PIL- Amlodipine 5mg, 10mg Tablets (PL 20075/0129, 0130): Change history
View Patient Information Leaflet (PIL- Amlodipine 5mg, 10mg Tablets (PL 20075/0129, 0130))
Last updated on this site: 20 Jun 2025
Description of update: To update sections 4.4, 4.5 and 4.8 of the SmPC in line with the reference product Istin 5 mg tablets. Consequently, the PIL has been updated. In addition; there are editorial updates to SmPC section 4.8 and the PIL, there are also QRD updates to the PIL.
PIL sections updated: Heading, Introduction, 1, 2, 3, 4, 5 and 6.
Last updated on this site: 20 Jun 2025
Description of update: To update sections 4.4, 4.5 and 4.8 of the SmPC in line with the reference product Istin 5 mg tablets. Consequently, the PIL has been updated. In addition; there are editorial updates to SmPC section 4.8 and the PIL, there are also QRD updates to the PIL.
PIL sections updated: Heading, Introduction, 1, 2, 3, 4, 5 and 6.
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Changes: (Updated: 20 Jun 2025)
Description of update: To update sections 4.4, 4.5 and 4.8 of the SmPC in line with the reference product Istin 5 mg tablets. Consequently, the PIL has been updated. In addition; there are editorial updates to SmPC section 4.8 and the PIL, there are also QRD updates to the PIL.
PIL sections updated: Heading, Introduction, 1, 2, 3, 4, 5 and 6.
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Changes: (Updated: 25 Feb 2025)
To update PIL Section 4 to include the side effect ‘bleeding gums’, in line with MHRA Request (SA 19076603) to include a warning about amlodipine and gingival bleeding.
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Changes: (Updated: 02 Nov 2023)
Description of update: To update sections 2, 4.3, 4.4, 4.5, 4.8 and 5.1 of the SmPC in line with current guidance and the reference product Istin Tablets. Consequentially, the PIL has been updated.
PIL sections updated: 2, 3, 4 and 6.
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Changes: (Updated: 02 Nov 2023)
Description of update: To update sections 2, 4.3, 4.4, 4.5, 4.8 and 5.1 of the SmPC in line with current guidance and the reference product Istin Tablets. Consequentially, the PIL has been updated.
PIL sections updated: 2, 3, 4 and 6.
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Changes: (Updated: 20 Sep 2022)
Linked to amended product entry
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Changes: (Updated: 20 Sep 2022)
initial upload