Ferrum lek chewable tablets 100mg №10×3

Name:
Ferrum lek tabl zhev. 100mg in strips No. 10×3 Main active ingredient Iron iii hydroxide polymaltose Release form tablets Composition Active ingredient: 100 mg of iron III in the form of a polymaltose complex of iron III hydroxide. Excipients: dextrates, macrogol 6000, aspartame E951, chocolate essence, talc.
Description:
White-brown marbled, round, flat tablets with bevelled edges. Dosage 100 mg Pharmacological properties Pharmacodynamics Iron is present in all cells of the body and is necessary for the functioning of enzymes that control vital processes. The appointment of iron preparations reduces the violations of erythropoiesis caused by iron deficiency. Polynuclear molecules of iron hydroxide III are surrounded by polymaltose molecules non-covalently bound to them, which in general constitutes a complex with a molecular weight of approximately 50 kDa, which, due to its size, passes through the membrane of mucous membranes by a simple diffusion mechanism 40 times more weakly than the hexaaqua iron II ion. The complex is stable and does not release iron ions under physiological conditions. The structure of the complex is similar to that of ferritin, a natural iron-storing protein found in the body. Due to this similarity, iron III from this complex is absorbed through an active absorption process. Any iron-binding protein in the gastrointestinal fluid and on the surface of the epithelium can capture iron III through a competitive ligand exchange mechanism. The absorbed iron is mainly stored in the liver in combination with ferritin, then in the bone marrow it is incorporated into hemoglobin. The complex of iron hydroxide III and polymaltose does not have the pro-oxidant properties inherent in ferrous salts. The sensitivity of very low and low density lipoproteins to oxidizing factors is therefore reduced. Ferrum Lek® in the form of tablets does not cause staining of teeth. Pharmacokinetics Using the method of twin isotopes (55Fe and 59Fe), it was found that iron absorption, determined by the level of hemoglobin in erythrocytes, is inversely proportional to the administered dose (the higher the dose, the lower the level of absorption). There is a statistically significant inverse correlation between the degree of iron deficiency and the amount of absorbed iron (the higher the iron deficiency, the better iron is absorbed). The highest level of absorption is observed in the duodenum and jejunum. The absorption of the ferric iron complex is a controlled process. When using the drug Ferrum Lek®, the degree of absorption is about 10%. The bioavailability of iron from iron III polymaltose complex hydroxide is worse, at least at the beginning of treatment, than from iron II preparations. The increase in serum iron levels after administration does not correlate with total absorption measured in erythrocytes. Iron accumulates primarily in the liver, where it binds to ferritin and is incorporated into the hemoglobin structure in the bone marrow. Unabsorbed iron is excreted in the feces. The amount of iron excreted from the body along with the exfoliating cells of the epithelium of the gastrointestinal tract and skin, as well as with sweat, bile and urine is about 1 mg per day. In women, the loss of iron in menstrual blood should also be taken into account. Indications for use Treatment of latent iron deficiency. Treatment of iron deficiency anemia (manifest iron deficiency). Contraindications hypersensitivity to the active or excipients of the drug; excess iron (eg, hemochromatosis, hemosiderosis) and disorders of iron utilization (eg, lead anemia, sidero-achrestic anemia, thalassemia); anemia not due to iron deficiency (eg, hemolytic anemia, megaloblastic anemia due to vitamin B12 deficiency). Use during pregnancy and lactation Pregnancy According to clinical studies on the use of the drug Ferrum Lek® 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. Animal studies have not shown any risk to the mother, embryo or fetus. Use during pregnancy, however, should be considered with caution. Breastfeeding Breast milk normally contains iron associated with lactoferrin. It is not known how much iron III hydroxide in combination with polymaltose passes into breast milk. It is unlikely that taking the drug Ferrum Lek® by lactating women can cause unwanted reactions in infants. As a precautionary measure, women of childbearing age and women during pregnancy or breastfeeding, the use of Ferrum Lek® is recommended only after consulting a doctor in order to assess the benefit / risk ratio. Method of administration and doses For oral administration. Take during or immediately after a meal. The tablet can be chewed or swallowed whole. The daily dose can be taken at one time or divided into several doses. The dose of the drug and the duration of administration depend on the degree of iron deficiency. Manifest iron deficiency The dose and duration of treatment depend on the degree of iron deficiency. Treatment of iron deficiency anemia continues until normalization of the hemoglobin (Hb) value, then for several more weeks at a dose corresponding to the dose for the treatment of latent (latent) iron deficiency (without anemia), to replenish iron stores, on average 3-5 months. Children 0-12 years old: take the drug in the form of a syrup. Children over 12 years of age, adults: Usually 1 to 3 chewable tablets per day (100 to 300 mg). Latent iron deficiency Treatment takes about one to two months. Children under 1 year: due to the appointment of very low doses, the drug in the form of tablets or syrup is not used for this indication. Children from 1 to 12 years of age: take the drug in the form of a syrup. Children over 12 years old, adults: 1 chewable tablet daily (100 mg). Table: Daily doses of Ferrum Lek® for the prevention and treatment of iron deficiency Dosage form Manifest iron deficiency Latent iron deficiency Children (> 12 years