MODAFINIL- modafinil tablet 
Mylan Pharmaceuticals Inc.

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MEDICATION GUIDE
MODAFINIL TABLETS, USP
CIV

(moe daf′ i nil)

100 mg and 200 mg

Read the Medication Guide that comes with modafinil tablets 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 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:

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

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 if it works in children under the age of 17.

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:

narcolepsy
obstructive sleep apnea (OSA). Modafinil tablets are used with other medical treatments for this sleep disorder. Modafinil tablets do 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.
shift work disorder (SWD)

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 is 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:

are allergic to any of its ingredients. See the end of this Medication Guide for a complete list of ingredients in modafinil tablets.
have had a rash or allergic reaction to either modafinil (modafinil tablets) or armodafinil (NUVIGIL®*). These medicines are very similar.

What should I tell my doctor before taking modafinil tablets?

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

have a history of mental health problems, including psychosis
have heart problems or had a heart attack
have high blood pressure. Your blood pressure may need to be checked more often while taking modafinil tablets.
have liver or kidney problems
have a history of drug or alcohol abuse or addiction
are pregnant or planning to become pregnant. It is not known if modafinil will harm your unborn baby.
are breast-feeding. It is not known if modafinil passes into your milk. Talk to your doctor about the best way to feed your baby if you take modafinil tablets.

Tell your doctor about all the medicines you take, including prescription and nonprescription 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:

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 modafinil tablets. Women who use one of these methods of birth control may have a higher chance for getting pregnant while taking modafinil tablets, and for one month after stopping modafinil tablets. Talk to your doctor about birth control choices that are right for you while taking modafinil tablets.

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?

Take modafinil tablets exactly as prescribed by your doctor. Your doctor will prescribe the dose of modafinil tablets that is right for you. Do not change your dose of modafinil tablets without talking to your doctor.
People with narcolepsy or OSA usually take modafinil tablets one time each day in the morning.
People with SWD usually take modafinil tablets about one hour before their work shift.
Do not change the time of day you take modafinil tablets unless you have talked to your doctor. If you take modafinil tablets too close to your bedtime, you may find it harder to go to sleep.
You can take modafinil tablets with or without food.
If you take more than your prescribed dose or if you take an overdose of modafinil tablets, call your doctor or poison control center right away.

Symptoms of an overdose of modafinil tablets may include:

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

What should I avoid while taking modafinil tablets?

Do not drive a car or do other dangerous activities until you know how modafinil tablets affect 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 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:

a serious rash or serious allergic reaction. (See “What is the most important information I should know about modafinil tablets?”)
mental (psychiatric) symptoms, including:
depression
feeling anxious
hearing, seeing, feeling, or sensing things that are not really there (hallucinations)
an extreme increase in activity and talking (mania)
thoughts of suicide
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 modafinil tablets include:

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

Modafinil tablets are not approved for use in children for any medical condition. In studies of modafinil tablets in children with narcolepsy, side effects included:

Tourette’s syndrome
hostile behavior
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 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?

Store modafinil tablets at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Keep modafinil tablets and all medicines out of the reach of children.

General information about 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 1-877-446-3679 (1-877-4-INFO-RX).

What are the ingredients in modafinil tablets?

Active ingredient: modafinil

Inactive ingredients: croscarmellose sodium, dibasic calcium phosphate (anhydrous), lactose monohydrate, magnesium stearate, microcrystalline cellulose and povidone.

*The brand listed is a trademark of its respective owner.

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

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

REVISED JANUARY 2013
MDFL:R3mmt

Revised: 01/2013
 
Mylan Pharmaceuticals Inc.