Ferrum lek official instructions. Ferrum lek, chewable tablets

In this article you can read the instructions for use of the drug Ferrum Lek. Reviews of site visitors - consumers of this medicine, as well as the opinions of specialist doctors on the use of Ferrum Lek in their practice are presented. We kindly ask you to actively add your reviews about the drug: whether the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not stated by the manufacturer in the annotation. Analogues of Ferrum Lek in the presence of existing structural analogues. Use for the treatment of anemia and iron deficiency in adults, children (including infants), as well as during pregnancy and breastfeeding. Composition of the drug.

Ferrum Lek- antianemic drug. Ferrum Lek contains iron in the form of a complex compound of iron (3) hydroxide polymaltosate.

The molecular mass of the complex is so large (about 50 kDa) that its diffusion through the gastrointestinal mucosa 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 into a structure similar to the structure of the natural iron compound - ferritin. Due to this similarity, the iron in this complex is absorbed only through active absorption. Iron-binding proteins located on the surface of the intestinal epithelium absorb iron (3) 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 complex (3) hydroxide polymaltosate does not have the pro-oxidant properties inherent in iron salts (2).

Compound

Iron (3) hydroxide polymaltosate + excipients.

Pharmacokinetics

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 greater the iron deficiency, the better the absorption). Iron is absorbed to the greatest extent in the duodenum and jejunum. The remaining (unabsorbed) iron is excreted in the 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. Women experience additional iron loss during menstruation, which must be taken into account.

After intramuscular administration of the drug, iron quickly enters the bloodstream: 15% of the dose - after 15 minutes, 44% of the dose - after 30 minutes.

Indications

• treatment of latent iron deficiency;
• treatment of iron deficiency anemia;
• prevention of iron deficiency during pregnancy;
• conditions in which treatment with oral iron preparations is ineffective or impracticable (for the injection form).

Release forms

Syrup (sometimes mistakenly called drops).

Chewable tablets 100 mg.

Solution for intramuscular administration (injections in injection ampoules).

Instructions for use and dosage regimen

Syrup and tablets

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

The syrup can be mixed with fruit or vegetable juices or added to baby food. The measuring spoon included in the package is used for precise dosing of syrup.

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

Children under 1 year of age are prescribed 2.5-5 ml (1/2-1 scoop) of syrup per day.

Children aged 1 to 12 years - 5-10 ml (1-2 scoops) of syrup per day.

Children over 12 years of age, adults and mothers breastfeeding - 1-3 chewable tablets or 10-30 ml (2-6 scoops) of syrup per day.

Pregnant women are prescribed 2-3 chewable tablets or 20-30 ml (4-6 scoops) of syrup until hemoglobin levels normalize. After this, you should continue to take 1 chewable tablet or 10 ml (2 scoops) of syrup per day, at least until the end of pregnancy to replenish iron reserves in the body.

For latent iron deficiency, the duration of treatment is about 1-2 months.

Children aged 1 to 12 years - 2.5-5 ml (1/2-1 measuring spoon) of syrup per day.

Children over 12 years old, adults and mothers breastfeeding - 1 chewable tablet or 5-10 ml (1-2 measuring spoons) of syrup per day.

Pregnant women are prescribed 1 chewable tablet or 5-10 ml (1-2 scoops) of syrup per day.

Ampoules

The drug in solution form can only be administered intramuscularly. Intravenous administration of the drug is not allowed!

Before administering the first therapeutic dose, each patient should be given a test dose of 1/4-1/2 ampoule (25-50 mg of iron) for adults and 1/2 the daily dose for children. If there are no adverse reactions within 15 minutes after administration, the remainder of the initial daily dose is administered.

Doses of the drug Ferrum Lek are selected individually in accordance with the general iron deficiency, calculated using the following formula:

Total iron deficiency (mg) = body weight (kg) × (estimated Hb level (g/l) - detected Hb (g/l)) × 0.24 + deposited iron (mg).

For body weight up to 35 kg: calculated Hb level = 130 g/l, deposited iron = 15 mg/kg body weight.

With a body weight of more than 35 kg: calculated Hb level = 150 g/l, deposited iron = 500 mg.

