Maltofer® Foul (Maltofer® Fol)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceIron (III) hydroxide polymaltosate + Folic acidIron (III) hydroxide polymaltosate + Folic acid
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  • Lickferr-Folly
    capsules inwards 
    FarmSirma Soteks, ZAO     Russia
  • Maltofer® Foul
    pills inwards 
    Vifor (International) Inc.     Switzerland
    • Dosage form: & nbspchewing tablets
    Composition:

    1 tablet contains:

    active substances:

    iron (III) hydroxide polymaltosate

    357.0 mg

    equivalent to iron

    100.0 mg

    folic acid

    0.35 mg

    Excipients:

    dextrates

    232.0 mg

    macrogol 6000

    37.0 mg

    talcum pure

    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 tablets of brown color with impregnations of white color, with a risk.
    Pharmacotherapeutic group:Iron preparation + vitamin
    ATX: & nbsp

    B.03.A.D.   Preparations of iron in combination with folic acid

    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 about 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 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 orropoiesis.

    The effectiveness of the Maltofer® Fole preparation for normalizing the 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 is not correlated 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 noted in the duodenum and small intestine. As in the case of other oral iron preparations, the relative absorption of iron from iron (III), the polymethyltosate hydroxide, defined as incorporation into hemoglobin, decreases with increasing doses of iron. In addition, a correlation was observed between the degree of iron deficiency (in particular serum ferritin concentration) and the relative amount of absorbed iron (i.e., the greater the 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 gastrointestinal tract, particularly in the duodenum and small intestine.When taking folic acid at a dose of 0.35 mg, absorption is about 80%.

    Distribution

    The distribution of iron from iron (III) after the absorption of polymalthosate hydroxide was studied in a study using the technique of double isotopes (55Fe and 59Ff). 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 the preparation of Maltofer® Foul, chewable tablets (100 mg of iron, 0.35 mg of folic acid) are rapidly absorbed, with a maximum folate concentration in the blood plasma equal to 11 ng / ml, reached 0.75 hours after taking the drug. Folic acid intensively binds to blood plasma proteins, penetrates the blood-brain barrier (GEB), the placenta and into breast milk.

    Biotransformation

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

    The excretion of folic acid occurs mainly in the kidneys, as well as through the digestive tract.

    Folic acid is excreted by hemodialysis.

    Indications:Iron deficiency anemia, including during pregnancy and during breastfeeding.
    Contraindications:
    • The established hypersensitivity to iron (III) hydroxide polymaltosate, (folic acid or to any auxiliary substance.
    • 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 a deficiency of vitamin B12).
    Pregnancy and lactation:

    Pregnancy

    Data of 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.

    Breastfeeding period

    Breast milk of a woman contains iron, associated with lactoferrin. The amount of iron that passes from iron (III) hydroxide polymaltose 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 women during pregnancy and breastfeeding should take Maltofer® Foal only after consulting a doctor.

    Dosing and Administration:

    For oral administration.

    The daily dose of the drug can be divided into several receptions or taken at a time.

    Maltofer® Fole should be taken during or immediately after meals, the tablet 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 content of hemoglobin (Hb). After this, the drug should be continued 1 tablet per 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 (from 200 mg of iron and 0.70 mg of folic acid to 300 mg of iron and 1.05 mg of folic acid) per day until the normal hemoglobin (Hb). After that, 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 demand for iron in connection with pregnancy.

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

    Side effects:

    The safety and tolerability of the preparation Maltofer® Fall 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.

    Unwanted drug reactions. observed in clinical trials

    Classes and systems of organs

    Very frequent (≥1/10)

    Frequent (≥1/100, <1/10)

    Infrequent (≥1/1000, <1/100)

    Disturbances from the nervous system

    -

    -

    Headache

    Disorders from the gastrointestinal tract

    Stool color change1

    Diarrhea, nausea, indigestion

    Vomiting, constipation, abdominal pain, discoloration of tooth enamel2.

    Disturbances from the skin and subcutaneous tissues

    -

    -

    Rash3, 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.

    3 Including exanthema.

    Spontaneous post-marketing reports of adverse drug reactions

    In very rare cases (≥ 0.001% and <0.01%), allergic reactions to folic acid are possible.

    Deviations of laboratory indicators

    No data available.

    Overdose:

    In case of an overdose of the drug, Maltofer® Foul iron overload or intoxication is unlikely, due to the low toxicity of iron (III), polymethyltosate hydroxide and controlled iron uptake. About cases of unintentional poisoning with a legal outcome are not 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.
    Interaction:

    Interactions of iron (III) hydroxide of polymaltosate with tetracycline or aluminum hydroxide have been studied. There is no significant decrease in tetracycline absorption. 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 polymaltosate 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 auranofina, no interactions with iron (III) hydroxide with polymaltose.

    Also, no 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. 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 a selective determination of hemoglobin), 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.

    Special instructions:

    It is assumed that taking Maltofer® Foll should not have an effect on the daily need for insulin in patients with diabetes mellitus. 1 chewable tablet contains 0.04 bread units.

    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 the preparation Maltofer® Fall, dark staining of the stool can be noted, but this has no clinical significance.

    Effect on the ability to drive transp. cf. and fur:

    No data available. It is unlikely that the preparation Maltofer® Fall influences the ability to drive vehicles and mechanisms.

    Form release / dosage:

    Tablets chewing 100 mg + 0.35 mg.

    Packaging:

    For 10 tablets in blisters of aluminum foil, laminated with polyethylene.

    For 1 or 3 blisters together with instructions for use are placed in a cardboard box.

    Storage conditions:

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

    Keep out of the reach of children.

    Shelf life:

    5 years.

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

    Terms of leave from pharmacies:On prescription
    Registration number:П N011982 / 01
    Date of registration:11.10.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:Vifor (International) Inc.Vifor (International) Inc. Switzerland
    Manufacturer: & nbsp
    VIFOR, S.A. Switzerland
    Representation: & nbspTakeda Pharmaceuticals Ltd.Takeda Pharmaceuticals Ltd.
    Information update date: & nbsp28.03.2018
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