Ferrum Lek chewable tablets 100mg, No. 90

Х treatment of latent iron deficiency;
Х treatment of iron deficiency anemia;
Х prevention of iron deficiency during pregnancy.

Inside, the 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 The
duration of treatment is about 1-2 months.
Children over 12 years of age, adults and mothers who are breastfeeding
1 chewable tablet (100 mg) Ferrum LekЃ per day.
Iron deficiency anemia
Duration of treatment is about 3-5 months. After normalization of the hemoglobin concentration, you should continue taking the drug for several more weeks in order to replenish the iron stores in the body.
Children over 12 years of age, adults and breastfeeding mothers
1-3 chewable tablets (100-300 mg) Ferrum LekЃ per day.
Pregnant women
Latent iron deficiency and prevention of iron deficiency
1 chewable tablet (100 mg) Ferrum LekЃ per day.
Iron deficiency anemia
2-3 chewable tablets (200-300 mg) Ferrum LekЃ per day until the hemoglobin concentration is normalized.
Thereafter, you should continue to take 1 chewable tablet per day, at least until the end of pregnancy, to replenish iron stores in the body.

1 chewable tablet contains:
Active substance: iron (III) hydroxide 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; dextracts - to obtain 730.0 mg.

Х hypersensitivity to the components of the drug,
Х iron overload of the body (for example, in cases of hemochromatosis, hemosiderosis);
Х impaired iron utilization (for example, anemia caused by lead intoxication, sideroachrestic anemia, thalassemia);
Х anemias not associated with iron deficiency (eg, hemolytic anemia, megaloblastic anemia due to vitamin B12 deficiency);
Х children under 12 years of age (for this dosage form).

Carefully

There is no data.

Trade name of the drug:

Ferrum LekЃ.

International non-proprietary name or group name:

iron (III) hydroxide polymaltose.

Dosage form

Chewable tablets.

Composition

1 chewable tablet contains:
Active substance: iron (III) hydroxide 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; dextracts - to obtain 730.0 mg.

Description

Round flat tablets of dark brown color interspersed with light brown color, beveled.

Pharmacotherapeutic group

Antianemic agent. Iron supplement.

ATX code : B03AV05.

Pharmacological properties

Pharmacodynamics
The molecular weight of the complex is so high - about 50 kDa, that its diffusion through the mucous membrane of the gastrointestinal tract is 40 times slower than the 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 in a structure similar to that of the natural iron compound, ferritin. Due to this similarity, the iron (III) of this complex is absorbed only by active absorption. Iron-binding proteins located on the surface of the intestinal epithelium and in the gastrointestinal fluid absorb iron (III) from the complex through competitive ligand exchange. The absorbed iron is mainly deposited in the liver, where it binds to ferritin. Later in the bone marrow, it is incorporated into hemoglobin.
The polymaltose complex of iron (III) hydroxide, unlike iron (II) salts, does not possess prooxidant properties. The sensitivity of lipoproteins (eg, very low density lipoproteins and low density lipoproteins) to oxidation is reduced.
Pharmacokinetics
Studies using the double isotope method (55Fe and 59Fe) have shown that the absorption of iron, measured by the level of 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).
Maximum absorption of iron occurs in the duodenum and jejunum. Unabsorbed iron is excreted in feces. Its excretion with exfoliating epithelial cells of the gastrointestinal tract and skin, as well as with sweat, bile and urine is approximately 1 mg of iron per day.
In women, additional iron loss occurs during menstruation, which must be taken into account.

Indications for use

Х treatment of latent iron deficiency;
Х treatment of iron deficiency anemia;
Х prevention of iron deficiency during pregnancy.

Contraindications for use

Х hypersensitivity to the components of the drug,
Х iron overload of the body (for example, in cases of hemochromatosis, hemosiderosis);
Х impaired iron utilization (for example, anemia caused by lead intoxication, sideroachrestic anemia, thalassemia);
Х anemias not associated with iron deficiency (eg, hemolytic anemia, megaloblastic anemia due to vitamin B12 deficiency);
Х children under 12 years of age (for this dosage form).

