PROVIGIL- modafinil tablet 
Cephalon, Inc.

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Medication Guide

PROVIGIL (pro-vij-el) C-IV

(modafinil)

Tablets

Read the Medication Guide that comes with PROVIGIL 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 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:

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 disfigured.

PROVIGIL is not approved for use in children for any medical condition.

It is not known if PROVIGIL is safe or if it works in children under the age of 17.

What is PROVIGIL?

PROVIGIL is a prescription medicine used to improve wakefulness in adults who are very sleepy due to one of the following diagnosed sleep disorders:

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 advice about good sleep habits and using other treatments.

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Who should not take PROVIGIL?

Do not take PROVIGIL if you:

What should I tell my doctor before taking PROVIGIL?

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

Tell your doctor about all the medicines you take, including prescription and non-prescription 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. Your dose of PROVIGIL or certain other medicines may need to be changed.

Especially, tell your doctor if you use or take:

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 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?

Symptoms of an overdose of PROVIGIL may include:

What should I avoid while taking PROVIGIL?

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:

Common side effects that can happen in anyone who takes PROVIGIL include:

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

PROVIGIL is not approved for use in children for any medical condition. In studies of PROVIGIL in children with narcolepsy, side effects included:

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.

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.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store PROVIGIL?

General information about PROVIGIL

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PROVIGIL for a condition for which it was not prescribed. Do not give PROVIGIL to other people, even if they have the same symptoms you have. It may harm them and it is against the law.

This Medication Guide summarizes 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 that is written for health professionals. For more information, call 1-800-896-5855, or go to www.PROVIGIL.com.

What are the ingredients in PROVIGIL?

Active Ingredient: modafinil

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

Distributed by:

Cephalon, Inc.

Frazer, PA 19355

PROVMG-001

Revised October 2010

This Medication Guide has been approved by the U.S. Food and Drug Administration.

© 2004-2010 Cephalon, Inc., or its affiliates. All rights reserved.

Revised: 01/2013
 
Cephalon, Inc.