Factor 0.24 = 0.0034 × 0.07 × 1000 (iron content in Hb = 0.34%, total blood volume = 7% of body weight, factor 1000 - conversion from g to mg).

Calculation of the total dosage for iron replacement due to blood loss

With a known amount of lost blood, intramuscular administration of 200 mg of iron (2 ampoules) leads to an increase in hemoglobin equivalent to 1 blood unit (400 ml with a hemoglobin content of 150 g/l).

Amount of iron to be replaced (mg) = number of blood units lost x 200 or number of ampoules required = number of blood units lost x 2.

When the final hemoglobin level is known, the above formula is used, taking into account the fact that the deposited iron does not need to be replenished.

Amount of iron to be replaced (mg) = body weight (kg) × (estimated Hb level (g/L) - detected Hb level (g/L)) x 0.24

Usual doses of Ferrum Lek

Adults and elderly patients are prescribed 100-200 mg (1-2 ampoules) depending on the hemoglobin level; children - 3 mg/kg per day (0.06 ml/kg body weight per day).

The maximum daily dose for adults is 200 mg (2 ampoules); for children - 7 mg/kg per day (0.14 ml/kg body weight per day).

Rules for administering the drug

The drug is administered deeply intramuscularly alternately into the right and left buttocks.

In order to reduce pain and avoid skin staining, the following rules should be followed:

the drug should be injected into the upper outer quadrant of the buttock using a needle 5-6 cm long;

before injection, after disinfection of the skin, the subcutaneous tissues should be moved down 2 cm to prevent subsequent leakage of the drug;

after administration of the drug, the subcutaneous tissues should be released, and the injection site should be pressed and held in this position for 1 minute.

Before using the solution for intramuscular injection, ampoules should be carefully inspected. Only ampoules containing a homogeneous solution without sediment should be used. The solution for intramuscular injection should be used immediately after opening the ampoule.

Side effect

• feeling of heaviness;
• feeling of fullness and pressure in the epigastric region;
• nausea;
• constipation;
• diarrhea;
• There is a dark coloration of the stool (black stool), which is due to the excretion of unabsorbed iron and has no clinical significance.

Contraindications

• excess iron in the body (for example, hemochromatosis);
• disorders of iron utilization (for example, anemia caused by lead intoxication, sideroachrestic anemia);
• anemia not associated with iron deficiency (for example, hemolytic anemia, megaloblastic anemia caused by cyanocobalamin deficiency);
• Osler-Rendu-Weber syndrome;
• infectious kidney diseases in the acute stage;
• uncontrolled hyperparathyroidism;
• decompensated cirrhosis of the liver;
• infectious hepatitis;
• 1st trimester of pregnancy;
• hypersensitivity to the components of the drug.

Use during pregnancy and breastfeeding

During controlled studies, when using the drug in the 2nd and 3rd trimesters of pregnancy, no negative effects on the mother or fetus were observed. No harmful effects on the fetus were detected when using the drug in the 1st trimester of pregnancy.

Use in children

It can be used according to indications and in doses taking into account the patient’s age. For children under 12 years of age, due to the need to prescribe the drug in low doses, it is preferable to use it in syrup form.

special instructions

Chewable tablets and syrup do not stain tooth enamel.

The drug in injection form should be used only in a hospital setting.

When prescribing Ferrum Lek to patients with diabetes mellitus, it should be taken into account that 1 chewable tablet and 1 ml of syrup contain 0.04 XE.

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.

Taking the drug does not affect the results of stool tests for occult blood (selectively for hemoglobin).

Impact on the ability to drive vehicles and operate machinery

Does not affect the ability to concentrate.

Drug interactions

Ferrum Lek for intramuscular injection should not be used simultaneously with iron preparations for oral administration.

Concomitant use of Ferrum Lek with ACE inhibitors may increase the systemic effects of parenteral iron preparations.

Analogues of the drug Ferrum Lek

Structural analogues of the active substance:

• Polymaltose iron;
• Maltofer;
• Fenyuls Complex;
• Ferri.

