Maltofer Foul chewable tablets, No. 30

Iron deficiency anemia, including during pregnancy and breastfeeding.

For oral administration.
The daily dose of the drug can be divided into several doses or taken at a time.
MaltoferЃ Fol should be taken during or immediately after a meal, the tablets can be chewed or swallowed whole.
Treatment of iron deficiency anemia outside of pregnancy
1 tablet 1-3 times a day for 3-5 months until the normal hemoglobin (Hb) content is reached. After that, taking the drug should be continued at 1 tablet per day for several more months in order to restore iron stores in the body.
Treating iron deficiency anemia during pregnancy
2 to 3 tablets (200 mg iron and 0.70 mg folic acid to 300 mg iron and 1.05 mg folic acid) per day until the normal hemoglobin (Hb) level is reached. After this, treatment should be continued at least until the end of pregnancy, taking 1 tablet (100 mg of iron and 0.35 mg of folic acid) per day, in order to replenish iron stores and meet the increased need for iron due to pregnancy.
MaltoferЃ Foul is not recommended for children under 12 years of age.

1 tablet contains:

active ingredients:

iron (III) hydroxide polymaltose - 357.0 mg

equivalent to the iron content - 100.0 mg

folic acid - 0.35 mg

Excipients:

dextrates - 232.0 mg

macrogol 6000 - 37.0 mg

purified talc - 21.0 mg

sodium cyclamate - 9.0 mg

vanillin - 2.9 mg

cocoa powder - 29.0 mg

chocolate flavor - 0.6 mg

microcrystalline cellulose up to 730.0 mg

• Established hypersensitivity to iron (III) hydroxide polymaltosate, folic acid, or to any excipient.

• Iron overload (eg, hemosiderosis, hemochromatosis).

• Impaired iron utilization (eg, lead anemia, sideroachrestic anemia, thalassemia).

• Anemia not associated with iron deficiency (eg, hemolytic anemia or megaloblastic anemia caused by vitamin B12 deficiency).

• Not recommended for children under 12 years of age.

Tradename:

MaltoferЃ Fol

International non-proprietary name or group name:

iron (III) hydroxide polymaltose + folic acid

Chemical name:

iron (III) hydroxide polymaltose and folic acid

Dosage form:

chewable tablets

Composition:

1 tablet contains:

active ingredients:

iron (III) hydroxide polymaltose - 357.0 mg

equivalent to the iron content - 100.0 mg

folic acid - 0.35 mg

Excipients:

dextrates - 232.0 mg

macrogol 6000 - 37.0 mg

purified talc - 21.0 mg

sodium cyclamate - 9.0 mg

vanillin - 2.9 mg

cocoa powder - 29.0 mg

chocolate flavor - 0.6 mg

microcrystalline cellulose up to 730.0 mg

Description

Round, flat brown tablets interspersed with white, scored.

Pharmacotherapeutic group:

iron preparation + vitamin.

ATX code:

B03AD04

Pharmacological properties

Pharmacodynamics
In iron (III) hydroxide polymaltose, the multinuclear iron (III) hydroxide is externally surrounded by a plurality of covalently linked polymaltose molecules, resulting in a total average molecular weight of approximately 50 kDa. The structure of the multinucleated core of iron (III) hydroxide polymaltose is similar to the structure of the core of the ferritin protein, a physiological iron depot. Iron (III) hydroxide polymaltose is stable and does not release a large amount of iron ions under physiological conditions. Due to its size, the diffusion rate of iron (III) hydroxide of polymaltosate through the mucous membrane is approximately 40 times less than that of the iron (II) complex. Iron from iron (III) hydroxide of polymaltose is actively absorbed in the intestine.
Folic acid (folate) belongs to the group of vitamins B. It is a precursor of tetrahydrofolate, which is a coenzyme of various metabolic processes, including the biosynthesis of purines and thymidylates of nucleic acids; it is necessary for the synthesis of nucleoproteins and for the maintenance of normal erythropoiesis.
The efficacy of MaltoferЃ for normalizing hemoglobin levels and replenishing iron depot has been demonstrated in numerous randomized controlled clinical trials using placebo control or an active comparison drug in adults and children with different iron depot status.

