Ferrolek-zdorovya

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT FERROLEC-ZDOROVYE (FERROLEC-ZDOROVYE)

Composition:

Active substances: ferrous iron in the form of ferrous sulfate heptahydrate; DL-serine;

5 ml of the preparation contain ferrous iron 34.35 mg in the form of ferrous sulfate heptahydrate – 171 mg; DL-serine – 129 mg;

Excipients: ascorbic acid (E 300); glucose; fructose; ethanol 96%; purified water; "Raspberry" flavoring containing: propylene glycol (E 1520), ethanol 96%, alpha-tocopherol (E 307), ascorbic acid (E 300), purified water.

Pharmaceutical form. Syrup.

Main physicochemical properties: a semi-transparent liquid, from light yellow to dark brown in color, with a raspberry aroma.

Pharmacotherapeutic group. Antianaemic agents. Iron preparations in combination with other substances. ATC code B03AE10.

Pharmacological properties.

Pharmacodynamics.

Iron is essential for maintaining the body's vital functions: it is a component of hemoglobin, myoglobin, and various enzymes; it reversibly binds oxygen and participates in redox reactions; it stimulates erythropoiesis. Iron is also stored in tissue depots (bone marrow, liver, spleen). The amino acid serine, which is part of the medicinal product, promotes more efficient absorption of iron and its entry into systemic circulation, resulting in rapid restoration of iron levels in the body to required values. This ensures better tolerability of the drug and allows for a reduction in the necessary iron dose.

Pharmacokinetics.

Absorption. When administered orally, approximately 10–15% of iron in the divalent form is generally absorbed in the duodenum and upper part of the small intestine. Additionally, particularly with increased iron intake, passive transport of iron occurs in the body.

Iron absorption significantly increases in the case of iron deficiency in the body, as well as during enhanced erythropoiesis. The highest absorption rate (50–60%) is observed when hemoglobin levels and blood iron content are low, while absorption intensity decreases again as these parameters normalize.

Maximum serum iron concentration is achieved within 2–4 hours after drug administration.

Distribution. In the blood, iron in the trivalent form binds to transferrin and is transported to sites of hematopoiesis or storage. When fully saturated, total plasma transferrin can bind a maximum of 12 mg of iron. This amount is relatively small, and in cases of iron intoxication due to oral or parenteral administration, the iron-binding capacity of transferrin may become overwhelmed, leading to the release of free, unbound iron into plasma, which is toxic.

Iron storage occurs after binding to apoferritin in the form of ferritin, particularly in the liver, spleen, and bone marrow.

Iron crosses the placental barrier and is excreted in small amounts into breast milk.

Elimination. Only about 1 mg of iron is excreted daily via desquamated skin and mucosal cells, bile, and urine. During menstruation, iron losses amount to approximately 1 mg per day.

The majority of iron derived from hemoglobin breakdown (20–30 mg per day) is reused by the body for the resynthesis of hemoglobin.

Clinical characteristics.

Indications.

Treatment of iron deficiency in the body.

Contraindications.

• Hypersensitivity to the active ingredients or to other components of the medicinal product.
• Haemosiderosis, haemochromatosis.
• Anaemias due to disorders of iron metabolism (iron-refractory anaemia; lead anaemia, thalassaemia, sideroachrestic anaemia).
• All other types of anaemia not caused by iron deficiency (haemolytic anaemia, megaloblastic anaemia due to vitamin B12 deficiency).
• Concurrent use of parenteral iron formulations.
• Oesophageal stricture and other obstructive gastrointestinal disorders.
• Intestinal diverticulum, intestinal obstruction.
• Regular blood transfusions.

Interaction with other medicinal products and other forms of interaction.

Iron salts reduce the absorption of concurrently administered drugs such as tetracycline, DNA gyrase inhibitors (e.g., ciprofloxacin, levofloxacin, norfloxacin, ofloxacin), bisphosphonates, penicillamine, levodopa, carbidopa, and methyldopa.

Iron salts reduce the absorption of thyroxine and zinc.

Iron absorption is reduced when taken simultaneously with cholestyramine, antacids (containing aluminium, magnesium, calcium, bismuth), as well as supplements of calcium and magnesium.

