SmPC - Montelukast 10mg Film coated Tablets: Change history
View Summary of Product Characteristics (SmPC - Montelukast 10mg Film coated Tablets)
Last updated on this site: 29 Jul 2026
Description of update: To update section 4.4 of the SmPC to implement the wording agreed by the MHRA following a safety review of the risk of persistent neuropsychiatric reaction after discontinuation of montelukast. Consequently, the PIL is also being updated.
Additionally, section 4.2 and 4.4 of the SmPC and section 2 and 4 of the leaflet has been updated with editorial changes.
Date of approval: 15/07/2026
SmPC sections updated: 4.2, 4.4 and 10
Last updated on this site: 29 Jul 2026
Description of update: To update section 4.4 of the SmPC to implement the wording agreed by the MHRA following a safety review of the risk of persistent neuropsychiatric reaction after discontinuation of montelukast. Consequently, the PIL is also being updated.
Additionally, section 4.2 and 4.4 of the SmPC and section 2 and 4 of the leaflet has been updated with editorial changes.
Date of approval: 15/07/2026
SmPC sections updated: 4.2, 4.4 and 10
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Changes: (Updated: 29 Jul 2026)
Description of update: To update section 4.4 of the SmPC to implement the wording agreed by the MHRA following a safety review of the risk of persistent neuropsychiatric reaction after discontinuation of montelukast. Consequently, the PIL is also being updated.
Additionally, section 4.2 and 4.4 of the SmPC and section 2 and 4 of the leaflet has been updated with editorial changes.
Date of approval: 15/07/2026
SmPC sections updated: 4.2, 4.4 and 10
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Changes: (Updated: 04 Jun 2025)
Correct version uploaded.
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Changes: (Updated: 21 Sep 2022)
Initial upload