Ferum lek 100 mg. Ferrum Lek

Instructions for medical use

medicine

Ferrum Lek ®

Tradename

Ferrum Lek ®

International generic 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, with a chamfer.

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 any effect harmful effects 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. Most high level absorption is noted in the duodenum and jejunum. Absorbed iron is mainly stored in the liver in combination with ferritin, then in bone marrow it is included in hemoglobin. Unabsorbed iron is excreted in feces. The amount of iron excreted from the body along with exfoliated epithelial cells 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

Polynuclear molecules of iron hydroxide (III), in the preparation Ferrum Lek ®, are surrounded non-covalently with associated polymaltose molecules, forming a complex with molecular weight about 50 kDa, which, due to its size, in comparison with divalent iron (II), passes through the membrane of the intestinal mucosa 40 times weaker through 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 symptoms (weakness, fatigue, dizziness, tachycardia, pain and dry skin) and laboratory symptoms 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 may stain stool dark color. 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 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 mellitus Please note 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

This medicine is suitable for both adults and children. We will consider reviews of Ferrum Lek in this article.

Compound

Unlike many other drugs, this one comes in several completely different forms:

Syrup in glass bottles of 100 ml.
Chewable tablets in packs of 30 or 50 pieces.
Solutions for intramuscular administration in ampoules of 2 ml.
Solution for intramuscular administration in ampoules of 5 ml.

The composition of the drug is actually one-component and includes iron necessary for normal functioning body doses. The drug in the form of syrup and tablets "Ferrum Lek", according to patient reviews, is often used.

Indications

Prescribed for the following conditions:

Hidden iron deficiency.
Anemia caused by a lack of iron in the blood.
As prophylactic during pregnancy and lactation, as well as during abnormally heavy menstruation.

Reviews of Ferrum Lek injections are also available in large numbers.

Intramuscular and intravenous solutions are used in situations where there is a need to quickly replenish the lack of iron in the blood. These include:

Severe anemia, caused by severe blood loss.
When iron stops being absorbed in the intestines, including inflammatory processes in the gastrointestinal tract.
If oral intake of iron-containing drugs does not work.
Due to certain reasons, the inability to take iron orally.

It is worth noting that reviews of Ferrum Lek are mostly positive.

Intravenous and intramuscular solutions It is not recommended to administer it in the same syringe with other drugs. The injection site must be treated with ointments based on mucopolysaccharides. Solutions can only be administered under conditions inpatient treatment under the supervision of a specialist.

Taking pills can cause stool to turn black. This is a normal reaction to taking the drug and additional treatment does not require. The effect of Ferrum Lek does not affect the patient’s psychomotor functions, so you can drive a car while taking the drug.

Overdose

In fact, it is quite difficult to overdose on the drug in the form of syrup and tablets, since the excess active substance not absorbed by the intestines into the blood. Another thing is intramuscular and intravenous solutions. IN in this case An overdose is possible, and it is characterized by the following symptoms:

Vomit.
Nausea.
Lightening of the skin.
Diarrhea with bloody impurities.
Pain in the stomach area.
Cold and clammy sweat.
Cramps.
Depressed state of the nervous system.
Tachycardia.
Weakening of the pulse.

With such symptoms, treatment is carried out with drugs based on deferoxamine.

Adverse reactions

The drug in the form of syrup and tablets can cause the development of the following conditions:

Feeling of fullness and heaviness in the stomach.
Constipation.
Nausea.
Diarrhea.
The feces turn black.

When administering the Ferrum Lek solution, according to patient reviews, in addition to the symptoms listed above, the following may also develop:

Dizziness.
Vomit.
Decreased blood pressure.
Joint pain.
Enlarged lymph nodes.
Headache.
Temperature increase.
Allergy.
A state of general malaise.
Darkening may be observed at the injection site skin and painful lumps.

According to reviews, the instructions for Ferrum Lek are very detailed. Special treatment the manifestation of side effects from the use of the drug does not require. As a rule, symptoms go away on their own some time after stopping the medication.

Contraindications

Any form of the drug is under absolute ban for patients suffering from the following conditions:

Anemia not due to iron deficiency.
Failure in the system of utilization and absorption of iron.
Excess iron in the blood.
The individual reaction of the body to the active substance of the drug.

Is Ferrum Lek prescribed during pregnancy? Reviews confirm that doctors prescribe the medicine, but not in the first trimester. Injections are also contraindicated in the following pathologies:

Acute kidney infections.
Osler-Rendu-Weber syndrome.
Liver cirrhosis of decompensated type.
Uncontrolled hepiropathyroidism.
First trimester of pregnancy.
Hepatitis.

