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Intended for UK patients and members of the public

Raponer XL Prolonged-release Tablets

Active Ingredients

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

Report a side effect or a product complaint

Raponer XL 2mg Prolonged-release Tablets

PL Number:
0142/1215
MA Holder:
Accord-UK Ltd
Product Classification:
POM
Product Status:
Active

Product Documentation

  • 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.

    PIL sections updated – Heading, 2, 4 and 6.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

Report a side effect or a product complaint

Raponer XL 4mg Prolonged-release Tablets

PL Number:
0142/1216
MA Holder:
Accord-UK Ltd
Product Classification:
POM
Product Status:
Active

Product Documentation

  • 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.

    PIL sections updated – Heading, 2, 4 and 6.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

Report a side effect or a product complaint

Raponer XL 8mg Prolonged-release Tablets

PL Number:
0142/1217
MA Holder:
Accord-UK Ltd
Product Classification:
POM
Product Status:
Active

Product Documentation

  • 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.

  • 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.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at yellowcard.mhra.gov.uk. By reporting side effects, you can help provide more information on the safety of this medicine.

Report a side effect or a product complaint

General FAQs

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