Feraccru

HOS-096644 · has-adverse-reaction-information · PDF-Seite 4

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 clinical studies to date 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). 4 Table 1: Adverse reactions observed during clinical studies to date System organ class Common Uncommon Nervous system disorders Headache Gastrointestinal disorders Abdominal pain (including upper Small intestinal bacterial abdomen) Flatulence overgrowth Constipation Vomiting Abdominal discomfort/ distension Diarrhoea Discoloured faeces Nausea Skin and subcutaneous tissue Acne disorders Erythema Musculoskeletal and Joint stiffness connective tissue disorders Pain in extremity General disorders and Thirst administration site conditions Investigations Blood alkaline phosphatase increased Blood thyroid stimulating hormone increased Gamma-glutamyltransferase increased Paediatric population The safety profil

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HOS-096640 · has-contraindication-information · PDF-Seite 3

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. • Haemochromatosis and other iron overload syndromes. • Patients receiving repeated blood transfusions.

HOS-096639 · has-indication-information · PDF-Seite 2

Feraccru is indicated for the treatment of iron deficiency in adults and adolescents aged 12 years and older.

HOS-096642 · has-interaction-information · PDF-Seite 3

No interaction studies have been performed with ferric maltol. Based on an in vitro study maltol is glucuronised through UGT1A6 (see section 5.2). Food has been shown to inhibit uptake of Feraccru: The treatment should be taken on an empty stomach (see section 4.2) Intravenous administration of iron salts Concomitant administration of Feraccru 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. 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. 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, 3 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. Pharmacodynamic interactions Concomitant use of iron and dimercaprol is nephrotoxic (see section 4.4). Concomitant use of chloramphenicol will delay plasma iron clearance, incorporation of iron into red blood cells and interfere with erythropoiesis (see section 4.4). Concomitant use of iron with methyldopa may antagonise the hypotensive effect of methyldopa (see section 4.4).

HOS-096643 · has-pregnancy-information · PDF-Seite 4

Pregnancy 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. Feraccru may be considered during pregnancy if necessary. Breastfeeding 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. Feraccru 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.

HOS-096641 · has-warning-information · PDF-Seite 3

Iron deficiency or iron deficiency anaemia (IDA) diagnosis should be made based on blood tests; it is important to investigate the cause of the iron deficiency and to exclude underlying causes of anaemia other than iron deficiency. Feraccru is not recommended for use in patients with inflammatory bowel disease (IBD) flare or in IBD- patients with haemoglobin (Hb) <9.5 g/dl. Concomitant administration of ferric maltol with intravenous iron, dimercaprol, chloramphenicol or methyldopa is to be avoided (see section 4.5). This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product. This medicinal product also contains Allura Red AC (E 129) and Sunset Yellow FCF (E 110): these may cause allergic reactions. This medicine contains less than 1 mmol sodium (23 mg) per capsule, that is to say essentially ‘sodium-free’.