PIL - Co-codamol Tablets BP 8/500mg: Change history
View Patient Information Leaflet (PIL - 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
PIL sections updated: Introduction, 2, 3, 4, 5 and 6
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
PIL sections updated: Introduction, 2, 3, 4, 5 and 6
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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
PIL sections updated: Introduction, 2, 3, 4, 5 and 6
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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.
PIL sections updated – 2, 3, 5 and 6.
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Changes: (Updated: 22 Sep 2022)
initial upload