Pharmacokinetics
Absorption
Iron from iron (III) hydroxide of polymaltose is absorbed according to a controlled mechanism. The increase in serum iron after administration of the drug does not correlate with total iron absorption, measured as incorporation into hemoglobin (Hb). Studies with radiolabeled iron (III) hydroxide polymaltose have revealed a strong correlation between the incorporation of iron into erythrocytes and the iron content throughout the body. The maximum activity of absorption of iron from iron (III) polymaltose hydroxide is noted in the duodenum and small intestine. As with other oral iron preparations, the relative absorption of iron from iron (III) polymaltose hydroxide, defined as incorporation into hemoglobin, decreases with increasing iron doses. Besides,a correlation was observed between the severity of iron deficiency (in particular, the concentration of ferritin in the blood serum) and the relative amount of absorbed iron (that is, the more pronounced the iron deficiency, the better the relative absorption). In patients with anemia, the absorption of iron from iron (III) polymaltose hydroxide, in contrast to iron salts, increased in the presence of food.
Folic acid is absorbed mainly in the gastrointestinal tract, in particular in the duodenum and small intestine. When folic acid is taken at a dose of 0.35 mg, absorption is about 80%.
Distribution The
distribution of iron from iron (III) polymaltose hydroxide after absorption was studied in a study using the double isotope technique (55Fe and 59Fe).
The maximum concentration of folic acid in the blood is reached after 30-60 minutes. In a study of single doses in 12 healthy women, it was shown that folic acid from MaltoferЃ Fol, chewable tablets (100 mg iron, 0.35 mg folic acid) is rapidly absorbed, with a maximum plasma folate concentration of 11 ng / ml , is achieved within 0.75 hours after taking the drug.
Folic acid binds intensively to blood plasma proteins, crosses the blood-brain barrier (BBB), the placenta and into breast milk.
Biotransformation
Absorbed iron binds to transferrin and is used for the synthesis of hemoglobin in the bone marrow or is stored, mainly in the liver, where it binds to ferritin.
Folic acid is metabolized in the cells of the small intestine and liver, as well as in other organs. After that, folates associated with transport proteins are distributed to all organs.
Excretion
Non-absorbed iron is excreted by the intestines (in the feces).
The excretion of folic acid occurs mainly by the kidneys, as well as through the digestive tract.
Folic acid is eliminated by hemodialysis.

Indications for use

Iron deficiency anemia, including during pregnancy and breastfeeding.

Contraindications

• Established hypersensitivity to iron (III) hydroxide polymaltosate, folic acid, or to any excipient.

• Iron overload (eg, hemosiderosis, hemochromatosis).

• Impaired iron utilization (eg, lead anemia, sideroachrestic anemia, thalassemia).

• Anemia not associated with iron deficiency (eg, hemolytic anemia or megaloblastic anemia caused by vitamin B12 deficiency).

Application during pregnancy and during breastfeeding

Pregnancy There are no
data from clinical trials on the use of MaltoferЃ Foul in the first trimester of pregnancy. To date, there have been no reports of serious adverse reactions after taking the drug MaltoferЃ Fol orally in therapeutic doses for the treatment of anemia during pregnancy. Data obtained in animal studies have shown no danger to the fetus and mother.
In studies carried out in pregnant women after the end of the first trimester of pregnancy, no undesirable effects of MaltoferЃ Fol were found in relation to mothers and / or newborns. In this regard, an adverse effect on the fetus when using the drug MaltoferЃ Fol is unlikely.
Breastfeeding period
A woman's breast milk contains iron, which is associated with lactoferrin. The amount of iron that passes from iron (III) polymaltose hydroxide into breast milk is unknown. It is unlikely that the use of the drug Maltofer Fol in women who are breastfeeding can lead to undesirable effects in a child.
As a precautionary measure, women of childbearing age and women during pregnancy and breastfeeding should take MaltoferЃ Fol only after consulting a doctor.

