SmPC - Co-codamol 15/500mg Film-coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Co-codamol 15/500mg Film-coated Tablets)
Last updated on this site: 08 Apr 2025
IAin C.I.3.a - SmPC sections 4.4, 4.5 and 4.8 and PIL have been updated in line with the PRAC recommendation for paracetamol (EPITT No 20105) for high anion gap metabolic acidosis (HAGMA) due to pyroglutamate acidosis.
Last updated on this site: 08 Apr 2025
IAin C.I.3.a - SmPC sections 4.4, 4.5 and 4.8 and PIL have been updated in line with the PRAC recommendation for paracetamol (EPITT No 20105) for high anion gap metabolic acidosis (HAGMA) due to pyroglutamate acidosis.
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Changes: (Updated: 08 Apr 2025)
IAin C.I.3.a - SmPC sections 4.4, 4.5 and 4.8 and PIL have been updated in line with the PRAC recommendation for paracetamol (EPITT No 20105) for high anion gap metabolic acidosis (HAGMA) due to pyroglutamate acidosis.
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Changes: (Updated: 03 May 2023)
Variation description:
Update to SPC section 4.4 and PIL in line with the recommendations following MHRA review of myasthenia gravis (SA 19083871).
Update to PIL in line with the recommendations following MHRA review of CNS depressants (SA 18643283).
Additional update to SPC section 4.2 for 15/500mg strength only to correct strength from ‘500mg/15mg’ to ‘15mg/500mg’ in the renal insufficiency table.
Amends to the PIL in line with the latest QRD template (Version 10.3), and correction of ‘cinacelet’ to ‘cinacalcet’.
SmPC sections updated- 4.2, 4.4 and 10
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Changes: (Updated: 22 Sep 2022)
initial upload