Frequently asked questions
How much iron does FERACCRU® contain?
Each FERACCRU® capsule contains 30 mg iron (as ferric maltol).1
Is FERACCRU® suitable for vegans or vegetarians?
No, FERACCRU® contains lactose and gelatin of bovine (beef) origin. It is not suitable for vegans or vegetarians.1,2
Does FERACCRU® contain sugar?
FERACCRU® contains a very small amount (0.087g) of sugar per capsule.2 FERACCRU® contains lactose, which is a milk sugar.1
Are FERACCRU® capsules modified/prolonged release?
No, FERACCRU® capsules are an immediate-release formulation.1
How should FERACCRU® be taken?
FERACCRU® should be taken whole on an empty stomach (with half a glass of water). FERACCRU® should not be taken with food, as this reduces the absorption of iron.1
Can patients open FERACCRU® capsules?
FERACCRU® capsules should not be opened. They should be swallowed whole.1
Can the contents of FERACCRU® capsules be poured down a feeding/NGT/PEG tube?
FERACCRU® capsules should not be opened. They should be swallowed whole with half a glass of water. We do not have any information on using FERACCRU® with this mode of administration.1
Can patients take other vitamin or mineral supplements while on FERACCRU®?
The absorption of oral iron may be reduced by calcium and magnesium salts. They should be taken at least 2 hours apart from FERACCRU®.1
What is the shelf life of FERACCRU® after opening the bottle?
The shelf life is 45 days.1
Can patients still take FERACCRU® beyond the 45-day shelf life after first opening the bottle?
Patients should not take FERACCRU® capsules past this shelf life. However, as each bottle of FERACCRU® contains 56 capsules and patients should take one capsule twice a day, there should be no need to take FERACCRU® past this shelf life.1
Can children take FERACCRU®?
The safety and efficacy of FERACCRU® in children (17 years and under) have not yet been established. No data are available.1
Can FERACCRU® be used to treat IDA not caused by IBD?
Yes, FERACCRU® is licensed to treat iron deficiency, with or without anaemia.1
Can FERACCRU® be used in patients with Hb <9.5 g/dL?
Yes, with the exception of patients with IBD and Hb <9.5 g/dL.1
Can patients with an IBD flare take FERACCRU®?
No, FERACCRU® should not be used in patients with an IBD flare.1 In the AEGIS-IBD study patients’ IBD had to be in remission or mild to moderate in activity.3
Can patients with hepatic impairment take FERACCRU®?
FERACCRU® has not been studied in patients with hepatic impairment and therefore there are no clinical data on the need to adjust the dose in these patients.1
Is FERACCRU® suitable for patients who are pregnant?
The use of FERACCRU® may be considered during pregnancy if necessary. A moderate amount of data on the oral use of ferric iron in pregnant women indicate no malformative nor foeto/neonatal toxicity. Systemic exposure to the intact ferric maltol complex is negligible.1
Can FERACCRU® be used during breastfeeding?
FERACCRU® can be used during breastfeeding if clinically needed. 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.1
Does FERACCRU® affect patients’ 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.1
IBD, inflammatory bowel disease; IDA, iron deficiency anaemia; Hb, haemoglobin; NGT, nasogastric tube; PEG, percutaneous endoscopic gastrostomy.
References:
- FERACCRU® Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/feraccru-epar-product-information_en.pdf. Accessed April 2021.
- Norgine Data on File. DOF-FERAC-002. Final Allergens, excipients, Special Populations. February 2019.
- Gasche C, et al. Inflamm Bowel Dis 2015;21(3):579–588.
