Accord Logo

Intended for UK patients and members of the public

SmPC - Co-codamol 8/500mg Tablets: Change history

Back to products
  • View Summary of Product Characteristics (SmPC - Co-codamol 8/500mg Tablets)

    Last updated on this site: 10 Apr 2025

    To update sections 4.4, 4.5 and 4.8 of the SmPC to bring in line with the PRAC recommendation (EPITT No 20105) for high anion gap metabolic acidosis (HAGMA) due to pyroglutamate acidosis. Consequently, the PIL has been updated.

    View change history

    • Changes: (Updated: 10 Apr 2025)

      To update sections 4.4, 4.5 and 4.8 of the SmPC to bring in line with the PRAC recommendation (EPITT No 20105) for high anion gap metabolic acidosis (HAGMA) due to pyroglutamate acidosis. Consequently, the PIL has been updated.

    • Changes: (Updated: 09 Apr 2025)

      PRAC update (EPITT No 20105) for high anion gap metabolic acidosis (HAGMA) due to pyroglutamate acidosis

    • Changes: (Updated: 10 Apr 2024)

      Description of update: To update section 4.5 of the SPC to bring in line with the Reference product Co-codamol 8/500 Tablets (PL 17780/0510; MAH: Zentiva Pharma UK Limited) dated 16th June 2023.

      SmPC Sections updated: 4.5 & 10.

    • Changes: (Updated: 19 May 2023)

      Variation Description:

      • 1. To update section 4.4 of the SmPC and PIL section 2 to bring in line with the recommendations following MHRA review of myasthenia gravis (SA 19083871).

      • 2. To update section 2 of the PIL in line with the recommendations following MHRA review of CNS depressants (SA 18643283).

      • The PIL has also been updated to align with the latest QRD template (Version 10.3, 09/2022) as well as the correction of grammar and spelling.

      SmPC sections updated- 4.4 and 10.

    • Changes: (Updated: 19 May 2023)

      Variation Description:

      • 1. To update section 4.4 of the SmPC and PIL section 2 to bring in line with the recommendations following MHRA review of myasthenia gravis (SA 19083871).

      • 2. To update section 2 of the PIL in line with the recommendations following MHRA review of CNS depressants (SA 18643283).

      • The PIL has also been updated to align with the latest QRD template (Version 10.3, 09/2022) as well as the correction of grammar and spelling.

      SmPC sections updated- 4.4 and 10.

    • Changes: (Updated: 22 Sep 2022)

      initial upload

    Back to Top

    View product information as a: