Maltofer tab Gesves. 100mg 30 pieces

Description

Composition
Active substance:
1 tablet contains: iron (III) hydroxide polimaltozat 357.0 mg based on iron 100.0 mg.
Excipients:
Dextrates 232.0 mg Macrogol 6000 37.0 mg Purified talc 21.0 mg of sodium cyclamate, 9.0 mg of Vanillin 2.9 mg Cocoa powder 29.0 mg chocolate flavor 0.6 mg Microcrystalline cellulose 730.0 mg up.
Description:
Round, flat tablets with brown patches white with Valium.
Product form:
Chewable tablets of 100 mg. 10 tablets in aluminum foil blisters, laminated with polyethylene. 1 or 3 blisters with instructions for use placed in a cardboard box.
Contraindications
Mounted hypersensitivity to iron (III) hydroxide polimaltozatu or any excipient. iron overload (e.g., hemosiderosis, hemochromatosis). Disturbances of iron utilization (e.g., lead anemia, sideroahrestical anemia, thalassemia). Anemia is not associated with iron deficiency (e.g., hemolytic anemia, or megaloblastic anemia due to vitamin B12 deficiency). Children under the age of 12 years (due to the need destination of small doses in this age group is recommended to use the drug Maltofer®, drops for oral administration of 50 mg / ml, or Maltofer® syrup 10 mg / ml).
Dosage
100 mg
Indications
Treatment of iron deficiency without anemia (latent iron deficiency) and symptomatic treatment of iron deficiency anemia. Increased need for iron during pregnancy and during breast-feeding, blood donation, an intensive growth of vegetarianism and the elderly.
Interaction with other drugs
We studied the interaction of iron (III) hydroxide polimaltozata with tetracycline or aluminum hydroxide. A significant reduction in absorption of tetracycline was observed. The tetracycline concentration in blood plasma did not fall below an effective level. Absorption of iron from iron (III) hydroxide polimaltozata not reduced under the influence of aluminum hydroxide or tetracycline. Thus, iron (III) hydroxide polimaltozat can be used simultaneously with tetracycline and other phenolic compounds and 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, auranofin and paracetamol was not detected interactions with iron (III) hydroxide polimaltozatom. Also not mentioned interaction of iron (III) hydroxide polimaltozata components of food, such as phytic acid, oxalic acid, tannins, sodium alginate, salts of choline and choline, vitamin A, vitamin D3 and vitamin E, soybean oil and soybean meal. These results indicate that iron (III) hydroxide polimaltozat can be taken during or immediately after eating. Taking the drug does not affect the results of the determination of occult blood (with selective determination of hemoglobin), so do not need to interrupt treatment. It is necessary to avoid the simultaneous use of parenteral and oral iron preparations since the absorption of iron taken by mouth, is slowing.
Overdose
In the case of drug overdose Maltofer® iron overload or intoxication are unlikely, due to the low toxicity of iron (III) hydroxide and polimaltozata controlled gripper iron. Cases of unintentional poisoning deaths were reported.
pharmachologic effect
Pharmacological group:
Iron preparation.
Pharmacodynamics:
The iron (III) hydroxide polimaltozate polynuclear iron hydroxide (III) is surrounded by a plurality of outside covalently bound molecules polimaltozata, which gives a total average molecular weight of approximately 50 kDa. Polynuclear iron core structure (III) hydroxide polimaltozata similar to that of ferritin protein core – physiological depot iron. Iron (III) hydroxide polimaltozat stable in physiological conditions does not produce large amounts of iron ions. Due to the size of the degree of diffusion of iron (III) hydroxide polimaltozata mucosal approximately 40 times less than the hexahydrate iron complex (II). Iron from iron (III) hydroxide polimaltozata actively absorbed in the intestine. Efficiency Maltofer® preparation for the normalization of hemoglobin and replenishment of iron stores has been demonstrated in many randomized controlled clinical trials using placebo controls or active comparator, conducted in adults and children with different status iron stores.
Pharmacokinetics:
Suction
Iron from iron (III) hydroxide polimaltozata sucked in accordance with a controlled mechanism. Increasing the iron content of the whey after the drug is not correlated with the overall absorption of iron, measured as the incorporation into hemoglobin (Hb). Studies with Radiolabeled iron (III) hydroxide polimaltozatom revealed a strong correlation between the inclusion of iron in the red cells and the content of iron in the body. Maximum activity suction iron from iron (III) hydroxide polimaltozata observed in the duodenum and small intestine. As in the case of other oral iron preparations, the relative absorption of iron from iron (III) hydroxide polimaltozata detected as incorporation into hemoglobin, decreases with increasing doses of iron. Furthermore, there was a correlation between the severity of iron deficiency (in particular, serum ferritin concentration) and the relative amount vsosavshegosya iron (i.e., the more pronounced deficiency of iron, the better the relative absorption). Patients with anemia absorption of iron from iron (III) hydroxide polimaltozata in contrast to iron salts increased in the presence of food.
