Ferrum Lek - instructions for use, dose, side effects, contraindications

Active substance: iron (III) hydroxide polymaltosate 400 mg, in terms of iron - 100 mg.
Excipients: macrogol 6000 - 37.0 mg; aspartame - 1.5 mg; chocolate flavoring - 0.6 mg; talc - 21.0 mg; dextrates to 730.0 mg.

Description:

Round flat tablets of dark brown color with impregnations of light brown color, with a facet.

Pharmacotherapeutic group:Anti-anemic agent. The preparation of iron.

ATX: & nbsp

B.03.A.B Preparations of iron (trivalent) for oral administration

B.03.A.B.05 Iron hydroxide polymaltosate

Pharmacodynamics:

The molecular mass of the complex is so great - 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 under physiological conditions does not release iron ions. The iron of multinuclear active zones of the complex is connected in a structure similar to the structure of a natural iron-ferritin compound. Due to this similarity, iron (III) of this complex is absorbed only by active absorption. The iron-binding proteins 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 included in the hemoglobin.

The polymaltose complex of iron (III) hydroxide, unlike iron (II) salts, does not possess pro-oxidant 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) showed that iron absorption, measured by hemoglobin level in erythrocytes, is inversely proportional to the dose (the higher the 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 the iron deficiency, the better the absorption). The maximum absorption of iron occurs in the duodenum and jejunum. Unabsorbed iron is excreted with feces. Its excretion with exfoliating cells of the epithelium of the gastrointestinal tract and skin, and also with sweat, bile and urine is approximately 1 mg of iron per day. In women during menstruation, there is an additional loss of iron, 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 (for example, in cases of hemochromatosis, hemosiderosis);
impairment of iron utilization (eg, anemia caused by lead intoxication, sidero-achestic anemia, thalassemia);
anemia not related to iron deficiency (eg, hemolytic anemia, megaloblastic anemia due to vitamin B12 deficiency);
children under 12 years (for this dosage form).

Carefully:

No data.

Pregnancy and lactation:

During controlled studies in pregnant women (the 2nd and 3rd trimester of pregnancy), there was no adverse effect on the mother and fetus organisms. There was no adverse effect on the fetus when taking drugs in the first trimester of pregnancy.

When using a breast-feeding medicine, only a small part of iron from its complex with polymaltose enters the breast milk; thus, the occurrence of undesirable effects in breastfed infants is unlikely.

Dosing and Administration:

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 receptions.

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) of Ferrum Lek® per day.

Iron-deficiency anemia

Duration of treatment is about 3-5 months. After the normalization of the hemoglobin concentration, the drug should be continued for several more weeks to replenish the iron stores in the body.

Children over 12 years of age, adults and mothers breastfeeding

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

Pregnant women

Latent iron deficiency and iron deficiency prevention

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 stores in the body.

Daily doses of the drug Ferrum Lek® Tablets for the prevention and treatment of iron deficiency in the body

	Iron Deficiency anemia	Latent deficit gland	Prevention of iron deficiency
Children over 12 years of age, adults and nursing mothers	1 -3 chewable tablets (100-300 mg of iron)	1 tablet chewing (100 mg of iron)	---
Pregnant women	2-3 tablets chewing (200-300 mg of iron)	1 tablet chewing (100 mg of iron)	1 tablet chewing (100 mg of iron)

Side effects:

Ferrum Lek® is generally well tolerated.

Side effects are mainly of an easy and transient nature.

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 is unknown - according to available data, it was not possible to establish the frequency of occurrence.

From the gastrointestinal tract: rarely: abdominal pain, nausea, constipation, diarrhea, indigestion, vomiting, fecal color change (due to the excretion of non-absorbed iron, has no clinical significance).

From the skin and subcutaneous tissue: rarely: urticaria, rash, itching of the skin.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

When an overdose of the drug Ferrum Lek®, there were no signs of intoxication or excess iron in the body,since iron from the active substance is not present in the gastrointestinal tract in free form and is not absorbed by passive diffusion.

Interaction:

Interaction with other drugs or food products is not revealed.

Simultaneous use of ferromaltosate hydroxide with parenteral preparations of iron and other oral preparations of iron (III) is not recommended because of pronounced inhibition of absorption of orally administered iron.

Special instructions:

The Ferrum Lek® tablets do not 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 utilized only after the cure of the underlying disease.

When using the preparation of Ferrum Lek®, the stool can be stained in a dark color, which does not have any clinical significance. The preparation of Ferrum Lek® does not affect the results of the test for latent blood (selective for hemoglobin); thus, it is not required to stop iron therapy.

Note for patients with diabetes mellitus: 1 Chewable tablet Ferrum Lek® contains 0.04 bread units (XE).

Note for patients with phenylketonuria: the preparation of Ferrum Lek® contains aspartame (E951), which is a source of phenylalanine, in an amount equivalent to 1.5 mg per tablet.

Effect on the ability to drive transp. cf. and fur:Ferrum Lek® does not affect the ability to drive a car and control mechanisms that require increased concentration.

Form release / dosage:

Tablets chewing 100 mg.

Packaging:10 tablets are placed on a strip or blister. For 3, 5 or 9 strips or blisters are placed in a cardboard box along with instructions for medical use.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use the drug after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N012698 / 01

Date of registration:04.04.2007

The owner of the registration certificate: Lek dd Lek dd Slovenia

Manufacturer: & nbsp

LEK d.d. Slovenia

Representation: & nbspSANDOZ SANDOZ Switzerland

Information update date: & nbsp19.06.2014

Illustrated instructions

Instructions

Ferrum Lek® (Ferrum Lek®)