Analogs by pharmacological group (drugs for the treatment of iron deficiency):

• Actiferrin compositum;
• Aloe syrup with iron;
• Biovital elixir;
• Biofer;
• Venofer;
• Vitrum Superstress;
• Vitrum Circus;
• Hemofer;
• Gyno Tardiferon;
• Likferr 100;
• Maltofer;
• Maltofer Fall;
• Multi tabs Active;
• Pikovit Complex;
• Sorbifer Durules;
• Merz special dragee;
• Stress formula with iron;
• Supradin Kids Junior;
• Tardiferon;
• Totema;
• Ferlatum;
• Ferretab comp.;
• Ferrinate;
• Ferro Folgamma;
• Ferrogrademet;
• Ferronal;
• Ferrum Lek;
• Heferol;
• Enfamil with iron.

If there are no analogues of the drug for the active substance, you can follow the links below to the diseases for which the corresponding drug helps, and look at the available analogues for the therapeutic effect.

Today, blood diseases take first place among all pathologies of the body. The most common of them is anemia, the causes of which are numerous: from bad habits, poor environment to severe diseases of the bone marrow and other hematopoietic organs. Everyone who is faced with the problem of anemia will look for effective means for themselves in order to say goodbye to this scourge as quickly as possible. In cases of iron deficiency anemia, one of the priority is Ferrum Lek. “How to take the drug?”, “Can it be done if you have leukemia?”, “How long does it take for the medicine to work?” ‒ questions that have gained the most popularity on forums among patients. Answers to them can be obtained by reading the instructions for the drug.

Iron is one of the most important microelements; it plays a leading role in the formation of hemoglobin, a protein involved in oxygen-carbon dioxide metabolism.

Iron deficiency leads to anemia, which leads to oxygen starvation of the body. Causes of anemia:

• poor nutrition;
• bad habits;
• passive lifestyle;
• diseases of the hematopoietic organs;
• leukemia;
• massive bleeding;
• focus of chronic inflammation.

Composition and release forms

The active ingredient of the drug is ferric iron. Among all the dosage forms of Ferrum Leka, three are distinguished.

Solution for intramuscular administration

Each ampoule contains 2 milliliters of solution, which is equivalent to 100 mg of iron. Immediately after the injection, an iron depot is created, which is released for several more days. Well suited for helping in critical conditions, especially if there are disturbances in the absorption of iron in the digestive tract. Despite this, this route of administration gives the greatest number of various complications. Each package contains 5 ampoules with injection solution.

Pills

Syrup

One milliliter contains 5 mg of active ingredient. The drug is available in a dark bottle with a screw cap, packed in a cardboard box. Well suited for use in pediatrics, as well as for the treatment of patients who need to take less than 100 mg per day.

Oral forms are more effective than injection forms, and they are also safer in relation to allergic manifestations. In most cases, especially after massive bleeding, in order to quickly stabilize the patient, the drug is immediately used in both injections and tablets. This allows you to quickly form an iron depot, which allows you to stabilize hemoglobin and red blood cells. As the condition normalizes, they switch to tablet form to consolidate the effect.

Analogues

If for some reason Ferrum Lek is not suitable for the patient and he has to choose another iron supplement, this will not be a big problem, since there are several similar equally effective remedies.

If you need to choose a substitute for intramuscular and intravenous administration, worthy analogues are the drugs Maltofer, Dextrafer, Ferrolek. As for syrup or tablets, Orofer and Ferumbo are good options.

Pharmacological properties

The drug Ferrum Lek, regardless of the form of release, is intended for the treatment of iron deficiency anemia, it works due to the iron sucrose included in it. With its help, hemoglobin increases in the blood, and signs of anemia disappear. In forms for internal administration, the substance remains in its native state, and the injection solution contains dextran as an adjuvant, which allows the iron to enter directly into the bloodstream, bypassing the gastrointestinal tract.

The types of forms do not differ in their therapeutic effect; in all three cases, iron is absorbed equally well. The only difference is how quickly you need to get the desired result.

Indications for use

Ferrum Lek injections are prescribed for the following conditions:

• anemia caused by massive blood loss;
• patient intolerance to excipients included in oral medications;
• inflammatory diseases of the mucous membrane of the digestive system that interfere with the absorption of iron.

