MEDICATION GUIDE

 What is the most important information I should know about armodafinil tablets?

Armodafinil tablets are a federal controlled substance (C-IV) because it can be abused or lead to dependence. Keep armodafinil tablets in a safe place to prevent misuse and abuse. Selling or giving away armodafinil 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.

Armodafinil 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 armodafinil 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, breathing or hoarseness

•

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 armodafinil tablets, stopping the medicine may not keep the rash from becoming life-threatening or causing you to be permanently disabled or disfigured.

Armodafinil tablets are not approved for use in children for any medical condition.

It is not known if armodafinil tablets are safe and effective in children under the age of 18.

 What are armodafinil tablets?

Armodafinil 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). Armodafinil tablets are used with other medical treatments for this sleep disorder. Armodafinil 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)

Armodafinil tablets will not cure these sleep disorders. Armodafinil tablets may help the sleepiness caused by these conditions, but it may not stop all your sleepiness. Armodafinil tablets do not take the place of getting enough sleep. Follow your doctor’s advice about good sleep habits and using other treatments.

 Do not take armodafinil tablets if you:

•

are allergic to any of its ingredients. See the end of this Medication Guide for a complete list of ingredients in armodafinil tablets.

•

have had a rash or allergic reaction to either armodafinil tablets (NUVIGIL®) or modafinil (PROVIGIL®). These medicines are very similar.

 Before you take armodafinil 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 armodafinil 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 armodafinil tablets will harm your unborn baby.

Pregnancy Registry: There is a registry for women who become pregnant during treatment with armodafinil tablets. The purpose of this registry is to collect information about the safety of armodafinil 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.

•

are breastfeeding. It is not known if armodafinil passes into your milk. Talk to your doctor about the best way to feed your baby if you take armodafinil tablets.

 Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Armodafinil tablets and many other medicines can interact with each other, sometimes causing side effects. Armodafinil tablets may affect the way other medicines work, and other medicines may affect how armodafinil tablets works. Your dose of armodafinil 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 armodafinil tablets. Women who use one of these methods of birth control may have a higher chance for getting pregnant while taking armodafinil tablets, and for one month after stopping armodafinil tablets. You should use effective birth control while taking armodafinil tablets and for one month after your final dose. Talk to your doctor about birth control choices that are right for you while taking armodafinil 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 armodafinil tablets and other medicines together. Do not start any new medicines with armodafinil tablets unless your doctor has told you it is okay.

 How should I take armodafinil tablets?

•

Take armodafinil tablets exactly as prescribed by your doctor. Your doctor will prescribe the dose of armodafinil tablets that is right for you. Do not change your dose of armodafinil tablets without talking to your doctor.

•

Your doctor will tell you the right time of day to take armodafinil tablets.

•

People with narcolepsy or OSA usually take armodafinil tablets one time each day in the morning.

•

People with SWD usually take armodafinil tablets about 1 hour before their work shift.

•

Do not change the time of day you take armodafinil tablets unless you have talked to your doctor. If you take armodafinil tablets too close to your bedtime, you may find it harder to go to sleep.

•

You can take armodafinil tablets with or without food.

•

If you take more than your prescribed dose or if you take an overdose of armodafinil tablets, call your doctor or poison control center right away.

Symptoms of an overdose of armodafinil 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

•

Anxiety                                            •  Shortness of breath

 What should I avoid while taking armodafinil tablets?

•

Do not drive a car or do other dangerous activities until you know how armodafinil 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 armodafinil tablets.

 What are the possible side effects of armodafinil tablets?

Armodafinil tablets may cause serious side effects. Stop taking armodafinil 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 armodafinil tablets?”)

•

mental (psychiatric) symptoms, including:

•

depression                                                               º  feeling anxious

•

hearing, seeing, feeling, or sensing things              º  an extreme increase in activity and talking (mania) 
that are not really there (hallucinations)                  º  aggressive behavior

•

thoughts of suicide

•

other mental problems

•

symptoms of a heart problem, including chest pain, abnormal heart beats, and trouble breathing.

The most common side effects of armodafinil tablets include:

•

headache          •  nausea

•

dizziness           •  trouble sleeping

These are not all the possible side effects of armodafinil 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 armodafinil tablets?

•

Store armodafinil tablets at room temperature between 68° to 77°F (20° to 25°C).

•

Keep armodafinil tablets and all medicines out of the reach of children.

 General information about the safe and effective use of armodafinil tablets.

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

You can ask your pharmacist or healthcare provider for information about armodafinil tablets that is written for health professionals.