Instructions for Hemoferon oral solution 200 ml bottle
Composition
active ingredients: 1 ml of solution contains 40 mg of ferric ammonium citrate (equivalent to 8.2 mg of elemental iron), 0.3 mg of folic acid, 0.01 mg of cyanocobalamin;
excipients: ethanol, methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sorbitol (E 420), sodium saccharin, sodium chloride, disodium edetate (Trilon B), raspberry flavoring, purified water.
Dosage form
Oral solution.
Main physicochemical properties: transparent liquid of red-brown color, sweet in taste, with a characteristic raspberry odor.
Pharmacotherapeutic group
Antianemic agents. Iron preparations in combination with various substances.
ATX code B0ZA E01.
Pharmacological properties
Pharmacodynamics.
Hemoferon is a balanced complex of bivalent iron, vitamin B12 and folic acid, which are necessary for the process of normal hematopoiesis in the bone marrow. Iron is a component of hemoglobin, myoglobin, various enzymes, reversibly binds oxygen and ensures its transport to tissues, participates in redox reactions, stimulates erythropoiesis. The need for iron especially increases during the period of active growth, pregnancy, breastfeeding, menstruation and other bleeding.
Folic acid together with cyanocobalamin stimulates erythropoiesis, participates in the synthesis of amino acids, nucleotides, nucleic acids, choline metabolism. During pregnancy, it is necessary for the normal development of the fetus's nerve fibers, protects it from the effects of teratogenic factors, plays an important role in the reactions of cellular immunity. Cyanocobalamin participates in the synthesis of nucleotides, is an important factor in the normal growth and development of epithelial cells, for normal hematopoiesis and maturation of erythrocytes, is necessary for the metabolism of folic acid and the synthesis of myelin. Cyanocobalamin and folic acid also prevent the development of megaloblastic anemia and neurological disorders.
Pharmacokinetics.
When administered orally, the ferric ion, which is part of the drug, is almost completely absorbed from the digestive tract into the systemic circulation. The maximum concentration of iron in the blood serum is reached 2–4 hours after taking the drug. Iron is almost completely bound to plasma transferrins and is involved in the formation of hemoglobin, myoglobin, cytochrome oxidase, catalase and peroxidase or is deposited in the cells of the reticuloendothelial system. The half-life is approximately 12 hours. It is excreted in feces, urine and sweat. The binding of folic acid to plasma proteins is 60–65%, its metabolism occurs in the liver. It is excreted mainly by the kidneys, partially through the intestines.
Indication
Treatment of iron deficiency and folate deficiency anemia of various etiologies; conditions associated with an increased body need for iron and other components of the drug (pregnancy, breastfeeding, period of intensive growth and puberty, hypochlorhydria, acute and chronic blood loss, burn disease, condition after gastric surgery, celiac disease, sharp weight loss).
Contraindication
Hypersensitivity to the components of the drug.
Excessive accumulation of iron in the body (hemosiderosis, hemochromatosis) or predisposition to it.
All other types of anemia, as well as conditions not caused by iron deficiency (hypo-, aplastic and hemolytic anemia, sideroachrestic anemia, iron-refractory anemia, anemia in lead poisoning, thalassemia, hemoglobinopathies, pernicious anemia); blood transfusion, erythremia, erythrocytosis, acute thromboembolism, neoplasms, except for conditions accompanied by megaloblastic anemia, cirrhosis of the liver, uricopoporphyria, esophageal stenosis and/or other obstructive diseases of the digestive tract, acute inflammatory bowel diseases, gastric and duodenal ulcer in the acute stage, intestinal diverticulum, intestinal obstruction, regular blood transfusions, simultaneous use of parenteral forms of iron. Abdominal pain, nausea and vomiting of unknown etiology.
Interaction with other medicinal products and other types of interactions
With the simultaneous use of Hemoferon and antacids containing bismuth, aluminum, magnesium, calcium, as well as with the use of cholestyramine, cimetidine, the absorption of the drug from the gastrointestinal tract decreases.
Solid food, black tea, coffee, dairy products, eggs, bread, and raw cereals reduce iron absorption.
Tetracycline antibiotics, as well as penicillamine, form complex compounds with Hemoferon, as a result of which they reduce iron absorption and the effect of the drug.