Indications for the use of Ferrum Leka for internal use are:

• prevention of anemia in children, pregnant women, during lactation;
• treatment of mild or latent iron deficiency anemia.

To understand which form of medication is best to use, you need to know exactly the level of iron deficiency. This indicator can be calculated using the following formula: body weight (kilograms) is multiplied by the difference between the hemoglobin norm and current indicators, multiplied again by 0.24. This result is supplemented by the amount of iron from the body’s reserves (determined using a blood test for serum iron. When it decreases below normal, it can be judged that the reserves are depleted). With a weight of less than 35 kg, a hemoglobin value of 130 is taken as the norm; above this weight - 150.

Directions for use and doses

The duration of treatment and doses of Ferrum Lek are adjusted individually, paying attention to the patient’s age and the severity of the disease. The effect of treatment is equally good, regardless of which form of the drug the patient chooses.

In the absence of impaired absorption in the lumen of the digestive organs with anemia, it is better to choose oral forms for children and adults. They are also suitable for the treatment of pathology of any severity. Another great advantage of these drugs is that the iron that enters the intestines is released gradually, without having an aggressive effect on the body.

The injection medicine is used in the treatment of anemia caused by iron deficiency, when there is a malfunction of the digestive system. To calculate the number of ampoules of solution needed for a course of treatment, you need to divide the total iron deficiency indicator by one hundred.

The duration of therapy with Ferrum Lecom is 4–5 months, of which 2–3 are spent eliminating anemia and a few more to replenish iron reserves.

How to take for adults

Treatment of anemia in adults is carried out in various dosages, depending on the severity of the disease.

For treatment, the daily dose is 200-300 mg, it must be divided into several doses, no more than 100 mg at a time. If the choice fell on the ampoule form, no more than 200 mg can be given per day; the medicine must be administered deeply intramuscularly, adhering to all the rules of asepsis and antisepsis.

As a preventative measure, use 1 tablet or 10 ml of syrup per day.

Use in children

From 1 year to 12 years, you should take no more than 100 mg of the substance per day. For this category you can already use tablets. For children weighing less than 35 kg, the daily dose is calculated individually, based on indicators of iron deficiency. For prevention, you need to take no more than 5 ml of syrup per day.

Use in pregnant and lactating women

The drug Ferrum Lek is allowed to be taken with low hemoglobin during pregnancy and lactation. For treatment you need to drink 2-3 tablets a day, for prevention - 1 tablet or 10 ml of syrup per day throughout pregnancy. Syrup and tablets can be taken in any trimester, the injection form only from the 13th week.

For all categories of patients, it is recommended to divide the daily dose into several doses so that iron is supplied evenly, in small quantities. It is better to take the drug after meals to avoid irritation of the digestive tract mucosa. You should not drink it with milk or tea; these products will inactivate the effect of the drug, and the desired effects will not be obtained.

When not to use

Contraindications for the use of Ferrum Leka of any dosage form are:

• anemia not associated with iron deficiency;
• allergies to the components of the product;
• inflammatory processes of the gastrointestinal mucosa (gastritis, enterocolitis, Crohn's disease).

Before starting treatment with this drug, it is necessary to do tests of the kidneys, thyroid gland, and liver. The presence of hepatitis, cirrhosis, hyperthyroidism, and acute infectious kidney diseases in the patient does not allow the use of this medicine.

Side effects

As for side effects, Ferrum Leka drugs rarely cause them, but they still exist, and they should be given due attention. While taking the drug, you may experience:

• heaviness, pain in the stomach;
• dyspeptic disorders;
• inflammation of the gastrointestinal mucosa;
• allergies;
• general malaise;
• fever.

When taking oral medications, the stool turns black. Injection administration of Ferrum Leka can lead to compaction at the injection site and pain.

Overdose

Cases of overdose occur most often with parenteral administration. During internal administration, exceeding the required dose is almost impossible, since excess iron is simply not absorbed into the intestines, but is excreted in the feces. Symptoms of overdose are:

• vomit;
• abdominal pain;
• gastrointestinal bleeding;
• weakness;
• dizziness;
• cardiopalmus;
• depression of the nervous system;
• convulsions;
• arthritis;
• myalgia.

