Feraccru

5). Treatment duration will depend on the severity of iron deficiency, but generally at least 12-weeks treatment is required. It is recommended the treatment is continued as long as necessary to replenish the body iron stores according to blood tests.

73 m2). 73 m2) are available. Paediatric population The safety and efficacy of Feraccru in children (17 years and under) has not yet been established. No data are available Method of administration Oral use. 5).

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.

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).

5 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 abdomen) Flatulence Constipation Abdominal discomfort/ distension Diarrhoea Discoloured faeces Nausea Small intestinal bacterial overgrowth Vomiting Skin and subcutaneous tissue disorders Acne Erythema Musculoskeletal and connective tissue disorders Joint stiffness Pain in extremity General disorders and administration site conditions 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.

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.

5 g/dl. 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’.

1. • Haemochromatosis and other iron overload syndromes. • Patients receiving repeated blood transfusions.