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You should not take PROVIGIL if you have had a rash or allergic reaction to PROVIGIL or NUVIGIL® (armodafinil) Tablets [C-IV], or are allergic to any of the following ingredients: modafinil, armodafinil, lactose monohydrate, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, povidone, and magnesium stearate.
PROVIGIL is a prescription medicine used to improve wakefulness in adults who experience excessive sleepiness (ES) due to one of the following diagnosed sleep disorders: obstructive sleep apnea (OSA), shift work sleep disorder, also known as shift work disorder, or narcolepsy.
Provigil is not approved for children for any condition. It is not known if PROVIGIL is safe or if it works in children under the age of 17.
Avoid drinking alcohol. What should I tell my doctor before starting PROVIGIL?
Symptoms of a heart problem, including: chest pain, abnormal heart beats, and trouble breathing.
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PROVIGIL may cause serious side effects including a serious rash or a serious allergic reaction that may affect parts of your body such as your liver or blood cells. Any of these may need to be treated in a hospital and may be life-threatening. If you develop a skin rash, hives, sores in your mouth, blisters, peeling, or yellowing of your skin or eyes, trouble swallowing or breathing, dark urine, or fever, stop taking PROVIGIL and call your doctor right away or get emergency help.
What important information should I know about PROVIGIL?
PROVIGIL is a federally controlled substance (C-IV), so use PROVIGIL only as directed and keep in a safe place to prevent misuse and abuse. It is against the law to sell or give PROVIGIL to another person.
PROVIGIL is a prescription medicine used to improve wakefulness in adults who experience excessive sleepiness (ES) due to one of the following diagnosed sleep disorders: obstructive sleep apnea (OSA), shift work sleep disorder, also known as shift work disorder, or narcolepsy.
Mental (psychiatric) symptoms, including: depression, feeling anxious, sensing things that are not really there, increase in activity (mania), thoughts of suicide, aggression, other mental problems.
Common side effects of PROVIGIL are headache, nausea, feeling nervous, stuffy nose, diarrhea, back pain, feeling anxious, trouble sleeping, dizziness, and upset stomach. These are not all the side effects of PROVIGIL.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088, or by fax at 1-800-FDA-0178.
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Symptoms of a heart problem, including: chest pain, abnormal heart beats, and trouble breathing.
In patients with OSA, PROVIGIL is used along with other medical treatments for this sleep disorder. PROVIGIL is not a replacement for your current treatment. Consult your doctor about the importance of continuing your current OSA treatment while taking PROVIGIL.
PROVIGIL is a prescription medicine used to improve wakefulness in adults who experience excessive sleepiness (ES) due to one of the following diagnosed sleep disorders: obstructive sleep apnea (OSA), shift work sleep disorder, also known as shift work disorder, or narcolepsy.
Mental (psychiatric) symptoms, including: depression, feeling anxious, sensing things that are not really there, increase in activity (mania), thoughts of suicide, aggression, other mental problems.
What important information should I know about PROVIGIL?
PROVIGIL is a federally controlled substance (C-IV), so use PROVIGIL only as directed and keep in a safe place to prevent misuse and abuse. It is against the law to sell or give PROVIGIL to another person.
This information does not take the place of talking with your doctor for medical advice about your condition or treatment.
For more information, ask your doctor or call 1-800-896-5855.
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