PIL - Co-codamol 8/500mg Tablets - PL 20075/0702: Change history

Description of update:

1) To update section 4.4 of the SmPC in line with the MHRA letter (Annex 1) - review of the CMDh recommended warnings for Opioid Use Disorder (OUD).

2) To update sections 4.2, 4.4, 4.5 and 4.8 of the SmPC and sections 2, 3, 4 and 5 PIL in line with PSUSA/00000851/202503 for codeine/paracetamol containing medicines to include the following information: interactions with gabapentinoids, Sphincter of Oddi dysfunction, hyperalgesia, central sleep apnoea (CSA), opioid drug disorder (OUD), storage information. In addition, a spelling has been corrected in SmPC section 4.3 and the leaflet/labelling wording in section 4.4 has been aligned with the current approved text.

Date of approval: 30/04/2026

SmPC sections updated: 4.2, 4.3, 4.4, 4.5, 4.8 and 10

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.

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.