FERACCRU Capsules, hard Ref.[7648] Active ingredients: Ferric maltol

Feraccru should not be used in patients with inflammatory bowel disease (IBD) flare or in IBD-patients with haemoglobin (Hb) <9.5 g/dl.

Iron preparations in excess may cause toxicity especially among children. Feraccru must not be administrated to children (see section 4.2).

Special care should be taken if other dietary and/or iron salt supplementation are used concurrently.

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 has not been studied in patients with impaired renal (eGFR<15 ml/min/1.73 m²) and/or impaired hepatic function

This medicinal product contains lactose: patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.

This medicinal product also contains Allura Red AC (E129) and Sunset Yellow FCF (E110): these may cause allergic reactions.

No drug interaction studies have been performed with Feraccru. Based on an in vitro study maltol is glucuronised through UGT1A6 (see section 5.2).

Food has been shown to inhibit uptake of Feraccru: Feraccru should be taken on an empty stomach (see section 4.2)

Intravenous administration of iron salts

Concomitant administration of Feraccru and intravenous iron should be avoided as the combination may induce hypotension or even collapse due to the fast release of iron resulting 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.

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 avoid 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.

No effect is expected from an oral iron product.

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).

Table 1. Adverse reactions observed during clinical studies to date:

Nervous system disorders

Uncommon: Headache

Gastrointestinal disorders

Common: Abdominal pain (including upper abdomen), Flatulence, Constipation, Abdominal discomfort/distension, Diarrhoea, Nausea

Uncommon: Small intestinal bacterial overgrowth, Vomiting

Skin and subcutaneous tissue disorders

Uncommon: Acne, Erythema

Musculoskeletal and connective tissue disorders

Uncommon: Joint stiffness, Pain in extremity

General disorders and administration site conditions

Uncommon: Thirst

Investigations

Blood alkaline phosphatase increased, Blood thyroid stimulating hormone increased, Gamma-glutamyltransferase increased

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Not applicable.