SmPC - Co-codamol 8/500mg Tablets - PL 20075/0702: Change history
View Summary of Product Characteristics (SmPC - Co-codamol 8/500mg Tablets - PL 20075/0702)
Last updated on this site: 07 May 2026
Description of update:
1) To update section 4.4 of the SmPC in line with the MHRA letter (Annex 1) - review of the CMDh recommended warnings for Opioid Use Disorder (OUD).
2) To update sections 4.2, 4.4, 4.5 and 4.8 of the SmPC and sections 2, 3, 4 and 5 PIL 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. In addition, a spelling has been corrected in SmPC section 4.3 and the leaflet/labelling wording in section 4.4 has been aligned with the current approved text.
Date of approval: 30/04/2026
SmPC sections updated: 4.2, 4.3, 4.4, 4.5, 4.8 and 10
Last updated on this site: 07 May 2026
Description of update:
1) To update section 4.4 of the SmPC in line with the MHRA letter (Annex 1) - review of the CMDh recommended warnings for Opioid Use Disorder (OUD).
2) To update sections 4.2, 4.4, 4.5 and 4.8 of the SmPC and sections 2, 3, 4 and 5 PIL 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. In addition, a spelling has been corrected in SmPC section 4.3 and the leaflet/labelling wording in section 4.4 has been aligned with the current approved text.
Date of approval: 30/04/2026
SmPC sections updated: 4.2, 4.3, 4.4, 4.5, 4.8 and 10