Interaction with other drugs

Varieties of Ferrum Leka cannot be used simultaneously. You must wait five days between injection and internal administration. The use of ACE inhibitors together with iron significantly increases its absorption, possibly causing overdose symptoms.

Determining the effectiveness of treatment

Treatment of iron deficiency anemia should be carried out under the control of laboratory blood parameters, namely general and biochemical analysis. Once ferritin levels and other blood parameters are restored, the drug is taken for several more months.

Storage

Ferrum Lek should be stored at a temperature no higher than 25C, in a dark place protected from light.

Price

The tablet form of Ferrum Leka costs 300-400 rubles, the price of syrup is 200 rubles, and the injection solution, 5 ampoules of 2 ml - 800-1000 rubles.

KNF (medicine included in the Kazakhstan National Formulary of Medicines)

Manufacturer: Lek Pharmaceuticals d.d.

Anatomical-therapeutic-chemical classification: Ferric oxide polymaltose complexes

Registration number: No. RK-LS-5No. 020516

Registration date: 15.05.2014 - 15.05.2019

Instructions

• Russian

Tradename

Ferrum Lek®

International nonproprietary name

Dosage form

Chewable tablets 100 mg

Compound

One chewable tablet contains

active substance - iron 100.00 mg (in terms of iron (III) hydroxide polymaltose complex 400.00 mg),

Excipients: macrogol 6000, aspartame, chocolate essence, talc, dextrates

Description

Tablets are round in shape, with a flat surface, interspersed with white-brown color, with a bevel.

Pharmacotherapeutic group

Hematopoiesis stimulants. Iron supplements. Iron preparations (trivalent) for oral administration. Iron polyisomaltosate

Code ATX В03АВ05

Pharmacological properties

Pharmacokinetics

Iron in Ferrum Lek® chewable tablets is contained in the form of a complex of iron (III) hydroxide and polymaltose, in which its particles are embedded in polymer carbohydrate molecules (polymaltose). In this form, iron does not have a harmful effect on the gastrointestinal tract and does not interact with food. At the same time, the bioavailability of iron also increases. Iron absorption, determined by the level of hemoglobin in red blood cells, is inversely proportional to the administered dose (the higher the dose, the lower the level of absorption). The structure of the complex of iron (III) hydroxide and polymaltose is similar to the structure of ferritin, a natural iron-storing protein found in the body. Due to this similarity, iron (III) from this complex is absorbed through the process of active absorption. The highest level of absorption is observed in the duodenum and jejunum. Absorbed iron is mainly stored in the liver in combination with ferritin, then in the bone marrow it is incorporated into hemoglobin. Unabsorbed iron is excreted in feces. The amount of iron excreted from the body along with exfoliated epithelial cells of the gastrointestinal tract and skin, also with sweat, bile and urine, is about 1 mg per day. In women, iron loss through menstrual blood should be taken into account.

Pharmacodynamics

Multinuclear molecules of iron (III) hydroxide, in the Ferrum Lek® preparation, are surrounded non-covalently with associated polymaltose molecules, forming a complex with a molecular weight of about 50 kDa, which, due to its size, is 40 times weaker in comparison with divalent iron (II). passes through the membrane of the intestinal mucosa using the mechanism of simple diffusion. The complex is stable under physiological conditions; iron ions are not released from it.

In the Ferrum Lek® preparation, the complex of iron (III) hydroxide and polymaltose does not have the pro-oxidant properties inherent in ferrous iron salts. The sensitivity of very low and low density lipoproteins to oxidizing factors is therefore reduced.

Iron, which is part of the drug, is deposited in the liver in the form of a complex with ferritin, then included in hemoglobin, thereby quickly replenishing iron deficiency and restoring hemoglobin levels in the body. When treated with the drug, there is a gradual regression of clinical (weakness, fatigue, dizziness, tachycardia, soreness and dry skin) and laboratory symptoms of iron deficiency.

