PIL - Raponer XL 2mg, 4mg, 8mg Prolonged-release Tablets: Change history
View Patient Information Leaflet (PIL - Raponer XL 2mg, 4mg, 8mg Prolonged-release Tablets)
Last updated on this site: 11 Jun 2026
Description of update:
Update to SmPC sections 4.4 and 4.8 and PIL section 2 in line with PSUSA/00002661/202507 recommendations regarding impulse control disorders (ICDs), specifically aggressive behaviours.
Date of approval: 04/06/2026
PIL sections updated: 2 and 6
Last updated on this site: 11 Jun 2026
Description of update:
Update to SmPC sections 4.4 and 4.8 and PIL section 2 in line with PSUSA/00002661/202507 recommendations regarding impulse control disorders (ICDs), specifically aggressive behaviours.
Date of approval: 04/06/2026
PIL sections updated: 2 and 6
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Changes: (Updated: 11 Jun 2026)
Description of update:
Update to SmPC sections 4.4 and 4.8 and PIL section 2 in line with PSUSA/00002661/202507 recommendations regarding impulse control disorders (ICDs), specifically aggressive behaviours.
Date of approval: 04/06/2026
PIL sections updated: 2 and 6
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Changes: (Updated: 09 Jun 2026)
Description of update:
Update to SmPC section 4.8, and PIL section 4 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: 04/06/2026
PIL sections updated: 2 and 6
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Changes: (Updated: 20 Jul 2023)
Variation Description: To update section 4.8 of the SmPC and section 4 of PIL in line with the PRAC recommendation PRAC-PSUSA/00002661/202207 for Ropinirole containing products - a causal relationship between ropinirole and spontaneous penile erection. In addition the PIL has been updated to align with the latest QRD template (Version 10.3, 09/2022) as well as the correction of grammar and spelling.
PIL sections updated – Heading, 2, 4 and 6.
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Changes: (Updated: 21 Sep 2022)
Initial upload