Glucocorticoids can enhance the stimulation of erythropoiesis by Hemoferon.
Ascorbic acid increases the bioavailability of iron when taken orally. Concomitant administration of vitamin E may reduce the pharmacological action of iron in the body.
Concomitant administration of iron preparations with nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the irritating effect of iron on the mucous membrane of the digestive tract. Iron salts reduce absorption when used simultaneously with bisphosphonates.
Folic acid absorption is reduced when taken simultaneously with analgesics, anticonvulsants, sulfonamides, cytostatics (methotrexate), triamterene and trimethoprim, neomycin, polymyxins, tetracyclines.
When used simultaneously, folic acid reduces the effects of primidone, para-aminosalicylic acid (PASA), sulfasalazine, oral hormonal contraceptives, chloramphenicol, and phenytoin, increasing their metabolism.
Concomitant intravenous administration of chloramphenicol may slow iron absorption and reduce the hematopoietic effect of cyanocobalamin.
Absorption of cyanocobalamin is reduced when used concomitantly with anticonvulsants, aminosalicylic acid, oral hormonal contraceptives, kanamycin, neomycin, polymyxins, colchicine, ranitidine, potassium preparations, tetracyclines. It should also be taken into account that vitamin B12 may enhance allergic reactions caused by vitamin B1.
The drug is not recommended to be combined with methotrexate, disulfiram, pyrimethamine, allopurinol.
Application features
Do not exceed the recommended doses of the drug. It is better to take the drug 30–40 minutes before meals, washed down with juice or plain water. Before starting treatment, it is necessary to exclude pernicious anemia and establish the etiology of anemia, since anemias associated with inflammatory syndromes are not amenable to treatment with iron preparations. Iron deficiency anemia may be a consequence of latent blood loss, the cause of which must be identified before starting treatment.
To avoid reduced iron absorption, it is not recommended to take the drug within 1–2 hours after consuming the following foods: black tea, coffee, dairy products, eggs, bread, raw cereals, mineral water.
Hemoferon should be prescribed with caution to patients with chronic liver diseases (hepatitis, liver dysfunction), gastrointestinal tract (history of gastric and duodenal ulcers, enteritis, ulcerative colitis, Crohn's disease), kidney disease, including acute kidney infections, and people suffering from rheumatoid arthritis, leukemia, and angina.
To prevent constipation, the drug must be taken with plenty of fluids.
While taking the drug, black discoloration of the stool may occur, which may interfere with the diagnosis of chronic gastrointestinal bleeding. A test for occult blood (benzidine test) may sometimes give positive results.
Oral administration of iron preparations should not be combined with parenteral administration, as well as with repeated blood transfusions.
Serum iron and hemoglobin levels should be monitored systematically. If long-term use of iron preparations is necessary, the following parameters should be assessed every 4 weeks: hemoglobin level, erythrocytes and such indicators as mean cell volume (MCV), mean hemoglobin content in erythrocytes (MCH), reticulocyte count, serum iron, transferrin. Ferritin determination allows for the assessment of iron accumulation: a serum ferritin level < 15 μg/l indicates that there are no iron stores in the body. With long-term use, monitoring of vitamin B12 levels is necessary.
The lack of effect when using the drug may be due to impaired absorption processes in the intestine, inhibition of hematopoiesis, the administration of certain medications (antimetabolites), as well as a deficiency of other vitamins.
The drug should not be used for more than 6 months, except in cases of prolonged bleeding, menorrhagia.
Use during pregnancy or breastfeeding
The drug can be used during pregnancy and breastfeeding only as prescribed and under the supervision of a doctor in case of laboratory-determined iron deficiency, without exceeding the recommended doses.
Ability to influence reaction speed when driving vehicles or other mechanisms
Caution should be exercised when driving vehicles, as dizziness may sometimes occur when using the drug.
Method of administration and doses
The drug is taken orally, preferably 30–40 minutes before meals.
The dosage of the drug is carried out using a measuring cup or dosing syringe, which are included.
For the treatment of iron deficiency and folate deficiency anemia, adults and children over 12 years of age are prescribed 15–20 ml of Hemoferon solution per day.
