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PIL- Telmisartan 20mg, 40mg, 80mg Tablets: Change history

  • Update to SmPC section 4.8, and PIL section 4 in line with PRAC recommendations to add side effect dizziness with frequency uncommon. Additional update to SmPC section 4.4 to add missing wording "II receptor".

    Additional updates to the PIL in line with QRD.

     

    Date of approval: 07/07/2026

    PIL sections updated: Heading, 2, 4 and 6

    • Changes: (Updated: 14 Jul 2026)

      Update to SmPC section 4.8, and PIL section 4 in line with PRAC recommendations to add side effect dizziness with frequency uncommon. Additional update to SmPC section 4.4 to add missing wording "II receptor".

      Additional updates to the PIL in line with QRD.

       

      Date of approval: 07/07/2026

      PIL sections updated: Heading, 2, 4 and 6

    • Changes: (Updated: 29 Dec 2025)

      Description of update: To update the SmPC and PIL in line with the reference product, Micardis.

      Date of approval: 22/12/2025

      PIL sections updated: 1, 2, 3, 4, 5 and 6

    • Changes: (Updated: 13 May 2025)

      Type IAIN variation to Update to SmPC sections 4.4, 4.8 and PIL sections 2 and 4 in line with PRAC recommendations (EPITTNo 20104) for intestinal angioedema.

    • Changes: (Updated: 22 Sep 2022)

      initial upload

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