Preparation
FML Capsule: Each capsule contains Iron 30 mg as Ferric Maltol INN.
Indication
FML is indicated for the treatment of iron deficiency in adults.
Contraindication
• Hypersensitivity to the active substance or to any of the excipients.
• Haemochromatosis and other iron overload syndromes.
• Patients receiving repeated blood transfusions.
Dosage & Administration
The recommended dose is one capsule twice daily, morning and evening, on an empty stomach. Treatment duration will depend on the severity of iron deficiency but generally at least 12 weeks of treatment is required. The treatment should be continued as long as necessary to replenish the body iron stores according to blood tests.
Side Effect
Inflammatory bowel disease (IBD) flare, iron overload, constipation, discolored stools, stomach pain, nausea or vomiting, stomach area discomfort or bloating.
Drug Interaction
Concomitant use of iron products with Dimercaprol may increase the risk of nephrotoxicity.
Use Children
The safety and efficacy of Ferric maltol in children has not been established.
Use Pregnancy Lactation
Pregnant women:
Ferric maltol is not absorbed systemically as an intact complex following oral administration, and maternal use is not expected to result in fetal exposure to the drug. Ferric maltol may be considered during pregnancy if necessary.
Lactating women:
Ferric maltol is not available systemically and is therefore unlikely to pass into the mother's milk. Ferric maltol can be used in lactating women if clinically needed.
Packaging
FML Capsule: Each box contains 5X10’s capsules in alu-alu blister pack.
Storage
Store below 30 ºC. Protect from light and moisture. Keep all medicines out of the reach of children.
