SmPC - Raponer XL 2mg Prolonged-release Tablets: Change history

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

SmPC sections updated: 4.4 and 4.8

Description of update: To update sections 4.2, 4.3, 4.4, 4.8, 5.1, 5.2 and 5.3 of the SmPC in line with reference product Requip® XL 2 mg, 4 mg, 8 mg prolonged-release tablets (PL: 10592/0293, 0295, 0296; MAH: GlaxoSmithKline UK; Dated: 22/09/2023). Additional editorial and formatting updates have been made to sections 4.2, 4.4, 4.8 and 5.1 of the SmPC, and section 4.8 of the SmPC has been updated in line with MedDRA.

SmPC Sections updated: 4.2, 4.3, 4.4, 4.8, 5.1, 5.2 and 5.3.

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.

SmPC sections updated – 4.8 and 10.

Initial upload