SmPC - Co-codamol 15/500mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Co-codamol 15/500mg Film-coated Tablets)
Last updated on this site: 29 May 2026
Update to SPC sections 4.2, 4.4, 4.5, 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.
Additional editorial amends made in SPC and PIL.
Variation Approval date: 21/05/2026
SmPC sections updated: 4.2, 4.4, 4.5, 4.8 and 10
Last updated on this site: 29 May 2026
Update to SPC sections 4.2, 4.4, 4.5, 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.
Additional editorial amends made in SPC and PIL.
Variation Approval date: 21/05/2026
SmPC sections updated: 4.2, 4.4, 4.5, 4.8 and 10
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Changes: (Updated: 29 May 2026)
Update to SPC sections 4.2, 4.4, 4.5, 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.
Additional editorial amends made in SPC and PIL.
Variation Approval date: 21/05/2026
SmPC sections updated: 4.2, 4.4, 4.5, 4.8 and 10
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Changes: (Updated: 29 May 2026)
Update to SPC sections 4.2, 4.4, 4.5, 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.
Additional editorial amends made in SPC and PIL.
Variation Approval date: 21/05/2026
SmPC sections updated: 4.2, 4.4, 4.5, 4.8 and 10
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Changes: (Updated: 16 May 2025)
Renewal. Date of renewal: 23/01/2025.
SmPC sections updated: 9 & 10.
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Changes: (Updated: 08 Apr 2025)
IAin C.I.3.a - SmPC sections 4.4, 4.5 and 4.8 and PIL have been updated in line with the PRAC recommendation for paracetamol (EPITT No 20105) for high anion gap metabolic acidosis (HAGMA) due to pyroglutamate acidosis.
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Changes: (Updated: 03 May 2023)
Variation description:
Update to SPC section 4.4 and PIL in line with the recommendations following MHRA review of myasthenia gravis (SA 19083871).
Update to PIL in line with the recommendations following MHRA review of CNS depressants (SA 18643283).
Additional update to SPC section 4.2 for 15/500mg strength only to correct strength from ‘500mg/15mg’ to ‘15mg/500mg’ in the renal insufficiency table.
Amends to the PIL in line with the latest QRD template (Version 10.3), and correction of ‘cinacelet’ to ‘cinacalcet’.
SmPC sections updated- 4.2, 4.4 and 10
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Changes: (Updated: 22 Sep 2022)
initial upload