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Important facts NUVIGIL® (nu–vij–el) Tablets [C-IV] Generic name: armodafi nil What is NUVIGIL? NUVIGIL is a prescription medicine used to improve wakefulness in adults who are very sleepy due to one of the following diagnosed sleep disorders: • Narcolepsy • Obstructive sleep apnea (OSA). NUVIGIL is used with other medical treatments for this sleep disorder. NUVIGIL does not take the place of using your CPAP machine or other treatments that your doctor has prescribed for this condition. It is important that you continue to use these treatments as prescribed by your doctor. • Shift work disorder (SWD) NUVIGIL will not cure these sleep disorders. NUVIGIL may help the sleepiness caused by these conditions, but it may not stop all your sleepiness. NUVIGIL does not take the place of getting enough sleep. Follow your doctor’s advice about good sleep habits and using other treatments. NUVIGIL is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep NUVIGIL in a safe place to prevent misuse and abuse. Selling or giving away NUVIGIL may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs. What should I avoid while taking NUVIGIL? • Do not drive a car or do other dangerous activities until you know how NUVIGIL affects you. People with sleep disorders should always be careful about doing things that could be dangerous. Do not change your daily habits until your doctor tells you it is okay. • You should avoid drinking alcohol. It is not known how drinking alcohol will affect you when taking NUVIGIL. What should I tell my doctor before taking NUVIGIL? Tell your doctor about all of your medical conditions including, if you: • Have a history of mental health problems, including psychosis • Have heart problems or had a heart attack • Have high blood pressure. Your blood pressure may need to be checked more often while taking NUVIGIL. • Have liver or kidney problems • Have a history of drug or alcohol abuse or addiction • Are pregnant or planning to become pregnant. It is not known if NUVIGIL will harm your unborn baby. • Are breastfeeding. It is not known if NUVIGIL passes into your milk. Talk to your doctor about the best way to feed your baby if you take NUVIGIL. Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, herbal supplements, and hormonal birth control. • Women who use hormonal birth control may have a higher chance for getting pregnant while taking NUVIGIL, and for one month after stopping NUVIGIL. What is the most important information I should know about NUVIGIL? NUVIGIL may cause serious side effects including a serious rash or a serious allergic reaction that may affect parts of your body such as your • Skin rash, hives, sores in your mouth, or your skin blisters and peels • Swelling of your face, eyes, lips, tongue, or throat • Trouble swallowing or breathing • Fever, shortness of breath, swelling of the legs, yellowing of the skin or whites of the eyes, or dark urine. If you have a severe rash with NUVIGIL, stopping the medicine may not keep the rash from becoming life-threatening or causing you to be permanently disabled or disfigured. NUVIGIL is not approved for use in children for any medical condition. It is not known if NUVIGIL is safe or if it works in children under the age of 17. What are possible side effects of NUVIGIL? NUVIGIL may cause serious side effects. Stop taking NUVIGIL and call your doctor right away or get emergency help if you get any of the following: • A serious rash or serious allergic reaction. (See “What is the most important information I should know about NUVIGIL?”) • Mental (psychiatric) symptoms, including: depression, feeling anxious, hearing, seeing, feeling, or sensing things that are not really there (hallucinations), an extreme increase in activity and talking (mania), thoughts of suicide, aggressive behavior, or other mental problems • Symptoms of a heart problem, including chest pain, abnormal heart beats, and trouble breathing. Common side effects that can happen in anyone who takes NUVIGIL include: headache, nausea, dizziness, and trouble sleeping. Who should not take NUVIGIL? Do not take NUVIGIL if you: • Are allergic to any of its ingredients. See the end of the Medication Guide for a complete list of ingredients in NUVIGIL. • Have had a rash or allergic reaction to either armodafinil (NUVIGIL) or modafinil (PROVIGIL® ). These medicines are very similar. Need more information? Read the Medication Guide that comes with NUVIGIL before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your condition or treatment. Talk to your doctor or pharmacist, go to www.NUVIGIL.com, or call 1-800-896-5855. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, call 1-800-FDA-1088, or by fax at 1-800-FDA-0178. liver or blood cells. Any of these may need to be treated in a hospital and may be life-threatening. Stop taking NUVIGIL and call your doctor right away or get emergency help if you have any of these symptoms: ©2010 Cephalon, Inc. All rights reserved. NUV-271 7 Dec 2010 Printed in USA.