old) Adults Tablets 1 – 3 tablets (100 – 300 mg) 1 tablet (100 mg) If you forget to take Ferrum Lek® on time, continue taking the drug as usual. Do not take a double dose to make up for a single missed dose. Side effects The safety and tolerability of iron was assessed based on a meta-analysis of 24 publications or reports from clinical trials, including 1473 patients. The main adverse reactions that were reported in these studies occurred in 4 classes of systemic organs. Discoloration of feces is a well-known adverse drug reaction to oral iron preparations (in 23% of patients), but this adverse event is not of clinical significance. Other commonly reported side effects were gastrointestinal disturbances (nausea, constipation, diarrhea and abdominal pain). The frequency of development of adverse reactions is defined as follows: very frequent (?1/10), frequent (?1/100 and <1/10), infrequent (?1/1000 and <1/100), rare (?1/10 000 and <1/1000), very rare (<1/10000), frequency unknown (cannot be estimated from available data). Immune system disorders Very rare: allergic reactions. Nervous system disorders Uncommon: headache. Gastrointestinal disorders Very common: discoloration of feces1. Frequent: abdominal pain, constipation, diarrhea, nausea, dyspepsia. Uncommon: Vomiting3, tooth staining, gastritis. Skin and subcutaneous tissue disorders Uncommon: pruritus, rash5,6, urticaria6, erythema6. Muscular, skeletal and connective tissue disorders Rare: muscle spasms4, myalgia. 1 "Discoloration of feces" occurred less frequently in the meta-analysis, but is a well-known drug effect of oral iron therapy in general. Therefore, it was categorized as a "very common" adverse event. 2 Includes: abdominal pain, dyspepsia, epigastric discomfort, bloating. 3 Includes: vomiting, regurgitation. 4 Includes: involuntary muscle contraction, tremor. 5 Includes: rash, rash macular, rash vasculitis. 6 Post-marketing reported reactions, estimated incidence <1/491 patients (upper limit of 95% confidence interval). Adverse Events Based on Post-Marketing Spontaneous Reporting No additional adverse drug reactions were identified. Impact on the results of laboratory and instrumental studies No data available. Reporting adverse reactions It is important to report suspected adverse reactions after registration of a medicinal product in order to ensure continuous monitoring of the benefit-risk balance. Healthcare professionals are encouraged to report any suspected adverse drug reactions through national adverse drug reaction and drug failure reporting systems. The patient, if he experiences any adverse reactions, should consult a doctor. This recommendation applies to any adverse reactions, including those not listed in the package insert. By reporting adverse reactions, you help to get more information about the safety of the drug. Overdose Cases of overdose, iron overload or intoxication with iron polymaltose complex have not been observed due to its low toxicity (for example, for mice or rats, the lethal dose is 50% (LD50)> 2000 mg Fe / kg body weight). No fatal accidental poisonings have been reported. Interaction with other drugs Due to the fact that iron is part of a complex compound, ionic interactions with food components (oxalates, tannin, etc.) and drugs (tetracyclines, antacids) are unlikely. 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. Co-administration with other parenteral or oral iron formulations should be avoided as this leads to a significant reduction in the absorption of iron taken by mouth. Studies in rats with tetracycline, aluminum, acetylsalicylic acid, sulfasalazine, calcium carbonate, calcium acetate, calcium phosphate in combination with vitamin D3, bromazepam, magnesium aspartate, D-penicillinamine, methyldopa, acetaminophen and auranofin showed no interaction with iron (III) hydroxide polymaltose complex. In addition, there is no interaction of iron (III), polymaltose complex hydroxide with food components such as phytic acid, oxalic acid, tannin, sodium malginate, choline and choline salts, vitamin A, vitamin D3 and vitamin E, soybean oil and soybean flour in in vitro studies. These results indicate that iron(III) hydroxide polymaltose complex can be taken during or immediately after a meal. Interactions of iron(III) polymaltose complex hydroxide with tetracyclines or aluminum hydroxide were investigated in three human trials (crossover study, 22 patients per study). No significant decrease in tetracycline absorption was observed. The plasma concentration of tetracycline did not fall below the minimum inhibitory concentration required for bacteriostasis. Iron absorption from iron(III) polymaltose complex hydroxide was not reduced when co-administered with aluminum hydroxide and tetracycline. Therefore, iron (III) hydroxide polymaltose complex can be taken simultaneously with tetracyclines or other phenolic compounds and aluminum hydroxide. PrecautionsTreatment of anemia should always be under medical supervision. If there is no effect (increase in hemoglobin level by approximately 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 lead to iron overload. Anemia can be caused by infections or neoplasms. Since iron begins to be fully absorbed by the body only after the underlying disease has been cured, an assessment of the risk-benefit ratio is required. Due to the fact that doses for children under 12 years of age are lower than for adults, syrup is prescribed instead of tablets. When taking the drug, feces may turn dark in color, which has no clinical significance. Information for patients with diabetes: one tablet contains 0.04 bread units. The drug contains aspartame E 951 (precursor of phenylalanine), in the amount of 1.5 mg per tablet. The substance may cause harmful effects in patients with phenylketonuria. Storage conditionsKeep out of the reach of children. Store at a temperature not exceeding 25 °C. Buy Ferrum Lek chewable tablets 100mg No. 10×3