Maltofer foul Table Gesves. 100mg 30 pieces

Description

Composition
Active substance:
1 tablet contains: iron (III) hydroxide polimaltozat 357.0 mg equivalent iron content of 100.0 mg Folic acid 0.35 mg.
Excipients:
Dextrates 232.0 mg, 37.0 mg macrogol 6000, 21.0 mg Purified talc, sodium cyclamate, 9.0 mg, 2.9 mg vanillin, cocoa powder 29.0 mg, 0.6 mg chocolate flavor, microcrystalline cellulose to 730.0 mg.
Description:
Round, flat tablets with brown patches white with Valium.
Product form:
Chewable Tablets 100 mg + 0.35 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, folic acid or any auxiliary substance. 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).
Dosage
100 mg
Indications
Iron deficiency anemia, including during pregnancy and breastfeeding.
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. folic acid treatment can increase the metabolism of phenytoin that results in a decrease in the 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 seizures. Patients receiving phenytoin and other anticonvulsants, should consult a physician before starting 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 hematopoietic response to folic acid due to the antagonistic effect of chloramphenicol. Although the significance and mechanism of interaction is unclear, patients receiving both drugs at the same time, should carefully monitor hematologic response to folic acid treatment.
Overdose
In the case of drug overdose Maltofer® Foul 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. It has been reported that excessive dose of folic acid can cause disorders of the central nervous system (eg, altered mental state, sleep disturbance, irritability and hyperactivity), nausea, bloating and flatulence.
pharmachologic effect
Pharmacological group:
Iron preparation + vitamin.
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. Folic acid (folate) refers to a group of vitamin B. This precursor tetrahydrofolate, which is a coenzyme of various metabolic processes, including biosynthesis of purines and thymidylate nucleic acids; it is necessary for the synthesis of nucleoprotein and for maintenance of normal erythropoiesis. 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. Folic acid is absorbed primarily in the gastrointestinal tract, particularly in the duodenum and small intestine. When folic acid at a dose of 0.35 mg of absorption is about 80%.
Distribution
Distribution of iron from iron (III) hydroxide polimaltozata after absorption was studied in a study using dual isotope technique (55Fe and 59Fe). Maximum concentration of folic acid in blood is achieved in 30-60 minutes. In single dose study in 12 healthy women it has shown that folic acid from preparation Maltofer® Foul Chewable tablets (100 mg of iron, 0.35 mg folic acid) is rapidly absorbed, with peak concentration of folate in the plasma equal to 11 ng / ml achieved through 0.75 hours after dosing. Folic acid binds extensively to plasma proteins, penetrates the blood-brain barrier (BBB), placenta and into breast milk.
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. Folic acid is metabolized in cells of the small intestine and liver, and other organs. After that folate-related transport proteins, are distributed to all organs.
breeding
Nevsosavsheysya iron displayed intestine (faeces). folic acid excretion occurs mainly kidneys and the digestive tract. Folic acid is derived by hemodialysis.
Pregnancy and breast-feeding
Pregnancy
Data from clinical studies on the use of the drug Maltofer® foul in the I trimester of pregnancy are not available. So far, there were no reports of serious adverse reactions after taking the drug orally in Maltofer® Foul therapeutic doses for the treatment of anemia during pregnancy. Data obtained in animal studies have shown no hazard to the fetus and mother. In studies conducted in pregnant women after the I trimester of pregnancy, does not reveal any adverse effects of the drug Maltofer® foul against mothers and / or babies. In this regard, an adverse effect on the fetus in the application preparation is unlikely Maltofer® Foul
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® Foul breastfeeding women, can lead to undesirable effects in children. As a precaution, women of childbearing age and women during pregnancy and breastfeeding should take the drug Foul Maltofer® only after consulting your doctor.
Conditions of supply of pharmacies
On prescription.
side effects
Safety and tolerability of the drug Maltofer® Foul 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 stool; often, diarrhea, nausea, dyspepsia; infrequently, 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
In very rare cases (> 0.001%, and
Laboratory Abnormalities
Data not available.
special instructions
It is assumed that the drug Maltofer® foul shall not affect the daily need for insulin in patients with diabetes mellitus. 1 chewable tablet contains 0.04 bread units. Foul Maltofer® preparation contains folic acid, the reception of which can lead to masking of vitamin B12 deficiency. 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® Foul can be observed a 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® Foul 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. Foul Maltofer® should be taken during or immediately after a meal, the tablet can be chewed or swallowed whole.
Treatment of iron deficiency anemia is pregnant
1 tablet 1-3 times a day for 3-5 months until a normal hemoglobin (Hb). Thereafter, the drug should continue, 1 tablet per day for a few more months in order to restore iron stores in the body.
Treatment of iron deficiency anemia during pregnancy
From 2 to 3 tablets (200 mg of iron and 0.70 mg folic acid and 300 mg of iron and 1.05 mg of folic acid) per day to achieve a normal hemoglobin (Hb). After this treatment should continue 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 fill the iron stores and to meet the increased due to pregnancy iron requirements. Foul Maltofer® not recommended for children under 12 years.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist