SmPC - Co-Codamol 8/500mg Tablets (PL 0142/1306): Change history
View Summary of Product Characteristics (SmPC - Co-Codamol 8/500mg Tablets (PL 0142/1306))
Last updated on this site: 03 Jun 2026
Description of update:
SmPC sections 4.2, 4.4, 4.8 and PIL for the above-listed MAs have been updated in line with the MHRA letter (Annex 1) dated - risk of OUD for codeine/paracetamol combination medicines.
SmPC sections 4.4, 4.5, 4.8 and PIL for the above-listed MAs have been updated in line with PSUSA/00000851/202503: Interactions with gabapentinoids, Sphincter of Oddi dysfunction, Hyperalgesia, Central Sleep apnoea (CSA), and to highlight the need to store the product in a safe and secure place.
Minor editorial amendments have been made to the PIL to align with QRD and correct typographical errors and grammar.
Date of approval: 22/05/2026
SmPC sections updated: 4.2, 4.4, 4.5 and 4.8
Last updated on this site: 03 Jun 2026
Description of update:
SmPC sections 4.2, 4.4, 4.8 and PIL for the above-listed MAs have been updated in line with the MHRA letter (Annex 1) dated - risk of OUD for codeine/paracetamol combination medicines.
SmPC sections 4.4, 4.5, 4.8 and PIL for the above-listed MAs have been updated in line with PSUSA/00000851/202503: Interactions with gabapentinoids, Sphincter of Oddi dysfunction, Hyperalgesia, Central Sleep apnoea (CSA), and to highlight the need to store the product in a safe and secure place.
Minor editorial amendments have been made to the PIL to align with QRD and correct typographical errors and grammar.
Date of approval: 22/05/2026
SmPC sections updated: 4.2, 4.4, 4.5 and 4.8
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Changes: (Updated: 03 Jun 2026)
Description of update:
SmPC sections 4.2, 4.4, 4.8 and PIL for the above-listed MAs have been updated in line with the MHRA letter (Annex 1) dated - risk of OUD for codeine/paracetamol combination medicines.
SmPC sections 4.4, 4.5, 4.8 and PIL for the above-listed MAs have been updated in line with PSUSA/00000851/202503: Interactions with gabapentinoids, Sphincter of Oddi dysfunction, Hyperalgesia, Central Sleep apnoea (CSA), and to highlight the need to store the product in a safe and secure place.
Minor editorial amendments have been made to the PIL to align with QRD and correct typographical errors and grammar.
Date of approval: 22/05/2026
SmPC sections updated: 4.2, 4.4, 4.5 and 4.8