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PIL - Spironolactone Tablets BP 25mg, 50mg, 100mg: Change history

  • Description of update:

    - To update sections 4.3, 4.4, 4.5, 4.8, 5.2 and 5.3 of the SmPC and PIL in line with the reference product Aldactone 25mg Film-coated Tablets (PL00057/0928, Pfizer Ltd, May 2019).

    - Additionally the section 4.4 of the SmPC and section 2 of PIL has been updated to include information on sodium excipients.

    - Update to the ATC code in section 5.1 of the SmPC.

    - Update to the tablet description in section 6 of the PIL at request of PIQ.

    PIL sections updated: 1, 2, 3, 4 and 6.

    • Changes: (Updated: 14 Feb 2024)

      Description of update:

      - To update sections 4.3, 4.4, 4.5, 4.8, 5.2 and 5.3 of the SmPC and PIL in line with the reference product Aldactone 25mg Film-coated Tablets (PL00057/0928, Pfizer Ltd, May 2019).

      - Additionally the section 4.4 of the SmPC and section 2 of PIL has been updated to include information on sodium excipients.

      - Update to the ATC code in section 5.1 of the SmPC.

      - Update to the tablet description in section 6 of the PIL at request of PIQ.

      PIL sections updated: 1, 2, 3, 4 and 6.

    • Changes: (Updated: 22 Sep 2022)

      Initial upload

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