SmPC- Telmisartan 20mg Tablets: Change history
View Summary of Product Characteristics (SmPC- Telmisartan 20mg Tablets)
Last updated on this site: 14 Jul 2026
Update to SmPC section 4.8, and PIL section 4 in line with PRAC recommendations to add side effect dizziness with frequency uncommon. Additional update to SmPC section 4.4 to add missing wording "II receptor". Additional updates to the PIL in line with QRD.
Date of approval: 07/07/2026
SmPC sections updated: 4.4, 4.8 and 10.
Last updated on this site: 14 Jul 2026
Update to SmPC section 4.8, and PIL section 4 in line with PRAC recommendations to add side effect dizziness with frequency uncommon. Additional update to SmPC section 4.4 to add missing wording "II receptor". Additional updates to the PIL in line with QRD.
Date of approval: 07/07/2026
SmPC sections updated: 4.4, 4.8 and 10.
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Changes: (Updated: 14 Jul 2026)
Update to SmPC section 4.8, and PIL section 4 in line with PRAC recommendations to add side effect dizziness with frequency uncommon. Additional update to SmPC section 4.4 to add missing wording "II receptor". Additional updates to the PIL in line with QRD.
Date of approval: 07/07/2026
SmPC sections updated: 4.4, 4.8 and 10.
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Changes: (Updated: 29 Dec 2025)
Description of update: To update the SmPC and PIL in line with the reference product, Micardis.
Date of approval: 22/12/2025
SmPC sections updated: 4.2, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3 and 10
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Changes: (Updated: 13 May 2025)
Type IAIN variation to Update to SmPC sections 4.4, 4.8 and PIL sections 2 and 4 in line with PRAC recommendations (EPITTNo 20104) for intestinal angioedema.
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Changes: (Updated: 19 Dec 2022)
Updates to sections 9 & 10.
MHRA Renewal approval date – 14/12/2022
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Changes: (Updated: 19 Dec 2022)
SmPC sections updated – 9 and 10
MHRA Renewal approval date – 14/12/2022
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Changes: (Updated: 22 Sep 2022)
initial upload