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

Source: European Medicines Agency (EU)  Revision Year: 2026  Publisher: Norgine B.V., Antonio Vivaldistraat 150, 1083 HP Amsterdam, Netherlands

Product name and form

Feraccru 30 mg hard capsules.

Pharmaceutical Form

Hard capsule.

Red capsule (19 mm long x 7 mm diameter) printed "30".

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 monohydrate, 0.3 mg of Allura Red AC (E129) and 0.1 mg Sunset Yellow FCF (E110).

For the full list of excipients, see section 6.1.

Active Ingredient

Ferric maltol contains iron in a stable ferric state as a complex with a trimaltol ligand. The complex is designed to provide, in a controlled way, utilisable iron for uptake across the intestinal wall and transfer to the iron transport and storage proteins in the body (transferrin and ferritin, respectively). The complex dissociates on uptake from the gastro-intestinal tract and the complex itself does not enter the systemic circulation.

List of Excipients

Capsule contents:

Lactose monohydrate
Sodium laurilsulfate
Magnesium stearate
Colloidal anhydrous silica
Crospovidone (Type A)

Capsule shell:

Hypromellose
Brilliant Blue FCF (E133)
Allura Red AC (E129)
Titanium dioxide (E171)
Sunset Yellow FCF (E110)

Printing Ink:

Shellac glaze-45% (20% esterfied) in Ethanol
Iron oxide black
Propylene glycol
Ammonium hydroxide

Pack sizes and marketing

HDPE bottles with a child-proof polypropylene push-lock. Each pack contains 14, 50, 56 or 100 (2 bottles of 50) capsules.

Not all pack sizes may be marketed.

Marketing authorization holder

Norgine B.V., Antonio Vivaldistraat 150, 1083 HP Amsterdam, Netherlands

Marketing authorization dates and numbers

EU/1/15/1075/001
EU/1/15/1075/002
EU/1/15/1075/003
EU/1/15/1075/004

Date of first authorisation: 18 February 2016
Date of latest renewal: 25 November 2020

Drugs

Drug Countries
FERACCRU Austria, Estonia, Finland, Croatia, Ireland, Lithuania, Poland, United Kingdom

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