Maltofer Fall chewable tablets №10×3

NameMaltofer Fall tab. zhev.v blist.v pack No. 10×3 Main active ingredient Iron iii hydroxide polymaltose + folic acid Release form tablets Pharmacodynamics Mechanism of action kDa. The polynuclear centers of iron (III) of polymaltose hydroxide are structurally similar to the natural iron depot protein ferritin. This macromolecular complex is stable and does not release large amounts of iron under physiological conditions. Due to its large size, the degree of diffusion of iron (III) polymaltose hydroxide through the mucosal membrane is approximately 40 times lower than the degree of diffusion of the iron (II) hexaaqua complex. Iron (III) hydroxide polymaltose comes from the intestines by active transport. Folic acid belongs to the B vitamins. It is a precursor of tetrahydrofolate, a coenzyme involved in various metabolic processes, including the biosynthesis of purines and thymidylates of nucleic acids; it is also necessary for the synthesis of nucleoproteins and the maintenance of a normal level of erythropoiesis. Pharmacodynamic effects Absorbed iron binds to transferrin and is used to synthesize hemoglobin (Hb) in the bone marrow or is deposited, mainly in the liver, where it binds to ferritin. Pharmacokinetics Absorption The absorption of iron (III) polymaltose hydroxide occurs according to a controlled mechanism. An increase in the level of iron in the blood serum after taking the complex does not correlate with the total absorption of iron, assessed by its inclusion in Hb. Studies using radioactively labeled iron (III) polymaltose hydroxide showed a clear correlation between the percentage of iron absorption by erythrocytes (incorporation in Hb) and absorption in terms of the whole body. The most active absorption of the iron (III) hydroxide polymaltose complex occurs in the duodenum and jejunum. As with other oral iron preparations, the relative extent of absorption of iron from iron(III) polymaltose hydroxide, as measured by its incorporation into Hb, decreased with increasing doses of iron. A correlation was also observed between the degree of iron deficiency (i.e., serum ferritin level) and the amount of iron absorbed (i.e., the greater the iron deficiency, the better the absorption). When using the drug Maltofer® Foul, the degree of absorption is about 10%. It has been shown that in patients with anemia, the absorption of iron from the polymaltose complex of iron (III) hydroxide, in contrast to iron salts, increases in the presence of food. Folic acid is mainly absorbed in the small intestine, mainly in the duodenum and jejunum. After taking 0.35 mg of folic acid, 80% of its absorption can be expected. Distribution The distribution of iron after absorption of iron(III) polymaltose hydroxide was demonstrated in a study using the double isotope technique (55Fe and 59Fe). The maximum concentration of folic acid in the blood plasma is reached after 30-60 minutes. In a single dose study of Maltofer® Fol (100 mg iron, 0.35 mg folic acid) chewable tablets, conducted on 12 healthy volunteers, rapid absorption of folic acid was demonstrated with a maximum folate concentration of 11 ng / ml 0.75 hours after administration. doses. Biotransformation of Iron (III) hydroxide polymaltose after absorption is used for the synthesis of hemoglobin (Hb) in the bone marrow or is deposited, mainly in the liver, where it binds to ferritin. Folic acid is metabolized in the cells of the intestine and liver, as well as in other organs. The resulting folates bind to transport proteins and are distributed to all organs. Excretion Unabsorbed iron is excreted in the feces. Removal of folic acid is carried out by the kidneys, as well as through the digestive tract. Pharmacokinetics in special populations Renal, hepatic and heart failure. No data available. Indications for use Treatment and prevention of latent (hidden) iron deficiency and iron deficiency anemia (clinically expressed iron deficiency) with an increased need for folic acid during pregnancy and breastfeeding. Iron deficiency and its severity must be established and confirmed by appropriate laboratory tests. Method of administration and doses For oral administration. Treatment of iron deficiency anemia and supplementing the increased need for folic acid: 1 chewable tablet 2-3 times a day (from 200 mg of iron and 0.70 mg of folic acid to 300 mg of iron and 1.05 mg of folic acid) until hemoglobin levels normalize. After normalization of hemoglobin: 1 chewable tablet daily throughout pregnancy to build up iron stores. Treatment and prevention of latent iron deficiency and increased need for folic acid: 1 chewable tablet (100 mg of iron and 0.35 mg of folic acid) per day. The daily dose should be taken all at once or divided into several doses. The drug Maltofer® Foul should be taken during or immediately after a meal. Chewable tablets can also be swallowed whole or chewed. If you forget to take Maltofer® Foul on time, continue taking the drug as usual. Do not take a double dose to make up for a single missed dose. Renal insufficiency No studies have been conducted in patients with renal insufficiency. No data available. Hepatic impairment No studies have been conducted in patients with hepatic impairment. No data available. Use during pregnancy and lactation Pregnancy To date, there have been no reports of the development of serious adverse reactions when taking the drug Maltofer® Fol at recommended therapeutic doses for the treatment of anemia during pregnancy. Animal studies have not shown any risk to mother or fetus. There are no data from clinical studies on the use of this drug in the first trimester of pregnancy. In clinical studies of taking the drug Maltofer® Fol in the second and third trimesters of pregnancy, there was no undesirable effect of the drug on the body of the mother and / or newborns. Thus, the presence of a negative effect of the drug Maltofer® Fola on the health of the fetus seems unlikely. Breastfeeding Breast milk normally contains iron associated with lactoferrin. It is not known how much iron (III) polymaltose hydroxide passes into breast milk. It is unlikely that the intake of Maltofer® Foul by lactating women can cause undesirable effects in infants. As a precautionary measure, women of childbearing age and women during pregnancy or breastfeeding, the