Ferrum Lek (Iron (III) hydroxide polymaltose) tablets, syrup

The composition and form of issue:

Chewable tablets, 1 tab. contains active substance:

iron (III) hydroxide polymaltose 400 mg

(in terms of iron — 100 mg)

excipients: macrogol 6000 aspartame flavor chocolate talc dexterity

in strips of 10 PCs. in cardboard pack 3 strip.

Syrup. 5 ml (1 scoop) contains active substance:

iron (III) hydroxide polymaltose 200 mg

(in terms of iron 50 mg)

excipients: sucrose, sorbitol (solution), methyl parahydroxybenzoate parahydroxybenzoate ethanol flavour, creamy sodium hydroxide water

in dark glass bottles of 100 ml (with measuring spoon) in the paper cartons 1 a bottle.

Description pharmaceutical form:

Chewable tablets: round, flat, dark brown interspersed with light brown color with beveled.

Syrup: a clear solution brown.

Pharmacokinetics:

Studies using the method of double isotope (55Fe and 59Fe) have shown that absorption of iron measured by hemoglobin in red blood cells, is inversely proportional to the dose (higher dose, the lower the absorption). There is a statistically negative correlation between the degree of iron deficiency and the amount of absorbed iron (the higher iron deficiency, the better absorption). Most of the iron absorbed in the duodenum and jejunum of the intestines.

The remaining (unabsorbed) iron is excreted in faeces. Its excretion with the exfoliating cells of the epithelium of the gastrointestinal tract and skin as well as sweat, bile and urine, approximately 1 mg of iron per day. In women during menstruation there is an additional loss of iron that must be taken into account.

Description pharmacological action:

The molecular weight of the complex is so large — about 50 kDa, its diffusion through the gastrointestinal mucosa to 40 times slower than diffusion of divalent iron. The complex is stable in physiological conditions not releases iron ions. Iron multi-core active zones of the complex are connected in a structure similar to the structure of natural compounds of iron — ferritin. Because of this similarity, the iron complex is absorbed only by active suction. Iron binding capacity of proteins on the surface of the intestinal epithelium to absorb iron (III) complex by competitive ligand exchange. Absorbed iron is mainly deposited in the liver, where it is associated with the San. Later in the bone marrow, it is included in the hemoglobin.

The complex of iron (III)-hydroxide polymaltose does not possess prooxidant properties inherent in salts of iron (II).

Indications:

• treatment of latent iron deficiency
• treatment of iron deficiency anemia
• prevention of iron deficiency during pregnancy.

Contraindications:

• hypersensitivity to the drug
• iron overload of the body (e.g. in cases of hemochromatosis)
• violation of the utilization of iron (e.g., anemia caused by lead poisoning, anemia sideroahrestical)
• anaemia not related to iron deficiency (e.g. haemolytic, megaloblastic caused by a deficiency of cyanocobalamin).

Application of pregnancy and breast-feeding:

During controlled studies in pregnant women (II, III trimesters of pregnancy) is not marked negative impact on the mother and fetus. Not detected harmful effects on the fetus when taking medications in the first trimester of pregnancy.

Side effects:

Observed side effects were generally weak and transient. In very rare cases, possible gastrointestinal disorders like a feeling of fullness and pressure in the epigastric region, nausea, constipation or diarrhea. Probably dark coloration of the stool due to iron excretion nevsosavsheysya, having no clinical importance.

Drug interactions:

Interaction with other drugs or food products not identified.

Method of application and dose:

Inside, during or immediately after a meal.

Chewable tablets ferrum Lek can be chewed or swallowed whole.

Daily dose can be divided into several doses or taken all at one time.

Syrup ferrum Lek can be mixed with fruit or vegetable juices or added to baby food.

Dose and duration of treatment depend on the degree of iron deficiency.

Invested in packaging measuring spoon is used for accurate dosing of syrup ferrum Lek.

Iron deficiency anemia

The duration of treatment is about 3-5 months. After normalization of the hemoglobin level should continue taking the drug for several weeks to replenish iron in the body.

Children under one year of age: 2.5 ml (1/2 scoop) — 5 ml (1 measuring spoon) of syrup ferrum Lek a day.

Children aged 1 to 12 years: 5-10 ml (1-2 measuring spoons) syrup ferrum Lek a day. Children older than 12 years, adults and mothers, nursing the child: 1-3 chewable tabl. or 10-30 ml (2-6 scoops), syrup ferrum Lek.

Latent iron deficiency

The duration of treatment is about 1-2 months.

Children aged 1 to 12 years: 2.5–5ml (1/2–1 tablespoon) syrup ferrum Lek a day.

Children older than 12 years, adults and mothers, nursing the child: 1 tab. or 5-10 ml (1-2 measuring spoons) syrup ferrum Lek a day.

Pregnant women

Iron deficiency anemia

2-3 chewable tabl. per day or 20-30 ml (4-6 servings) of syrup ferrum Lek until normal hemoglobin levels. After that you should continue to take 1 chewable tabl. or 10 ml (2 measuring spoon) of syrup per day, at least until the end of the pregnancy to replenish the iron stores in the body.

Latent iron deficiency and prevention of iron deficiency

One chewable tablet or 5-10 ml (1-2 measuring spoons) syrup ferrum Lek a day.

Daily doses of the drug ferrum Lek for the prevention and treatment of iron deficiency in the body

(-) Due to the fact that for this group of patients required a low dose of iron, is not recommended in these cases to use the tablets or syrup.

Overdose:

With an overdose of syrup or chewable tablets ferrum Lek were observed for signs of intoxication or iron overload, because iron from active substance is not present in the gastrointestinal tract and is not absorbed by passive diffusion.

Special instructions:

Children under the age of 12 years in connection with the need to use low doses of the drug, preferably the appointment ferrum Lek in the form of syrup.

Neither the chewable tablets nor syrup ferrum Lek do not cause staining of tooth enamel.

In cases of anemia due to an infectious or malignant disease, iron accumulates in the reticuloendothelial system, which is mobilized and utilized only after curing the underlying disease. Iron supplementation does not affect the results of the sample for occult blood (selective for hemoglobin).

Notice for diabetics: 1 chewable tabl. or 1 ml of syrup ferrum Lek containing 0.04 HEH.