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: 17 Aug 2026
Description of update: To update section 4.4 of the SmPC and section 2 of the PIL to implement the wording agreed by the MHRA following a safety review of the risk of persistent neuropsychiatric reaction after discontinuation of the finished product montelukast. In addition, there are editorial updates to SmPC sections 1, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 5.2 and the PIL.
Date of approval: 13/08/2026
SmPC sections updated: 1, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 5.2 and 10
Last updated on this site: 17 Aug 2026
Description of update: To update section 4.4 of the SmPC and section 2 of the PIL to implement the wording agreed by the MHRA following a safety review of the risk of persistent neuropsychiatric reaction after discontinuation of the finished product montelukast. In addition, there are editorial updates to SmPC sections 1, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 5.2 and the PIL.
Date of approval: 13/08/2026
SmPC sections updated: 1, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6, 4.8, 4.9, 5.1, 5.2 and 10
PIL sections updated: 2, 4 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.