Method of administration and dosage

For oral administration.
The daily dose of the drug can be divided into several doses or taken at a time.
MaltoferЃ Fol should be taken during or immediately after a meal, the tablets can be chewed or swallowed whole.
Treatment of iron deficiency anemia outside of pregnancy
1 tablet 1-3 times a day for 3-5 months until the normal hemoglobin (Hb) content is reached. After that, taking the drug should be continued at 1 tablet per day for several more months in order to restore iron stores in the body.
Treating iron deficiency anemia during pregnancy
2 to 3 tablets (200 mg iron and 0.70 mg folic acid to 300 mg iron and 1.05 mg folic acid) per day until the normal hemoglobin (Hb) level is reached. After this, treatment should be continued at least until the end of pregnancy, taking 1 tablet (100 mg of iron and 0.35 mg of folic acid) per day, in order to replenish iron stores and meet the increased need for iron due to pregnancy.
MaltoferЃ Foul is not recommended for children under 12 years of age.

Overdose

In the case of an overdose with MaltoferЃ Fol, iron overload or intoxication is unlikely, which is associated with the low toxicity of iron (III) hydroxide polymaltosate and controlled uptake of iron. Cases of unintentional fatal poisoning have not been reported.
There are reports that an excessive dose of folic acid can cause disturbances in the central nervous system (in particular, changes in mental state, sleep disturbances, irritability and hyperactivity), nausea, bloating and flatulence.

Interaction with other medicinal products

Interactions of iron (III) hydroxide of polymaltose with tetracycline or aluminum hydroxide were studied. No significant decrease in the absorption of tetracycline was observed. The concentration of tetracycline in blood plasma did not fall below the effective level. The absorption of iron from iron (III) hydroxide of polymaltose was not reduced under the influence of aluminum hydroxide or tetracycline. Thus, iron (III) hydroxide polymaltose can be used simultaneously with tetracycline and other phenolic compounds, as well as with aluminum hydroxide.
In studies in rats using tetracycline, aluminum hydroxide, acetylsalicylic acid, sulfasalazine, calcium carbonate, calcium acetate and calcium phosphate in combination with vitamin D3, bromazepam, magnesium aspartate, D-penicillamine, methyldopa, paracetamol and auranofin, no interactions with iron were found (III) hydroxide with polymaltose.
Also, there was no interaction of iron (III) polymaltose hydroxide with food components such as phytic acid, oxalic acid, tannin, sodium alginate, choline and choline salts, vitamin A, vitamin D3 and vitamin E, soybean oil and soy flour. These results suggest that iron (III) hydroxide polymaltosate can be taken during or immediately after a meal.
Taking the drug does not affect the results of occult blood determination (with selective hemoglobin determination), therefore, there is no need to interrupt treatment.
It is necessary to avoid the simultaneous use of parenteral and oral iron preparations, since the absorption of iron taken by mouth is slowed down.
Folic acid treatment can increase the metabolism of phenytoin, which leads to a decrease in the concentration of phenytoin in the blood serum, especially in patients with folate deficiency. Although this interaction is not clinically relevant, an increase in the frequency of seizures may be observed in some patients. Patients taking phenytoin or other anticonvulsants should consult a doctor before taking a folic acid medication.
It was found that the simultaneous use of chloramphenicol and folic acid in patients with folate deficiency can lead to a weakening of the hematopoietic response to folic acid due to the antagonistic effect of chloramphenicol. Although the significance and mechanism of interaction is unclear, in patients receiving both drugs at the same time, the hematological response to folic acid treatment should be closely monitored.

special instructions

It is assumed that taking Maltofer Fol should not affect the daily insulin requirement in patients with diabetes mellitus. 1 chewable tablet contains 0.04 bread units.
The drug MaltoferЃ Fol contains folic acid, the intake of which can lead to masking of vitamin B12 deficiency.
Anemia can be caused by infectious diseases or malignant neoplasms. Since iron can be taken only after the underlying cause of the disease has been eliminated, the balance between the benefits and risks of treatment should be determined.
During treatment with MaltoferЃ Fol, dark staining of feces may occur, but this has no clinical significance.

Influence on the ability to drive vehicles, mechanisms

No data available. It is unlikely that the drug Maltofer Fol affects the ability to drive vehicles and mechanisms.

Forms of issue

Chewable tablets 100 mg + 0.35 mg.
10 tablets in blisters of aluminum foil laminated with polyethylene.
1 or 3 blisters, together with instructions for use, are placed in a cardboard box.

Storage conditions

In a dark place at a temperature not exceeding 25 ? C.
Keep out of the reach of children.

Shelf life

5 years.
Do not use after the expiration date printed on the package.

Vacation conditions

On prescription.