Interaction

It is prohibited to take Ferrum Lek simultaneously in different forms of the drug, for example, in syrup and in the form of injections. After a course of injections, you should take a five-day break before continuing therapy with tablets or syrups containing iron. Side effects from the use of drugs for intravenous or intramuscular administration may be aggravated by simultaneous use ACE inhibitors. This is confirmed by the instructions for use and reviews of Ferrum Lek.

Analogs

The main analogues are “Sorbifer” and “Maltofer”. Let's compare them:

"Maltofer" and "Ferrum Lek" contain similar contents of the active ingredient, therefore therapeutic effect from their use will be virtually the same. Both drugs are produced by serious pharmaceutical companies with a good reputation, so the choice depends solely on the individual preferences of the attending physician and the tolerability of one form or another. Maltofer, however, is able to offer more forms for oral administration, which are supplemented with drops and solution. This allows you to select the optimal dosage of the drug in each specific situation. In the case of Ferrum Lek, this option is excluded, since the tablets and syrup contain the same amount of iron - 100 mg. If the patient requires a smaller dosage, then it makes sense to give preference to Maltofer drops. Thus, if we consider drugs from the point of view of convenience, then Maltofer certainly wins.

"Sorbifer" and "Ferrum Lek". Many patients claim that Sorbifer is less tolerated by the body and more often causes irritation of the gastric mucosa and constipation. However, this is most likely due to an individual reaction to the components of the drug. If such signs appear, it is better to switch to another drug and select until you find the most best option. The composition of the drugs is somewhat different: “Sorbifer” is produced on the basis of ferrous sulfate, and “Ferrum Lek” is made from polymaltose hydroxide. Both substances are well accepted by the body and do not cause an overdose of iron. However, the active ingredient Ferrum Lek is similar in composition to what is found in the body, therefore the absorption of the drug is more successful. “Sorbifer,” in turn, has the ability to slowly release iron, so it is preferable for people with a tendency to nausea.

Ferrum Lek is a product that is available in the form of syrup and chewable tablets. The medicinal drug is classified as an antianemic drug. Included active component iron protrudes. The action of Ferrum Lek is aimed at treating hidden iron deficiency, anemia with concomitant iron deficiency, as well as for the prevention of iron deficiency in pregnant women. Can be used in childhood.

Dosage form

The drug Ferrum Lek is available in several dosage forms:

Chewable tablets, which have a round shape, flat-cylindrical surface, dark brown color. They are packaged in blister packs of 10 pieces.
Syrup for oral administration – clear liquid, which is brown in color, is contained in a 100 ml dark glass bottle.
Solution for parenteral intramuscular injection- opaque brown liquid without visible impurities and particles, contained in glass ampoules of 2 ml.

Description and composition

Ferrum Lek chewable tablets are dark brown in color, with light inclusions allowed. The drug units are flat, round and chamfered.

One tablet contains 400 mg of iron polymaltose hydroxide.

Additional components include:

macrogol 6000;
aspartame;
chocolate flavor;
talc;
dextrates.

Ferrum Lek syrup is characterized by transparency and brown color.

Per 5 ml of liquid there are 200 mg of iron polymaltose hydroxide. Excipients in the syrup form include:

sucrose;
sorbitol;
methyl parahydroxybenzoate;
propyl parahydroxybenzoate;
ethanol;
cream flavor;
sodium hydroxide;
purified water.

1 ampoule (2 ml) of solution for intramuscular administration contains 100 mg of iron (III) and water for injection.

Pharmacological group

The medication is classified as an antianemic drug. Due to the content of ferric iron in dosage forms for oral administration (tablets, syrup), it retains its structure and is well absorbed due to active transportation; the spatial model resembles the natural iron compound in the human body - ferritin.

In solution for parenteral administration also contains ferric iron in combination with dextran. Due to this, after intramuscular administration of the drug, it is possible to quickly replenish iron reserves in the human body.

Indications for use

The main medical indication for the use of the drug is the replenishment of iron in the human body.

for adults

Tablets and syrup are used as follows: medical indications:

Latent (hidden) iron deficiency.
Iron-deficiency anemia.
Prevention of iron deficiency in pregnant women.

