lting from saturation of transferrin caused by intravenous iron.
Impact of Feraccru on absorption of other medicinal products
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 Feraccru.
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.
Medicinal products that may impact absorption and distribution of iron from Feraccru 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.
Pharmacodynamic interactions
Concomitant use of iron with dimercaprol should be avoided as the combination of dimercaprol and iron is nephrotoxic.
Concomitant use of chloramphenicol with iron should be avoided as chloramphenicol delays plasma iron clearance, incorporation of iron into red blood cells and interferes with erythropoiesis.
Concomitant use of iron with methyldopa should be avoided as oral iron may antagonise the hypotensive effect of methyldopa.
4.6 Fertility, pregnancy and lactation
Pregnancy
There are no data from the use of Feraccru in pregnant women. Ferric maltol is not systemically available.
Definitive animal studies are not available for maltol with respect to reproductive toxicity. As a precautionary measure, it is preferable to avod the use of Feraccru during pregnancy.
Breastfeeding
Ferric maltol is not available systemically and is therefore unlikely to pass into the mother's milk. No clinical studies are available to date. As a precautionary measure, it is preferable to avoid the use of Feraccru during breast-feeding.
Fertility
There are no data on the effect of ferric maltol on human fertility. Ferric maltol is not systemically available. Fertility was unaffected following maltol treatment in animal studies. However, the conducted reproductive toxicity studies are insufficient to discard any risk in humans.
4.7 Effects on ability to drive and use machines
No effect is expected from an oral iron product.
4.8 Undesirable effects
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
Table 1 presents all adverse reactions occurring during the 12 week controlled phase and during the 52 week extension phase in subjects with IBD treated with Feraccru.
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).
Table 1: Adverse reactions observed during the 12 week controlled phase of study AEGIS 1/2 and the 52 week extension phase in subjects with IBD
SYSTEM ORGAN CLASS
COMMON
(≥ 1/100 to < 1/10)
UNCOMMON
(≥ 1/1000 to < 1/100)
Nervous system disorders
Headache
Gastrointes |
