FML 30

Ferric Maltol delivers iron for uptake across the intestinal wall and transfer to transferrin and ferritin. It has been shown to increase serum iron parameters, including ferritin and transferrin saturation (TSAT) Ferric Maltol capsule should be taken in oral route, preferably on an empty stomach, at least 1 hour before or 2 hours after meals. Do not open, break or chew Ferric Maltol capsule. The recommended dosage of Ferric Maltol is 30 mg twice daily. 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 until ferritin levels are within the normal range. Use in children and adolescents: Safety and effectiveness of ferric maltol have not been established in pediatric patients. 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. There are no data on the presence of ferric maltol in human milk, the effects on the breastfed child or the effects on milk production. Ferric maltol is not absorbed systemically as an intact complex by the mother following oral administration and breastfeeding is not expected to result in exposure of the child to ferric maltol. No data is available regarding overdose of ferric maltol in patients. Early signs and symptoms of iron overdose may include nausea, vomiting, abdominal pain and diarrhea. In more serious cases there may be evidence of hypoperfusion, metabolic acidosis and systemic toxicity. Dosages of ferric maltol in excess of iron needs may lead to accumulation of iron in storage sites leading to hemosiderosis. Oral Iron preparations Store in a cool (below 25°C) and dry place protected from light. Keep away from the reach of children.

Iron Deficiency Anemia

Ferric Maltol delivers iron for uptake across the intestinal wall and transfer to transferrin and ferritin. It has been shown to increase serum iron parameters, including ferritin and transferrin saturation (TSAT)

Nonsalt, oral formulation of ferric iron Supplements iron stores found in hemoglobin, myoglobin, and enzymes; works to transport oxygen via hemoglobin Delivers iron for uptake across the intestinal wall and transfer to transferrin and ferritin

Adult Dose: Iron Deficiency An iron replacement product indicated for iron deficiency 30 mg PO BID Continue as long as necessary until ferritin levels are within the normal range Treatment duration depends on severity of iron deficiency but generally at least 12 weeks of treatment is required

Take 1 hr before or 2 hr after a meal

1-10% Flatulence (4.6%) Diarrhea (4%) Constipation (4%) Discolored feces (4%) Abdominal pain (2.9%) Nausea (1.7%) Vomiting (1.7%) Abdominal pain (1.7%) Abdominal discomfort (1.1%) Abdominal distension (1.1%)

Avoid use in patients with an active inflammatory bowel disease flare, as there is potential risk of increased inflammation in the gastrointestinal tract Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children ages ≤6 years; keep this product out of reach of children Iron overload Excessive therapy with iron products can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis; do not administer to patients with evidence of iron overload or patients receiving IV iron Assess iron parameters before initiating treatment and monitor during therapy

Hypersensitivity to active substance or to any of the excipients Hemochromatosis and other iron overload syndromes Patients receiving repeated blood transfusions

There are no empirical data on avoiding drug interactions between ferric maltol and concomitant oral medication Concomitant use of some oral drugs may reduce bioavailability of iron after ferric maltol administration Separate the administration of ferric maltol from these drugs; duration of separation may depend on the absorption characteristics of the medication concomitantly administered, such as time to peak concentration or whether the drug is an immediate- or extended-release product; monitor clinical response to ferric maltol Coadministration of ferric maltol with some oral medications may also decrease the bioavailability of some drugs For oral drugs for which reductions in bioavailability may cause clinically significant effects on its safety or efficacy, separate ferric maltol administration by at least 4 hr; monitor clinical responses to concomitant drugs as appropriate Dimercaprol Coadministration of iron products with dimercaprol may increase the risk of nephrotoxicity Avoid use with dimercaprol

Pregnancy Not absorbed systemically as an intact complex following oral administration Maternal use is not expected to result in fetal exposure to the drug Animal data In animal reproduction studies, oral administration of ferric or ferrous compounds to gravid CD1-mice and Wistar rats during organogenesis at doses 13-32 times the recommended human dose resulted in no adverse developmental outcomes Overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes, and fetal malformation Clinical considerations Untreated iron deficiency anemia (IDA) in pregnancy is associated with adverse maternal outcomes such as postpartum anemia Adverse pregnancy outcomes associated with IDA include increased risk for preterm delivery and low birth weight Lactation There are no data on the presence of ferric maltol in human milk, the effects on the breastfed child, or the effects on milk production

Store in a cool (below 25°C) and dry place protected from light. Keep away from the reach of children.