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: 29 May 2026
Description of update:
1: To update SmPC sections 4.2 and 4.4 and PIL section 3 in line with the MHRA letter (Annex 1) - review of the CMDh recommended warnings for Opioid Use Disorder (OUD).
2: To update SmPC sections 4.4, 4.5, 4.8 and PIL sections 2, 4 and 5 in line with PSUSA/00000851/202503 for codeine/paracetamol containing medicines to include the following information: interactions with gabapentinoids, Sphincter of Oddi dysfunction, hyperalgesia, central sleep apnoea (CSA), opioid drug disorder (OUD), storage information.
Date of approval: 30/04/2026
SmPC sections updated: 4.2, 4.4, 4.5, 4.8 and 10
Last updated on this site: 29 May 2026
Description of update:
1: To update SmPC sections 4.2 and 4.4 and PIL section 3 in line with the MHRA letter (Annex 1) - review of the CMDh recommended warnings for Opioid Use Disorder (OUD).
2: To update SmPC sections 4.4, 4.5, 4.8 and PIL sections 2, 4 and 5 in line with PSUSA/00000851/202503 for codeine/paracetamol containing medicines to include the following information: interactions with gabapentinoids, Sphincter of Oddi dysfunction, hyperalgesia, central sleep apnoea (CSA), opioid drug disorder (OUD), storage information.
Date of approval: 30/04/2026
SmPC sections updated: 4.2, 4.4, 4.5, 4.8 and 10
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Changes: (Updated: 29 May 2026)
Description of update:
1: To update SmPC sections 4.2 and 4.4 and PIL section 3 in line with the MHRA letter (Annex 1) - review of the CMDh recommended warnings for Opioid Use Disorder (OUD).
2: To update SmPC sections 4.4, 4.5, 4.8 and PIL sections 2, 4 and 5 in line with PSUSA/00000851/202503 for codeine/paracetamol containing medicines to include the following information: interactions with gabapentinoids, Sphincter of Oddi dysfunction, hyperalgesia, central sleep apnoea (CSA), opioid drug disorder (OUD), storage information.
Date of approval: 30/04/2026
SmPC sections updated: 4.2, 4.4, 4.5, 4.8 and 10
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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]
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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.
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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.
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Changes: (Updated: 22 Sep 2022)
initial upload