Information letter No. 01I-1430/21 of 26.10.2021 on the introduction of new safety data in the instructions for use of the drug Nexium® (INN — Esomeprazole) 10 mg


The following sections of the instructions for medical use of the drug have been amended; - "Side Effects." - The information has been updated. Information was added to subsection: "Skin and subcutaneous tissue disorders": acute generalized exanthematous pustulosis and drug rash with eosinophilia and systemic symptoms (DRESS syndrome) with an incidence of "very rare". data [...]