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

Source: European Medicines Agency (EU)  Revision Year: 2020  Publisher: Norgine B.V., Antonio Vivaldistraat 150, 1083 HP Amsterdam, Netherlands

Product name and form

Feraccru 30 mg hard capsules.

Pharmaceutical Form

Capsules, hard.

Red capsule (19 mm long x 7 mm diameter).

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.

Active Ingredient Description
Ferric maltol

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:

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

Pack sizes and marketing

HDPE bottles with a child-proof polypropylene push-lock. Each bottle contains 56 capsules.

Marketing authorization holder

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

Marketing authorization dates and numbers

EU/1/15/1075/001

Date of first authorisation: 18 February 2016

Drugs

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

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