use of the drug Maltofer® is recommended only after consultation with a doctor in order to assess the benefit / risk ratio. PrecautionsTreatment of anemia should always be under medical supervision. If there is no effect (the level of hemoglobin has not increased by about 20-30 g / l after 3 weeks), the treatment plan should be reviewed. Caution should be exercised when prescribing the drug to patients who have had multiple blood transfusions, since iron enters with red blood cells, which can cause iron overload. During the period of treatment with Maltofer® Fol, it is possible that the staining of feces in a dark color is not of clinical significance. The drug Maltofer® Foul contains folic acid and may mask the symptoms of vitamin B12 deficiency. Infections or tumors can cause anemia. Since iron can only be used if the underlying disease is under control, a benefit/risk assessment is recommended in these situations. It is assumed that taking the drug Maltofer® Fol will not affect the insulin regimen in patients with diabetes mellitus. One chewable tablet contains 0.03 bread units. Interaction with other drugs The interaction of iron (III) polymaltose hydroxide with tetracycline and aluminum hydroxide has been studied in clinical trials. There was no significant reduction in tetracycline absorption. The concentration of tetracycline in blood plasma did not fall below the level that provides the required effectiveness. Aluminum hydroxide and tetracycline did not reduce the absorption of iron(III) polymaltose hydroxide in human studies. Therefore, iron (III) polymaltose hydroxide can be taken simultaneously with tetracycline or other phenolic substances, as well as aluminum hydroxide. Studies conducted in rats did not reveal any interactions with tetracycline, aluminum hydroxide, acetylsalicylates, sulfasalazine, calcium carbonate, calcium acetate and calcium phosphate in combination with vitamin D3, bromazepam, magnesium aspartate, D-penicillamine, methyldopa, paracetamol and auranofin . Also, no in-vitro interactions were found with food components such as phytic acid, oxalic acid, tannin, sodium alginate, choline and its salts, vitamin A, vitamin D3, vitamin E, soybean oil and soy flour. These results indicate that the drug Maltofer® Foul can be taken with or immediately after meals. The drug does not affect the results of the test for the presence of occult blood (selective hemoglobin test), so there is no need to stop treatment for analysis. Simultaneous parenteral and oral administration of iron preparations should be avoided, since this significantly reduces the absorption of oral iron. Treatment with folic acid can increase the metabolism of phenytoin, leading to a decrease in its concentration in serum, especially in patients with folic acid deficiency. Despite the fact that this phenomenon is usually not clinically significant, in some patients the incidence of seizures may increase. Patients taking phenytoin or any other anticonvulsants should consult their doctor before starting folic acid treatment. It has been reported that the combined use of folic acid with chloramphenicol in patients with folic acid deficiency may have an antagonistic effect on the hematopoietic response to folic acid. Although the significance and mechanism of this interaction remain unclear, the hematological response to folic acid treatment in patients taking both drugs should be closely monitored. Contraindications History of hypersensitivity to iron (III) hydroxide polymaltose, folic acid or any of the excipients; iron overload (eg, hemochromatosis or hemosiderosis); violations of iron utilization (anemia associated with lead poisoning, sideroahrestic anemia, thalassemia), anemia not associated with iron deficiency (for example, hemolytic anemia or megaloblastic anemia caused by vitamin B12 deficiency). Composition One tablet contains: active substances: 100 mg of iron in the form of iron (III) polymaltose hydroxide (357 mg) and 0.35 mg of folic acid; excipients: dextrates, macrogol 6000, purified talc, sodium cyclamate, vanillin, cocoa powder, chocolate flavor and microcrystalline cellulose. Overdose In case of an overdose of iron (III) polymaltose hydroxide, signs of poisoning and iron overload are unlikely, due to the low toxicity of the drug and controlled absorption of iron. There are no reports of accidental poisoning with a fatal outcome. When using too high doses of folic acid, it is possible to develop changes in the central nervous system (changes in mental state, disturbances in sleep and wakefulness, increased irritability, hyperactivity), nausea and flatulence. Side effects The safety and tolerability of iron(III) hydroxide polymaltose (with and without folic acid) has been evaluated in numerous clinical trials and published reports. The assessment of the frequency of adverse reactions is given on the basis of the following classification: often (?1/100, <1/10), infrequently (?1/1000, <1/100), rarely (?1/10000, <1/1000), very rarely (<1/10000). The following side effects have been reported in these trials: Gastrointestinal disorders Very common: Discoloration of feces1 Common: Diarrhoea, nausea, dyspepsia Uncommon: Vomiting, constipation, abdominal pain, staining of teeth Skin and subcutaneous tissue disorders Uncommon : rash3, pruritus Nervous system disorders Uncommon: headache "Discoloration of feces" has been reported very frequently as an adverse reaction (23% of patients) and is an undesirable effect associated with oral iron preparations. "Teeth staining" has been reported as an adverse reaction observed in 0.6% of patients and is an undesirable effect associated with oral iron preparations. The term "exanthema" has been combined with the term "rash" and is referred to as "rash". Adverse reactions reported in the post-marketing period No additional adverse reactions were identified. Impact on the results of laboratory and instrumental studies No data available. If the listed adverse reactions occur, as well as a reaction not indicated in the instructions for use, you should consult a doctor. Storage conditions In a place protected from light at a temperature not exceeding 25 ° C. Keep away from children. Buy Maltofer Fall chewable tablets No. 10x3 Price for Maltofer Fall chewable tablets No. 10x3 Instructions for use for Maltofer Fall chewable tablets No.