SmPC- Paracetamol 500mg Tablets: Change history

Last updated on this site: 07 Aug 2026

Renewal.

MHRA approval date: 04/08/2026

SPC sections updated: 9 and 10

Changes: (Updated: 07 Aug 2026)

Renewal.
MHRA approval date: 04/08/2026
SPC sections updated: 9 and 10
Changes: (Updated: 18 Feb 2026)

To replace the blister from Aluminium (9μm)/glassine paper (35g/m2) with Aluminium (25μm)/paper (25g/m2); section 6.5 (Nature and content of container) of the SPC and the container closure system of the product are updated.
Changes: (Updated: 08 May 2025)

To update sections 4.4, 4.5, 4.8 of the SmPC and the PIL in line with the PRAC recommendation (EPITT No 20105) for high anion gap metabolic acidosis (HAGMA) due to pyroglutamate acidosis.
Changes: (Updated: 23 Mar 2023)

Website administration update
Changes: (Updated: 27 Feb 2023)

Initial upload. Product launched 21/02/2023.

Changes: (Updated: 07 Aug 2026)