Ferrum Lek, Chewable tablets 100mg, 50pcs

Composition

1 chewable tablet contains:

• Active ingredient:
• iron (in the form of iron (III) hydroxide polymaltosate) 100 mg;
• excipients:
• chocolate essence,
• aspartame (E 951),
• talc,
• macrogol 6000,
• dextrates.

Pharmacological action

Ferrum Lek is an antianemic drug.

Pharmacodynamics

The molecular weight of the complex is so large-about 50 kDa-that its diffusion through the gastrointestinal mucosa is 40 times slower than that of divalent iron. The complex is stable and does not release iron ions under physiological conditions. The iron of the multicore active zones of the complex is bound together in a structure similar to that of the natural iron compound 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 ligand exchange. Absorbed iron is mainly deposited in the liver, where it binds to ferritin. Later in the bone marrow, it is incorporated into hemoglobin.

Iron (III) Complex polymaltose hydroxide does not have the pro-oxidant properties inherent in iron (II) salts.

Pharmacokinetics

Studies using the double isotope method (55Fe and 59Fe) showed that iron absorption, 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). Most iron is absorbed in the duodenum and jejunum.

The remaining (unabsorbed) iron is excreted in the faeces. 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, there is an additional loss of iron during menstruation, which must be taken into account.

Indications

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

Use during pregnancy and lactation

In the course of controlled studies in pregnant women (II, III trimesters of pregnancy), no negative effects on the body of the mother and fetus were noted.

No harmful effects on the fetus were detected when taking medications in the first trimester of pregnancy.

In the course of controlled studies, when using the drug in the second and third trimesters of pregnancy, there was no negative effect on the body of the mother or fetus. No harmful effects on the fetus were detected when using the drug in the first trimester of pregnancy.

Contraindications

• Hypersensitivity to the components of the drug.
• Excessive iron content in the body (for example, hemochromatosis).
• Iron utilization disorders (for example, anemia caused by lead intoxication, sideroachrestic anemia).
• Anemia that is not associated with iron deficiency (for example, hemolytic anemia, megaloblastic anemia caused by a lack of cyanocobalamin).

Side effects

The reported side effects were mostly mild and transient.

According to WHO, adverse reactions are classified according to their frequency as follows: very common (≥1/10), common (≥1/100,

From the gastrointestinal tract: very rarely — abdominal pain, nausea, constipation, diarrhea, dyspepsia, vomiting, fecal discoloration (due to the removal of non-absorbed iron, has no clinical significance).

From the skin and subcutaneous tissue: very rarely-urticaria, rash, itchy skin.

Interaction

Interaction with other drugs or food products was not detected.

Simultaneous use with parenteral iron preparations and other oral preparations of iron (III) hydroxide polymaltosate is not recommended due to the pronounced inhibition of the absorption of oral iron.

How to take, course of use and dosage

Inside, during or immediately after a meal.

Ferrum Lek chewable tablets can be chewed or swallowed whole.

The daily dose can be divided into several doses or taken at one time.

The dose and duration of treatment depend on the degree of iron deficiency.

Overdose

Symptoms: when overdosing on Ferrum Lek syrup or chewable tablets, there were no signs of intoxication or excess iron in the body, since iron from the Active ingredient is not present in the gastrointestinal tract in free form and is not absorbed by passive diffusion.

Special instructions

For children under 12 years of age, due to the need to prescribe low doses of the drug, it is preferable to prescribe Ferrum Lek in the form of syrup.

Neither chewable tablets nor Ferrum Lek syrup cause tooth enamel staining.

In cases of anemia caused by an infectious or malignant disease, iron accumulates in the reticulo-endothelial system, from which it is mobilized and disposed of only after the underlying disease is cured.

When using Ferrum Lek, the stool may turn dark, which does not have any clinical significance. Taking iron supplements does not affect the results of the occult bleeding test (selective for hemoglobin).

Notice for diabetics: 1 chewable tablet or 1 ml of Ferrum Lek syrup contains 0.04 XE.

Notice 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 a car or perform work that requires an increased rate of physical and mental reactions.

The drug does not affect the ability to concentrate attention.

Product form

Ferrum Lek chewable tablets.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

5 years

Active ingredient

Iron III hydroxide polymaltose

Conditions of release from pharmacies

By prescription

Dosage form

tablets for resorption

Description

Children as prescribed by a doctor, Pregnant women as prescribed by a doctor, Children over 12 years of age, Nursing mothers as prescribed by a doctor, Adults as prescribed by a doctor

Indications

Prevention of Iron Deficiency, Anemia, Bleeding