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Hematogen (Pastilles, Lozenges) Instructions for Use

ATC Code

B03AE10 (Iron preparations in combination with other drugs)

Clinical-Pharmacological Group

Antianemic drug. Vitamin complex with a trace element

Pharmacotherapeutic Group

Iron preparation + other preparations

Pharmacological Action

A means for the correction of metabolic processes. It is a source of high-quality protein, fats, carbohydrates, and minerals, which are contained in proportions close to the composition of human blood. The biologically complete protein contains all amino acids in a ratio optimal for the body.

It stimulates hematopoiesis, promotes the absorption of iron in the intestine, increases the hemoglobin content in the blood, and increases the plasma ferritin level.

Indications

Use for the following conditions.

  • Iron deficiency anemia for the purpose of stimulating hematopoiesis and correcting hemoglobin and ferritin levels.
  • States of inadequate or unbalanced nutrition to provide a source of complete protein, fats, carbohydrates, and minerals.
  • The convalescence period after infectious and other debilitating illnesses to support recovery and metabolic processes.

ICD codes

ICD-10 code Indication
D50 Iron deficiency anemia
E63.9 Nutritional deficiency, unspecified
Z54 Convalescence
ICD-11 code Indication
3A00.Z Iron deficiency anemia, unspecified
5B7Z Malnutrition, unspecified
8D40.0 Encephalopathy due to nutritional deficiency
8D40.1 Neuropathy due to nutritional deficiency
8D40.2 Myopathy due to nutritional deficiency
8D40.3 Intellectual developmental disorder due to nutritional deficiency
8D40.Y Other specified diseases of the nervous system due to nutritional deficiency
QB7Z Convalescence, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer orally. Adhere strictly to the recommended daily intake to avoid exceeding the safe level of iron and other components.

For the pastilles/lozenges dosage form: take 1 to 2 pastilles two to three times per day. The total daily dose should not exceed 6 pastilles. Suck or chew the pastilles.

Adverse Reactions

Adverse reactions are generally infrequent and mild, primarily related to the gastrointestinal system due to iron content.

From the digestive system: nausea, diarrhea, epigastric discomfort. These effects are often dose-dependent. Allergic reactions, including skin rash, itching, and urticaria, may occur in individuals with hypersensitivity to any component of the formulation.

Drug Interactions

Concurrent administration with other oral iron-containing products increases the risk of cumulative iron overload and gastrointestinal side effects.

The absorption of iron may be reduced when taken concomitantly with tetracycline antibiotics, quinolones, bisphosphonates, levothyroxine, and antacids containing aluminum, calcium, or magnesium. Maintain a minimum 2-hour interval between the intake of this drug and these medications.

Avoid concurrent use with angiotensin-converting enzyme (ACE) inhibitors, as iron may potentiate their cough-inducing effect.

Contraindications

Do not use under the following conditions.

  • Known hypersensitivity to any of the active or excipient components of the formulation.
  • All types of anemia not associated with iron deficiency (e.g., hemolytic, megaloblastic, aplastic anemia).
  • Disorders of carbohydrate metabolism, including diabetes mellitus, due to the sugar content in the pastilles.
  • Hemochromatosis, hemosiderosis, and other conditions associated with iron overload.

Overdose

Acute overdose is characterized by symptoms of iron intoxication, which may manifest in several phases.

Early symptoms (within 6 hours) include nausea, vomiting, abdominal pain, diarrhea, and lethargy. Later stages (after 6-24 hours) may involve metabolic acidosis, drowsiness, and shock. Gastrointestinal bleeding and hepatic necrosis are possible in severe cases.

Seek immediate medical attention. Treatment is symptomatic and supportive; gastric lavage may be considered. In severe intoxication, administer a specific iron chelator as prescribed.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Revival And Development, LLC (Russia)

Dosage Form

Bottle OTC Icon Hematogen C Chewable pastilles: 30 g

Dosage Form, Packaging, and Composition

Chewable pastilles brown or dark brown in color, divided into plates, with a specific odor.

5 g (1 plate)
Iron sulfate heptahydrate 15 mg
Food grade black albumin 250 mg
Ascorbic acid (vit. C) 5 mg

Excipients: condensed milk – 1983 mg, molasses – 1250 mg, sucrose – 2277 mg, vanillin – 0.67 mg.

30 g (1 pastille) – wrappers made of film material.

Marketing Authorization Holder

Revival And Development, LLC (Russia)

Dosage Form

Bottle OTC Icon Hematogen C Chewable lozenges: 50 g

Dosage Form, Packaging, and Composition

Chewable pastilles brown or dark brown in color, divided into plates, with a specific odor.

5 g (1 plate)
Iron sulfate heptahydrate 15 mg
Food grade black albumin 250 mg
Ascorbic acid (vit. C) 5 mg

Excipients: condensed milk – 1990 mg, molasses – 1250 mg, sucrose – 2268 mg, vanillin – 0.6 mg.

