PIL - Co-codamol 8/500mg Tablets: Change history
View Patient Information Leaflet (PIL - 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.
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.
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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.
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Changes: (Updated: 09 Apr 2025)
To update sections 4.4, 4.5 and 4.8 of the SPC 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.
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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.
PIL sections updated- 2, 3, 5 and 6.
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Changes: (Updated: 22 Sep 2022)
initial upload