Heferol (Capsules) Instructions for Use

Marketing Authorization Holder

Alkaloid AD (Macedonia)

ATC Code

B03AA02 (Ferrous fumarate)

Active Substance

Ferrous fumarate (Ph.Eur. European Pharmacopoeia)

Dosage Form

Heferol

Capsules 350 mg: 30 pcs.

Dosage Form, Packaging, and Composition

30 pcs. – dark glass bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Antianemic drug

Pharmacotherapeutic Group

Hematopoiesis stimulant – iron preparation

Pharmacological Action

Antianemic agent. Iron is a trace element that stimulates erythropoiesis.

When iron is used in the form of salts, its deficiency in the body is quickly replenished, which leads to a gradual regression of clinical (weakness, fatigue, dizziness, tachycardia, soreness and dryness of the skin) and laboratory symptoms of anemia.

Pharmacokinetics

When taken orally, it has high absorption and bioavailability.

It is absorbed mainly in the duodenum and the proximal part of the jejunum.

C_max is reached after 4 hours.

Protein binding is 90% or more (mainly with hemoglobin).

It is deposited in the form of ferritin or hemosiderin in hepatocytes and the reticuloendothelial system, a small amount – in the form of myoglobin in the muscles.

T_1/2 is about 12 hours.

Indications

Treatment and prevention of iron deficiency conditions during pregnancy; due to impaired iron absorption from the gastrointestinal tract; due to prolonged bleeding; due to unbalanced and inadequate nutrition.

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 one 350 mg capsule once to three times daily.

For the prevention of iron deficiency during pregnancy, administer one 350 mg capsule once daily.

Adjust the dosage for pediatric patients based on body weight and iron requirements; do not use in children under 12 years unless specifically directed.

Take capsules at least one hour before meals for optimal absorption.

If gastrointestinal irritation occurs, administer with a small amount of food, acknowledging that this may reduce absorption.

Swallow the capsule whole with a glass of water; do not chew or crush.

Continue treatment for several months after hemoglobin levels normalize to replenish iron stores.

Regularly monitor hematological parameters such as hemoglobin, serum ferritin, and transferrin saturation to guide therapy duration.

Avoid concomitant intake with antacids, dairy products, tea, or coffee; separate administration by at least two hours.

Adverse Reactions

In some cases temporary adverse effects on the gastrointestinal tract (feeling of fullness and discomfort in the stomach, nausea, vomiting), allergic reactions, constipation.

Contraindications

Hypersensitivity to ferrous fumarate; diseases accompanied by the accumulation of iron in the body (aplastic and hemolytic anemia, thalassemia, hemosiderosis, hemochromatosis); disorders of iron absorption (sideroachrestic anemia, lead anemia, pernicious anemia /vitamin B₁₂ deficiency/); anemia not associated with iron deficiency.

Use in Pregnancy and Lactation

It can be used during pregnancy and during lactation (breastfeeding) according to indications, in recommended doses and dosage forms.

Use in Hepatic Impairment

Use with caution in hepatic insufficiency.

Use in Renal Impairment

Use with caution in renal insufficiency.

Pediatric Use

It can be used in children according to indications in age-appropriate recommended doses and dosage forms.

Geriatric Use

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), alcoholism (active or in remission – for solutions containing ethanol), bronchial asthma, hepatic or renal insufficiency, rheumatoid arthritis, blood transfusion.

Before starting therapy, it is necessary to determine the content of iron and ferritin in the blood serum.

During treatment with ferrous fumarate, darker staining of the stool is possible.

Solid food, bread, raw cereals, dairy products, eggs, tea reduce the absorption of iron.

Drug Interactions

Antacids, calcium preparations, etidronate, drugs that reduce the acidity of gastric juice (including histamine H₂-receptor blockers, M-anticholinergics, proton pump inhibitors, antacids, preparations containing carbonates, bicarbonates, phosphates, oxalates), pancreatin, pancrelipase reduce absorption (iron preparations should be taken 1 hour before or 2 hours after their use).

Ascorbic acid increases absorption.

Ferrous fumarate reduces the absorption of fluoroquinolones, penicillamine, tetracyclines (it is recommended to take them 2 hours before or 2 hours after taking iron preparations).

Large doses of iron preparations reduce the intestinal absorption of zinc preparations (the latter are recommended to be taken 2 hours after taking iron preparations). Ethanol increases absorption and the risk of toxic complications.

Cholestyramine, phenytoin, phenobarbital, carbamazepine, sulfasalazine, hormonal contraceptives, folic acid antagonists, trimethoprim, triamterene reduce the absorption of iron.

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.