Feraccru 30mg hard capsules
1. Name of the medicinal product
Feraccru 30 mg hard capsules
2. Qualitative and quantitative composition
Each capsule contains 30 mg iron (as ferric maltol).
Excipient(s) with known effect:
Each capsule contains 91.5 mg of lactose, 0.5 mg of Allura Red AC (E129) and 0.3 mg Sunset Yellow FCF (E110).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsules, hard.
Red capsule (19 mm long x 7 mm diameter).
4. Clinical particulars
4.1 Therapeutic indications
Feraccru is indicated in adults for the treatment of iron deficiency.
4.2 Posology and method of administration
Posology
The recommended dose is one capsule twice daily, morning and evening, on an empty stomach (see section 4.5).
Treatment duration will depend on the severity of iron deficiency but generally at least 12-weeks treatment is required. The treatment should be continued as long as necessary to replenish the body iron stores according to blood tests.
Paediatric population
The safety and efficacy of Feraccru in children (17 years and under) has not yet been established. No data are available (see section 4.4).
The elderly and patients with hepatic or renal impairment
No dose adjustment is needed in elderly patients. No clinical data on the need to adjust the dosage in patients with impaired hepatic or renal function are available (see section 4.4).
Method of administration
Oral use.
Feraccru capsules should be taken whole on an empty stomach (with half a glass of water), as the absorption of iron is reduced when Feraccru is taken with food (see section 4.5).
4.3 Contraindications
• 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.
4.4 Special warnings and precautions for use
Feraccru should not be used in patients with inflammatory bowel disease (IBD) flare or in IBDpatients 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 and/or 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.
4.5 Interaction with other medicinal products and other forms of interaction
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 resu |
