SmPC - Co-codamol 15 mg/500 mg Effervescent Tablets: Change history
View Summary of Product Characteristics (SmPC - Co-codamol 15 mg/500 mg Effervescent Tablets)
Last updated on this site: 18 Aug 2025
Description of update: To update sections 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2 & 5.3 of
the SmPC for the finished product Co-codamol 15mg/500 mg effervescent tablets to update the product information in-line with changes to the reference product Solpadol 30mg/500mg Caplets following assessment of the same change. Consequently the PIL is also being updated. Additional updates include; formatting updates to SmPC sections 4.4, 4.5,4.6, 4.7, 4.9 and the PIL, editorial updates to SmPC sections 4.5, 4.8 and the PIL, and QRD updates to the PIL.
Date of approval: 13/08/2025
SmPC sections updated: 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3 and 10
Last updated on this site: 18 Aug 2025
Description of update: To update sections 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2 & 5.3 of
the SmPC for the finished product Co-codamol 15mg/500 mg effervescent tablets to update the product information in-line with changes to the reference product Solpadol 30mg/500mg Caplets following assessment of the same change. Consequently the PIL is also being updated. Additional updates include; formatting updates to SmPC sections 4.4, 4.5,4.6, 4.7, 4.9 and the PIL, editorial updates to SmPC sections 4.5, 4.8 and the PIL, and QRD updates to the PIL.
Date of approval: 13/08/2025
SmPC sections updated: 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3 and 10
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Changes: (Updated: 18 Aug 2025)
Description of update: To update sections 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2 & 5.3 of
the SmPC for the finished product Co-codamol 15mg/500 mg effervescent tablets to update the product information in-line with changes to the reference product Solpadol 30mg/500mg Caplets following assessment of the same change. Consequently the PIL is also being updated. Additional updates include; formatting updates to SmPC sections 4.4, 4.5,4.6, 4.7, 4.9 and the PIL, editorial updates to SmPC sections 4.5, 4.8 and the PIL, and QRD updates to the PIL.
Date of approval: 13/08/2025
SmPC sections updated: 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3 and 10
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Changes: (Updated: 10 Nov 2023)
Description of update: To update sections 4.3, 4.4, 4.5, 4.6, 4.8 and 4.9 in line with the new proposed reference product Solpadol 30mg/500mg Effervescent Tablets (PL 53886/0072, MAH: Opella Healthcare UK Limited). Consequentially, the PIL has been updated. Further editorial updates have been made to the PIL.
SmPC Sections updated: 4.3, 4.4, 4.5, 4.6, 4.8, 4.9 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