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NUVIGIL (ARMODAFINIL) TABLETS: INFORMATION FOR PATIENTS

Physicians are advised to discuss the following issues with patients for whom they prescribe Nuvigil (Armodafinil).

Armodafinil (Nuvigil) is indicated for patients who have abnormal levels of sleepiness. Nuvigil has been shown to improve, but not eliminate, this abnormal tendency to fall asleep. Therefore, patients should not alter their previous behavior with regard to potentially dangerous activities (e.g., driving, operating machinery) or other activities requiring appropriate levels of wakefulness, until and unless treatment with Nuvigil (Armodafinil) tablets has been shown to produce levels of wakefulness that permit such activities. Patients should be advised that Nuvigil is not a replacement for sleep.

Patients should be informed that it may be critical that they continue to take their previously prescribed treatments (e.g., patients with OSA receiving CPAP should continue to do so).

Patients should be informed of the availability of a Medication Guide, and they should be instructed to read it prior to taking Armodafinil (Nuvigil) tablets. The complete text of the Medication Guide is provided at the end of this labeling.

Patients should be advised to contact their physician if they experience rash, depression, anxiety, or signs of psychosis or mania.

Manufactured and distributed by Cephalon, Teva pharmaceutical companies and their divisions.

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