Ferrum lek Chewable tablets 100mg, 90pcs

Composition

1 chewable tablet contains:

Active ingredient:  iron (III) hydroxide polymaltosate 400 mg, in terms of iron-100 mg. Auxiliary substances:  macrogol 6000-37.0 mg; aspartame-1.5 mg; chocolate flavor-0.6 mg; talc – 21.0 mg; dextrates-up to 730.0 mg

Pharmacological action

Antianemic agent. Iron preparation.

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, 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. 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 have pro-oxidant properties. The sensitivity of lipoproteins (for example, very low-density lipoproteins and low-density lipoproteins) to oxidation is reduced.

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).

Maximum iron absorption occurs in the duodenum and jejunum. Unabsorbed iron is excreted in the faeces. 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, 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.

Contraindications

• hypersensitivity to the components of the drug;
• iron overload in the body (for example, in cases of hemochromatosis, hemosiderosis);
• violation of the utilization of iron (e. g., anemia caused by lead poisoning, sideroachrestic anemia, thalassemia);
• anemia not related to iron deficiency (eg, hemolytic anemia, megaloblastic anemia due to a deficiency of vitamin b 12);
• children up to age 12 years (for this dosage form).

Side effects

Ferrum Lek® is generally well tolerated. Side effects are mostly mild and transient in nature.

According to the World Health Organization (WHO), adverse reactions are classified according to their frequency as follows: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1000, <1/100), rare (≥1/10000, <1/1000) and very rare (

Nervous system disorders

infrequently: headache.

Disorders of the gastrointestinal tract

are very common: fecal discoloration (due to the removal of non-absorbed iron, has no clinical significance);

often: diarrhea, nausea, dyspepsia;

very rare: abdominal pain, constipation, vomiting, discoloration of tooth enamel.

Skin and subcutaneous tissue disorders

are very rare: urticaria, rash, itchy skin.

Interaction

Ferrum Lek® contains complex-bound iron, which causes a low probability of ionic interactions with food components (oxalates, tannins, etc. ), as well as with other drugs (for example, tetracyclines, antacids).

Interactions with other drugs or food products were 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, 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.

The dose 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 breast-feeding mothers 1 chewable tablet (100 mg) of Ferrum Lek® per day.

Iron deficiency anemia

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

Children over 12 years of age, adults and breast-feeding mothers

1-3 chewable tablets (100-300 mg) of Ferrum Lek® per day.

Pregnant women

Latent iron deficiency and prevention of iron deficiency 1 chewable tablet (100 mg) of Ferrum Lek® per day.

Iron deficiency anemia

2-3 chewable tablets (200-300 mg) of Ferrum Lek® per day, until the hemoglobin concentration is normalized. After that, you should continue to take 1 chewable tablet per day, at least until the end of pregnancy to replenish iron reserves in the body.

Overdose

Overdose of Ferrum Lek® did not cause 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

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 is not of any clinical significance. Ferrum Lek® does not affect the results of the occult blood test (selective for hemoglobin); therefore, it is not necessary to suspend therapy with iron.

Note for diabetic patients: 1 Ferrum Lek® chewable tablet 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 manage mechanisms that require increased concentration of attention.

Form of production

Chewable tablets.

Active ingredient

Iron III hydroxide polymaltose

Conditions of release from pharmacies

By prescription

Dosage form

tablets for resorption

Description

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

Indications

Bleeding, Anemia, Iron Deficiency Prevention