SmPC - Montelukast 5mg chewable Tablets: Change history
View Summary of Product Characteristics (SmPC - Montelukast 5mg chewable Tablets)
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
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Changes: (Updated: 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
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Changes: (Updated: 26 Sep 2024)
To update SmPC sections 4.4, 4.8 and PIL section 2 in line with information of reference product (Singulair 10 mg film-coated tablets; DCP procedure number: FI/H/0104/001; MAH: N.V. ORGANON) for Montelukast 4 mg & 5 mg Chewable Tablets.
Additionally, applicant has updated SmPC and PIL with editorial changes and PIL with the full form of European Economic Area and United Kingdom (Northern Ireland) as QRD template related changes in line with reference products.
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Changes: (Updated: 21 Sep 2022)
Initial upload