Universal reference book for medicines
Name of the preparation: MALTOFER® FOL (MALTOFER® FOL)

Active substance: folic acid, iron polymaltose

Type: Anti-anemic drug

Manufacturer: VIFOR (International) (Switzerland) manufactured by VIFOR (Switzerland)
Composition, form of production and packaging

Chew tablets of brown color with impregnations of white color, round, flat, with a risk.

1 tab.

iron (III) hydroxide polymaltosate 357 mg,

equivalent to iron content of 100 mg

folic acid 0.35 mg

Excipients: dextrates 232 mg, macrogol 6000-37 mg, talc purified 21 mg, sodium cyclamate 9 mg, vanillin 2.9 mg, cocoa powder 29 mg, chocolate flavor 0.6 mg, microcrystalline cellulose up to 730 mg.

10 pieces.
- blisters (1) - packs of cardboard.
10 pieces.
- blisters (3) - packs cardboard


INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2017.

PHARMACHOLOGIC EFFECT

The drug is iron + vitamin.

In iron (III), the polymethyltosate hydroxide multinucleated iron (III) hydroxide is surrounded from the outside by a number of covalently bound polymaltosate molecules, which provides a total average molecular weight of about 50 kDa.
The structure of the active substance of the preparation Maltofer ® Fole 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, incl.
biosynthesis of purines and thymidylates of nucleic acids; it is necessary for the synthesis of nucleoproteins and for the maintenance of normal erythropoiesis.
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 application 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 polymaltozate revealed a strong correlation between the inclusion of iron in erythrocytes and the iron content in the entire body. The maximum activity of iron absorption from iron (III) hydroxide polymaltose is noted in the duodenum and small intestine. As with other iron preparations for oral administration, 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 into the digestive tract, mainly in the duodenum and small intestine.
When taking folic acid at a dose of 0.35 mg, the absorption is about 80%.
Distribution

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

C max of folic acid in the blood is reached after 30-60 minutes.
In a single-dose study, 12 healthy women showed that folic acid from the Maltofer® Fol preparation, chewable tablets (100 mg of iron, 0.35 mg of folic acid) is rapidly absorbed, with Cmax of folate in blood plasma equal to 11 ng / ml is achieved 0.75 h after taking the drug.
Folic acid binds intensely to blood plasma proteins, penetrates the BBB, placental barrier, is excreted in breast milk.

Metabolism

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 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).

DOSING MODE

The drug is taken orally during or immediately after a meal.
Tablets can be chewed or swallowed whole.
The daily dose of the drug can be divided into several receptions or taken at a time.

Treatment of iron deficiency anemia outside of pregnancy

1 tab.
1-3 times / day for 3-5 months until the normal content of hemoglobin (Hb) is reached. After that, taking the drug should be continued for 1 tab./sut for another few months in order to restore iron stores in the body.
Treatment of iron deficiency anemia in 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) / day until the normal hemoglobin (Hb) is reached.
After this, treatment should be continued at least until the end of pregnancy, taking 1 tab.
(100 mg of iron and 0.35 mg of folic acid) / 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 EFFECT

Safety and tolerability of the preparation Maltofer ® has been evaluated in a variety of clinical studies.

The frequency of side effects was determined as follows: very often (? 1/10), often (? 1/100, <1/10), infrequently (? 1/1000, <1/100).

The main undesirable drug reactions noted in these studies occurred in the following three classes of systems and organs.

Undesirable drug reactions observed in clinical trials

From the nervous system: infrequently - a headache.

From the side of the digestive system: very often - a change in the color of stool 1 ;
often - diarrhea, nausea, dyspepsia; infrequently - vomiting, constipation, abdominal pain, discoloration of tooth enamel 2 .
From the skin and subcutaneous tissues: infrequently - rash 3 , itching.

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

2. An adverse event was recorded in 0.6% of patients, this is a well-known undesirable drug reaction for iron preparations for oral administration.

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.

CONTRAINDICATIONS

- established hypersensitivity to iron (III) hydroxide polymaltosate, folic acid or to any auxiliary substance;

- Iron overload (hemochromatosis, hemosiderosis);

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

- Anemia, not associated with iron deficiency (hemolytic anemia or megaloblastic anemia, caused by a lack of vitamin B 12 ).

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 in oral therapeutic doses for the treatment of anemia in pregnancy. The data obtained from animal studies did not indicate a hazard 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 the preparation Maltofer ® Foul by women breastfeeding, can lead to undesirable effects in the child.
As a precaution to women of childbearing age, women during pregnancy and during breastfeeding should take the drug Maltofer ® Fall only after consulting a doctor.

APPLICATION FOR CHILDREN

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

SPECIAL INSTRUCTIONS

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.
It is assumed that taking Maltofer ® Fole 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 B deficiency 12 .

During treatment with Maltofer ® Fall, dark staining of the stool may be noted, but this has no clinical significance.

Impact on the ability to drive vehicles and manage mechanisms

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

In the case of an overdose of the preparation Maltofer® Fall, iron overload or intoxication is unlikely, due to the low toxicity of iron (III), the 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 CNS disorders (in particular, changes in mental state, sleep disturbance, irritability and hyperactivity), nausea, bloating and flatulence.

DRUG INTERACTION

The interaction of iron (III) hydroxide of polymaltosate with tetracycline and aluminum hydroxide was studied.
There was 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 D 3 , bromazepam, magnesium aspartate, D-penicillamine, methyldopa, paracetamol and auranofin, no interaction with iron ((III) hydroxide with polymaltosate.

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 D 3 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 a selective determination of hemoglobin), so there is no need to interrupt treatment.

It is necessary to avoid simultaneous use of iron preparations for parenteral administration and ingestion, since 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 who receive phenytoin or other anticonvulsants should consult their physician before taking the 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.
TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of the reach of children, protected from light at a temperature of no higher than 25 ° C.
Shelf life - 5 years.
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