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: 12 May 2026
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
PIL sections updated: 2, 3, 4, 5 and 6
Last updated on this site: 07 May 2026
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
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.