FEXERIC Film-coated tablet Ref.[49917] Active ingredients: Ferric citrate

Source: European Medicines Agency (EU)  Revision Year: 2019  Publisher: Akebia Europe Limited, c/o Matheson, 70 Sir John Rogersons Quay, Dublin 2, Ireland

Product name and form

Fexeric 1 g film-coated tablets.

Pharmaceutical Form

Film-coated tablet.

Peach-coloured, oval shaped, film-coated tablet, embossed with “KX52”. Tablets are 19 mm long, 7.2 mm thick and 10 mm wide.

Qualitative and quantitative composition

Each film-coated tablet contains 1 g of ferric citrate coordination complex (equivalent to 210 mg of ferric iron).

Excipients with known effect: Each film-coated tablet contains sunset yellow FCF (E110) (0.99 mg) and Allura Red AC (E129) (0.70 mg).

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ferric citrate

Ferric citrate is a phosphate binder and iron replacement product. It is used for the control of serum phosphorus levels and the treatment of iron deficiency anemia in adult patients with chronic kidney disease on dialysis.

List of Excipients

Tablet core:

Starch, pregelatinised
Calcium stearate

Film-coating:

Hypromellose
Titanium Dioxide
Triacetin
Sunset Yellow FCF (E110)
Allura Red AC (E129)
Indigo Carmine

Pack sizes and marketing

HDPE bottles with child-resistant closure with desiccant.

Pack size: 200 film-coated tablets.

Marketing authorization holder

Akebia Europe Limited, c/o Matheson, 70 Sir John Rogerson’s Quay, Dublin 2, Ireland

Marketing authorization dates and numbers

EU/1/15/1039/001

Date of first authorisation: 23 September 2015

Drugs

Drug Countries
FEXERIC Austria, Estonia, Ireland, Lithuania, Poland

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