Ferronal-Belmed

General characteristics. Structure:

Active agent: 35 mg of iron (there correspond 300 mg of iron (II) of a gluconate of a dihydrate);

Excipients: magnesium stearate, starch corn, cellulose powder, talc, stearic acid, silicon dioxide high-disperse, shellac, cocoa butter, macrogoal 4000, sucrose, calcium carbonate, K 90 povidone, gland red oxide.

Pharmacological properties:

Pharmacodynamics. Iron preparation, has hemopoietic (erythropoietic) effect, fills shortage of iron in an organism, recovers a hemoglobin content. At course treatment promotes regression of clinical and laboratory symptoms of anemia.

Pharmacokinetics. Absorption and bioavailability - high (it is soaked up and acquired better, than other forms of iron in view of a low ionization constant). It is soaked up preferential in a duodenum and a proximal part of a jejunum. Communication with proteins - 90% and more (it is preferential with hemoglobin). The insignificant quantity - in the form of a myoglobin in muscles is deposited in the form of ferritin or hemosiderin in hepatocytes and reticuloendothelial system.

Norms of physiological losses of iron: for men and women in a postmenopause - 1mg/put, for women in a premenopauza - 1,5-2 mg/day.

Indications to use:

Iron scarce anemia (prevention and treatment) caused by various reasons: as a result of bleedings (a polymenorrhea, uterine bleedings, childbirth, hemorrhoids, a peptic ulcer of a stomach and duodenum, surgical interventions, frequent nasal bleedings, blood loss at various other diseases); as a result of the increased need for iron at pregnancy or a lactation, during intensive growth, donorship, at burns, a hemodialysis; at insufficiency of intake of iron with food or disturbance of its absorption at chronic diarrhea, an achlorhydria, a gastroektomiya, a Gee's disease, a disease Krone, enteritis.

Route of administration and doses:

Dosage: to adults and teenagers with body weight more than 50 kg to take 1-2 pill 2-3 times a day. To children 1 tablet 2-3 times a day is more senior than six years. It should be noted that the maximum daily dose of 6 mg of iron on 1 kg of body weight at children should not be exceeded.

Type and duration of use: tablets, coated, do not chew and wash down with enough water or mineral water. It is recommended to take for half an hour to food. Duration of treatment depends on a look and disease severity. Treatment by iron preparations for achievement of therapeutic success is required within not less than 8 weeks. After normalization of level of hemoglobin, it is necessary to continue treatment 6-8 weeks for filling of depot of iron.

Features of use:

Use during pregnancy and in the period of a lactation.

Pregnancy: reports on side effects at reception of oral iron preparations in therapeutic doses during pregnancy are unknown. Damage of a fruit and abortion was not observed. Iron preparations are properly tested for animals on possible toxic properties

Lactation period: proofs of harmful effects from reception of oral iron preparations in therapeutic doses in the period of a lactation are not known.

Use at pregnancy and during feeding by a breast - according to the recommendation of the doctor.

Precautionary measures. Patients with rare hereditary problems of intolerance of fructose, glucose galactose, malabsorption or insufficiency of sucrose-isomaltose should not accept drug.

In order to avoid possible overdoses by iron, care is recommended if nutritional supplements or other salts of iron are used.

At already existing inflammation or an ulcer of a mucous membrane of a stomach the advantage of treatment has to be carefully weighed and the risk of deterioration in gastrointestinal diseases is weighed. Ferronal-Belmed it is necessary to apply with care at a peptic ulcer of a stomach and duodenum, inflammatory diseases of intestines, alcoholism, hepatitis, pancreatitis, a liver or renal failure, blood diseases, severe bleedings, hemotransfusion. At prolonged use digestive tract erosive cankers are possible.

Drug can paint fecal masses in dark color and it to mask the concealed hemorrhage.

During therapy it is necessary to carry out periodic blood tests.

To children up to 6 years this dosage form is not applied.

Influence on ability to control of motor transport and other potentially dangerous mechanisms. Medicine does not influence ability to drive the car and to work with mechanisms.

Side effects:

Frequency of the possible side effects which are listed below is defined as follows:

Very often (> 1/10)

Often (> 1/100 to <1/10)

Infrequently (> 1/1.000 to <1/100)

Seldom (> 1/10.000 to <1/1.000)

Very seldom (<1/10.000)

It is not known (it cannot be estimated on the basis of the available data)

Often: coloring of a chair in black color which is caused by iron sulfite, formed in a human body. Coloring is absolutely harmless.

Infrequently: heartburn, locks, diarrhea, nausea, vomiting, abdominal pain, allergic reactions (itch, urticaria), dermahemia, hyperthermia, dizziness, dentagra, thorax pain, pharyngalgia, dorsodynia, gastralgia, irritability.

At emergence of these symptoms drug should be cancelled. The problem with locks can be solved by balancing of a diet.

Interaction with other medicines:

- salts of iron reduce absorption of tetracyclines, Penicillaminum, Methyldopums and levodopas;

- salts of iron influence a resorption of antibacterial agents of derivatives of a hinolon (for example, ciprofloxacin, levofloxacin, norfloxacin, ofloxacin);

- salts of iron reduce absorption of thyroxine at the patients receiving replacement therapy by thyroxine;

- digestion of iron decreases at simultaneous use of Colestyraminum, antacids (calcium, magnesium, aluminum salts), additives, calciferous and magnesium;

- joint use of salts of iron with NPVP can increase irritant action of iron on a mucous membrane of digestive tract;

- iron-binding substances, such as phosphates, oksalaga and fitata, milk, tea and coffee interfere with digestion of iron.

Drug should not be accepted within the next few 2-3 hours to or after reception of the above-stated substances.

Contraindications:

- the known hypersensitivity to any of components;

- disorders of utilization of iron (sideroblastny anemia, lead anemia, thalassemia);

- organism overload iron (for example, hemochromatosis, chronic hemolysis);

- the anemias caused by an infection or a tumor if at the same time there is a lack of iron.

Overdose:

Symptoms: an abdominal pain, vomiting, diarrhea, a lock, a lethargy, a low pulse, hypotonia, a coma, a collapse (symptoms of a peripheral circulator collapse or are shown within 30 min. after reception or are late at several o'clock).

Metabolic acidosis, spasms, fever, a leukocytosis (during 12-24 h after reception).

Acute renal and hepatic necroses (2-4 days after reception). In hard cases the lethal outcome is possible.

Treatment: at the initial stages cause vomiting, carry out a gastric lavage. Then appoint Deferoxaminum in a dose which is selected individually depending on disease severity. The hemodialysis for removal of iron is inefficient, but can be used for acceleration of removal iron-дефероксаминового a complex.

Storage conditions:

To store in the place protected from moisture and light at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity 3 years. Not to use after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

On 50 tablets in glass jars or on 10 tablets in a blister strip packaging. Each can or five blister strip packagings with the application instruction are placed in a pack from a cardboard.