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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 is PROVIGIL (modafinil), and what does it do?
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.
Tell your doctor about all of your health conditions including if you have: history of mental health problems (including psychosis), heart problems or had a heart attack, high blood pressure, liver or kidney problems, a history of drug or alcohol abuse or addiction, or are pregnant, planning to become pregnant, or breastfeeding.
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.
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For more information, ask your doctor or call 1-800-896-5855.
Stop taking PROVIGIL and call your doctor right away or get emergency help if you get any of the following serious side effects:
What should I avoid while taking PROVIGIL? Do not drive or do other dangerous activities until you and your doctor know how PROVIGIL affects you.
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.
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 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 are possible side effects of PROVIGIL?
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What are possible side effects of PROVIGIL?
PROVIGIL will not cure these sleep disorders, PROVIGIL may help the sleepiness caused by these conditions, but it may not stop all your sleepiness. PROVIGIL does not take the place of getting enough sleep. Follow your doctor's adivce about good sleep habits and using other treatments.
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.
Important Safety Information
Symptoms of a heart problem, including: chest pain, abnormal heart beats, and trouble breathing.
What important information should I know about PROVIGIL?
Avoid drinking alcohol. What should I tell my doctor before starting PROVIGIL?
Tell your doctor about all of the medicines you take. Women who use hormonal birth control may have a higher chance of getting pregnant, while taking and for one month after stopping PROVIGIL. Talk to your doctor about other birth control methods while taking PROVIGIL.
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