potassium citrate / potassium hydrogen carbonate

This medicine is authorised for use in the European Union.


Sibnayal is a medicine used to treat patients from the age of one year with distal renal tubular acidosis (dRTA), a disease in which the kidneys do not remove acid through the urine well enough. This results in a build-up of acid in the blood, which leads to a range of symptoms including hearing and growth problems, vomiting, kidney stones and lack of alertness. The disease also causes levels of potassium in the blood to fall, which can lead to muscle weakness and paralysis.

Sibnayal contains the active substances potassium citrate and potassium hydrogen carbonate.

This EPAR was last updated on 30/06/2023

Authorisation details

Product details
Agency product number
Active substance
  • Potassium citrate monohydrated
  • Potassium hydrogen carbonate
International non-proprietary name (INN) or common name
  • potassium citrate
  • potassium hydrogen carbonate
Therapeutic area (MeSH)
Acidosis, Renal Tubular
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Advicenne S.A.
Date of issue of marketing authorisation valid throughout the European Union
Contact address

262 rue du Faubourg Saint Honoré
75008 Paris

Product information

27/06/2023 Sibnayal - EMEA/H/C/005407 - IB/0009

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Mineral supplements

Therapeutic indication

Sibnayal is indicated for the treatment of distal renal tubular acidosis (dRTA) in adults, adolescents and children aged one year and older.

Assessment history

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