Ferric maltol

No clinical data on the need to adjust the dose in patients with impaired hepatic function are available.

No clinical data on the need to adjust the dose in patients with renal impairment (eGFR <15 ml/min/1.73 m²) are available.

Absorption of oral iron may be reduced by calcium and magnesium salts (such as magnesium trisilicate). Administration of iron preparations with such compounds should be separated by at least 2 hours.

Concomitant administration of ferric maltol with intravenous iron is to be avoided.

Concomitant administration of oral ferric maltol and intravenous iron may induce hypotension or even collapse due to the fast release of iron resulting from saturation of transferrin caused by intravenous iron.

Absorption of both iron and antibiotic may be reduced if oral iron is given with tetracycline. Administration of iron preparations and tetracyclines should be separated by 2 to 3 hours.

Concomitant administration of ferric maltol with chloramphenicol is to be avoided. Concomitant use of chloramphenicol will delay plasma iron clearance, incorporation of iron into red blood cells and interfere with erythropoiesis.

Concomitant administration of ferric maltol with dimercaprol is to be avoided. Concomitant use of iron and dimercaprol is nephrotoxic.

Concomitant administration of ferric maltol with methyldopa is to be avoided. Concomitant use of iron with methyldopa may antagonise the hypotensive effect of methyldopa.

Oral iron is known to reduce the absorption of penicillamine, bisphosphonates, ciprofloxacin, entacapone, levodopa, levofloxacin, levothyroxine (thyroxine), moxifloxacin, mycophenolate, norfloxacin and ofloxacin. These medicinal products should be given at least 2 hours apart from ferric maltol.

Ferric maltol is not recommended for use in patients with inflammatory bowel disease (IBD) flare or in IBD-patients with haemoglobin (Hb) <9.5 g/dl.

Food has been shown to inhibit uptake of ferric maltol. The treatment should be taken on an empty stomach.

A moderate amount of data on the oral use of ferric iron in pregnant women indicate no malformative nor feto/neonatal toxicity. Systemic exposure to the intact ferric maltol complex is negligible.

Ferric maltol may be considered during pregnancy if necessary.

No effects of oral ferric iron have been shown in breastfed newborns/infants of treated mothers Ferric maltol is not available systemically and is therefore unlikely to pass into the mother's milk. Ferric maltol can be used during breast feeding if clinically needed.

Fertility

There are no data on the effect of ferric maltol on human fertility. No effects on fertility are anticipated since systemic exposure to ferric maltol is negligible.

Ferric maltol has no or negligible influence on the ability to drive and use machines.

Summary of the safety profile

The most frequently reported adverse reactions were gastrointestinal symptoms (abdominal pain [8%], flatulence [4%], constipation [4%], abdominal discomfort [2%]/distension [2%] and diarrhoea [3%]) and these were mainly mild to moderate in severity. Reported severe adverse reactions were abdominal pain [4%], constipation [0.9%] and diarrhoea [0.9%].

Tabulated list of adverse reactions

The table below presents all adverse reactions occurring clinical studies to date with ferric maltol. Adverse reaction frequencies are defined as: very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000) or very rare (<1/10000).

Adverse reactions observed during clinical studies to date: