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: 16 Apr 2026
Update to SPC sections 4.2, 4.4, 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.
MHRA recommendations for Opioid use disorder (OUD) in codeine/paracetamol combination products is to align with the PSUSA recommendations.
Additional editorial amends made in SPC and PIL.
PIL sections updated: 2, 3, 4, 5 and 6
Approval date: 09/04/2026
Last updated on this site: 16 Apr 2026
Update to SPC sections 4.2, 4.4, 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.
MHRA recommendations for Opioid use disorder (OUD) in codeine/paracetamol combination products is to align with the PSUSA recommendations.
Additional editorial amends made in SPC and PIL.
SPC sections updated: 4.2, 4.4, 4.8 and 10
Approval date: 09/04/2026
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.