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SmPC - Paracetamol 500mg Tablets (PL 20075/0060): Change history

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  • View Summary of Product Characteristics (SmPC - Paracetamol 500mg Tablets (PL 20075/0060))

    Last updated on this site: 22 Jul 2025

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

    SmPC sections 4.4, 4.5 and 4.8

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    • Changes: (Updated: 22 Jul 2025)

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

      SmPC sections 4.4, 4.5 and 4.8

    • Changes: (Updated: 12 Jul 2023)

      Description of update: To update section 4.4 of the SmPC in line with the reference product, Anadin Paracetamol tablets (PL 44673/0204).

      SmPC sections updated: 4.4, 10.

    • Changes: (Updated: 18 May 2023)

      Document formatting update only - no change to content

    • Changes: (Updated: 22 Sep 2022)

      Initial upload

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