Orofer-M is used for the treatment of iron deficiency anemia in adults by replenishing low iron levels in the body.
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Orofer-M contains ferric maltol, a non-salt oral iron formulation. It supplies iron needed for the formation of hemoglobin, myoglobin, and essential enzymes, supporting oxygen transport in the blood. The iron is absorbed through the intestine and stored as transferrin and ferritin.
Take the capsule on an empty stomach, preferably 1 hour before or 2 hours after meals. Swallow the capsule whole with water. Do not open, chew, or crush it.
The recommended dose is 30 mg twice daily (PO BID). Treatment duration depends on the severity of iron deficiency but usually requires at least 12 weeks. Therapy should be continued until ferritin levels return to normal.
- Avoid use during an active inflammatory bowel disease flare, as it may worsen gastrointestinal inflammation.
- Excessive iron therapy can lead to iron overload (hemosiderosis).
- Do not use in patients receiving intravenous iron therapy.
- Assess iron levels before starting treatment and monitor regularly.
- Accidental overdose of iron can be fatal in children under 6 years; keep out of reach of children.
Concomitant use with dimercaprol may increase the risk of kidney toxicity and should be avoided.
Ferric maltol may reduce the absorption of certain medicines, including mycophenolate, ethynyl estradiol, ciprofloxacin, and doxycycline.
Separate administration by at least 4 hours where clinically necessary.
Food may reduce iron absorption; taking the capsule on an empty stomach is recommended.
Commonly reported side effects include:
Flatulence
Diarrhea or constipation
Dark-colored stools
Abdominal pain or discomfort
Nausea and vomiting
Although specific overdose data are limited, excessive intake may cause nausea, vomiting, abdominal pain, diarrhea, and in severe cases, metabolic acidosis and systemic toxicity. Chronic overdose may result in iron accumulation and hemosiderosis.
Ferric maltol is not systemically absorbed as an intact complex, so fetal exposure is not expected. Animal studies show no harmful effects on fetal development. There is no evidence of transfer into breast milk, and breastfeeding is not expected to expose the infant to the drug. Use during pregnancy or lactation should be based on medical advice.
Store below 25°C in a cool, dry place, protected from light. Keep out of reach of children.
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