PIL - Co-trimoxazole Tablets BP 80/400mg: Change history
View Patient Information Leaflet (PIL - Co-trimoxazole Tablets BP 80/400mg)
Last updated on this site: 20 Mar 2026
Description of update: To update sections 4.3, 4.4 and 4.6 of the SmPC and PIL in line with PRAC recommendation (PSUSA/00003045/202501).
Date of approval: 14/03/2026
PIL sections updated: 2, 4 and 6
Last updated on this site: 20 Mar 2026
Description of update: To update sections 4.3, 4.4 and 4.6 of the SmPC and PIL in line with PRAC recommendation (PSUSA/00003045/202501).
Date of approval: 14/03/2026
PIL sections updated: 2, 4 and 6
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Changes: (Updated: 20 Mar 2026)
Description of update: To update sections 4.3, 4.4 and 4.6 of the SmPC and PIL in line with PRAC recommendation (PSUSA/00003045/202501).
Date of approval: 14/03/2026
PIL sections updated: 2, 4 and 6
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Changes: (Updated: 23 Jul 2025)
PRAC recommendations on signals (EPITT no 20135): Update to SPC 4.8 and PIL for circulatory shock.
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Changes: (Updated: 23 Jul 2025)
PRAC recommendations on signals (EPITT no 20135): Update to SPC 4.8 and PIL for circulatory shock.
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Changes: (Updated: 11 Feb 2025)
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.
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Changes: (Updated: 20 Sep 2022)
Initial upload