PIL - Co-trimoxazole Tablets BP 80/400mg: Change history

PRAC recommendations on signals (EPITT no 20135): Update to SPC 4.8 and PIL for circulatory shock.

1. To update sections 4.1 and 4.2 of the SmPC in line with reference product Co-Trimoxazole 80 mg/400 mg Tablets (MA number: PL 39699/0036; MAH: Aspen Pharma Trading Limited; Dated: 27/02/2024). Consequently, the PIL has been updated. 2. To update section 5.1 of the SmPC in line with the EMA request to add new text regarding EUCAST breakpoint data.