The solution for intramuscular administration is intended for rapid replenishment of iron in the human body in the following pathological conditions:

Blood loss leading to severe iron deficiency.
Impaired absorption of iron in the intestines.
Pathological conditions in which the use oral forms iron does not give the necessary therapeutic result.

for children

Any dosage form of the drug can be used for children (tablets can be used for adolescents over 12 years of age) for the same medical reasons as for adults.

The medicine can be used for pregnant or breastfeeding women for the purpose of treatment or prevention iron deficiency conditions. The solution for parenteral administration can only be used in the II and III trimester.

Contraindications

There are a number of contraindications for the use of the drug Ferrum Lek. All dosage forms cannot be used in the following situations:

Individual intolerance to any of the components of the drug.
Excessive iron content in the body.
Violation of the process of iron utilization in tissues (lead anemia, thalassemia).
Development of anemia, the pathogenesis of which is not associated with iron deficiency (megaloblastic, hemolytic anemia).

The syrup should not be used with concomitant glucose-galactose malabsorption, sucrose intolerance and other disorders of the digestion and absorption of carbohydrates. The tablets should not be used for children under 12 years of age. Additionally, there are contraindications for the solution, which is administered intramuscularly, these include:

Osler-Rendu-Weber syndrome.
Pregnancy in the first trimester.
Decompensated cirrhosis of the liver.
Infectious pathology of the kidneys in acute stage currents.
Uncontrolled hyperparathyroidism.
Infectious hepatitis.

Applications and dosages

The medication is recommended for use during meals or immediately after it. Ferrum Lek tablets can be chewed or swallowed whole. Dosages calculated per day can be taken at one time, or can be divided into several. The duration of the course is determined by the doctor, basing his decision on the degree of iron deficiency.

Ferrum Lek syrup can be mixed with fruit or vegetable juice or added to baby food.

When treating iron deficiency anemia, a course of treatment lasting from 3 to 5 months is indicated. After bringing the hemoglobin level to normal, the use of the product should continue for several weeks. When treating latent iron deficiency, the course of treatment is from 1 to 2 months.

for adults

Adult patients with iron deficiency anemia are advised to take 1 to 3 tablets or 10-30 ml of syrup per day, and for the treatment of hidden iron deficiency - 1 tablet or 5 to 10 ml of syrup.

for children

When treating iron deficiency anemia in children under 1 year of age, you need to take from 2.5 to 5 ml of syrup per day.

To cure the same disease in children from one to 12 years of age, you need to drink from 5 to 10 ml of syrup per day. Therapy for latent iron deficiency for this category of patients involves taking from 2.5 to 5 ml of syrup.

In children over 12, when treating anemia with concomitant iron deficiency, use 1 to 3 tablets or 10 to 30 ml of syrup. To treat latent iron deficiency in the same group, take 1 tablet or 5-10 ml of syrup per day.

for pregnant women and during lactation

Treatment of iron deficiency anemia in pregnant women involves taking 2-3 tablets or 20-30 ml of syrup per day.

In order to cure hidden iron deficiency, pregnant patients use 1 tablet or 10 ml of syrup.

When conducting preventive measures against iron deficiency in pregnant women, you need to take 1 chewable tablet or 5 to 10 ml of Ferrum Lek syrup.

Side effects

While taking tablets or syrup for oral administration, nausea, abdominal pain, periodic or diarrhea may develop. Less commonly, a rash with an itching sensation appears on the skin and develops.

After intramuscular administration of a solution for parenteral administration, joint pain may appear and increase The lymph nodes, increase body temperature, bother headache, dizziness, nausea, periodic, and also a decrease in systemic blood pressure.

Interaction with other drugs

Clinically significant interaction of oral and parenteral forms of the drug with medicines others pharmacological groups has not been established. The simultaneous use of oral and parenteral forms of iron supplements is not recommended, as this may cause disruption of its absorption in the intestine.

special instructions

Before use medication There are a few special instructions to pay attention to:

For children under 12 years of age, the dosage form syrup may be used.
Tablets or syrup for oral use do not cause discoloration of the enamel.
When taking oral forms of the drug, the stool may become darker in color.
The drug does not affect the reliability of test results on occult blood in feces.
Oral forms contain sugar, so dosage adjustment of hypoglycemic drugs may be required in persons with concomitant.

Overdose

Significantly exceeding the dose of oral forms of the drug did not lead to intoxication, since excess iron ceased to be absorbed and was excreted in the feces. In case of overdose with parenteral forms, an excess of iron in the body is possible with the development of hemosiderosis. Treatment is symptomatic.

