Hemofer (Drops) Instructions for Use

Marketing Authorization Holder

Medana Pharma, SA (Poland)

ATC Code

B03AA05 (Ferric chloride)

Active Substance

Ferrous chloride (BP British Pharmacopoeia)

Dosage Form

Hemofer

Oral drops 157 mg/1 ml: dropper bottle 10 ml or 30 ml

Dosage Form, Packaging, and Composition

Oral drops in the form of a transparent yellow-green liquid with a characteristic odor.

Excipients : sodium benzoate, citric acid, sodium hydroxide, sorbitol, dextrose, flavoring, purified water.

10 ml – dark glass dropper bottle (1) – cardboard boxes.
30 ml – dark glass dropper bottle (1) – cardboard boxes.

Clinical-Pharmacological Group

Antianemic drug

Pharmacotherapeutic Group

Hematopoiesis stimulant – iron preparation

Pharmacological Action

Antianemic drug. Iron is necessary for the normal functioning of the body, is part of hemoglobin, myoglobin, cytochrome C, stimulates erythropoiesis; reversibly binds oxygen and participates in redox reactions.

Pharmacokinetics

The degree of iron absorption depends on its valence, the degree of acidity of the gastric contents, and the iron deficiency in the body (ferrous iron preparations do not require preliminary reduction and are easily absorbed). With a significant deficiency, the degree of iron absorption reaches 25%. As this deficiency normalizes, the degree of iron absorption gradually decreases. Iron ions are absorbed in the initial parts of the small intestine and in the duodenum. Food, mainly milk and its products, as well as eggs, reduces iron absorption. Absorbed iron binds to ferritin and is stored mainly in the liver.

Indications

• Treatment of clinically pronounced iron deficiency anemia;
• Treatment of latent iron deficiency;
• Prevention of iron deficiency during pregnancy, during lactation, in women of childbearing age; in children, in adolescents, in adults (in persons following a vegetarian diet and in elderly patients) in accordance with developed recommendations.

ICD codes

Dosage Regimen

The dosage regimen is set individually. The drug is taken orally, between meals, with water or juice.

For anemia treatment, the maximum dose for children is 3 mg/kg/day, for adults – 180-200 mg/day.

For prevention, the drug dose is reduced by 2-3 times.

The duration of therapy is at least 2 months. With a clinically significant iron deficiency, the hemoglobin level normalizes only 2-3 months after the start of treatment. Then, to restore iron stores in the body, Hemofer is prescribed in prophylactic doses for several months.

The duration of the course of therapy in premature infants is from 3 to 5 months.

The daily dose can be taken orally in one or several doses, between meals, with water or juice.

1 ml contains 157 mg of ferric chloride (44 mg of elemental iron), 1 ml corresponds to 30 drops (1 drop contains about 1.5 mg of elemental iron).

Adverse Reactions

From the digestive system lack of appetite, nausea, abdominal pain, flatulence, diarrhea, constipation.

Contraindications

• Excess iron in the body (including hemosiderosis);
• Anemias not associated with iron deficiency (hemolytic anemia, megaloblastic anemia);
• Anemias due to impaired iron utilization (sideroblastic anemia, lead anemia);
• Hypersensitivity to the components of the drug.

Use in Pregnancy and Lactation

Hemofer can be used during pregnancy and lactation if indicated.

Pediatric Use

For anemia treatment, the maximum dose for children is 3 mg/kg/day.

The duration of the course of therapy in premature infants is from 3 to 5 months.

Special Precautions

It is not recommended to use the drug in case of impaired digestion and absorption processes in the gastrointestinal tract.

During the intake of Hemofer, stools may be darker due to the increased iron content in the intestines. If dark staining of teeth appears, the drug can be taken through a straw or the mouth should be rinsed immediately after its use.

When prescribing Hemofer to patients with diabetes mellitus, it should be taken into account that the drug contains glucose.

Control of laboratory parameters

During treatment, it is recommended to monitor the concentration of hemoglobin and iron in the blood every 4 weeks. After achieving normal hematological values, the drug should be used for another 6-8 weeks.

Overdose

Symptoms epigastric pain, nausea, vomiting, diarrhea or constipation, in more severe cases – drowsiness, pallor, hypovolemic shock up to coma.

Treatment drug withdrawal, gastric lavage, administration of laxatives, symptomatic therapy, administration of deferoxamine.

Drug Interactions

Antacids reduce iron absorption.

With simultaneous use of Hemofer with tetracyclines, the absorption of iron and antibiotics is reduced.

Storage Conditions

The drug should be stored in a place protected from light, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 2 years.

Pharmacy dispensing terms

The drug is dispensed by prescription.

Dispensing Status

Rx Only

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.