Feraccru

ferric maltol

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An overview of Feraccru and why it is authorised in the EU

Feraccru is an iron-containing medicine used to treat iron deficiency (lack of iron) in adults.

Feraccru contains the active substance ferric maltol.

What is Feraccru and what is it used for?

Feraccru is an iron-containing medicine used to treat iron deficiency (lack of iron) in adults.

Feraccru contains the active substance ferric maltol.

How is Feraccru used?

Feraccru is available as capsules (30 mg). The recommended dose is one capsule taken twice a day, morning and evening, on an empty stomach. Treatment duration depends on the severity of the iron deficiency, but generally at least 12 weeks of treatment are required.

The medicine can only be obtained with a prescription.

For more information about using Feraccru, see the package leaflet or contact your doctor or pharmacist.

How does Feraccru work?

The active substance in Feraccru, ferric maltol, is an iron-containing compound. When taken by mouth, it is absorbed by the cells of the gut; the iron is then released from the compound and transported and stored in the body, helping to restore normal levels in patients with iron deficiency. This helps correct reduced production of haemoglobin (the oxygen-carrying pigment in red blood cells), anaemia (low levels of red blood cells) and any symptoms of the condition. Iron is an essential building block for haemoglobin and the body can produce more haemoglobin and correct anaemia once iron stores are replenished.

What benefits of Feraccru have been shown in studies?

Feraccru is effective at increasing haemoglobin levels in patients with iron deficiency and anaemia, (defined as haemoglobin levels lower than 12 g/dl for women and 13 g/dl for men).

In a study of 128 patients, those taking Feraccru for 12 weeks had their haemoglobin levels increase on average from 11.0 to 13.2 g/dl whereas in patients taking placebo (a dummy treatment) haemoglobin levels remained at around 11.1 g/dl. In addition, around 65% of patients taking Feraccru achieved normal levels of haemoglobin compared with 10% of those on placebo.

What are the risks associated with Feraccru?

The most common side effects with Feraccru (which may affect up to 1 in 10 people) are symptoms affecting the gut such as abdominal (belly) pain, flatulence (passing wind), constipation, abdominal discomfort and distension, and diarrhoea; these side effects are usually of mild to moderate intensity.

Severe side effects include abdominal pain, constipation and diarrhoea. For the full list of side effects of Feraccru, see the package leaflet.

Feraccru must not be used in patients with iron overload disorder (haemachromatosis) or in patients receiving repeated blood transfusions. For the full list of restrictions, see the package leaflet.

Why is Feraccru authorised in the EU?

The European Medicines Agency decided that Feraccru’s benefits are greater than its risks and it can be authorised for use in the EU. Feraccru has been shown to be effective in increasing haemoglobin levels in patients with iron deficiency anaemia. Data on how the medicine is absorbed in the body show that Feraccru can also have an effect on patients with iron deficiency who have not already developed anaemia. The safety profile of Feraccru is considered acceptable, with side effects that are mostly mild to moderate in intensity and in line with those of other iron preparations.

What measures are being taken to ensure the safe and effective use of Feraccru?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Feraccru have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Feraccru are continuously monitored. Side effects reported with Feraccru are carefully evaluated and any necessary action taken to protect patients.

Other information about Feraccru

Feraccru received a marketing authorisation valid throughout the EU on 18 February 2016.

Name Language First published Last updated
Feraccru : EPAR - Medicine overview BG = bălgarski 2016-03-18 2018-04-23
Feraccru : EPAR - Medicine overview ES = español 2016-03-18 2018-04-23
Feraccru : EPAR - Medicine overview CS = čeština 2016-03-18 2018-04-23
Feraccru : EPAR - Medicine overview DA = dansk 2016-03-18 2018-04-23
Feraccru : EPAR - Medicine overview DE = Deutsch 2016-03-18 2018-04-23
Feraccru : EPAR - Medicine overview ET = eesti keel 2016-03-18 2018-04-23
Feraccru : EPAR - Medicine overview EL = elliniká 2016-03-18 2018-04-23
Feraccru : EPAR - Medicine overview EN = English 2016-03-18 2018-04-23
Feraccru : EPAR - Medicine overview FR = français 2016-03-18 2018-04-23
Feraccru : EPAR - Medicine overview IT = italiano 2016-03-18 2018-04-23
Feraccru : EPAR - Medicine overview LV = latviešu valoda 2016-03-18 2018-04-23
Feraccru : EPAR - Medicine overview LT = lietuvių kalba 2016-03-18 2018-04-23
Feraccru : EPAR - Medicine overview HU = magyar 2016-03-18 2018-04-23
Feraccru : EPAR - Medicine overview MT = Malti 2016-03-18 2018-04-23
Feraccru : EPAR - Medicine overview NL = Nederlands 2016-03-18 2018-04-23
Feraccru : EPAR - Medicine overview PL = polski 2016-03-18 2018-04-23
Feraccru : EPAR - Medicine overview PT = português 2016-03-18 2018-04-23
Feraccru : EPAR - Medicine overview RO = română 2016-03-18 2018-04-23
Feraccru : EPAR - Medicine overview SK = slovenčina 2016-03-18 2018-04-23
Feraccru : EPAR - Medicine overview SL = slovenščina 2016-03-18 2018-04-23
Feraccru : EPAR - Medicine overview FI = suomi 2016-03-18 2018-04-23
Feraccru : EPAR - Medicine overview SV = svenska 2016-03-18 2018-04-23
Feraccru : EPAR - Medicine overview HR = Hrvatski 2016-03-18 2018-04-23
Name Language First published Last updated
Feraccru : EPAR - Risk-management-plan summary (English only) 2016-03-18  

This EPAR was last updated on 18/07/2018 .

