.
Pharmacokinetics
Studies using the double isotope method (55Fe and 59Fe) showed that iron absorption, as measured by hemoglobin in red blood cells, is inversely proportional to the dose taken (the higher the dose, the lower the absorption). There is a statistically negative correlation between the degree of iron deficiency and the amount of iron absorbed (the higher the iron deficiency, the better the absorption). Iron is most absorbed in the duodenum and jejunum.
The remaining (non-absorbed) iron is excreted in the feces. Its excretion with exfoliating cells of the gastrointestinal tract and skin epithelium, as well as with sweat, bile and urine, is approximately 1 mg of iron per day. In women, during menstruation, an additional loss of iron occurs, which must be taken into account.
Indications
For oral use:
treatment of latent iron deficiency
treatment of iron deficiency anemia
prevention of iron deficiency during pregnancy and lactation.
Contraindications
excess iron in the body (e.g. hemochromatosis)
non-iron deficiency anemia (e.g. hemolytic anemia, megaloblastic anemia caused by cyanocobalamin deficiency)
hypersensitivity to pre Arata.
Use in children
Use is possible according to indications and in doses taking into account the age of the patient. For children under 12 years of age, in connection with the need to prescribe the drug in low doses, it is preferable to use in the form of a syrup.
Use during pregnancy and lactation
In controlled trials with the use of the drug in the II and III trimesters of pregnancy, there was no negative effect on the mother or fetus. There were no harmful effects on the fetus when using the drug in the first trimester of pregnancy.
Special instructions
In cases of anemia caused by an infectious or malignant disease, iron accumulates in the reticuloendothelial system, from which it is mobilized and utilized only after the underlying disease has been cured.
When using the Ferrum Lek ® preparation, the stool may become dark in color, which does not have any clinical significance. Ferrum Lek ® does not affect the results of the occult blood test (selective for hemoglobin), so it is not required to suspend iron therapy.
Note for patients with diabetes: 1 chewable tablet Ferrum Lek ® contains 0.04 bread units (XE).
Note for patients with phenylketonuria: Ferrum Lek ® contains aspartame (E951), a source of phenylalanine, in an amount equivalent to 1.5 mg per tablet.
Influence on the ability to drive vehicles, mechanisms
Ferrum Lek ® does not affect the ability to drive a car and control mechanisms that require increased concentration of attention.
Composition
1 chewing tablet contains:
Active substance:
iron (
iron polymaltose 400 mg, in terms of iron – 100 mg.
Excipients:
macrogol 6000 – 37.0 mg
aspartame – 1.5 mg
chocolate flavor – 0.6 mg
talc – 21.0 mg
dextrates – to obtain 730.0 mg.
Dosage and administration
Inside, tablets can be chewed or swallowed whole. The drug is recommended to be taken during or immediately after a meal.
The daily dose can be divided into several doses.
Doses and duration of treatment depend on the degree of iron deficiency.
Latent iron deficiency
Duration of treatment is about 1-2 months,
Children over 12 years of age, adults and mothers breastfeeding
1 chewable tablet (100 mg) Ferrum Lek ® per day.
Iron deficiency anemia
Duration of treatment is about 3-5 months. After normalizing the concentration of hemoglobin, you should continue taking the drug for several more weeks, to replenish iron stores in the body.
Children over 12 years old, adults and mothers who are breastfeeding
1-3 chewable tablets (100-300 mg) Ferrum Lek ® per day.
Pregnant women
Latent iron deficiency and prevention of iron deficiency
1 chewable tablet (100 mg) Ferrum Lek ® per day.
Iron deficiency anemia
2-3 chewable tablets (200-300 mg) Ferrum Lek ® per day until the hemoglobin concentration is normalized. After this, you should continue to take 1 chewable tablet per day, at least until the end of pregnancy to replenish iron stores in the body.
Daily doses of Ferrum Lek ® tablets for the prevention and treatment of iron deficiency in the body
Iron deficiency anemia Latent iron deficiency Prevention of iron deficiency
Children over 12 years old, adults and lactating mothers 1-3 chewable tablets (100-300 mg of iron) 1 chewable tablet (100 mg of iron) –
Pregnant women 2-3 chewable tablets (200-300 mg of iron) 1 chewable tablet (100 mg of iron) 1 tablet chewing (100 mg of iron)
Side effects
The reported side effects were mostly mild and transient.
According to WHO, adverse reactions are classified according to their frequency of development as follows: very often (? 1/10), often (? 1/100,
from the digestive tract: very rarely – pain in the abdomen, nausea, constipation, diarrhea, dyspepsia, vomiting, discoloration of feces (due to the removal of non-absorbed iron, has no clinical significance).
From the skin and subcutaneous tissue: very rarely – urticaria, rash, itching of the skin.
Drug interaction
No interaction with other drugs or food products has been identified.
Concomitant use with parenteral iron preparations and other oral iron (III) preparations, polymaltosate hydroxide is not recommended due to marked inhibition of absorption of oral iron.
Overdose
There were no signs of intoxication or excess iron in the body when overdosing on Ferrum Lek syrup or chewable tablets. The iron of the active substance is not present in the gastrointestinal tract in free form and is not absorbed by passive diffusion.
Storage conditions
At a temperature not exceeding 25 ° C.
Keep out of the reach and sight of children.
Shelf life
5 years.
Deystvuyushtee substance
irons III gidroksid polimalytozat
Terms and conditions
prescription
resorption tablets Dosage form
Prescribing
Prescribing
Children over 12 years old, Pregnant on purpose uw physician, nursing mothers, children prescribed by a doctor, Adults doctor’s prescription
Sandoz, Switzerland
