Label Changes for:

Requip XL (ropinirole extended-release tablets)

October 2008

Changes have been made to the PATIENT PACKAGE INSERT sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- October 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Sections Modified

PATIENT PACKAGE INSERT

IF YOU HAVE PARKINSON'S DISEASE

  • What are the possible side effects of Requip and Requip XL?
    • Some patients taking Requip or Requip XL get urges to behave in a way unusual for them. Examples of this are an unusual urge to gamble or increased sexual urges and behaviors. If you notice or your family notices that you are developing any unusual behaviors, talk to your healthcare provider. (added)

PATIENT PACKAGE INSERT

IF YOU HAVE RESTLESS LEGS SYNDROME (RLS)

  • What are the possible side effects of Requip?
    • Some patients taking Requip get urges to behave in a way unusual for them. Examples of this are an unusual urge to gamble or increased sexual urges and behaviors. If you notice or your family notices that you are developing any unusual behaviors, talk to your healthcare provider. (added)
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