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 Jun 2023
Variation Description: To update section 4.4 of the SmPC and PIL in line with the latest EC Excipient Guidelines (version 10.2). Update to SmPC section 4.6 in line with page 10 of the EMA "Guideline on risk assessment of medicinal products on human reproduction and lactation: from data to labelling (24.07.2008)". Updates to SmPC section 4.8 in line with MedDRA and QRD. Update to SmPC section 5.1 in line with WHO ATC Index. Additional editorial updates to SmPC sections 4.4, 4.6, 4.8, 5.1 and PIL, with QRD updates to the PIL.
SmPC sections updated – 4.4, 4.6, 4.8, 5.1 and 10.
Last updated on this site: 27 Jun 2023
Variation Description: To update section 4.4 of the SmPC and PIL in line with the latest EC Excipient Guidelines (version 10.2). Update to SmPC section 4.6 in line with page 10 of the EMA "Guideline on risk assessment of medicinal products on human reproduction and lactation: from data to labelling (24.07.2008)". Updates to SmPC section 4.8 in line with MedDRA and QRD. Update to SmPC section 5.1 in line with WHO ATC Index. Additional editorial updates to SmPC sections 4.4, 4.6, 4.8, 5.1 and PIL, with QRD updates to the PIL.
PIL sections updated – Header, 1, 2, 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.