Biofer (Tablets) Instructions for Use

Marketing Authorization Holder

Micro Labs Limited (India)

ATC Code

B03AD (Iron preparations in combination with folic acid)

Dosage Form

Biofer

Chewable tablets 100 mg+0.35 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Chewable tablets dark brown in color, round, with a score on one side; the presence of inclusions of a darker color is allowed.

Excipients: lactose monohydrate, magnesium stearate, mannitol, colloidal silicon dioxide, caramel, sodium methylparaben, sodium propylparaben, sodium chloride, purified talc, aspartame, chocolate flavor, vanilla flavor.

10 pcs. – Al/Al blisters (3) – cardboard packs.
10 pcs. – Al/Al blisters (6) – cardboard packs.

Clinical-Pharmacological Group

Antianemic drug

Pharmacotherapeutic Group

Hematopoiesis stimulant (vitamin + iron preparation)

Pharmacological Action

Antianemic drug. The drug Biofer contains iron in the form of iron (III) hydroxide polymaltose complex. This macromolecular complex is stable and does not release iron in the form of free ions in the gastrointestinal tract.

The structure of Biofer is similar to the natural iron compound ferritin. Due to this similarity, iron (III) is transported from the intestine into the blood by active transport. This property explains the impossibility of drug overdose, unlike simple iron salts, the absorption of which occurs along a concentration gradient.

The absorbed iron binds to ferritin and is stored in the body, mainly in the liver. Then, in the bone marrow, it is incorporated into hemoglobin.

The iron that is part of the iron (III) hydroxide polymaltose complex does not have pro-oxidant properties, unlike simple iron salts. There is a correlation between the severity of iron deficiency and the level of its absorption (the more severe the iron deficiency, the better the absorption). The most active absorption process occurs in the duodenum and small intestine.

Folic acid is a B vitamin that stimulates erythropoiesis and is involved in the synthesis of amino acids, nucleic acids, purines, pyrimidines, and in the metabolism of choline.

Taking the drug Biofer in the dosage form of chewable tablets does not cause staining of tooth enamel.

Pharmacokinetics

Data on the pharmacokinetics of the drug Biofer have not been provided.

Indications

• Treatment of latent and clinically expressed iron deficiency (iron deficiency anemia);
• Prevention of iron and folic acid deficiency, including before, during and after pregnancy (during lactation).

ICD codes

Dosage Regimen

The tablets should be taken orally during or immediately after a meal. They can be chewed or swallowed whole.

The drug dose and duration of therapy depend on the severity of the iron deficiency. The daily dose of the drug can be taken once a day.

For the treatment of clinically expressed iron deficiency (iron deficiency anemia), children over 12 years of age, adults, and women during lactation (breastfeeding) are prescribed 1 tablet 1-3 times/day for 3-5 months until the hemoglobin level in the blood normalizes. After that, the drug should be continued for several more months to restore iron stores in the body (1 tablet/day).

During pregnancy, 1 tablet of Biofer should be taken 2-3 times/day until hemoglobin normalizes. Then therapy should be continued in the regimen of 1 tablet once a day, at least until delivery, to restore iron stores.

For the treatment of latent iron deficiency and for the prevention of iron and folic acid deficiency, patients should take 1 tablet of the drug once a day.

The duration of treatment for iron deficiency anemia is 3-5 months until iron stores in the body are normalized; for pregnant women, at least until delivery.

The duration of treatment for latent iron deficiency is 1-2 months.

Adverse Reactions

From the digestive system very rarely (≥ 0.001% and < 0.01%) signs of gastrointestinal irritation may be noted, such as a feeling of fullness, pressure in the epigastric region, nausea, constipation, or diarrhea. Dark staining of the stool is possible due to the excretion of unabsorbed iron (has no clinical significance).

Other very rarely (≥ 0.001% and < 0.01%) – allergic reactions to folic acid.

Contraindications

• Iron overload (hemochromatosis);
• Impaired iron utilization (lead anemia, sideroblastic anemia, thalassemia);
• Non-iron deficiency anemias (hemolytic anemia or megaloblastic anemia caused by vitamin B₁₂ deficiency);
• Children under 12 years of age.

Use in Pregnancy and Lactation

In controlled studies during the II and III trimesters of pregnancy, no adverse effects of the drug on the mother and fetus were noted. During the first trimester of pregnancy, the drug should be used only if the potential benefit to the mother outweighs the possible risk to the fetus.

During lactation, the drug should be taken as indicated.

Pediatric Use

Contraindicated in children under 12 years of age.

Special Precautions

The drug should be used with caution in gastric and duodenal ulcers, as well as in inflammatory diseases of the gastrointestinal tract.

1 Biofer tablet contains 0.06 XE (bread units), which must be taken into account when prescribing to patients with diabetes mellitus.

Overdose

To date, no cases of intoxication or signs of iron overload have been reported in cases of drug overdose.

Drug Interactions

No interaction with other medicinal products has been identified.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F) in the original packaging (blister in a carton).

Shelf Life

The shelf life is 3 years.

Dispensing Status

The drug is dispensed by prescription.

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.