Authorisation details

Product details

Product details for Feraccru
NameFeraccru
Agency product numberEMEA/H/C/002733
Active substance

ferric maltol

International non-proprietary name (INN) or common name

ferric maltol

Therapeutic area Anemia, Iron-Deficiency
Anatomical therapeutic chemical (ATC) code B03AB

Publication details

Publication details for Feraccru
Marketing-authorisation holder

Shield TX (UK) Limited

Revision6
Date of issue of marketing authorisation valid throughout the European Union18/02/2016

Contact address:

Shield TX (UK) Limited
Northern Design Centre 
Baltic Business Centre 
Gateshead Quays NE8 3DF
United Kingdom

Product information

Product information

15/06/2018  Feraccru -EMEA/H/C/002733 -IB/0015

Name Language First published Last updated
Feraccru : EPAR - Product Information EN = English 2016-03-18 2018-07-18
Feraccru : EPAR - Product Information EN = English 2016-03-18 2018-07-18
Feraccru : EPAR - Product Information EN = English 2016-03-18 2018-07-18
Feraccru : EPAR - Product Information EN = English 2016-03-18 2018-07-18
Feraccru : EPAR - Product Information EN = English 2016-03-18 2018-07-18
Feraccru : EPAR - Product Information EN = English 2016-03-18 2018-07-18
Feraccru : EPAR - Product Information EN = English 2016-03-18 2018-07-18
Feraccru : EPAR - Product Information EN = English 2016-03-18 2018-07-18
Feraccru : EPAR - Product Information EN = English 2016-03-18 2018-07-18
Feraccru : EPAR - Product Information EN = English 2016-03-18 2018-07-18
Feraccru : EPAR - Product Information EN = English 2016-03-18 2018-07-18
Feraccru : EPAR - Product Information EN = English 2016-03-18 2018-07-18
Feraccru : EPAR - Product Information EN = English 2016-03-18 2018-07-18
Feraccru : EPAR - Product Information EN = English 2016-03-18 2018-07-18
Feraccru : EPAR - Product Information EN = English 2016-03-18 2018-07-18
Feraccru : EPAR - Product Information EN = English 2016-03-18 2018-07-18
Feraccru : EPAR - Product Information EN = English 2016-03-18 2018-07-18
Feraccru : EPAR - Product Information EN = English 2016-03-18 2018-07-18
Feraccru : EPAR - Product Information EN = English 2016-03-18 2018-07-18
Feraccru : EPAR - Product Information EN = English 2016-03-18 2018-07-18
Feraccru : EPAR - Product Information EN = English 2016-03-18 2018-07-18
Feraccru : EPAR - Product Information EN = English 2016-03-18 2018-07-18
Feraccru : EPAR - Product Information EN = English 2016-03-18 2018-07-18
Feraccru : EPAR - Product Information EN = English 2016-03-18 2018-07-18
Feraccru : EPAR - Product Information EN = English 2016-03-18 2018-07-18

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Feraccru : EPAR - All Authorised presentations EN = English 2016-03-18  
Feraccru : EPAR - All Authorised presentations EN = English 2016-03-18  
Feraccru : EPAR - All Authorised presentations EN = English 2016-03-18  
Feraccru : EPAR - All Authorised presentations EN = English 2016-03-18  
Feraccru : EPAR - All Authorised presentations EN = English 2016-03-18  
Feraccru : EPAR - All Authorised presentations EN = English 2016-03-18  
Feraccru : EPAR - All Authorised presentations EN = English 2016-03-18  
Feraccru : EPAR - All Authorised presentations EN = English 2016-03-18  
Feraccru : EPAR - All Authorised presentations EN = English 2016-03-18  
Feraccru : EPAR - All Authorised presentations EN = English 2016-03-18  
Feraccru : EPAR - All Authorised presentations EN = English 2016-03-18  
Feraccru : EPAR - All Authorised presentations EN = English 2016-03-18  
Feraccru : EPAR - All Authorised presentations EN = English 2016-03-18  
Feraccru : EPAR - All Authorised presentations EN = English 2016-03-18  
Feraccru : EPAR - All Authorised presentations EN = English 2016-03-18  
Feraccru : EPAR - All Authorised presentations EN = English 2016-03-18  
Feraccru : EPAR - All Authorised presentations EN = English 2016-03-18  
Feraccru : EPAR - All Authorised presentations EN = English 2016-03-18  
Feraccru : EPAR - All Authorised presentations EN = English 2016-03-18  
Feraccru : EPAR - All Authorised presentations EN = English 2016-03-18  
Feraccru : EPAR - All Authorised presentations EN = English 2016-03-18  
Feraccru : EPAR - All Authorised presentations EN = English 2016-03-18  
Feraccru : EPAR - All Authorised presentations EN = English 2016-03-18  
Feraccru : EPAR - All Authorised presentations EN = English 2016-03-18  
Feraccru : EPAR - All Authorised presentations EN = English 2016-03-18  

Pharmacotherapeutic group

Antianemic preparations

Therapeutic indication

Feraccru is indicated in adults for the treatment of iron deficiency anaemia (IDA) in patients with inflammatory bowel disease (IBD).

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Feraccru : EPAR - Public assessment report EN = English 2016-03-18  
CHMP summary of opinion for Feraccru EN = English 2015-12-18