When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to armodafinil or modafinil.

How to Use This Medicine:
Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• For daytime wakefulness: Take armodafinil in the morning.
• During shift work: Take armodafinil 1 hour before you begin working.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines and foods can affect how armodafinil works. Tell your doctor if you are taking any of the following:
  
  • Clomipramine, cyclosporine, diazepam, erythromycin, ketoconazole, midazolam, omeprazole, propranolol, or triazolam
  • Birth control medicine (such as ethinyl estradiol, estradiol, levonorgestrel, norethindrone, progesterone), a blood thinner (such as warfarin), an MAO inhibitor (such as isocarboxazid, phenelzine, selegiline, tranylcypromine), or seizure medicine (such as carbamazepine, phenobarbital, rifampin, phenytoin)
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, heart disease, high blood pressure, or a history of mental illness, depression, or drug or alcohol abuse.
• Armodafinil may prevent hormonal birth control from working. Use a second form of birth control while you are taking armodafinil, and continue to use both forms for 1 month after your last dose. If you do become pregnant, tell your doctor right away.
• Do not drive or do anything dangerous until you know how this medicine affects you.
• If you use a CPAP machine while you sleep, continue to use it. Armodafinil is not a substitute for a CPAP machine.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Fast, pounding, or uneven heartbeat
• Feeling unusually agitated, aggressive, confused, depressed, or excited
• Fever, shortness of breath, yellow skin or eyes, dark urine
• Seeing, hearing, or feeling things that are not there
• Suicidal thoughts
• Tremors or shaking

If you notice these less serious side effects, talk with your doctor:

• Anxiety or nervousness
• Dry mouth or increased thirst
• Headache or dizziness
• Mild skin rash or itching

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088