Carefully

There is no data.

Application during pregnancy and during breastfeeding

Before using the drug during pregnancy or during breastfeeding, you should consult your doctor.
In the course of controlled studies in pregnant women (2nd and 3rd trimesters of pregnancy), there was no negative effect on the organisms of the mother and fetus. No harmful effects on the fetus were detected when taking drugs in the first trimester of pregnancy.
Breast milk of a nursing mother normally contains iron bound to lactoferrin. There are no data on the amount of iron that gets into breast milk from the polymaltose complex. However, adverse effects are unlikely to occur in breastfed babies.

Method of administration and dosage

Inside, the 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 The
duration of treatment is about 1-2 months.
Children over 12 years of age, adults and mothers who are breastfeeding
1 chewable tablet (100 mg) Ferrum LekЃ per day.
Iron deficiency anemia
Duration of treatment is about 3-5 months. After normalization of the hemoglobin concentration, you should continue taking the drug for several more weeks in order to replenish the iron stores in the body.
Children over 12 years of age, adults and breastfeeding mothers
1-3 chewable tablets (100-300 mg) Ferrum LekЃ per day.
Pregnant women
Latent iron deficiency and prevention of iron deficiency
1 chewable tablet (100 mg) Ferrum LekЃ per day.
Iron deficiency anemia
2-3 chewable tablets (200-300 mg) Ferrum LekЃ per day until the hemoglobin concentration is normalized.
Thereafter, you should continue to take 1 chewable tablet per day, at least until the end of pregnancy, to replenish iron stores in the body.

Side effect

Ferrum LekЃ is generally well tolerated. Side effects are mostly mild and transient.
According to the World Health Organization (WHO), adverse reactions are classified according to their frequency of development as follows: very often (? 1/10), often (? 1/100, <1/10), infrequently (? 1/1000, < 1/100), rarely (? 1/10000, <1/1000) and very rarely (<1/10000); frequency unknown - from the available data, it was not possible to establish the frequency of occurrence.
Nervous system disorders
infrequently: headache.
Disorders from the gastrointestinal tract are
very common: change in the color of feces (due to the excretion of non-absorbed iron, has no clinical significance);
often:diarrhea, nausea, dyspepsia;
very rare: abdominal pain, constipation, vomiting, discoloration of tooth enamel.
Violations of the skin and subcutaneous tissues are
very rare: urticaria, rash, itching of the skin.
If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects that are not indicated in the instructions, inform your doctor.

Interaction with other medicinal products

Ferrum LekЃ contains complex-bound iron, which causes a low probability of ionic interactions with food components (oxalates, tannins, etc.), as well as with other drugs (eg, tetracyclines, antacids).
Interaction with other drugs or food products has not been identified.
Concomitant use with parenteral iron preparations and other oral iron (III) preparations polymaltosate hydroxide is not recommended due to the pronounced inhibition of absorption of orally supplied iron.

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 drug Ferrum LekЃ, the stool may turn dark, which does not have any clinical significance. Ferrum LekЃ does not affect the results of the occult blood test (selective for hemoglobin); thus, there is no need to suspend iron therapy.
Note for patients with diabetes mellitus: 1 Ferrum LekЃ chewable tablet contains 0.04 bread units (XE).
Note for patients with phenylketonuria: Ferrum LekЃ contains aspartame (E951), which is a source of phenylalanine, in an amount equivalent to 1.5 mg per tablet.

Influence on the ability to drive vehicles, mechanisms

Ferrum LekЃ does not affect the ability to drive a car and use mechanisms that require increased concentration.

Special precautions for disposal of unused medicinal products

Not applicable.

Release form

Chewable tablets 100 mg.
Primary packaging
10 tablets are placed in an Al / Al strip or in an Al / Al blister.
Secondary packaging
3, 5 or 9 strips or blisters are placed in a cardboard box along with instructions for medical use.

Storage conditions

At a temperature not higher than 25 ? C.
Keep out of the reach of children.

Shelf life

5 years.
Do not use the drug after the expiration date.

Vacation conditions

On prescription.