Indications for use

- treatment of latent iron deficiency anemia

- treatment of iron deficiency anemia (with clinical manifestations)

- iron deficiency during pregnancy

Directions for use and doses

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

Children over 12 years old, adults, nursing mothers

1-3 chewable Ferrum Lek® tablets per day. The duration of treatment is 3-5 months until hemoglobin levels normalize. After this, taking the drug should be continued for several more weeks to replenish iron reserves in the body.

Latent iron deficiency anemia

1 chewable tablet per day. Treatment continues for 1-2 months.

Pregnant women

Iron deficiency anemia with clinical manifestations

2-3 chewable tablets per day until normalization of hemoglobin levels is achieved. After this, therapy should continue with 1 chewable Ferrum Lek® tablet per day, at least until delivery to replenish iron stores.

Latent iron deficiency anemia and prevention of iron deficiency

anemia

1 chewable Ferrum Lek® tablet per day

Table: Daily doses of Ferrum Lek® for the prevention and treatment of iron deficiency

Side effects

Ferrum Lek® is generally well tolerated by patients. For the most part, adverse effects were mild and transient.

Very rarely

Abdominal pain, constipation, diarrhea, nausea, stomach pain, dyspepsia, vomiting

Urticaria, rash, exanthema, itching

Contraindications

Increased individual sensitivity to any of the components of the drug

Patients with iron overload (eg, hemochromatosis, hemosiderosis)

Hereditary fructose intolerance or glucose-galactose malabsorption

Disorders of iron utilization (anemia caused by lead intoxication, sideroachrestic anemia, thalassemia)

Anemia not due to iron deficiency (hemolytic anemia)

Drug interactions

So far, no interactions have been observed. Since iron is bound to the complex, there is little likelihood that ionic interaction will occur with food components (phytin, oxalates, tannin, etc.) and concomitantly taken medications (tetracyclines, antacids). The occult blood test (selective for Hb) is not impaired and therefore there is no need to interrupt iron therapy.

special instructions

The drug does not stain tooth enamel. Dosage forms of the drug Ferrum Lek® taken orally and other iron preparations can turn stool dark. This has no clinical significance.

For children under 12 years of age, due to the need to prescribe the drug in low doses, it is preferable to use it in syrup form. 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 prescribing the drug to patients with diabetes, it should be taken into account that one tablet contains 0.04 bread units. Ferrum Lek® tablets contain aspartame, a source of phenylalanine (phenylalanine precursor), in an amount equivalent to 1.5 mg per 1 tablet, which may cause an adverse effect on patients with phenylketonuria. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase deficiency should not take this medicine.

Pregnancy and lactation

The use of Ferrum Lek®, chewable tablets during pregnancy and lactation is possible only after consultation with a doctor. It is recommended to evaluate the benefit/risk ratio of using the drug.

Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

Does not affect

Overdose

Not identified

Release form and packaging

10 tablets are placed in a contour-free packaging made of aluminum foil.

10 tablets are placed in blister packs made of aluminum foil.

3 contour packages together with instructions for medical use in the state and Russian languages ​​are placed in a cardboard pack.

Storage conditions

Store at a temperature not exceeding 25°C.

Keep out of the reach of children!

Shelf life

Do not use after expiration date.

Conditions for dispensing from pharmacies

On prescription

Manufacturer/Packager

Registration Certificate Holder

Lek Pharmaceuticals d.d., Slovenia

Verovskova, 57, 1526 Ljubljana, Slovenia

Address of the organization that accepts claims from consumers regarding the quality of products (products) on the territory of the Republic of Kazakhstan

Representative office of JSC Sandoz Pharmaceuticals d.d. in the Republic of Kazakhstan

Almaty, st. Luganskogo 96,

Phone number - 258 10 48, fax: +7 727 258 10 47

e-mail: [email protected]

Attached files

Active substance

Iron hydroxide polymaltose (iron polymaltose)

Release form, composition and packaging

Chewable tablets dark brown, interspersed with light brown, round, flat, chamfered.

Excipients: macrogol 6000, aspartame, chocolate flavor, talc, dextrates.

10 pieces. - strips (3) - cardboard packs.

Syrup transparent, brown.

Excipients: sucrose, sorbitol (solution), methyl parahydroxybenzoate, propyl parahydroxybenzoate, ethanol, cream flavor, sodium hydroxide, water.

