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PIL- Amlodipine 5mg, 10mg Tablets: Change history

  • 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.

    • 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.

    • 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.

    • 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.

    • Changes: (Updated: 20 Sep 2022)

      Linked to amended product entry

    • Changes: (Updated: 20 Sep 2022)

      initial upload

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