SmPC- Co-codamol 30/500mg Tablets: Change history
View Summary of Product Characteristics (SmPC- Co-codamol 30/500mg Tablets)
Last updated on this site: 16 Apr 2026
Update to SPC sections 4.2, 4.4, 4.8 and PIL in line with PSUSA/00000851/202503 recommendations for Interactions with gabapentinoids, Sphincter of Oddi dysfunction, Hyperalgesia, Central Sleep apnoea (CSA), Opioid drug disorder (OUD), and the need to store the product in a safe and secure place.
MHRA recommendations for Opioid use disorder (OUD) in codeine/paracetamol combination products is to align with the PSUSA recommendations.
Additional editorial amends made in SPC and PIL.
SPC sections updated: 4.2, 4.4, 4.8 and 10
Approval date: 09/04/2026
Last updated on this site: 16 Apr 2026
Update to SPC sections 4.2, 4.4, 4.8 and PIL in line with PSUSA/00000851/202503 recommendations for Interactions with gabapentinoids, Sphincter of Oddi dysfunction, Hyperalgesia, Central Sleep apnoea (CSA), Opioid drug disorder (OUD), and the need to store the product in a safe and secure place.
MHRA recommendations for Opioid use disorder (OUD) in codeine/paracetamol combination products is to align with the PSUSA recommendations.
Additional editorial amends made in SPC and PIL.
SPC sections updated: 4.2, 4.4, 4.8 and 10
Approval date: 09/04/2026
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Changes: (Updated: 16 Apr 2026)
Update to SPC sections 4.2, 4.4, 4.8 and PIL in line with PSUSA/00000851/202503 recommendations for Interactions with gabapentinoids, Sphincter of Oddi dysfunction, Hyperalgesia, Central Sleep apnoea (CSA), Opioid drug disorder (OUD), and the need to store the product in a safe and secure place.
MHRA recommendations for Opioid use disorder (OUD) in codeine/paracetamol combination products is to align with the PSUSA recommendations.
Additional editorial amends made in SPC and PIL.
SPC sections updated: 4.2, 4.4, 4.8 and 10
Approval date: 09/04/2026
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Changes: (Updated: 09 Apr 2025)
To update sections 4.4, 4.5 and 4.8 of the SmPC in line with
PRAC recommendation (EPITT No 20105). Consequently, the
PIL has been updated.
In addition; the national text for the driving warning in PIL section 2 has been updated in line with MHRA guidelines, there are editorial updates to SmPC section 4.5 and the PIL and QRD updates to the PIL.
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Changes: (Updated: 21 Feb 2024)
Description of update: To update SmPC sections 4.4 and 5.1 of the SmPC in line with the reference product, Solpadol 30mg/500mg Caplets. Consequently, the PIL has been updated. Additionally, section 4.8 of the SmPC and the leaflet have editorial updates and updates in line with MedDRA and to align the pharmacotherapeutical group naming in section 5.1 of the SmPC with the WHO ATC Index.
SmPC Sections updated: 4.4, 4.8, 5.1 and 10.
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Changes: (Updated: 04 Sep 2023)
New product launch.
Launch date: 01/09/2023.