30 g (1 pastille) – wrappers made of film material.

Marketing Authorization Holder

Geness, LLC (Russia)

Manufactured By

Geness, LLC (Russia)

Dosage Form

Bottle OTC Icon Hematogen C Vita Tablets: 20 g, 30 g, 40 g, or 50 g

Dosage Form, Packaging, and Composition

Tablets brown or dark brown in color, with an aromatic odor, divided into segments.

100 g
Food grade black albumin 5 g
Ascorbic acid (vit. C) 0.1 g
Betacarotene 0.002 g
Iron (II) sulfate heptahydrate (ferrous sulfate) 0.3 g

Excipients: sweetened condensed milk – 39.8 g, starch molasses – 25 g, sucrose (granulated sugar, refined sugar) – 45.36 g, vanillin – 0.012 g.

20 g (1 tablet) – wrappers made of film material.
30 g (1 tablet) – wrappers made of film material.
40 g (1 tablet) – wrappers made of film material.
50 g (1 tablet) – wrappers made of film material.

Marketing Authorization Holder

Geness, LLC (Russia)

Manufactured By

Geness, LLC (Russia)

Or

Pharm-Pro, LLC (Russia)

Dosage Form

Bottle OTC Icon Hematogen C Vita Tablets: 20 g, 30 g, 40 g, or 50 g

Dosage Form, Packaging, and Composition

Tablets brown or dark brown in color, with an aromatic odor, divided into segments.

100 g
Food grade black albumin 5 g
Ascorbic acid (vit. C) 0.1 g
Betacarotene 0.002 g
Iron (II) sulfate heptahydrate (ferrous sulfate) 0.3 g

Excipients: sweetened condensed milk – 39.8 g, starch molasses – 25 g, sucrose (granulated sugar, refined sugar) – 45.36 g, vanillin – 0.012 g.

20 g (1 tablet) – wrappers made of film material.
30 g (1 tablet) – wrappers made of film material.
40 g (1 tablet) – wrappers made of film material.
50 g (1 tablet) – wrappers made of film material.

Marketing Authorization Holder

Revival And Development, LLC (Russia)

Dosage Form

Bottle OTC Icon Hematogen L Chewable pastilles: 6 or 10 pcs.

Dosage Form, Packaging, and Composition

Chewable pastilles 1 pastille (5 g)
Food grade black albumin 250 mg
Ferrous sulfate × 7H2O 15 mg
Lysine hydrochloride 50 mg

6 pcs. (30 g) – wrappers made of film material.
10 pcs. (50 g) – wrappers made of film material.

Marketing Authorization Holder

Revival And Development, LLC (Russia)

Dosage Form

Bottle OTC Icon Hematogen Nova Chewable pastilles: 30 g

Dosage Form, Packaging, and Composition

Chewable pastilles 1 pastille (30 g)
Food grade black albumin 1.5 g
Ferrous sulfate x 7H2O 90 mg

1 pc. – wrappers made of film material.

Marketing Authorization Holder

Revival And Development, LLC (Russia)

Dosage Form

Bottle OTC Icon Hematogen Nova Chewable lozenges: 50 g

Dosage Form, Packaging, and Composition

Chewable pastilles 1 pastille (50 g)
Food grade black albumin 2.5 g
Ferrous sulfate x 7H2O 150 mg

1 pc. – wrappers made of film material.

Marketing Authorization Holder

Pharmstandard-UfaVITA OJSC (Russia)

Manufactured By

Pharmstandard-Lexredstva OJSC (Russia)

Dosage Form

Bottle OTC Icon Hematogen VITAcomplex Chewable lozenges: 50 g

Dosage Form, Packaging, and Composition

Chewable pastilles brown or dark brown in color, divided into 6 rectangular segments, with a characteristic odor.

1 pastille (50 g)
Food grade black albumin 2.375 g
Ascorbic acid (vit. C) 50 mg
Pyridoxine hydrochloride (vit. B6) 2 mg
Folic acid 100 mcg
Ferrous sulfate heptahydrate (in terms of iron) 24.89 mg (5 mg)
Copper sulfate pentahydrate (in terms of copper) 0.98 mg (250 mcg)

Excipients: sweetened whole condensed milk – 16.88954 g, caramel starch molasses – 10.66336 g, sucrose (white crystalline sugar TS2) – 19.48213 g, vanillin – 12 g, glycerol – 500 mg.

1 pastille (50 g) – flexible packaging made of multilayer material.

Marketing Authorization Holder

Geness, LLC (Russia)

Dosage Form

Bottle OTC Icon Hematogen with cedar nut Tablets: 50 g

Dosage Form, Packaging, and Composition

Tablets 50 g
Food grade black albumin 2.5 g
Ferrous sulfate x 7H2O 150 mg

50 g – wrappers made of film material.

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