Iron Polymaltose Complex
Regulatory sources consulted
- aemps-cima-ft-83365
Approved indications
- Treatment of iron deficiency without anemia (latent iron deficiency) and iron deficiency anemia (manifest iron deficiency).
Contraindications
Absolute
- Hypersensitivity to the active substance or to any of the excipients.
- Iron overload (e.g., hemochromatosis, hemosiderosis).
- Disturbances in iron utilization (e.g., sideroblastic anemia, lead anemia, thalassemia).
- Anemia not caused by iron deficiency (e.g., hemolytic anemia or megaloblastic anemia).
Clinical warnings
- Infections or tumors can cause anemia. Since iron can only be absorbed after correction of the primary disease, a benefit/risk assessment is recommended. — AEMPS CIMA
Drug interactions
- LowTetracyclinesJ01AA
Mechanism: The iron in the polymaltose complex is in a non-ionic form, which reduces chelation and mutual absorption inhibition with tetracyclines compared to iron (II) salts.
Recommendation: No dosing interval is required between the administration of iron polymaltose and tetracyclines, unlike with iron (II) salts.
AEMPS CIMA FT 83365
Adverse events
Common (≥1%)
dark colored stools · nausea · constipation · abdominal pain · diarrhea
Rare but serious
hypersensitivity reactions
Pregnancy and lactation
FDA category: Not Assigned
Controlled clinical data in pregnancy after the first trimester have not shown adverse effects. No effects are anticipated in the breastfed infant. Use under medical supervision.