IMPORTANT SAFETY INFORMATION
What important information I should know about PROVIGIL?
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.
Stop taking PROVIGIL and call your doctor right away or get emergency help if
you have any of these symptoms: 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; or 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 PROVIGIL, stopping the medicine may not keep the
rash from becoming life-threatening or causing you to be permanently disabled or
PROVIGIL is not approved for use in children for any medical condition.
It is not known if PROVIGIL is safe or effective in children under 17 years of age.
Who should not take PROVIGIL?
Do not take PROVIGIL if you are allergic or developed a rash to modafinil or
armodafinil (NUVIGIL®) or any of the ingredients in PROVIGIL.
What should I tell my doctor before taking PROVIGIL?
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; have liver or kidney problems;
have a history of drug or alcohol abuse or addiction; are pregnant or planning to
become pregnant; or are breastfeeding.
Tell your doctor about all the medicines you take, including prescription
and over-the-counter medicines, vitamins, and herbal supplements. Hormonal birth
control methods may not work while you take PROVIGIL. Women who use one of these
methods of birth control may have a higher chance for getting pregnant while taking
PROVIGIL, and for one month after stopping PROVIGIL.
What should I avoid while taking PROVIGIL?
- Do not drive a car or do other dangerous activities until you know how PROVIGIL
- You should avoid drinking alcohol.
What are possible side effects of PROVIGIL?
PROVIGIL may cause serious side effects. Stop taking PROVIGIL 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 above)
- 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, and other mental problems
- symptoms of a heart problem,
including chest pain, abnormal heartbeat, and trouble breathing.
Common side effects of PROVIGIL include headache, back pain, nausea, feeling nervous,
stuffy nose, diarrhea, feeling anxious, trouble sleeping, dizziness, and upset stomach.
Tell your doctor if you get any side effect that bothers you or that does not go
away while taking PROVIGIL.
These are not all the side effects of PROVIGIL. For more information, ask your doctor
or pharmacist. Call your doctor for medical advice about side effects. You may report
side effects to FDA at 1-800-FDA-1088.
This information does not take the place of talking with your doctor for medical
advice about your condition or treatment.
Please read the Medication
Guide for Patients in the
Full Prescribing Information for PROVIGIL.
There is a registry for women who become pregnant during treatment with PROVIGIL.
The purpose of this registry is to collect information about the safety of PROVIGIL
during pregnancy. You or your doctor can get information and enroll you in the registry
by calling 1-866-404-4106 or by visiting www.PROVIGILpregnancyregistry.com.