Distribution
Distribution of iron from iron (III) hydroxide polimaltozata after absorption was studied in a study using dual isotope technique (55Fe and 59Fe)
biotransformation
Suck iron binds to transferrin and used for hemoglobin synthesis in bone marrow or stored primarily in the liver, where it binds to ferritin.
breeding
Nevsosavsheysya iron displayed intestine (faeces).
Pregnancy and breast-feeding
Pregnancy
So far, there were no reports of serious adverse reactions after taking the drug orally Maltofer® in therapeutic doses for the treatment of anemia during pregnancy. Data obtained in animal studies have shown no hazard to the fetus and mother. Data from clinical studies on the use of the drug Maltofer® I trimester of pregnancy are not available. In studies conducted in pregnant women after the I trimester of pregnancy, does not reveal any adverse effects of the drug Maltofer® for mothers and / or babies. In this regard, an adverse effect on the fetus in the application preparation Maltofer® unlikely.
Breastfeeding
Breast milk contains iron woman associated with lactoferrin. The amount of iron, the rolling of iron (III) hydroxide polimaltozata in breast milk is unknown. It is unlikely that the use of the drug Maltofer® women who are breastfeeding can lead to undesirable effects in children. As a precaution, women of childbearing age and women during pregnancy and breastfeeding should take the drug Maltofer® only after consulting your doctor. It is recommended to evaluate the risk-benefit ratio.
Conditions of supply of pharmacies
On prescription.
side effects
Safety and tolerability of the drug Maltofer® evaluated in numerous clinical studies. Main adverse drug reactions (ADRs) noted in these studies were the following three classes of systems and organs.
Adverse drug reactions observed in clinical trials
Disorders of the nervous system: Infrequent-headache
Disorders of the gastrointestinal tract: very often, change the color of feces, often, diarrhea, nausea, dyspepsia, rarely, vomiting, constipation, abdominal pain, discoloration of tooth enamel
Violations of the skin and subcutaneous tissue disorders: rarely, rash, pruritus
Spontaneous post-marketing reports of adverse drug reactions not observed additional adverse drug reactions.
Laboratory Abnormalities: not available.
special instructions
It is assumed that the drug Maltofer® should not affect the daily need for insulin in patients with diabetes mellitus. 1 chewable tablet contains 0.04 bread units. Anemia can be caused by infectious diseases or malignancies. As iron can be taken only after the removal of the main causes of the disease, determine the benefit-risk ratio of the treatment. During treatment Maltofer® may experience dark coloration of feces, but this has no clinical significance
The effect on the ability to operate vehicles, machinery
Data not available. It is unlikely that the drug Maltofer® affects the ability to drive, mechanisms.
Storage conditions
In the dark place at a temperature not higher than 25 C.
Keep out of the reach of children.
Dosing and Administration
For ingestion. The daily dose can be divided into several stages or receive at a time. Maltofer® should be taken during or immediately after a meal. Maltofer®, chewable tablets of 100 mg, can be chewed or swallowed whole.
The daily dose depends on the extent of iron deficiency. -Treatment of iron deficiency anemia
Children older than 12 years, adults, lactating women 1-3 tablets (100-300 mg of iron).
Pregnant women 2-3 tablets (200-300 mg of iron) -Treatment of iron deficiency without anemia
Children older than 12 years, adults, lactating women 1 tablet (50-100 mg of iron)
Pregnant women 1 tablet (100 mg of iron) iron requirement -Increase
Children older than 12 years old, adult, lactating women because of the necessity of low doses of the destination for this indication is recommended to use the drug Maltofer®, drops for oral administration of 50 mg / ml, or Maltofer® syrup 10 mg / ml
Pregnant women 1 tablet (100 mg of iron)
Treatment of iron deficiency anemia in children older than 12 years and adults
From 100 to 300 mg iron (1-3 tablets) per day for 3-5 months before normalization of hemoglobin (Hb). After this treatment should continue for several weeks in a dose that is described for the case of iron deficiency without anemia, with iron to replenish stocks.
Treatment of iron deficiency anemia during pregnancy
From 200 to 300 mg iron (2-3 tablets) per day to achieve a normal hemoglobin (Hb). After this treatment should continue at least until the end of pregnancy at a dose described in the case of iron deficiency without anemia, to replenish iron stores and meet the increased in connection with pregnancy iron requirements.
Treatment and prevention of iron deficiency without anemia in children older than 12 years and adults
100 mg (1 tablet) daily for 1-2 months. If needed for the prevention of a smaller dose can be used Maltofer® formulations drops for oral administration of 50 mg / ml, or Maltofer® syrup 10 mg / ml.
Use in children
Maltofer®, chewable tablets 100 mg are contraindicated for children under 12 years of age and younger. The dosage form and the concentration of drugs Maltofer®, drops for oral administration of 50 mg / ml and Maltofer® syrup 10 mg / ml, are better suited for receiving the recommended dose in this age group.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist