Gyno-tardiferon tab. prolong covering actions captivity. about. in blister in pack No. 10x3 (iron sulfate + folic acid)

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Gyno-Tardiferon No. 30 tablet p.o.prolong.

Instructions for medical use of the drug Gyno-Tardiferon ® Trade name Gyno-Tardiferon ® International nonproprietary name No Dosage form Sustained-release tablets, sugar-coated Composition One tablet contains: Active substance core - iron 1.5 H2O (in the form of iron (II ) sulfate) 256.30 mg (equivalent iron) 80.0 mg, excipients: ascorbic acid 30.0 mg, mucoprotease (anhydrous) 80.0 mg, potato starch 2.0 mg, eudragit S (copolymer of methacrylic acid and methyl methacrylate ) 20.84 mg, triethyl citrate 20.08 mg, povidone 17.0 mg, talc 22.0 mg, magnesium stearate 2.0 mg, hydrogenated castor oil 6.5 mg, magnesium trisilicate up to 495.0 mg Shell active substance - folic acid 0.350 mg, excipients: sodium bicarbonate 0.25 mg, talc 7.0 mg, titanium dioxide 16.0 mg, Carnauba wax 0.208 mg, eudragit E (butylated methacrylate copolymer base) 2.50 mg, sucrose 710.0 mg Description Tablets from white to light beige, biconvex, with a smooth surface, on a cross section - brown in color with a white border. Pharmacotherapeutic group Antianemic drugs, iron supplements in combination with other drugs. ATC code B03AE10 Pharmacological properties Pharmacokinetics The combination of iron (II) sulfate with mucoproteose ensures gradual release of the active substance (iron ions) and uniform absorption. Absorption and bioavailability of iron are high. Absorption of iron ions occurs in the initial parts of the small intestine. After oral administration, the peak concentration in the blood plasma is reached within 2 hours and its amount is proportional to the dose of iron sulfate. The half-life is 6 hours. Food, mainly milk and its products, reduces iron absorption. Absorbed iron binds to ferritin and is stored primarily in the liver. Typically 10-35% of the oral dose is absorbed. After ingestion, folic acid combines with intrinsic Castle factor (a specific glycoprotein) in the stomach and is absorbed in the upper part of the duodenum. Almost completely binds to plasma proteins. It is activated in the liver under the influence of the enzyme dihydrofolate reductase, turning into tetrahydrofolic acid. The maximum concentration in the blood is reached after 30-60 minutes. It is excreted by the kidneys both unchanged and in the form of metabolites. A study of the pharmacokinetic and pharmacoclinical data of the drug Gyno-Tardiferon® showed that iron absorption varies slightly under the influence of food intake. At the same time, the effectiveness of the drug, hemoglobin level and hematological parameters are maintained. In addition, the use of iron supplements during meals helps to minimize side effects from the digestive system. Pharmacodynamics Gyno-Tardiferon ® is an antianemic and hematopoietic agent that contains iron and replenishes its deficiency, in particular in iron deficiency anemia. The microelement iron is necessary for the functioning of the body: it is part of heme (hemoglobin, myoglobin, cytochrome) and non-heme enzymes: it reversibly binds oxygen and participates in a number of redox reactions, stimulates erythropoiesis. With a course of iron supplementation, there is a gradual regression of clinical (weakness, fatigue, dizziness, tachycardia, soreness and dry skin) and laboratory symptoms of anemia. Folic acid in the body is converted into tetrahydrofolic acid, which is necessary for the maturation of megaloblasts and their transformation into normoblasts. With its deficiency, a megaloblastic type of hematopoiesis develops. Folic acid occupies an important place in the metabolism of purines and pyrimidines, the synthesis of nucleic acids, the metabolism of amino acids (glycine, methionine and histidine). Insufficient consumption primarily affects tissues characterized by intense synthesis of nucleic acids and a high rate of cell division (hematopoietic organs and mucous membrane intestines). So-called macrocytic anemia develops. From the digestive organs, stomatitis, gastritis and enteritis are detected. Folic acid deficiency during pregnancy leads to prematurity, malnutrition of newborns, disturbances in their development, and the appearance of congenital deformities. Indications for use: prevention and treatment of iron/folate deficiency anemia - hidden iron deficiency and/or with simultaneous folic acid deficiency in children over 6 years of age, adults, as well as in women during pregnancy and lactation. Methods of administration and doses The dose and duration of treatment are selected individually under the control of hemoglobin and iron levels in the blood serum. Children from 6 to 10 years: 1 tablet per day. Adults and children over 10 years of age: 1-2 tablets per day, immediately before use or during meals, with water. Prevention of iron and folic acid deficiency, treatment of moderate anemia during pregnancy - 1 tablet per day. Treatment of severe iron/folate deficiency anemia - 1 tablet 2 times a day before meals. For nursing women - 1 tablet during the entire lactation period. Therapy is carried out until the peripheral blood picture normalizes (4-6 weeks). Treatment should continue after restoration of hemoglobin levels at a dose of 1 tablet per day before breakfast for 1-3 months. Side effects - Possible: darkening of the stool, which has no clinical significance - Rarely: - nausea - pain in the epigastric region - diarrhea - constipation Contraindications - hypersensitivity to the components of the drug - hemolytic anemia - hemosiderosis - hemochromatosis - aplastic anemia - megaloblastic anemia associated with vitamin B12 deficiency Drug interactions Since iron ions reduce the absorption of tetracyclines and penicillamine from the gastrointestinal tract, the simultaneous use of Gyno-Tardiferon® and these drugs should be avoided. Due to a decrease in iron absorption when taking antacids (calcium-, aluminum- and magnesium-containing products), the interval between their intake and Gyno-Tardiferon® should be at least 2 hours. Special instructions Gyno-Tardiferon® can be prescribed to patients with diabetes mellitus, since the amount of sucrose contained in the drug shell does not affect the total sugar level in the blood serum. When taking the drug, the color of your urine may darken. Due to the presence of sucrose in the drug, it should not be used in cases of fructose intolerance, glucose/galactose malabsorption syndrome, or sucrose-isomaltase deficiency (rare metabolic disorders). Use in pediatrics This dosage form is not prescribed to children under 6 years of age. Use during pregnancy and lactation The drug Gyno-Tardiferon® is used during pregnancy and lactation according to indications. Peculiarities of the drug's influence on the ability to drive a vehicle or operate potentially dangerous mechanisms. No effect. Overdose Taking recommended doses of the drug cannot lead to an overdose of Gyno-Tardiferon®. However, there have been isolated cases of overdose in children after accidental ingestion of a large amount of the drug. Symptoms: irritation and necrosis of the gastrointestinal tract, in most cases accompanied by nausea, vomiting and shock Treatment: raw eggs and milk should be taken orally, which will ensure the binding of iron ions in the gastrointestinal tract and their subsequent removal - if the drug was taken recently, it can be removed from stomach, causing the patient to vomit - gastric lavage using a 1% aqueous solution of sodium bicarbonate or prescribe deferoxamine - symptomatic therapy An overdose of folic acid is impossible due to its low content in the drug. Release form and packaging Sustained-release tablets, sugar-coated. 10 tablets per blister pack made of aluminum foil and polyvinyl chloride film 3 packs per cardboard box with instructions for medical use Storage conditions Store at temperatures up to 25°C Keep out of the reach of children! Shelf life 3 years Do not use after the expiration date indicated on the package Conditions for dispensing from pharmacies By prescription Manufacturer Pierre Fabre Medicine Production, France Etablissement Progipharm Rue du Lucee 45500 Gien, France (Progifarm) st. Liss, 45500 Gien, France