For the treatment of iron deficiency and folate deficiency anemia in children under 12 years of age, the drug is prescribed in the following doses (see table):
| Age | Therapeutic daily dose |
| 6–9 months | 5 ml |
| 10–12 months | 7.5 ml |
| 1–3 years | 10 ml |
| 4–6 years | 12.5 ml |
| 7–12 years | 15 ml |
The duration of the course of treatment is determined individually, depending on the course and severity of the disease. The average duration of the course of treatment is 1–3 months.
Children.
The drug is used in children from 6 months of age.
Overdose
If the recommended doses are exceeded, overdose symptoms are possible. A lethal dose of elemental iron is 180–300 mg/kg of body weight. However, for some patients, a dose of elemental iron of 30 mg/kg may be toxic. In young children, the risk of acute intoxication is particularly high: life-threatening intoxication is possible after taking 1 g of ferrous sulfate.
Overdose may increase adverse reactions. Symptoms of acute iron poisoning occur 10–60 minutes or several hours after taking the drug.
Symptoms: pain in the abdomen and epigastrium, nausea, vomiting (sometimes with blood in the vomit), diarrhea with green, and then tarry stools, melena. These phenomena may be accompanied by pallor of the skin, acrocyanosis, cyanosis, drowsiness, weakness, cold sticky sweat, decreased blood pressure, weak pulse, palpitations, confusion, hyperthermia, paresthesia, necrosis of the digestive tract mucosa, convulsions. If therapeutic measures are not taken, then after 12–48 hours shock and coma may develop, which will be accompanied by oliguria, toxic liver failure, coagulopathy, pathological type of Cheyne-Stokes breathing.
Therapeutic measures. In case of a significant overdose of the drug due to possible toxic effects, the patient should be given immediate assistance: wash the stomach with water or a solution of baking soda, or phosphate-buffered solution. The patient can consume raw eggs and milk, which will contribute to the formation of insoluble iron compounds in the gastrointestinal tract and its removal from the body.
If necessary, treat shock and acidosis. Patients with oliguria/anuria are prescribed peritoneal dialysis or hemodialysis.
The best way to determine the severity of the condition is to measure the serum iron content and serum iron-binding capacity (SIBC) of the blood. If the serum iron level is higher than the SIBC, systemic toxicity is possible.
Special therapy. Patients with symptoms of acute poisoning are prescribed the iron antidote deferoxamine (desferal). Chelation therapy with deferoxamine is performed in cases where:
a potentially lethal dose of 180–300 mg/kg of body weight or more was taken;
serum iron concentration above 400–500 mcg/dL;
the serum iron concentration exceeds the ULN and/or the patient has severe symptoms of iron intoxication, such as coma, shock.
In acute poisoning, 5–10 g of deferoxamine is administered orally to bind unabsorbed iron (the contents of 10–20 ampoules are dissolved in drinking water). To remove absorbed iron, deferoxamine is administered intramuscularly at 1–2 g every 3–12 hours. In severe cases accompanied by the development of shock, patients are prescribed an intravenous drip of 1 g of the drug and symptomatic therapy is carried out.
Side effects
On the part of the digestive tract: pain in the stomach area, nausea, vomiting, diarrhea or constipation, black stools, flatulence, discomfort (feeling of fullness) in the abdominal area, metallic taste in the mouth, darkening of teeth, loss of appetite.
Skin and subcutaneous tissue disorders: skin redness, itching and skin rashes, urticaria, acne, bullous rashes.
On the part of the immune system: hypersensitivity reactions (anaphylaxis, anaphylactic shock, bronchospasm).
From the nervous system: headache, dizziness, nervous excitement.
Cardiac: pain in the heart area, tachycardia.
Others: hot flashes, general weakness, sweating, hyperthermia. Prolonged unjustified use of the drug can lead to hemosiderosis.
Expiration date
2 years.
Storage conditions
Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
200 ml of solution in brown glass bottles, sealed with an aluminum cap, with a measuring cup and/or dosing syringe in a cardboard box.
Vacation category
Without a prescription.
Producer
Joint Ukrainian-Spanish enterprise "Sperco Ukraine".
Address
21027, Ukraine, Vinnytsia, 600-anniversary St., 25.
Phone: + 38(0432)52-30-36. E-mail: trade@sperco.com.ua
www.sperco.com.ua
