Provigil

Pronunciation

Generic Name: modafinil (moe-DAF-i-nil)
Brand Name: Provigil

Provigil is used for:

Improving wakefulness in patients with excessive sleepiness associated with narcolepsy or other sleep disorders. It may also be used for other conditions as determined by your doctor.

Provigil is a wakefulness-promoting agent. Exactly how it works is not known, but it is thought to work by altering the natural chemicals (neurotransmitters) in the brain.

Do NOT use Provigil if:

  • you are allergic to any ingredient in Provigil or to armodafinil
  • you have a history of developing a rash after taking Provigil or armodafinil
  • you have a history of certain heart or heart valve problems (eg, mitral valve prolapse, left ventricular hypertrophy)
  • you are taking cabazitaxel

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Provigil:

Some medical conditions may interact with Provigil. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have liver problems, kidney problems, heart problems (eg, chest pain, heart blood vessel problems, a recent heart attack), or high blood pressure
  • if you have a history of mental or mood problems (eg, depression, mania, psychosis), suicidal thoughts or actions, or alcohol or other substance abuse or dependence
  • if you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine)

Some MEDICINES MAY INTERACT with Provigil. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Azole antifungals (eg, ketoconazole, itraconazole) because they may increase the risk of Provigil's side effects
  • Carbamazepine, phenobarbital, prazosin, or rifampin because they may decrease Provigil's effectiveness
  • Amphetamines or other stimulants (eg, methylphenidate), anticoagulants (eg, warfarin), diazepam, hydantoins (eg, phenytoin), propranolol, or certain tricyclic antidepressants (eg, clomipramine, desipramine) because the risk of their side effects may be increased by Provigil
  • Axitinib, certain benzodiazepines (eg, midazolam, triazolam), cabazitaxel, cyclosporine, hormonal products (eg, birth control pills, certain hormone replacements), or ulipristal because their effectiveness may be decreased by Provigil

This may not be a complete list of all interactions that may occur. Ask your health care provider if Provigil may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Provigil:

Use Provigil as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Provigil comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Provigil refilled.
  • Provigil comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Provigil refilled.
  • Take Provigil by mouth with or without food.
  • Take Provigil in the morning unless otherwise directed by your doctor.
  • If you miss a dose of Provigil, take it as soon as possible. If you do not remember until late afternoon or evening, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Provigil.

Important safety information:

  • Provigil may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Provigil with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol while you are using Provigil.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Provigil; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Do NOT take more than the recommended dose or take more often than prescribed without check with your doctor.
  • Provigil cannot cure sleep disorders and it may not stop all of your sleepiness. Do not change your daily habits without first talking to your doctor. Discuss your level of sleepiness with your doctor at each visit. Do not use Provigil in place of getting enough sleep. Follow your doctor's instructions for good sleep habits and using other treatments.
  • Serious and sometimes fatal skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been rarely reported with Provigil. Contact your doctor right away if you develop a rash; red, swollen, blistered, or peeling skin; or blisters on the inside of the eyes, nose, or mouth.
  • Hormonal birth control (eg, birth control pills) may not work as well while you are using Provigil. To prevent pregnancy, use an extra form of birth control (eg, condoms) while you are taking Provigil and for 1 month after stopping Provigil.
  • Lab tests, including blood pressure and liver function, may be performed while you use Provigil. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Provigil with caution in the ELDERLY; they may be more sensitive to its effects.
  • Provigil should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Provigil while you are pregnant. It is not known if Provigil is found in breast milk. If you are or will be breast-feeding while you use Provigil, check with your doctor. Discuss any possible risks to your baby.

Some people who use Provigil for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Provigil suddenly, you may have WITHDRAWAL symptoms. These may include sleepiness. Discuss any questions or concerns with your doctor or pharmacist.

Possible side effects of Provigil:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; diarrhea; dizziness; headache; nausea; nervousness; stomach upset; stuffy nose; trouble sleeping.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); blisters on the inside of the eyes, nose, or mouth; chest pain; confusion; fast or irregular heartbeat; fever, chills, or sore throat; mental or mood changes (eg, aggression, agitation, anxiety, depression, exaggerated sense of well-being, hallucinations, irritability, nervousness); red, swollen, blistered, or peeling skin; severe or persistent headache; shortness of breath; suicidal thoughts or actions; swelling of the hands, ankles, or feet; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, stomach pain, yellowing of the skin or eyes); unusual bruising or bleeding; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include agitation; anxiety; chest pain; confusion; diarrhea; excitation; fast or slow heartbeat; hallucinations; nausea; restlessness; severe or persistent headache or dizziness; sleeplessness; tremor.

Proper storage of Provigil:

Store Provigil at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Provigil out of the reach of children and away from pets.

General information:

  • If you have any questions about Provigil, please talk with your doctor, pharmacist, or other health care provider.
  • Provigil is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Provigil or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Provigil. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Provigil. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Provigil.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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