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: 25 May 2023
Description of update: The following change has been notified:
C.I.z Change(s) in the Summary of product Characteristics, Labelling or Package Leaflet intended to implement the outcome of a PRAC signal recommendation: implementation of wording agreed by the competent authority that do not require any further assessment
- To update the SmPC and PIL to implement the signal recommendation (EPITT 19822) adopted at the 9-12 January 2023 PRAC meeting.
SmPC sections updated: 4.4, 4.8, 10.
Last updated on this site: 30 Oct 2025
B.II.b.1.b - QUALITY CHANGES - FINISHED PRODUCT - Manufacture - Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished product - Primary packaging site
- addition of Accord Healthcare Single Member S.A., Greece as an alternative site responsible for primary packaging site.
B.II.b.1.a - QUALITY CHANGES - FINISHED PRODUCT - Manufacture - Replacement or addition of a manufacturing site for part or all of the manufacturing process of the finished product - Secondary packaging site
-addition of Accord Healthcare Single Member S.A., Greece as an alternative site responsible for secondary packaging site.
B.II.b.2.c.2 - QUALITY CHANGES - FINISHED PRODUCT - Manufacture - Change to importer, batch release arrangements and quality control testing of the finished product - Replacement or addition of a manufacturer responsible for importation and/or batch release - Including batch control/testing
-addition of Accord Healthcare Single Member S.A., Greece as an alternative site responsible for importation and batch release including batch control/testing.
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.