Hemofer Prolongatum (Dragee) Instructions for Use

Marketing Authorization Holder

GlaxoSmithKline Trading, JSC (Russia)

Manufactured By

GlaxoSmithKline Pharmaceuticals, S.A. (Poland)

ATC Code

B03AA07 (Ferrous sulfate)

Active Substance

Ferrous sulfate (USP United States Pharmacopoeia)

Dosage Form

Hemofer Prolongatum

Dragees 325 mg: 30 pcs.

Dosage Form, Packaging, and Composition

Dragee of red color, in the form of a convex disk with a smooth shell; on the break of a white shade.

Excipients: lactose, eudragit, magnesium stearate, talc, sucrose, gum arabic, red pigment, gelatin.

10 pcs. – contour cell packs (3) – cardboard packs.

Clinical-Pharmacological Group

Antianemic drug

Pharmacotherapeutic Group

Hematopoiesis stimulant – iron preparation

Pharmacological Action

Antianemic agent containing iron. Iron is a trace element that is part of hemoglobin, myoglobin, and some enzymes. It reversibly binds oxygen, participates in a number of redox reactions, and stimulates erythropoiesis.

Pharmacokinetics

After oral administration, iron is absorbed mainly from the duodenum and the upper part of the jejunum. Absorption increases with iron deficiency. A high iron content in the blood reduces absorption.

Indications

Treatment of iron deficiency anemia; prevention of iron deficiency conditions during pregnancy with insufficient dietary iron intake.

ICD codes

Dosage Regimen

Determine the dosage individually based on the severity of the iron deficiency, the patient’s age, and clinical response.

For the treatment of iron deficiency anemia in adults, administer 1 dragee (325 mg ferrous sulfate) once or twice daily.

For the prevention of iron deficiency during pregnancy, administer 1 dragee once daily, as directed by a physician.

Take dragees at least 1 hour before meals to maximize absorption. If gastrointestinal discomfort occurs, administer with or immediately after food.

Swallow the dragee whole with a full glass of water. Do not chew, crush, or suck on the dragee.

Monitor serum iron and hemoglobin levels periodically to assess therapeutic response and avoid iron overload.

Continue therapy for several months after hemoglobin normalization to replenish iron stores.

Adverse Reactions

From the immune system: frequency unknown – hypersensitivity reactions, urticaria.

From the respiratory system: infrequently – laryngeal edema; frequency unknown – in elderly persons and patients with impaired swallowing function during an attack of suffocation or when a tablet enters the respiratory tract, there is a risk of esophageal damage or the development of bronchial necrosis.

From the digestive system frequently – constipation, diarrhea, abdominal bloating, abdominal pain, change in stool color, nausea; infrequently – defecation disorders, dyspepsia, vomiting, gastritis.

From the skin and subcutaneous tissues infrequently – itching, erythematous rash.

Contraindications

Hypersensitivity to ferrous sulfate; increased iron content in the body, in particular, anemia with normal or high iron levels (thalassemia, refractory anemia, aplastic anemia); intestinal obstruction.

Use in Pregnancy and Lactation

During pregnancy and breastfeeding, it is possible to use according to indications, in recommended doses and dosage forms.

If it is necessary to use ferrous sulfate in the first trimester of pregnancy, it should be used under medical supervision.

Use in Hepatic Impairment

It should be used with caution in patients with hepatic insufficiency.

Use in Renal Impairment

It should be used with caution in patients with renal insufficiency.

Pediatric Use

It is possible to use in children according to indications in age-appropriate recommended doses and dosage forms.

Geriatric Use

It should be used with caution in elderly patients.

Special Precautions

Use with caution in gastric and duodenal ulcers, inflammatory bowel diseases (enteritis, diverticulitis, ulcerative colitis, Crohn’s disease), chronic alcoholism (active or in remission), in allergic diseases, bronchial asthma, hepatitis, hepatic or renal insufficiency, rheumatoid arthritis, concomitant blood transfusion.

A combination of iron salt and folic acid is more preferable for iron deficiency anemia with folic acid deficiency.

During course use, systematic monitoring of serum iron and hemoglobin levels is necessary.

Drug Interactions

Under the influence of ascorbic acid, trivalent iron is converted into divalent iron, which contributes to the improvement of its absorption.

With the simultaneous use of ferrous sulfate and antacids containing aluminum, magnesium, calcium, as well as with cholestyramine, penicillamine, the absorption of iron from the gastrointestinal tract decreases.

With the simultaneous use of ferrous sulfate and tetracycline antibiotics, complex compounds are formed that reduce the absorption of both iron and antibiotics.

With the simultaneous use of ferrous sulfate with corticosteroids, an increase in the stimulation of erythropoiesis is possible.

Consumption of large amounts of tea contributes to a decrease in iron absorption.

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

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.