Intended for UK patients and members of the public
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.
Report a side effect or a product complaintProduct Documentation
Last updated on this site: 03 Jun 2026
Description of update:
SmPC sections 4.2, 4.4, 4.8 and PIL for the above-listed MAs have been updated in line with the MHRA letter (Annex 1) dated - risk of OUD for codeine/paracetamol combination medicines.
SmPC sections 4.4, 4.5, 4.8 and PIL for the above-listed MAs have been updated in line with PSUSA/00000851/202503: Interactions with gabapentinoids, Sphincter of Oddi dysfunction, Hyperalgesia, Central Sleep apnoea (CSA), and to highlight the need to store the product in a safe and secure place.
Minor editorial amendments have been made to the PIL to align with QRD and correct typographical errors and grammar.
Date of approval: 22/05/2026
SmPC sections updated: 4.2, 4.4, 4.5 and 4.8
Last updated on this site: 03 Jun 2026
Description of update:
SmPC sections 4.2, 4.4, 4.8 and PIL for the above-listed MAs have been updated in line with the MHRA letter (Annex 1) dated - risk of OUD for codeine/paracetamol combination medicines.
SmPC sections 4.4, 4.5, 4.8 and PIL for the above-listed MAs have been updated in line with PSUSA/00000851/202503: Interactions with gabapentinoids, Sphincter of Oddi dysfunction, Hyperalgesia, Central Sleep apnoea (CSA), and to highlight the need to store the product in a safe and secure place.
Minor editorial amendments have been made to the PIL to align with QRD and correct typographical errors and grammar.
Date of approval: 22/05/2026
PIL sections updated: Heading, 2, 3, 4, 5 and 6
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.
Report a side effect or a product complaintFor any further assistance, please get in touch.