Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: AVEROA SAS, 11 Avenue Paul Verlaine, 38100 Grenoble, France
Xoanacyl 1 g film-coated tablets.
| Pharmaceutical Form |
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Film-coated tablet. Peach-coloured, oval shaped, (19 mm long, 7.2 mm thick and 10 mm wide) embossed with "KX52" on one side. |
Each film-coated tablet contains 1 g of ferric citrate (as coordination complex , containing 210 mg of ferric iron).
Excipients with known effect: Each film-coated tablet contains 0.99 mg sunset yellow FCF (E110) and 0.70 mg allura red AC (E129).
For the full list of excipients, see section 6.1.
| Active Ingredient |
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Ferric citrate coordination complex is specifically designed to have a high surface area and a defined molar ratio of ferric iron to citrate. The high surface area of ferric citrate coordination complex impacts ferric iron solubility at physiological pH and allows part of ferric iron to be absorbed and supply iron to the metabolic pathway. Ferric citrate coordination complex has a dual mechanism of action, one that is associated with providing a source of ferric iron and one associated with decreasing the absorption of phosphorous. |
| List of Excipients |
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Tablet core: Pregelatinised starch Film-coating: Hypromellose |
High density polyethylene (HDPE) bottles sealed with child-resistant polypropylene screw caps, an aluminium foil heat-sealed with a polyethylene liner and two silica gel sachets.
Each bottle contains 200 film-coated tablets and is packed into a carton box.
AVEROA SAS, 11 Avenue Paul Verlaine, 38100 Grenoble, France
EU/1/25/1923/001
| Drug | Countries | |
|---|---|---|
| XOANACYL | Austria, Estonia, Italy, Lithuania |
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