Instruction for use: Maltofer Fol

Dosage form: Chewing tablets

Active substance: Ferri (III) hydroxydum polymaltosatum+ Acidum folicum

ATX

B03AD04 Dextriferron

Pharmacological groups

Iron preparation + vitamin [Macro and microelements in combinations]

Iron preparation + vitamin [Stimulants of hemopoiesis in combinations]

The nosological classification (ICD-10)

D50 Iron deficiency anemia: Iron deficiency in food; Anemia due to violations of hemoglobin synthesis and iron metabolism; Anemia of iron deficiency; Iron / folic deficiency anemia; Iron deficiency anemia

E61.1 Insufficiency of iron: Insufficient food intake of iron; Iron deficiency; Iron deficiency in women during pregnancy; Deficiency of iron and folic acid in pregnancy; Iron deficiency after surgery; Latent iron deficiency; Lack of iron during pregnancy and lactation; Inadequate intake of iron from food; Increased need for iron; Increased need for iron during menstruation; Disturbances of iron absorption from the digestive tract; Severe iron deficiency

O25 Malnutrition in pregnancy: Hypovitaminosis during pregnancy; Deficiency of vitamins and minerals in pregnancy; Deficiency of iron and folic acid in pregnancy; Iron deficiency in women during pregnancy; Iodine deficiency in pregnancy; Iodine deficiency in lactating women; Calcium deficiency in the mother's body; Calcium deficiency in pregnant women; Mineral deficiency during pregnancy; An additional source of folic acid during pregnancy; Correction of calcium metabolism disorders during pregnancy; Lack of iron during pregnancy and lactation; Pregnancy Period; Breastfeeding period; Increased need for vitamin B1 in pregnancy

O26.8 Other specified conditions associated with pregnancy: Abnormal course of pregnancy; Constipation in pregnant women; Early toxicosis of pregnancy; Toxicosis of pregnant women; Toxicosis of pregnant early; Asthenia of pregnant women; Heartburn during pregnancy; Appetite perverted in pregnant women; Vaginal discharge during pregnancy; Constipation during and after pregnancy; Nephropathies of pregnant women; Toxicosis of pregnancy; Fever in Pregnancy

Composition

Tablets chewing 1 tab.

active substance: Iron (III) hydroxide polymaltosate 357 mg

(Equivalent to 100 mg of iron)

Folic acid 0.35 mg

Auxiliary substances: dextrates - 232 mg; Macrogol 6000 - 37 mg; Talcum purified - 21 mg; Sodium cyclamate - 9 mg; Vanillin - 2.9 mg; Cocoa powder - 29 mg; Chocolate flavoring - 0.6 mg; MCC - up to 730 mg

Description of dosage form

Tablets: round flat, brown with impregnations of white color, with a risk.

Pharmachologic effect

Mode of action - Anti-anemic.

Pharmacodynamics

In iron (III), the polymethyltosate hydroxide multinucleated iron (III) hydroxide is surrounded from the outside by a number of covalently bound polymaltosate molecules, which gives a total average molecular weight of approximately 50 kDa. The structure of the multinucleated core of iron (III) hydroxide of polymaltose is similar to the structure of the core of the ferritin protein, the physiological depot of iron. Iron (III) hydroxide polymaltose is stable and under physiological conditions does not emit a large number of iron ions. Due to the size, the degree of diffusion of iron (III) polymethyltosate hydroxide through the mucosa is approximately 40 times less than that of the iron-hexahedral complex (II). Iron from iron (III) hydroxide polymaltozate 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, incl. Biosynthesis of purines and thymidylates of nucleic acids; It is necessary for the synthesis of nucleoproteins and maintenance of normal erythropoiesis.

The effectiveness of the Maltofer® Fol preparation for the normalization of hemoglobin content and iron depot replacement has been demonstrated in numerous randomized controlled clinical trials using placebo control or an active comparator in adults and children with different iron depot status.

