Armodafinil tablets

What is this medication?

ARMODAFINIL (ar moe DAF i nil) is used to treat excessive sleepiness caused by certain sleep disorders. This includes narcolepsy, sleep apnea, and shift work sleep disorder.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Nuvigil

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• bipolar disorder
• depression
• drug or alcohol abuse or addiction
• heart disease
• high blood pressure
• kidney disease
• liver disease
• schizophrenia
• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
• an unusual or allergic reaction to armodafinil, modafinil, medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking this medicine suddenly except upon the advice of your doctor. Stopping this medicine too quickly may cause serious side effects or your condition may worsen.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 17 years of age for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medicine with any of the following medications:

•amphetamine or dextroamphetamine

•dexmethylphenidate or methylphenidate

•MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

•pemoline

•procarbazine

This medicine may also interact with the following medications:

•antifungal medicines like itraconazole or ketoconazole

•barbiturates, like phenobarbital

•birth control pills or other hormone-containing birth control devices or implants

•carbamazepine

•cyclosporine

•diazepam

•medicines for depression, anxiety, or psychotic disturbances

•phenytoin

•propranolol

•triazolam

•warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your doctor or healthcare provider for regular checks on your progress. The full effect of this medicine may not be seen right away.

This medicine may affect your concentration, function, or may hide signs that you are tired. You may get dizzy. This medicine will not eliminate your abnormal tendency to fall asleep and is not a replacement for sleep. Do not change your previous behavior regarding potentially dangerous activities, such as driving, using machinery, or doing anything that needs mental alertness until you know how this drug affects you. Alcohol can make you more dizzy and may interfere with your response to this medicine or your alertness. Avoid alcoholic drinks.

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your healthcare provider right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips, or lymph nodes in your neck or under your arms.

Birth control pills may not work properly while you are taking this medicine. While using birth control pills, you will need an additional barrier method or an alternative non-hormonal method of birth control during treatment with armodafinil and for 1 month after stopping armodafinil. Talk to your doctor about which extra method of birth control is right for you.

It is unknown if the effects of this medicine will be increased by the use of caffeine. Caffeine is found in many foods, beverages, and medications. Ask your doctor if you should limit or change your intake of caffeine-containing products while on this medicine.

Do not stop previously prescribed treatments for your condition, such as a CPAP machine, except on the advise of your physician or healthcare provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• anxiety
• breathing or swallowing problems
• chest pain
• depressed mood
• elevated mood, decreased need for sleep, racing thoughts, impulsive behavior
• fast, irregular heartbeat
• hallucination, loss of contact with reality
• increased blood pressure
• mouth sores, blisters, or peeling skin
• rash, fever, and swollen lymph nodes
• redness, blistering, peeling, or loosening of the skin, including inside the mouth
• sore throat, fever, or chills
• suicidal thoughts or other mood changes
• tremors
• vomiting

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• headache
• nausea, diarrhea, or stomach upset
• nervousness
• trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.