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: 22 Apr 2026
Description of update:
SmPC sections 4.2, 4.4, 4.5, 4.8 and PIL have been updated 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 amendments have been made to the SmPC and PIL to align with QRD and to correct typographical errors and grammar.
Date of approval: 20/04/2026
SmPC sections updated: 4.2, 4.4, 4.5, 4.8 and 10.
Last updated on this site: 22 Apr 2026
SmPC sections 4.2, 4.4, 4.5, 4.8 and PIL have been updated 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 amendments have been made to the SmPC and PIL to align with QRD and to correct typographical errors and grammar.
Date of approval: 20/04/2026
PIL sections updated: Index, 1, 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.