SmPC - Trandolapril 4mg Capsules: Change history
View Summary of Product Characteristics (SmPC - Trandolapril 4mg Capsules)
Last updated on this site: 18 Dec 2025
Description of update: To update section 4.4 of SmPC and section 2 of PIL in line with MHRA request to update single-agent ACE inhibitors: delayed onset of angioedema and angiotensin converting enzyme (ACE) inhibitors.
Date of approval: 19/11/2025
SmPC sections updated: 4.4 and 10
Last updated on this site: 18 Dec 2025
Description of update: To update section 4.4 of SmPC and section 2 of PIL in line with MHRA request to update single-agent ACE inhibitors: delayed onset of angioedema and angiotensin converting enzyme (ACE) inhibitors.
Date of approval: 19/11/2025
SmPC sections updated: 4.4 and 10
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Changes: (Updated: 18 Dec 2025)
Description of update: To update section 4.4 of SmPC and section 2 of PIL in line with MHRA request to update single-agent ACE inhibitors: delayed onset of angioedema and angiotensin converting enzyme (ACE) inhibitors.
Date of approval: 19/11/2025
SmPC sections updated: 4.4 and 10
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Changes: (Updated: 04 Oct 2023)
Description of update: To update section 5.1 of the SmPC in line with the reference
product, Trandolapril 0.5 mg capsules, hard (PL 04569/0817, MAH: Mylan). Additionally, sections 4.4, 4.5 and 4.8 of the SmPC have been updated to correct typographical errors.
SmPC sections updated: 4.4, 4.5, 4.8, 5.1 and 10.
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Changes: (Updated: 22 Sep 2022)
Initial upload