NUVIGIL- armodafinil tablet
STAT Rx USA LLC
NUVIGIL (nu-vij-el) C-IV
Read the Medication Guide that comes with NUVIGIL 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 NUVIGIL?
NUVIGIL 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 NUVIGIL and call your doctor right away or get emergency help if you have any of these symptoms:
If you have a severe rash with NUVIGIL, stopping the medicine may not keep the rash from becoming life-threatening or causing you to be permanently disabled or disfigured.
NUVIGIL is not approved for use in children for any medical condition.
It is not known if NUVIGIL is safe or if it works in children under the age of 17.
What is NUVIGIL?
NUVIGIL is a prescription medicine used to improve wakefulness in adults who are very sleepy due to one of the following diagnosed sleep disorders:
NUVIGIL will not cure these sleep disorders. NUVIGIL may help the sleepiness caused by these conditions, but it may not stop all your sleepiness. NUVIGIL does not take the place of getting enough sleep. Follow your doctor's advice about good sleep habits and using other treatments.
Who should not take NUVIGIL?
Do not take NUVIGIL if you:
What should I tell my doctor before taking NUVIGIL?
Tell your doctor about all of your medical conditions including, if you:
Pregnancy Registry: There is a registry for women who become pregnant during treatment with NUVIGIL. The purpose of this registry is to collect information about the safety of NUVIGIL 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 by calling 1-866-404-4106.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. NUVIGIL and many other medicines can interact with each other, sometimes causing side effects. NUVIGIL may affect the way other medicines work, and other medicines may affect how NUVIGIL works. Your dose of NUVIGIL 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 NUVIGIL and other medicines together. Do not start any new medicines with NUVIGIL unless your doctor has told you it is okay.
How should I take NUVIGIL?
Symptoms of an overdose of NUVIGIL may include:
What should I avoid while taking NUVIGIL?
What are possible side effects of NUVIGIL?
NUVIGIL may cause serious side effects. Stop taking NUVIGIL 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 NUVIGIL include:
Tell your doctor if you get any side effect that bothers you or that does not go away while taking NUVIGIL.
These are not all the side effects of NUVIGIL. For more information, ask your doctor or pharmacist.
Some effects of NUVIGIL on the brain are the same as other medicines called “stimulants”. These effects may lead to abuse or dependence on NUVIGIL.
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 NUVIGIL?
General information about NUVIGIL
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NUVIGIL for a condition for which it was not prescribed. Do not give NUVIGIL 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 NUVIGIL. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about NUVIGIL that is written for health professionals. For more information, call 1-800-896-5855, or go to www.NUVIGIL.com.
What are the ingredients in NUVIGIL?
Active Ingredient: armodafinil
Inactive Ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, povidone, and magnesium stearate.
Frazer, PA 19355
NUVMG – 001
Revised October 2010
This Medication Guide has been approved by the U.S. Food and Drug Administration.
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