PIL - Lisinopril 5mg, 10mg, 20mg Tablets (PL 0142/0467, 0468, 0469): Change history
View Patient Information Leaflet (PIL - Lisinopril 5mg, 10mg, 20mg Tablets (PL 0142/0467, 0468, 0469))
Last updated on this site: 01 Apr 2026
Description of update:
SmPC section 4.4 and PIL section 2 for the above-listed MAs have been updated in line with the MHRA request for single-agent ACE inhibitors: delayed onset of angioedema and angiotensin converting enzyme (ACE) inhibitors.
Date of approval: 27/03/2026
SmPC sections updated: 4.4 and 10.
Last updated on this site: 01 Apr 2026
Description of update:
SmPC section 4.4 and PIL section 2 for the above-listed MAs have been updated in line with the MHRA request for single-agent ACE inhibitors: delayed onset of angioedema and angiotensin converting enzyme (ACE) inhibitors.
Date of approval: 27/03/2026
SmPC sections updated: 4.4 and 10.
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Changes: (Updated: 01 Apr 2026)
Description of update:
SmPC section 4.4 and PIL section 2 for the above-listed MAs have been updated in line with the MHRA request for single-agent ACE inhibitors: delayed onset of angioedema and angiotensin converting enzyme (ACE) inhibitors.
Date of approval: 27/03/2026
SmPC sections updated: 4.4 and 10.
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Changes: (Updated: 27 Jun 2023)
Variation Description: To update section 4.4 of the SmPC and PIL in line with the latest EC Excipient Guidelines (version 10.2). Update to SmPC section 4.6 in line with page 10 of the EMA "Guideline on risk assessment of medicinal products on human reproduction and lactation: from data to labelling (24.07.2008)". Updates to SmPC section 4.8 in line with MedDRA and QRD. Update to SmPC section 5.1 in line with WHO ATC Index. Additional editorial updates to SmPC sections 4.4, 4.6, 4.8, 5.1 and PIL, with QRD updates to the PIL.
PIL sections updated – Header, 1, 2, 4, 5 and 6.
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Changes: (Updated: 13 Jan 2023)
Website administration update.
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Changes: (Updated: 13 Jan 2023)
Website administration update.
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Changes: (Updated: 21 Sep 2022)
Initial upload