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Prescribing Information—commonly referred to as a PI—outlines important information about a medicine for those who are prescribing it—and for those who are taking it.

At the beginning of the PI are the brand and generic names of the drug. For example, "MIRAPEX" is a brand name and "pramipexole dihydrochloride" is the drug's generic name. The PI for MIRAPEX also provides the following key information:

• Description
• Clinical Pharmacology
• Clinical Studies
• Indications and Usage
• Contraindications
• Warnings
• Precautions
• Adverse Events
• Drug Abuse and Dependence
• Overdosage
• Dosage and Administration
• How Supplied
• Animal Toxicology

The PI is in Portable Document Format (PDF), a type of file that is used when the arrangement of the information—such as tables of data—needs to be kept intact. PDFs are commonly used on the Web, but they do require a supplement to your browser, the Adobe® Acrobat® Reader®. You probably already have Acrobat Reader installed; however, if you are unable to view the PI, then go to the Adobe Web site and follow the instructions. The Reader is simple, safe, and free of charge.

Important Information about MIRAPEX: MIRAPEX® (pramipexole dihydrochloride) Tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson’s disease.

Patients have reported falling asleep without any warning signs during activities of daily living, including operation of a motor vehicle, which sometimes resulted in accidents. Hallucinations and dizziness upon standing may occur.

The most commonly reported adverse events in early and late disease in clinical trials were dizziness, involuntary movement, hallucinations, headache, difficulty falling asleep, sleepiness and nausea.

Patients and caregivers should be informed that impulse control disorders/compulsive behaviors may occur while taking medicines, including pramipexole, to treat Parkinson's disease.

Please see full Prescribing Information.

This information is intended for US residents only.

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