SmPC - Co-codamol 30 mg/500 mg Effervescent Tablets: Change history
View Summary of Product Characteristics (SmPC - Co-codamol 30 mg/500 mg Effervescent Tablets)
Last updated on this site: 27 Apr 2026
Description of update: IB C.3.a: To update SmPC sections 4.2, 4.4, 4.8 and PIL in line with MHRA recommendation following review of PSUSA/00000851/202503 to amend directions in terms of opioid drug disorder (OUD).
IB C.3.b: To update SmPC sections 4.2, 4.4, 4.5, 4.8 and PIL in line with PRAC recommendation (PSUSA/00000851/202503). Additionally, there are editorial and QRD updates to SmPC sections 4.4 (15 mg/500 mg & 30 mg/500 mg only) and the PIL. There are editorial updates to SmPC section 4.8 (15 mg/500 mg & 30 mg/500 mg only).
Date of approval: 11/04/2026
SmPC sections updated: 4.2, 4.4, 4.5, 4.8 and 10
Last updated on this site: 27 Apr 2026
Description of update: IB C.3.a: To update SmPC sections 4.2, 4.4, 4.8 and PIL in line with MHRA recommendation following review of PSUSA/00000851/202503 to amend directions in terms of opioid drug disorder (OUD).
IB C.3.b: To update SmPC sections 4.2, 4.4, 4.5, 4.8 and PIL in line with PRAC recommendation (PSUSA/00000851/202503). Additionally, there are editorial and QRD updates to SmPC sections 4.4 (15 mg/500 mg & 30 mg/500 mg only) and the PIL. There are editorial updates to SmPC section 4.8 (15 mg/500 mg & 30 mg/500 mg only).
Date of approval: 11/04/2026
SmPC sections updated: 4.2, 4.4, 4.5, 4.8 and 10
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Changes: (Updated: 27 Apr 2026)
Description of update: IB C.3.a: To update SmPC sections 4.2, 4.4, 4.8 and PIL in line with MHRA recommendation following review of PSUSA/00000851/202503 to amend directions in terms of opioid drug disorder (OUD).
IB C.3.b: To update SmPC sections 4.2, 4.4, 4.5, 4.8 and PIL in line with PRAC recommendation (PSUSA/00000851/202503). Additionally, there are editorial and QRD updates to SmPC sections 4.4 (15 mg/500 mg & 30 mg/500 mg only) and the PIL. There are editorial updates to SmPC section 4.8 (15 mg/500 mg & 30 mg/500 mg only).
Date of approval: 11/04/2026
SmPC sections updated: 4.2, 4.4, 4.5, 4.8 and 10
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Changes: (Updated: 04 Aug 2025)
Description of update: To update sections 4.8, 5.1 and 5.2 of the SmPC to bring in line with the Reference product Solpadol 30mg/500mg Caplets. Consequently, the PIL has been updated. Additional updates include editorial and QRD updates to the PIL.
Date of approval: 29/07/2025
SmPC sections updated: 4.8, 5.1, 5.2 and 10
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Changes: (Updated: 19 May 2023)
Variation Description: 1) To update section 4.4 of the SmPC and section 2 of the PIL to include cautionary warning to patients with myasthenia gravis.
2) To update section 4.4 of the SmPC and section 2 of the PIL to highlight the drug interaction between co-codamol and antidepressants.
3) Typographical amendments to the PIL.
SmPC sections updated- 4.4 and 10.
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Changes: (Updated: 19 May 2023)
Variation Description: 1) To update section 4.4 of the SmPC and section 2 of the PIL to include cautionary warning to patients with myasthenia gravis.
2) To update section 4.4 of the SmPC and section 2 of the PIL to highlight the drug interaction between co-codamol and antidepressants.
3) Typographical amendments to the PIL.
SmPC sections updated- 4.4 and 10.
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Changes: (Updated: 22 Sep 2022)
initial upload