PIL- Enalapril maleate 2.5 mg, 5 mg, 10 mg, 20 mg Tablets: Change history
View Patient Information Leaflet (PIL- Enalapril maleate 2.5 mg, 5 mg, 10 mg, 20 mg Tablets)
Last updated on this site: 16 Feb 2026
Update to SmPC section 4.4 & PIL section 2 in line with MHRA request for single-agent ACE inhibitors: delayed onset of angioedema and angiotensin converting enzyme (ACE) inhibitors.
Approval date 07/02/2026.
SmPC sections updated: 4.4 and 10.
PIL sections updated: 2 and 6.
Last updated on this site: 16 Feb 2026
Update to SmPC section 4.4 & PIL section 2 in line with MHRA request for single-agent ACE inhibitors: delayed onset of angioedema and angiotensin converting enzyme (ACE) inhibitors.
Approval date 07/02/2026.
SmPC sections updated: 4.4 and 10.
PIL sections updated: 2 and 6.
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Changes: (Updated: 16 Feb 2026)
Update to SmPC section 4.4 & PIL section 2 in line with MHRA request for single-agent ACE inhibitors: delayed onset of angioedema and angiotensin converting enzyme (ACE) inhibitors.
Approval date 07/02/2026.
SmPC sections updated: 4.4 and 10.
PIL sections updated: 2 and 6.
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Changes: (Updated: 06 Nov 2025)
Type IAIN (B.II.b.1.a) variation application for addition of Accord Healthcare Single Member S.A., Greece as an alternative site responsible for secondary packaging site.
Type IAIN (B.II.b.2.C.2) variation application to add Accord Healthcare Single Member S.A., Greece as an alternative site responsible for importation and batch release including batch control/testing of the finished product.
Consequently, the PIL has been updated.
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Changes: (Updated: 18 Nov 2024)
To update SmPC sections 4.3, 4.4, 4.5, and PIL information in line with the reference product (Innovace 5 mg Tablets, Procedure number: SE/H/0404/002/DC, MAH: Organon Pharma (Ireland) Limited).
Additional editorial updates to SPC section 4.2, 4.8 and 5.2, and PIL.
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Changes: (Updated: 26 Feb 2024)
Description of update: New product launch. UK launch date: 23/02/2024.