What you should know about taking PROVIGIL
Click on a question below to find out more about PROVIGIL.
What is the most important information I should know about PROVIGIL?
PROVIGIL may cause you to have a serious rash or serious allergic reaction. Stop taking PROVIGIL and call your doctor right away or get emergency treatment if you have any of the following:
- Skin rash, hives, sores in your mouth, or your skin blisters and peels
- Swelling in your face, eyes, lips, tongue, or throat
- Trouble swallowing or breathing
- Hoarse voice
PROVIGIL is not approved for use in children.
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What is 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)
- In patients with OSA, PROVIGIL is used only 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
- Shift work sleep disorder (SWSD)
- Narcolepsy
You should be diagnosed with one of these sleep disorders before taking PROVIGIL. Sleepiness can be a symptom of other medical conditions that need to be treated.
- PROVIGIL will not cure the above 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 advice about good sleep habits and using other treatments
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Can I become addicted to PROVIGIL?
PROVIGIL is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep PROVIGIL in a safe place to prevent misuse and abuse. Selling or giving away PROVIGIL 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.
Some effects of PROVIGIL on the brain are the same as other medicines called “stimulants.” These effects may lead to abuse or dependence on PROVIGIL. Before starting PROVIGIL, tell your doctor if you have ever abused drugs, including other stimulant medicines.
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Who should not take PROVIGIL?
Do not take PROVIGIL if you
- Are allergic to any of its ingredients. The active ingredient is modafinil. Other ingredients in PROVIGIL tablets are croscarmellose sodium, lactose, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch
- Have had a rash or allergic reaction to armodafinil, the active ingredient in NUVIGIL™, because these medicines are very similar
PROVIGIL is not approved for use in children.
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Where can I get the most up-to-date information about PROVIGIL?
Read the Patient Information that comes with PROVIGIL before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment.
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What should I tell my doctor before starting PROVIGIL?
Tell your doctor about all of your health conditions, including if you
- Have a history of mental health problems
- 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
- Have ever had a mental problem called psychosis
- Are pregnant or planning to become pregnant. It is not known if PROVIGIL may harm your unborn baby
- Are breastfeeding. It is not known if PROVIGIL passes into your milk, or if it can harm your baby
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Can I take other medications (including birth control) at the same time as PROVIGIL?
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. PROVIGIL and many other medicines can interact with each other, sometimes causing side effects. PROVIGIL may affect the way other medicines work, and other medicines may affect how PROVIGIL works. Especially, tell your doctor if you use a hormonal birth control method. PROVIGIL can affect hormonal birth control methods, including pills, shots, implants, patches, vaginal rings, and hormone-releasing intrauterine devices (IUDs). Women who use hormonal birth control with PROVIGIL may have a higher chance of getting pregnant while taking PROVIGIL, and for one month after stopping PROVIGIL. Talk to your doctor about birth control methods that are right for you while using PROVIGIL.
Keep a list of all the medicines you take. Your doctor or pharmacist will tell you if it is safe to take PROVIGIL and other medicines together. Do not take other medicines with PROVIGIL unless your doctor has told you it is okay.
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How should I take PROVIGIL?
- Your doctor will prescribe the dose of PROVIGIL that is right for you. Take PROVIGIL exactly as prescribed by your doctor. Do not change your dose of PROVIGIL without talking to your doctor. Do not take more PROVIGIL than prescribed
- Your doctor will tell you the right time of day to take PROVIGIL
- Patients with narcolepsy or obstructive sleep apnea (OSA) usually take one dose of PROVIGIL every morning
- Patients with shift work sleep disorder (SWSD) usually take PROVIGIL about 1 hour before their work shift. Do not change the time of day you take PROVIGIL unless you have talked to your doctor. If you take PROVIGIL too close to your bedtime, you may find it harder to go to sleep
- You can take PROVIGIL with or without food
- If you take more than your prescribed dose or overdose, call your doctor or poison-control center right away
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What should I avoid while taking PROVIGIL?
- Do not drive or do other dangerous activities until you know how PROVIGIL 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
- Avoid drinking alcohol while taking PROVIGIL
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What are the possible side effects of PROVIGIL?
PROVIGIL may cause serious side effects. Call your doctor or get emergency help if you get any of the following:
- A serious rash or serious allergic reaction
- Mental (psychiatric) symptoms. Symptoms include depression, anxiety, hallucinations, mania, thoughts of suicide, aggression, or other mental problems
- Heart problems including chest pain
The most common side effects of PROVIGIL are headache, nausea, nervousness, stuffy nose, diarrhea, back pain, anxiety, trouble sleeping, dizziness, and upset stomach.
PROVIGIL may cause allergic reactions. If you get a rash, hives or other allergic reaction, stop taking PROVIGIL and call your doctor right away.
If you have either of the problems listed below or any other serious side effects while taking PROVIGIL, stop taking PROVIGIL and call your doctor or get emergency help:
- Chest pain
- Mental problems
Some effects of PROVIGIL on the brain are the same as other medicines called "stimulants." These effects may lead to abuse or dependence on PROVIGIL. Before starting PROVIGIL, tell your doctor if you have ever abused drugs, including other stimulant medicines.
These are not all of the possible side effects of PROVIGIL. For more information, ask your doctor or pharmacist. Tell your doctor if you get any side effect that bothers you or that does not go away while taking 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.
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Will my sleep be affected when I take PROVIGIL?
If you take PROVIGIL as directed, your ability to sleep when you want to will not typically be affected, although 5% of patients taking PROVIGIL in clinical studies experienced trouble sleeping, versus 1% who received a sugar pill.
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If I have obstructive sleep apnea (OSA) and am taking PROVIGIL, do I still need to use my breathing device when I sleep?
Yes. If you have OSA, it is important that you continue your current treatment, as PROVIGIL will not treat the obstruction that causes your blocked airway.
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Do I have to go back to my doctor every time I need a refill of PROVIGIL?
Your doctor can write in the number of refills you may need on your prescription or may be able to call in prescriptions for PROVIGIL to your pharmacy.
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How can I get additional information about PROVIGIL?
These questions summarize the most important information about PROVIGIL. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about PROVIGIL including the Full Prescribing Information. For more information, please call 1-800-896-5855.
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