SmPC- Paracetamol 500mg Tablets: Change history
View Summary of Product Characteristics (SmPC- Paracetamol 500mg Tablets)
Last updated on this site: 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.
View Summary of Product Characteristics (SmPC- Paracetamol 500mg Tablets)
Last updated on this site: 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.
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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.
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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.
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Changes: (Updated: 23 Mar 2023)
Website administration update
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Changes: (Updated: 14 Mar 2023)
New product (launched 08/03/2023)