MODAFINIL- modafinil tablet
CIMA LABS INC.
Modafinil Tablets C-IV
Read this Medication Guide before you start taking modafinil tablets and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.
What is the most important information I should know about modafinil tablets?
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 modafinil tablets and call your doctor right away or get emergency help if you have any of these symptoms:
If you have a severe rash with modafinil tablets, stopping the medicine may not keep the rash from becoming life-threatening or causing you to be permanently disabled or disfigured.
Modafinil tablets are not approved for use in children for any medical condition.
It is not known if modafinil tablets are safe or effective in children under 17 years of age.
What are modafinil tablets?
Modafinil tablets are a prescription medicine used to improve wakefulness in adults who are very sleepy due to one of the following diagnosed sleep disorders:
Modafinil tablets will not cure these sleep disorders. Modafinil tablets may help the sleepiness caused by these conditions, but it may not stop all your sleepiness. Modafinil tablets do not take the place of getting enough sleep. Follow your doctor's advice about good sleep habits and using other treatments.
Modafinil tablets are a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep modafinil tablets in a safe place to prevent misuse and abuse. Selling or giving away modafinil tablets 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.
Who should not take modafinil tablets?
Do not take modafinil tablets if you:
What should I tell my doctor before taking modafinil tablets?
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 modafinil tablets. The purpose of this registry is to collect information about the safety of modafinil tablets 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 over-the-counter medicines, vitamins, and herbal supplements. Modafinil tablets and many other medicines can interact with each other, sometimes causing side effects. Modafinil tablets may affect the way other medicines work, and other medicines may affect how modafinil tablets work. Your dose of modafinil tablets 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 modafinil tablets and other medicines together. Do not start any new medicines with modafinil tablets unless your doctor has told you it is okay.
How should I take modafinil tablets?
Symptoms of an overdose of modafinil tablets may include:
What should I avoid while taking modafinil tablets?
What are possible side effects of modafinil tablets?
Modafinil tablets may cause serious side effects. Stop taking modafinil tablets 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 modafinil tablets include:
Modafinil tablets are not approved for use in children for any medical condition including Attention Deficit Hyperactivity Disorder (ADHD). In studies of modafinil tablets 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 modafinil tablets.
These are not all the side effects of modafinil tablets. For more information, ask your doctor or pharmacist.
Some effects of modafinil tablets on the brain are the same as other medicines called “stimulants”. These effects may lead to abuse or dependence on modafinil tablets.
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 modafinil tablets?
General information about the safe and effective use of modafinil tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use modafinil tablets for a condition for which it was not prescribed. Do not give modafinil tablets 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 modafinil tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about modafinil tablets that is written for health professionals. For more information, call 1-888-483-8279.
What are the ingredients in modafinil tablets?
Active Ingredient: modafinil
Inactive Ingredients: lactose monohydrate, microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, povidone, and magnesium stearate.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Revised March 2020
Teva Pharmaceuticals USA, Inc.
Parsippany, NJ 07054
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