Storage conditions

The medication should be stored out of the reach of children, protected from moisture and direct sunlight. Storage temperature is room temperature. Expiration date of the product medicinal purposes Ferrum Lek is 5 years. Use after the expiration of the specified period seems inappropriate.

Medicines are dispensed from pharmacies by prescription.

Analogs

The drug Ferrum Lek has several direct and indirect analogues that exist on the modern pharmacological market. Among the most popular means, not inferior to the original drug in terms of therapeutic effectiveness, the following drugs are distinguished:

This drug is a direct analogue of Ferrum Leka, as it contains the same active ingredient. It differs only in the form of release, represented by a solution for intramuscular injections, and a dosage of 100 mg per ampoule. Can be used as a substitute as prescribed by your doctor.

Dextrafer

The drug Dextrafer is available in the form of a 5% solution for injection containing iron oxide dextran complex. It has pronounced antianemic properties. It is used for the treatment of iron deficiency conditions, and also as a substitute when treatment with iron preparations for oral use is ineffective.

The release form of the drug Orofer is capsules of size No. 2, containing a polymaltose complex of iron hydroxide in combination with. Is antianemic agent with a pronounced effect on metabolic processes. Used for the treatment and prevention of iron deficiency anemia, accompanied by deficiency associated with internal bleeding, impaired absorption from the gastrointestinal tract and poor nutrition. Contraindicated for children under 10 years of age.

Sorbitrim

Sorbitrim is an iron preparation that is manufactured in dosage form drops for oral administration. It is used to treat and prevent iron deficiency in adults, children, and pregnant women.

Price

The cost of Ferrum Leka is on average 1215 rubles. Prices range from 119 to 11,400 rubles.

Pharmacodynamics

The molecular mass of the complex is so large - 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 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.

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

Pharmacokinetics

Studies using the dual isotope method (55Fe and 59Fe) have shown that iron absorption, as 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 higher 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 in exfoliated epithelial cells of the gastrointestinal tract and skin, as well as in 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.

2. indications for use

treatment of latent iron deficiency,
treatment of iron deficiency anemia,
prevention of iron deficiency during pregnancy.

3. Method of application

Inside. It is recommended to take the drug during or immediately after meals. Ferrum Lek® chewable tablets can be chewed or swallowed whole.

The daily dose can be divided into several doses or taken at one time. Ferrum Lek® syrup can be mixed with fruit or vegetable juices or added to baby food.

Doses and duration of treatment depend on the degree of iron deficiency. The measuring spoon included in the package is used for precise dosing of Ferrum Lek® syrup.

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 one year of age: 2.5 ml (1/2 measuring spoon) - 5 ml (1 measuring spoon) Ferrum Lek® syrup per day.

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

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

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 scoop) Ferrum Lek® syrup per day.

Children over 12 years of age, adults and mothers breastfeeding: 1 tablet or 5-10 ml (1-2 scoops) of Ferrum Lek® syrup per day.

Pregnant women

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

Latent iron deficiency and prevention of iron deficiency. One chewable tablet or 5 -10 ml (1 - 2 scoops) of Ferrum Lek® syrup per day.

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

Due to the fact that low doses of iron are required for this group of patients, it is not recommended to use tablets or syrup in these cases.

4. Side effects

The side effects reported were mostly mild and transient.

In very rare cases, gastrointestinal disorders such as a feeling of fullness and pressure in the epigastric region, nausea, constipation or diarrhea are possible.

There may be a dark coloration of the stool due to the excretion of unabsorbed iron, which has no clinical significance.

5. Contraindications

increased sensitivity to the components of the drug,
iron overload in the body (for example, in cases of hemochromatosis),
impaired 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).

6. During pregnancy and lactation

During controlled studies in pregnant women (2nd - 3rd trimesters of pregnancy), no negative effects on the organisms of the mother and fetus were noted. No harmful effects on the fetus were detected when taking the drugs in the first trimester of pregnancy.

7. Interaction with other drugs

Interaction with other drugs or food products not found.

8. Overdose

In case of an overdose of 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.

9. Release form

Chewable tablets 100 mg - 30 or 50 pcs.

10. Storage conditions

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

Best before date

3 years.

11. Composition

1 chewable tablet contains:

iron (III) hydroxide polymaltosate 400 mg, in terms of iron - 100 mg.
Excipients : macrogol 6000, aspartame, chocolate flavor, talc, dextrates.

12. Conditions for dispensing from pharmacies

The drug is dispensed according to the prescription of the attending physician.