Pharmacokinetics

Suction. Iron from iron (III) hydroxide polymaltose is absorbed in accordance with the controlled mechanism. The increase in serum iron content after administration of the drug does not correlate with total iron absorption, measured as incorporation into hemoglobin (Hb). Studies with a labeled radioisotope of iron (III) hydroxide with polymaltozate revealed a strong correlation between the inclusion of iron in erythrocytes and the iron content throughout the body. The maximum activity of iron absorption from iron (III) hydroxide polymaltose is observed in the duodenum and small intestine. As with other oral iron preparations, the relative absorption of iron from iron (III), the polymethyltosate hydroxide, defined as incorporation into Hb, decreases with increasing iron doses. In addition, a correlation was observed between the severity of iron deficiency (in particular serum ferritin concentration) and the relative amount of absorbed iron (ie, the more iron deficiency, the better the relative absorption). In patients with anemia, absorption of iron from iron (III), polymethyltosate hydroxide, in contrast to iron salts, increased in the presence of food.

Folic acid is absorbed mainly in the digestive tract, particularly in the duodenum and small intestine. When taking folic acid at a dose of 0.35 mg, absorption is about 80%.

Distribution. Distribution of iron from iron (III) hydroxide of polymaltosate after absorption was studied in a study using the technique of double isotopes (55Fe and 59Fe).

Cmax of folic acid in the blood is reached after 30-60 minutes. In a single-dose study in 12 healthy women, folic acid from the Maltofer® Foll preparation, chewable tablets (100 mg iron, 0.35 mg folic acid) was rapidly absorbed, with Cmax folate in blood plasma equal to 11 ng / ml , Is achieved after 0.75 hours after taking the drug. Folic acid binds intensely to blood plasma proteins, penetrates the GEB, the placenta and into breast milk.

Biotransformation. The absorbed iron binds to transferrin and is used to synthesize Hb 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-sucked iron is excreted by the intestine (with feces).

The elimination of folic acid occurs mainly in the kidneys, as well as through the digestive tract. Folic acid is excreted by hemodialysis.

Indication of the drug Maltofer Fol

Iron deficiency anemia, incl. During pregnancy and during breastfeeding.

Contraindications

Established hypersensitivity to iron (III) hydroxide polymaltosate or to any auxiliary substance;

Overload with iron (eg hemosiderosis, hemochromatosis);

Impairment of iron utilization (eg lead anemia, sidero-achestic anemia, thalassemia);

Anemia not related to iron deficiency (eg hemolytic anemia or megaloblastic anemia caused by a lack of vitamin B12).

Application in pregnancy and breastfeeding

Data from clinical studies on the use of the preparation Maltofer® Fall in the I trimester of pregnancy are absent. To date, there have been no reports of serious adverse reactions after taking Maltofer® Fol inward at therapeutic doses in the treatment of anemia during pregnancy. The data obtained from animal studies showed no danger to the fetus and the mother. In studies conducted in pregnant women after the end of the first trimester of pregnancy, no undesirable effects of the preparation Maltofer® Fall on mothers and / or newborns were found. In this regard, adverse effects on the fetus when using the drug Maltofer® Fall is unlikely.

Breast milk of a woman contains iron, associated with lactoferrin. The amount of iron that passes from iron (III) hydroxide polymaltozate to breast milk is unknown. It is unlikely that the use of Maltofer® FoL by breast-feeding women can lead to undesirable effects in the child. As a precaution, women of childbearing age and during pregnancy and breastfeeding should take Maltofer® FoL only after consulting a doctor.

Side effects

Safety and tolerability of the drug Maltofer® Fol is evaluated in a variety of clinical studies. The main undesirable drug reactions (NLR) noted in these studies occurred in the following three classes of systems and organs (frequency was defined as: very often ≥1 / 10, often ≥1 / 100, <1/10, infrequently ≥ 1/1000, <1/100).

From the nervous system: infrequently - a headache.

From the digestive tract: very often - a change in the color of feces; Often - diarrhea, nausea, dyspepsia; Infrequently - vomiting, constipation, abdominal pain, discoloration of tooth enamel2.

From the skin and subcutaneous tissues: infrequently - rash (including exanthema), itching.

1 Often recorded as an undesirable phenomenon (in 23% of patients), this is a well-known NLR for oral iron preparations.

2 An adverse event was reported in 0.6% of patients, and this is a well-known NLR for oral iron preparations.

Spontaneous post-marketing reports on NLR. Very rarely (≥0,001% and <0,01%) allergic reactions to folic acid are possible.

Deviations of laboratory indicators. No data available.

