MIRAPEX: Registration

Important Information about MIRAPEX: MIRAPEX is indicated for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS).

MIRAPEX may cause you to fall asleep without any warning, even while doing normal daily activities, such as driving. Before taking MIRAPEX, talk to your doctor if you drink alcohol or take other medications that make you drowsy as these can increase the chance that MIRAPEX will make you feel sleepy or fall asleep when you should be awake. When taking MIRAPEX, hallucinations (seeing, hearing, feeling, or tasting something that isn't there) may occur and you may sometimes feel dizzy, nauseated, faint or sweaty when you sit up or stand quickly. In clinical trials for RLS, the most commonly reported side effects of MIRAPEX that were more frequent than with placebo are nausea, headache, and tiredness. Talk to your doctor if you experience any of these symptoms.

There have been reports of impulse control disorders and compulsive behaviors in patients taking certain medicines, including MIRAPEX. If you or your family members notice that you are experiencing new or increased gambling urges, increased sexual urges or other intense urges, such as compulsive shopping or eating, while taking MIRAPEX, talk to your doctor.

This information is intended for U.S. residents only. Products discussed herein may have different labeling in different countries.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1800 FDA 1088.

Please see full Prescribing Information, including patient information.

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