PIL - Co-codamol 15/500mg Film-coated Tablets: Change history

Update to SPC sections 4.2, 4.4, 4.5, 4.8 and PIL in line with PSUSA/00000851/202503 recommendations for Interactions with gabapentinoids, Sphincter of Oddi dysfunction, Hyperalgesia, Central Sleep apnoea (CSA), Opioid drug disorder (OUD), and the need to store the product in a safe and secure place.

Additional editorial amends made in SPC and PIL.

Variation Approval date: 21/05/2026

PIL sections updated: 2, 3, 4, 5 and 6

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’.

PIL sections updated- Heading, Introduction, 2, 3, 4 and 6.