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: 08 Apr 2026
1. To update sections 4.2, 4.4 and 4.8 of the SmPC and the PIL in line with the MHRA letter - risk of OUD for codeine mono-component medicines.
2. To update sections 4.4, 4.5 and 4.8 of the SmPC and the PIL to implement the wording agreed by the PRAC following the outcome of PSUR procedure (PSUSA/00000843/202501).
Date of approval: 31/03/2026
SmPC sections updated: 4.2, 4.4, 4.5, 4.8 and 10
Last updated on this site: 08 Apr 2026
1. To update sections 4.2, 4.4 and 4.8 of the SmPC and the PIL in line with the MHRA letter - risk of OUD for codeine mono-component medicines.
2. To update sections 4.4, 4.5 and 4.8 of the SmPC and the PIL to implement the wording agreed by the PRAC following the outcome of PSUR procedure (PSUSA/00000843/202501).
Date of approval: 31/03/2026
SmPC sections updated: 4.2, 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.