SmPC - Co-codamol Tablets BP 8/500mg: Change history
View Summary of Product Characteristics (SmPC - Co-codamol Tablets BP 8/500mg)
Last updated on this site: 12 Sep 2025
IA, B.II.e.1.a.1 – Change in immediate packaging of the finished product – qualitative and quantitative composition – change from Aluminium (9μm)/glassine paper (35g/m2) to Aluminium (25μm)/paper (25g/m2). SmPC Section 6.5 is updated accordingly. [Impl. date = 16/07/2025]
Last updated on this site: 12 Sep 2025
IA, B.II.e.1.a.1 – Change in immediate packaging of the finished product – qualitative and quantitative composition – change from Aluminium (9μm)/glassine paper (35g/m2) to Aluminium (25μm)/paper (25g/m2). SmPC Section 6.5 is updated accordingly. [Impl. date = 16/07/2025]
-
Changes: (Updated: 12 Sep 2025)
IA, B.II.e.1.a.1 – Change in immediate packaging of the finished product – qualitative and quantitative composition – change from Aluminium (9μm)/glassine paper (35g/m2) to Aluminium (25μm)/paper (25g/m2). SmPC Section 6.5 is updated accordingly. [Impl. date = 16/07/2025]
-
Changes: (Updated: 08 Apr 2024)
Description of update: To update section 4.5 of the SmPC in line with the reference product Co-codamol 8/500 Tablets (PL 17780/0071; MAH: Zentiva Pharma UK Limited) dated 16th June 2023. Additionally, the cartons have been updated with corrected paracetamol warning text.
SmPC Sections updated: 4.5 and 10.
No changes to PIL.
-
Changes: (Updated: 16 May 2023)
Variation Description: To update section 2 of the PIL following an MHRA review of CNS depressants (SA 18643283). Editorial changes have also been made throughout the PIL.
SmPC sections updated – 4.4 and 10.
-
Changes: (Updated: 22 Sep 2022)
initial upload