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* Instructions for medical use of the drug Ferrum Lek are published in free translation. THERE ARE CONTRAINDICATIONS. BEFORE USE, YOU MUST CONSULT WITH A SPECIALIST

Read these instructions carefully before you start using this medicine. Save the instructions, you may need them again. If you have any questions, consult your doctor. This medicine is prescribed for you personally and should not be given to others because it may harm them even if they have the same symptoms as you.

Registration number: P N012698/01-300715

Trade name of the drug: Ferrum Lek®
International nonproprietary name or generic name: iron (III) hydroxide polymaltosate.

Dosage form
Chewable tablets.

Compound
1 chewable tablet contains:
iron (III) hydroxide polymaltosate 400 mg, in terms of iron - 100 mg,
macrogol 6000 - 37.0 mg; aspartame - 1.5 mg; chocolate flavor - 0.6 mg; talc - 21.0 mg; dextrates - until 730.0 mg is obtained.

Description
Round flat tablets of dark brown color interspersed with light brown color, with a bevel.

Pharmacotherapeutic group
Antianemic agent. Iron supplement.

ATX code:В03АВ05.

Pharmacological properties

Pharmacodynamics
The molecular mass of the complex is so large - 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 into a structure similar to the structure 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 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 (eg, very low-density lipoproteins and low-density lipoproteins) to oxidation is reduced.
Pharmacokinetics
Studies using the dual isotope method (55Fe and 59Fe) have shown that iron absorption, as 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 higher the iron deficiency, the better the absorption). Maximum absorption of iron occurs in the duodenum and jejunum. Unabsorbed iron is excreted in the feces. Its excretion in exfoliated epithelial cells of the gastrointestinal tract and skin, as well as in 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.

Indications for use

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

Contraindications for use

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

Carefully

No data.

Use during pregnancy and breastfeeding

Before starting to use the drug during pregnancy or breastfeeding, you should consult your doctor.
In controlled studies in pregnant women (2nd and 3rd trimesters of pregnancy), no negative effects on the mother and fetus were observed. No harmful effects on the fetus were detected when taking the 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 entering mother's milk from the complex with polymaltose. However, the occurrence of undesirable effects in those on breastfeeding children are unlikely.

Directions for use and doses

Orally, the tablets can be chewed or swallowed whole. It is recommended to take the drug during or immediately after meals.
The daily dose can be divided into several doses.
Doses and duration of treatment depend on the degree of iron deficiency.

The duration of treatment is about 1-2 months,

The duration of treatment is about 3-5 months. After normalization of hemoglobin concentration, you should continue taking the drug for several more weeks to replenish iron reserves in the body.
Children over 12 years of age, adults and mothers breastfeeding
1-3 chewable tablets (100-300 mg) Ferrum Lek® per day.
Pregnant women

1 chewable tablet (100 mg) Ferrum Lek® per day.

2-3 chewable tablets (200-300 mg) Ferrum Lek® per day until the hemoglobin concentration normalizes. After this, 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 Ferrum Lek® tablets for the prevention and treatment of iron deficiency in the body

Side effect

Ferrum Lek® is generally well tolerated. Side effects are predominantly 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), нечасто (≥1/1000, <1/100), редко (≥1/10000, <1/1000) и очень редко (<1/10000); частота неизвестна - по имеющимся данным установить частоту возникновения не представлялось возможным.

infrequently: headache.

Often: change in the color of feces (due to the excretion of unabsorbed iron, has no clinical significance);
often: diarrhea, nausea, dyspepsia;
very rarely: abdominal pain, constipation, vomiting, discoloration of tooth enamel.

very rarely: urticaria, rash, itching of the skin.
If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

Interaction with other drugs

The composition of the drug Ferrum Lek® includes 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).
No interactions with other drugs or food products have been identified.
Concomitant use of polymaltosate hydroxide with parenteral iron preparations and other oral iron (III) preparations is not recommended due to the pronounced inhibition of the absorption of orally administered 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 Lek®, the stool may turn dark, which does not have any clinical significance. The drug Ferrum Lek® does not affect the results of the occult blood test (selective for hemoglobin); therefore, it is not necessary to interrupt iron therapy.
Note for patients with diabetes: 1 chewable tablet of Ferrum Lek® contains 0.04 bread units (XE).
Note for patients with phenylketonuria: Ferrum Lek® contains aspartame (E951), which is a source of phenylalanine, in an amount equivalent to 1.5 mg per tablet.

Impact on the ability to drive vehicles and machinery

Ferrum Lek® does not affect the ability to drive a car or operate machinery that requires increased concentration.