Side effects

The most common undesirable effects are associated with effects on the gastrointestinal tract. Characteristic manifestations are pain in the abdomen, nausea, rarely vomiting, stool disturbances, bloating and discoloration of tooth enamel as a result of the negative effects of iron.

Allergic manifestations occur in cases of individual hypersensitivity. Manifested by skin rashes, redness and itching of the skin, increased body temperature, spasm of the bronchial tree. Anaphylactic reactions rarely develop.

Other – fatigue, weakness, hot flashes. Long-term use of the drug causes the development of hemosiderosis.

Contraindications

Hypersensitivity to active or other components of the drug. excess iron (hemosiderosis, hemochromatosis), other types of anemia not associated with iron deficiency (hemolytic anemia, aplastic anemia, sideroahrestic anemia, iron-refractory anemia; anemia due to lead poisoning, thalassemia, etc.), esophageal stenosis and/or other obstructive gastrointestinal diseases; intestinal diverticulum, intestinal obstruction, regular blood transfusions, simultaneous use of parenteral forms of iron; children's age up to 7 years.

Application

Inside, with a glass of water, before meals.

Adults and children over 7 years of age: prevention of iron deficiency anemia - 1 tablet per day on an empty stomach.

Treatment for iron deficiency anemia: children over 7 years of age - 1 tablet (in the morning), adults - 1-2 tablets per day (morning and evening).

The duration of treatment is determined individually, depending on the severity of anemia. It is recommended to continue therapy for 1–3 months (at a dose of 1 tablet in the morning before breakfast) after normalization of hemoglobin levels.

Overdose

When using average therapeutic doses, the development of overdose symptoms does not occur. Manifestations of overdose are nausea, vomiting; with significantly exceeded doses, death is possible as a result of collapse. The lethal dose of the drug is 180–300 mg per kg of body weight. Primary symptoms appear after 60-120 hours, accompanied by pain in the abdomen, vomiting with blood, increased bowel movements, melena, weakness, drowsiness, and confusion. The skin is cold, clammy, moist, cyanotic. Decreased blood pressure, pulse, palpitations, shock, coma. Convulsions, signs of hyperventilation. Necrosis of the gastrointestinal mucosa. After 4-6 hours, an imaginary improvement occurs; after 12 hours, severe shock develops with symptoms of liver failure and coagulopathy.

First aid if you accidentally take a larger dose is to eat raw eggs or milk, which bind iron and interfere with its absorption. Perform gastric lavage.

Specific treatment is gastric lavage with saline or 1% sodium carbonate solution while taking a laxative.

The use of deferoxamine is indicated in case of obvious overdose of the drug. In case of acute poisoning, drink a solution of deferoxamine 5-10 g (10-20 ampoules dissolved in water). Or the drug is used parenterally at the rate of 1-2 g IM with an interval of 3-12 hours. It is possible to use infusions - 1 g of the drug intravenously.

Symptomatic therapy. The use of peritoneal dialysis and hemodialysis is acceptable.

Release form

P/O tablets in blisters No. 10.

Cardboard packaging (3 blisters) No. 30.

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