PIL - Sumatriptan 50mg, 100mg Film-coated Tablets: Change history

Last updated on this site: 05 Dec 2025

Correction to PIL section 2 in line with SPC section 4.6 - breast feeding should be avoided for 12 hours not 24 hours.

Approved 03/12/2025.

Changes: (Updated: 05 Dec 2025)

Correction to PIL section 2 in line with SPC section 4.6 - breast feeding should be avoided for 12 hours not 24 hours.
Approved 03/12/2025.
Changes: (Updated: 26 Sep 2025)

Description of update: To update sections 4.6 and 4.8 of the SmPC and sections 2 and 4 of the leaflet to implement the wording agreed by the PRAC following the outcome of the PSUR procedure (PSUSA/00002832/202409) for sumatriptan.
Date of approval: 19/09/2025
PIL sections updated: 2, 4 and 6
Changes: (Updated: 22 Sep 2022)

Initial upload

Changes: (Updated: 05 Dec 2025)