Iron absorption may be delayed with concurrent intravenous administration of chloramphenicol.

Glucocorticoids may enhance the erythropoiesis-stimulating effect of the medicinal product.

Vitamin C and citric acid enhance iron absorption.

Concomitant intake of vitamin E may reduce the pharmacological effect of iron in the child's body.

Concurrent use of iron salts and non-steroidal anti-inflammatory drugs (NSAIDs) may enhance the irritant effect of iron on the gastrointestinal mucosa.

The medicinal product should not be taken within 2–3 hours after administration of any of the above-mentioned drugs. If necessary, the effectiveness of concomitant drug administration should be monitored by medical or laboratory-diagnostic methods.

Use of dimercaprol may lead to formation of toxic complexes with iron.

Special precautions for use.

To avoid overdose, particular caution is required when using iron-containing medicinal products concomitantly with food or other supplements containing iron salts.

During treatment, approximately every 4 weeks and as necessary, the following parameters should be evaluated to determine the degree of iron deficiency, response to therapy, and the need for continued iron supplementation: hemoglobin level, erythrocyte count and erythrocyte indices [mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH)], reticulocyte count, serum iron, and transferrin. Determination of serum ferritin levels allows assessment of iron accumulation; a serum ferritin level < 15 mcg/L indicates absence of iron stores in the body.

Diabetic patients should be aware that the medicinal product contains carbohydrates: 1 measuring cup (5 mL) contains 3.1 g of a glucose and fructose mixture, equivalent to 0.26 carbohydrate exchange units (CEU).

To avoid reduced iron absorption, it is not recommended to take the medicinal product with black tea, coffee, or milk. Additionally, absorption may be reduced by solid food, bread, raw cereals, dairy products, and eggs; components of vegetarian diets (compounds forming iron complexes such as phosphates, phytates, and oxalates).

To prevent oral mucosal ulceration and dark dental staining, the medicinal product should not be taken undiluted or held in the mouth. The syrup should be taken with sufficient water. Black discoloration of teeth is reversible and can be avoided by taking the medicinal product during meals. After eating, thorough tooth brushing is recommended.

During treatment with the product, black discoloration of feces may occur due to excretion of unabsorbed iron. This is harmless and has no clinical significance.

The benzidine test or similar tests for detecting occult blood in feces may yield false-positive results. The medicinal product should be discontinued at least three days prior to such testing.

In patients with a history of gastrointestinal inflammation or ulcers, the risk of exacerbation of gastrointestinal disorders should be carefully weighed against the expected benefit of treatment.

Iron-containing medicinal products should be used with caution in patients with the following conditions: leukemia, chronic liver or kidney disease, inflammatory gastrointestinal disorders, peptic ulcer disease of the stomach or duodenum, and intestinal diseases (enteritis, ulcerative colitis, Crohn's disease).

If a patient has known sugar intolerances, medical advice should be sought before taking this product. The medicinal product may be harmful to teeth.

The product contains a small amount of alcohol (less than 100 mg per single dose).

Use during pregnancy or breastfeeding.

There are reports of fetal developmental abnormalities and miscarriages due to iron intoxication. During pregnancy, the medicinal product should be used only if the expected benefit outweighs the potential risk.

Iron-containing medicinal products have not been sufficiently studied for embryotoxicity in animal experiments.

During breastfeeding, the medicinal product may be used only if the expected benefit outweighs the potential risk.

Ability to affect reaction speed when driving or operating machinery.

Not studied.

Dosage and Administration

The medicinal product should be taken orally immediately before or during a meal, with a small amount of liquid (water or fruit tea). The daily dose is determined according to the patient's hemoglobin level, body weight, and age.

For oral administration, the recommended daily dose is 1.3–4 mg of iron per kilogram of body weight.

Dose for children aged 2 to 12 years: 5 ml 1–2 times daily.

Dose for adolescents aged 12 years and older, and adults: 5 ml 2–3 times daily.

For the treatment of children under 2 years of age, other dosage forms (oral drops) should be used.

