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 complaintDiscontinued Other versions of this medicine may still be available. Information for reference purposes.
Product Documentation
Last updated on this site: 05 Oct 2026
Description of update: To update sections 4.1, 4.2, 4.4, 5.1, 5.3 of the SmPC and sections 2, 3 of the leaflet in-line with information of reference product (Aprovel 75mg, 150 mg and 300 mg tablets; MAH: Sanofi Winthrop Industrie, France; EU procedure number: EMEA/H/C/000141). Additionally, applicant has updated sections 2, 3, 4.3, 4.5, 4.6, 4.8, 4.9, 5.2 of the SmPC and sections 1, 4, 5 and 6 of the leaflet with editorial changes.
Date of approval: 01/10/2026
SmPC sections updated: 2, 3, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3 and 10
Last updated on this site: 05 Oct 2026
Description of update: To update sections 4.1, 4.2, 4.4, 5.1, 5.3 of the SmPC and sections 2, 3 of the leaflet in-line with information of reference product (Aprovel 75mg, 150 mg and 300 mg tablets; MAH: Sanofi Winthrop Industrie, France; EU procedure number: EMEA/H/C/000141). Additionally, applicant has updated sections 2, 3, 4.3, 4.5, 4.6, 4.8, 4.9, 5.2 of the SmPC and sections 1, 4, 5 and 6 of the leaflet with editorial changes.
Date of approval: 01/10/2026
PIL sections updated: 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.