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PROVIGIL (MODAFINIL): MEDICATION GUIDE

Read the Medication Guide that comes with Provigil (Modafinil) before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your condition or treatment.

What is the most important information I should know about Modafinil (Provigil)?

Provigil (Modafinil) tablets 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 (Modafinil) and call your doctor right away or get emergency help if you have any of these symptoms:

  • hives, skin rash, sores in your mouth, or your skin blisters and peels
  • swelling of your face, lips, eyes, tongue, or throat
  • trouble swallowing or breathing
  • shortness of breath, fever, swelling of the legs, yellowing of the skin or whites of the eyes, or dark urine.

    If you have a severe rash with Modafinil (Provigil), stopping the medicine may not keep the rash from becoming life-threatening or causing you to be permanently disabled or disfigured.

    Modafinil (Provigil) tablets are not approved for use in children for any medical condition. It is not known if this medication is safe or if it works in children under the age of


    What is Modafinil (Provigil)?

    Provigil (Modafinil) 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). Modafinil (Provigil) is used with other medical treatments for this sleep disorder. This drug 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, pharmacist, or other healthcare professional.
  • shift work disorder (SWD)

    Modafinil (Provigil) tablets will not cure these sleep disorders. This medicine may help the sleepiness caused by these conditions, but it may not stop all your sleepiness. Provigil (Modafinil) does not take the place of getting enough sleep. Follow your doctor's advice about good sleep habits and using other treatments.

    Modafinil (Provigil) is a USA federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep this medication in a safe place to prevent misuse and abuse. Selling or giving away Provigil (Modafinil) may harm others, and is against the law. Tell your physician if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.


    Who should not take Provigil (Modafinil) tablets?

    Do not take Modafinil (Provigil) if you:

  • are allergic to any of its ingredients. See the end of this Medication Guide for a complete list of ingredients in Modafinil (Provigil) tablets.
  • have had a rash or allergic reaction to either Modafinil (Provigil) or Armodafinil (Nuvigil). These medicines are very similar.


    What should I tell my healthcare provider before taking Provigil (Modafinil) tablets?

    Tell your doctor about all of your medical conditions including, if you:

  • have heart problems or had a heart attack
  • have a history of mental health problems, including psychosis
  • have high blood pressure. Your blood pressure may need to be checked more often while taking Provigil (Modafinil).
  • have a history of drug or alcohol abuse or addiction
  • have liver or kidney problems
  • are pregnant or planning to become pregnant. It is not known if Modafinil (Provigil) will harm your unborn baby. Pregnancy Registry: There is a registry for women who become pregnant during treatment with this drug. The purpose of this registry is to collect information about the safety of Provigil (Modafinil) during pregnancy. Contact the registry as soon as you learn that you are pregnant, or ask your doctor to contact the registry for you. You or your doctor can get information and enroll you in the registry.
  • are breastfeeding. It is not known if Modafinil (Provigil) passes into your milk. Talk to your doctor or pharmacist about the best way to feed your baby if you take this medicine.

    Tell your doctor, pharmacist, or other healthcare professional about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Provigil (Modafinil) tablets and many other medicines can interact with each other, sometimes causing side effects. This medication may affect the way other medicines work, and other medicines may affect how this drug works. Your dose of Modafinil (Provigil) tablets or certain other medicines may need to be changed. Especially, tell your doctor if you use or take:

  • a hormonal birth control method, such as birth control pills, shots, implants, patches, vaginal rings, and intrauterine devices (IUDs). Hormonal birth control methods may not work while you take Provigil (Modafinil). Women who use one of these methods of birth control may have a higher chance for getting pregnant while taking this medicine, and for one month after stopping Provigil. Talk to your doctor about birth control choices that are right for you while taking Modafinil.

    Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine. Your doctor or pharmacist will tell you if it is safe to take Modafinil (Provigil) and other medicines together. Do not start any new medicines with Provigil unless your doctor has told you it is okay.


    How should I take Provigil (Modafinil)?

  • Take Provigil (Modafinil) tablets exactly as prescribed by your doctor. Your physician will prescribe the dose of this drug that is right for you. Do not change your dose of Provigil without talking to your healthcare provider.

  • Your doctor will tell you the right time of day to take Modafinil. - People with narcolepsy or OSA usually take Modafinil (Provigil) tablets one time each day in the morning. - People with SWD usually take this medicine about 1 hour before their work shift.

  • Do not change the time of day you take Modafinil (Provigil) tablets unless you have talked to your doctor. If you take this medication 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 if you take an overdose of Modafinil, call your healthcare provider or poison control center right away.

    Symptoms of an overdose of Provigil (Modafinil) tablets may include:

  • Restlessness
  • Trouble sleeping
  • Confusion
  • Feeling excited
  • Feeling disoriented
  • Hearing, seeing, feeling, or sensing things that are not really there (hallucinations)
  • A fast or slow heartbeat
  • Nausea and diarrhea
  • Chest pain
  • Increased blood pressure


    What should I avoid while taking Modafinil (Provigil) tablets?

  • Do not drive a car or do other dangerous activities until you know how Provigil (Modafinil) 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 Modafinil.


    What are possible side effects of Modafinil (Provigil)?

    Provigil (Modafinil) tablets may cause serious side effects. Stop taking this drug and call your physician right away or get emergency help if you get any of the following:

  • a serious rash or serious allergic reaction.
  • mental (psychiatric) symptoms, including: feeling anxious, depression, hearing, seeing, feeling, or sensing things that are not really there (hallucinations), thoughts of suicide, an extreme increase in activity and talking (mania), aggressive behavior, 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 Provigil (Modafinil) include:

  • diarrhea
  • back pain
  • headache
  • nausea
  • feeling anxious
  • dizziness
  • upset stomach
  • feeling nervous
  • stuffy nose
  • trouble sleeping

    Modafinil (Provigil) tablets are not approved for use in children for any medical condition. In studies of this medicine in children with narcolepsy, side effects included:

  • hostile behavior
  • Tourette's syndrome
  • increase in sudden loss of muscle tone and severe muscle weakness
  • increase in seeing and hearing things when falling asleep
  • increase in suicidal thoughts
  • low white blood count
  • painful menstrual periods

    Tell your doctor, pharmacist, or other healthcare professional if you get any side effect that bothers you or that does not go away while taking Provigil (Modafinil).

    These are not all the side effects of Modafinil. For more information, ask your doctor or pharmacist.

    Some effects of Provigil (Modafinil) on the brain are the same as other medicines called "stimulants". These effects may lead to abuse or dependence on Modafinil (Provigil).

    Call your doctor for medical advice about side effects. You may report side effects to FDA.


    How should I store Provigil (Modafinil) tablets?

  • Store Modafinil (Provigil) at room temperature between 68 and 77 F (20 and 25 C).
  • Keep Provigil (Modafinil) and all medicines out of the reach of children.


    General information about Provigil

    Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Modafinil (Provigil) for a condition for which it was not prescribed. Do not give this medication to other people, even if they have the same symptoms you have.

    This Medication Guide summarizes the most important information about Modafinil (Provigil) tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about this drug that is written for health professionals.


    What are the ingredients in Provigil (Modafinil) tablets?

    Active Ingredient: modafinil

    Inactive Ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, pregelatinized starch, povidone, magnesium stearate.

    Manufactured and distributed by Cephalon pharmaceutical company and its divisions.

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