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Neupro® (Rotigotine) Provided Clinically Relevant Improvements in Health-Related Quality of Life for People with Parkinson's Disease
Date:9/30/2010

eristics for full prescribing information (Approved 18th August 2010): http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000626/WC500026397.pdf

About Neupro® in the U.S.Neupro® (rotigotine) is indicated in the U.S. for the treatment of the signs and symptoms of early-stage idiopathic Parkinson's disease. In April 2008, UCB recalled Neupro® from the U.S. market after ongoing monitoring revealed that specific batches of Neupro® had deviated from their approved specification. Recently the U.S. Food and Drug Administration (FDA) has recommended that UCB reformulate Neupro® patches and UCB is working on the development of a new formulation. Patients and physicians with questions about the status of Neupro®, or about UCB's Patient Access program for Neupro®, may contact UCB Medical Information at 1-866-822-0068 (option 9).

Important Safety Information – U.S.Some patients treated with Neupro® reported falling asleep while engaged in activities of daily living, including operation of motor vehicles, which sometimes resulted in accidents. Some patients perceived no warning signs, such as excessive drowsiness. Hallucinations were reported in 2.0% of patients treated with Neupro® compared to 0.7% of patients on placebo. Neupro® contains metabisulfite. Neupro® should be used with caution in patients, especially those at risk for cardiovascular disease, because of the potential for symptomatic hypotension, syncope, elevated heart rate, elevated blood pressure, fluid retention, and/or weight gain. All Parkinson's disease patients are at a higher risk for melanoma and should be monitored regularly. The most commonly reported side effects in clinical trials were nausea, application site reactions, somnolence, dizziness, headache
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