The recommended treatment course for iron level normalization is 8 weeks. After achieving normal plasma iron concentration, treatment with the drug should be continued for several more weeks to replenish body iron stores.

In renal function disorders and severe liver diseases, the drug may be administered only under medical supervision.

Children. The syrup form of the medicinal product is indicated for children aged 2 years and older.

Overdose.

Symptoms

The risk of acute iron intoxication is particularly high in younger children; life-threatening poisoning may occur after ingestion of 1 g of iron sulfate. After accidental ingestion of a large amount of the drug, nausea, severe abdominal pain, diarrhea, and bloody vomiting due to hemorrhagic gastroenteritis may initially develop. In severe cases, cyanosis, impaired consciousness, and hyperpnea may develop as a result of acidosis and impaired peripheral circulation. Remission usually occurs approximately 4–6 hours later. Subsequently, within 12–48 hours, severe shock may develop, which may be accompanied by Cheyne-Stokes respiration, oliguria, toxic liver failure, and coagulopathy.

In some cases, central nervous system disorders such as paralysis, seizures, and coma may predominate; coagulation disorders are less common. In this phase of delayed shock, the outcome is usually fatal.

During the convalescence phase, gastrointestinal strictures and symptoms resembling intestinal obstruction may rarely occur.

Treatment

Measures to prevent absorption of a large amount of iron should be initiated as soon as possible. Prior to specific therapy, milk or raw eggs may be administered.

Symptomatic measures: induce vomiting, gastric lavage with water or a solution of sodium bicarbonate, or phosphate-buffered solution. If necessary, treat shock and acidosis.

Specific therapy: patients with symptoms of acute iron overdose and serum iron levels exceeding 300–350 µg/dL should be administered deferoxamine (desferal) orally and parenterally. In acute poisonings, to bind iron not yet absorbed from the gastrointestinal tract, administer 5–10 g of deferoxamine orally (contents of 10–20 vials dissolved in drinking water). To remove absorbed iron, deferoxamine should be administered intramuscularly at 1–2 g every 3–12 hours. In severe cases accompanied by shock, patients should receive intravenous infusion of 1 g of the drug (initial infusion rate should be 15 mg/kg/hour), along with symptomatic therapy.

A prerequisite for effective overdose treatment is continuous excretion of the iron complex from the body; therefore, patients with oliguria/anuria should undergo peritoneal dialysis or hemodialysis.

If necessary, supportive mechanical ventilation, circulatory support, radiological monitoring of toxin elimination, and repeated monitoring of serum iron levels and other blood serum parameters should be applied during shock therapy.

In cases of severe intoxication: administer calcium disodium edetate parenterally.

Side effects.

Immune system disorders: allergic reactions, including anaphylaxis, skin rashes, exanthema, urticaria, pruritus.

Gastrointestinal disorders: when high doses are used, mild gastrointestinal complications may occur, such as a feeling of fullness in the stomach, flatulence, constipation or diarrhea, abdominal pain, nausea, epigastric pain, dyspepsia, vomiting. Taking the medication with food may reduce the frequency of these adverse effects (see section "Method of administration and dosage").

If used incorrectly, i.e. if the medicinal product is held in the mouth, ulcerative stomatitis may occur. In elderly patients and patients with swallowing disorders, incorrect use also carries a risk of esophageal injury or development of bronchial necrosis.

During treatment, black discoloration of teeth may occur, which is reversible. This can be avoided by taking the medicinal product during meals. Dark-colored stools may also occur during treatment due to excretion of unabsorbed iron. This is harmless and has no clinical significance.

Reporting suspected adverse reactions.

Reporting of adverse reactions after medicinal product registration is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the following link: https://aisf.dec.gov.ua.

Shelf life. 2 years.

The shelf life of the product after opening the bottle is no more than 1 year.

Storage conditions. Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging. 100 ml in a bottle with a measuring cup in a box; 200 ml in a bottle with a dosing syringe-pipette in a box.

Prescription status. Prescription only.

Manufacturer: Limited liability company "Pharmaceutical Company "Zdorovya".

Manufacturer's address and place of business activity.

22, Shevchenka Street, Kharkiv, Kharkiv Oblast, 61013, Ukraine.