SmPC - Paracetamol 500mg Effervescent Tablets: Change history
View Summary of Product Characteristics (SmPC - Paracetamol 500mg Effervescent Tablets)
Last updated on this site: 08 Apr 2025
To update sections 4.4, 4.5 and 4.8 of the SmPC in line with PRAC recommendation (EPITT No 20105) for high anion gap metabolic acidosis (HAGMA) due to pyroglutamate acidosis. Consequently, the PIL has been updated.
In addition, there are editorial updates to SmPC sections 4.4 and 4.8.
Last updated on this site: 08 Apr 2025
To update sections 4.4, 4.5 and 4.8 of the SmPC in line with PRAC recommendation (EPITT No 20105) for high anion gap metabolic acidosis (HAGMA) due to pyroglutamate acidosis. Consequently, the PIL has been updated.
In addition, there are editorial updates to SmPC sections 4.4 and 4.8.
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Changes: (Updated: 08 Apr 2025)
To update sections 4.4, 4.5 and 4.8 of the SmPC in line with PRAC recommendation (EPITT No 20105) for high anion gap metabolic acidosis (HAGMA) due to pyroglutamate acidosis. Consequently, the PIL has been updated.
In addition, there are editorial updates to SmPC sections 4.4 and 4.8.
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Changes: (Updated: 23 Mar 2023)
Website administration update
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Changes: (Updated: 23 Mar 2023)
Website administration update
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Changes: (Updated: 23 Mar 2023)
Website administration update
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Changes: (Updated: 23 Mar 2023)
Website administration update.
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Changes: (Updated: 09 Jan 2023)
To update sections 4.4 and 4.5 of the SPC in line with the Pharmacovigilance Risk Assessment Committee (PRAC) recommendations (PSUSA/00002311/202105) to add a warning regarding the risk of high anion gap metabolic acidosis when paracetamol is used concomitantly with flucloxacillin. Consequentially, the PIL has been updated. In addition, the label has been updated to correct a spelling error for `medicines'.
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Changes: (Updated: 21 Sep 2022)
Initial upload