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First assessment of individual RLS domains in new post-hoc analyses of Neupro® studies
Date:4/25/2012

w.neupro.com/">www.neupro.com.

Neupro® in the U.S. Important Safety Information

Neupro® contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life threatening or less severe asthmatic episodes in certain susceptible people.

Patients treated with Neupro® have reported falling asleep while engaged in activities of daily living and somnolence. In clinical trials for the highest recommended Neupro® dose, the incidence of the treatment difference between Neupro® and placebo for somnolence was 16% for early-stage Parkinson's disease, 4% for advanced-stage Parkinson's disease, and 6% for Restless Legs Syndrome. Some patients perceived no warnings signs, such as excessive drowsiness. Patients should be advised to exercise caution while driving, operating heavy machinery or working at heights during treatment with Neupro®.

There is an increased risk for hallucinations in patients with advanced-stage Parkinson's disease treated with Neupro®. In clinical trials for the highest recommended Neupro® dose, the incidence of the treatment difference between Neupro® and placebo for hallucinations was 4%, and this difference increased with increasing dose. Patients also may experience new or worsening mental status and behavioral changes, which may be severe, including psychotic-like behavior during Neupro® treatment or after starting or increasing the dose of Neupro®.

Neupro® may cause symptomatic postural/orthostatic hypotension and syncope, especially during dose escalation, elevated blood pressure, elevated heart rate, weight gain and fluid reten
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