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: 27 Apr 2026
Description of update: IB C.3.a: To update SmPC sections 4.2, 4.4, 4.8 and PIL in line with MHRA recommendation following review of PSUSA/00000851/202503 to amend directions in terms of opioid drug disorder (OUD).
IB C.3.b: To update SmPC sections 4.2, 4.4, 4.5, 4.8 and PIL in line with PRAC recommendation (PSUSA/00000851/202503). Additionally, there are editorial and QRD updates to SmPC sections 4.4 (15 mg/500 mg & 30 mg/500 mg only) and the PIL. There are editorial updates to SmPC section 4.8 (15 mg/500 mg & 30 mg/500 mg only).
Date of approval: 11/04/2026
SmPC sections updated: 4.2, 4.4, 4.5, 4.8 and 10
Last updated on this site: 27 Apr 2026
Description of update: IB C.3.a: To update SmPC sections 4.2, 4.4, 4.8 and PIL in line with MHRA recommendation following review of PSUSA/00000851/202503 to amend directions in terms of opioid drug disorder (OUD).
IB C.3.b: To update SmPC sections 4.2, 4.4, 4.5, 4.8 and PIL in line with PRAC recommendation (PSUSA/00000851/202503). Additionally, there are editorial and QRD updates to SmPC sections 4.4 (15 mg/500 mg & 30 mg/500 mg only) and the PIL. There are editorial updates to SmPC section 4.8 (15 mg/500 mg & 30 mg/500 mg only).
Date of approval: 11/04/2026
PIL sections updated: Introduction, 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.