100 ml - dark glass bottles (1) complete with a measuring spoon - cardboard packs.

pharmachologic effect

Antianemic drug. The preparation contains iron in the form of a complex compound of iron (III) hydroxide polymaltosate.

The molecular mass of the complex is so large (about 50 kDa) that its diffusion through the gastrointestinal mucosa 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 into a structure similar to the structure of the natural iron compound - ferritin. Due to this similarity, the iron in this complex is absorbed only through 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 hydroxide polymaltosate does not have the pro-oxidant properties inherent in iron (II) salts.

Pharmacokinetics

Studies using the dual isotope method (55 Fe and 59 Fe) have shown that iron absorption, measured by red blood cell hemoglobin levels, is inversely proportional to the dose administered (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 greater the iron deficiency, the better the absorption). Iron is absorbed to the greatest extent in the duodenum and jejunum. The remaining (unabsorbed) iron is excreted in the 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/day. Women experience additional iron loss during menstruation, which must be taken into account.

Indications

- treatment of latent iron deficiency;

- treatment of iron deficiency;

- prevention of iron deficiency during pregnancy.

Contraindications

- excess iron content in the body (for example, hemochromatosis);

- disorders of iron utilization (for example, anemia caused by lead intoxication, sideroachrestic anemia);

- anemia not associated with iron deficiency (for example, hemolytic anemia, megaloblastic anemia caused by iron deficiency);

- hypersensitivity to the components of the drug.

Dosage

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

The syrup can be mixed with fruit or vegetable juices or added to baby food. The measuring spoon included in the package is used for precise dosing of syrup.

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

Children under 1 year of age Prescribe 2.5-5 ml (1/2-1 measuring spoon) of syrup/day.

5-10 ml (1-2 scoops) syrup/day.

1-3 tab. chewing or 10-30 ml (2-6 scoops) syrup/day.

Pregnant women Prescribe 2-3 tablets. chewing or 20-30 ml (4-6 scoops) of syrup until hemoglobin levels normalize. After this, you should continue to take 1 tablet. chewing or 10 ml (2 scoops) syrup/day, at least until the end to replenish iron reserves in the body.

At latent iron deficiency The duration of treatment is about 1-2 months.

Children aged 1 to 12 years- 2.5-5 ml (1/2-1 measuring spoon) syrup/day.

Children over 12 years of age, adults and mothers breastfeeding,- 1 tab. chewing or 5-10 ml (1-2 scoops) syrup/day.

Pregnant women 1 tablet is prescribed. chewable or 5-10 ml (1-2 scoops) syrup/day.

Daily doses of Ferrum Lek for the prevention and treatment of iron deficiency in the body.

* - due to the fact that this group of patients requires low doses of iron, it is not recommended in these cases to prescribe the drug in the form of tablets or syrup.

Side effects

From the digestive system: very rarely - a feeling of heaviness, a feeling of fullness and pressure in the epigastric area, nausea, diarrhea. When taking the drug, stool becomes dark in color, which is due to the excretion of unabsorbed iron and has no clinical significance.

The side effects reported were mostly mild and transient.

Overdose

In cases of overdose of Ferrum Lek for oral administration, no signs of intoxication or signs of excess iron intake into the body have been described to date, since iron from the active substance is not present in the gastrointestinal tract in free form and is not absorbed by passive diffusion.

Drug interactions

No interactions with other drugs or foods were noted.

special instructions

Chewable tablets and syrup do not stain tooth enamel.

When prescribing Ferrum Lek to patients with diabetes mellitus, it should be taken into account that 1 tablet. chewable and 1 ml of syrup contains 0.04 XE.

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.

Taking the drug does not affect the results of stool tests for occult blood (selectively for hemoglobin).

Use in pediatrics

Children under 12 years of age Due to the need to prescribe the drug in low doses, it is preferable to use it in the form of syrup.

Impact on the ability to drive vehicles and operate machinery

Does not affect the ability to concentrate.

Storage conditions and periods

The drug should be stored out of the reach of children at a temperature not exceeding 25°C. The shelf life of chewable tablets is 5 years, syrup - 3 years. Do not use after expiration date.