Interaction

The interaction of iron (III) hydroxide of polymaltosate with tetracycline or aluminum hydroxide was studied. A significant reduction in tetracycline absorption was not observed. The concentration of tetracycline in the blood plasma did not drop below the effective level. Absorption of iron from iron (III) hydroxide polymaltozate did not decrease under the influence of aluminum hydroxide or tetracycline. Thus, iron (III) hydroxide polymaltozate 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 interaction with iron (Iii) hydroxide with polymaltose.

The interaction of iron (III) hydroxide of polymaltosate 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 soybean flour has also not been observed. These results indicate that iron (III) hydroxide polymaltose can be taken during or immediately after ingestion.

The administration of the drug does not affect the results of the detection of hidden blood (with selective determination of Hb), therefore, it is not necessary to interrupt treatment.

It is necessary to avoid the simultaneous use of parenteral and oral iron preparations, since the absorption of iron taken orally slows down.

Treatment with folic acid can increase the metabolism of phenytoin, which leads to a decrease in serum phenytoin concentration, especially in patients with folate deficiency. Although this interaction is not clinically significant, some patients may experience an increase in the frequency of convulsive seizures. Patients receiving phenytoin or other anticonvulsants should consult a physician before taking a drug containing folic acid.

It was found that the simultaneous use of chloramphenicol and folic acid in patients with folate deficiency can lead to a weakening of the hemopoietic response to folic acid due to the antagonistic effect of chloramphenicol. Although the significance and mechanism of interaction are unclear, patients receiving both drugs should carefully monitor the hematologic response to folic acid therapy.

Dosing and Administration

Inside.

The daily dose of the drug can be divided into several receptions or taken at a time. Maltofer® Fol should be taken during or immediately after meals, the tablets can be chewed or swallowed whole.

Treatment of iron deficiency anemia outside of pregnancy. According to 1 table. 1-3 times a day for 3-5 months until the normal content of Hb is reached. After that, the drug should be continued 1 tablet / day for several more months in order to restore iron stores in the body.

Treatment of iron deficiency anemia during pregnancy. From 2 to 3 tablets / day (from 200 mg of iron and 0.7 mg of folic acid to 300 mg of iron and 1.05 mg of folic acid) until the normal content of Hb is reached. After that, the treatment should be continued at least until the end of pregnancy, taking 1 tablet / day (100 mg of iron and 0.35 mg of folic acid), in order to replenish iron stores and meet the increased demand for iron in connection with pregnancy.

Maltofer® Fol is not recommended for children under 12 years of age.

Overdose

In the case of an overdose of the Maltofer® Fol preparation, iron overload or intoxication is unlikely, due to the low toxicity of iron (III), polymethyltosate hydroxide and controlled iron uptake. No cases of unintentional poisoning with a lethal outcome were reported.

There are reports that an excessive dose of folic acid can cause disorders of the central nervous system (in particular, changes in mental state, sleep disturbance, irritability and hyperactivity), nausea, bloating and flatulence.

Special instructions

It is assumed that taking Maltofer® Fol should not affect the daily need for insulin in patients with diabetes mellitus. 1 chewable tablet contains 0.04 XE.

The preparation Maltofer® Fol contains folic acid, the reception of which can lead to the masking of vitamin B12 deficiency.

Anemia can be caused by infectious diseases or malignant neoplasms. Since iron can only be taken after the root cause of the disease has been eliminated, the relationship between benefit and risk of treatment should be determined.

During treatment with Maltofer® Fol, dark staining of the stool can be noted, but this is not clinically relevant.

Influence on the ability to drive vehicles and work with machinery. No data available. It is unlikely that the preparation Maltofer® Fol has an effect on the ability to drive vehicles, mechanisms.

Release form

Tablets are chewable, 100 mg + 0.35 mg. In a blister of aluminum foil, laminated PE, 10 pcs. 1 or 3 bl. In a cardboard box.

Manufacturer

Vifor C.A. Ruth de Moncor, 10, SN-1752, Villars-sur-Glane, Switzerland

The legal entity in whose name the registration certificate / company issuing the quality control certificate is issued: Vifor (International) Inc. Rehenstrasse 37, SN-9014 Art. Gallen, Switzerland.

The organization that accepts consumer claims: OOO Takeda Pharmaceuticals. 119048, Moscow

Conditions of supply of pharmacies

On prescription.

Storage conditions of the drug Maltofer Fol

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life of the drug Maltofer Fol

5 years.

Do not use after the expiry date printed on the package.