IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

ARMODAFINIL - ORAL

(AR-moe-DAF-i-nil)

COMMON BRAND NAME(S): Nuvigil

USES: Armodafinil decreases extreme sleepiness due to narcolepsy and other sleep disorders such as difficult/irregular breathing during sleep (e.g., obstructive sleep apnea/hypopnea syndrome-OSAHS). It is also used to decrease sleepiness due to work schedules that interfere with a normal sleep routine (shift work sleep disorder-SWSD). It is not known how armodafinil works to increase wakefulness. It is thought to work by affecting certain substances in the brain that control the sleep/wake cycle. Armodafinil does not make up for lack of sleep. It should not be used to treat tiredness or hold off sleep in people who do not have a sleep disorder.

HOW TO USE: Read the Medication Guide provided by your pharmacist before your start using armodafinil and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food, usually once daily in the morning or as directed by your doctor. If you are using armodafinil for shift work sleep disorder, take this medication 1 hour before you start your work shift or as directed by your doctor. If you are using this drug for sleep apnea (OSAHS), also continue your other current treatment (e.g., CPAP machine) unless your doctor tells you to stop. Dosage is based on your medical condition and response to treatment. Use this medication exactly as prescribed to get the most benefit from it. Rarely, use of this medication can result in abnormal drug-seeking behavior (addiction). Do not increase your dose, take it more frequently, or use it for a longer time than prescribed. Properly stop this medication when so directed. Tell your doctor if your condition persists or worsens.

SIDE EFFECTS: Headache, nausea, dry mouth, anxiety, dizziness, and difficulty sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these rare but serious side effects occur: easy bleeding/bruising, signs of infection (e.g., fever, persistent sore throat), mental/mood changes (e.g., agitation, confusion, depression, hallucinations, rare thoughts of suicide), unusual tiredness, dark urine, yellowing eyes/skin. Seek immediate medical attention if any of these rare but very serious side effects occur: severe abdominal pain, chest pain, fast/pounding/irregular heartbeat. Rarely, this medication may cause a serious (rarely fatal) rash. You may not be able to tell this serious reaction apart from a minor rash. Therefore, stop taking this drug and seek immediate medical attention if you develop any rash. A very serious allergic reaction to this drug is rare. However, stop taking armodafinil and seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash/hives, skin blisters/peeling, sores in the mouth, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing/swallowing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking armodafinil, tell your doctor or pharmacist if you are allergic to it; or to modafinil; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: certain heart problems (e.g., enlarged heart, mitral valve problem), history of problems (e.g., chest pain, irregular heartbeat) after taking stimulants such as amphetamines. Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, heart problems (e.g., chest pain, heart attack, irregular heartbeat), liver problems, kidney problems, mental/mood disorders (e.g., depression, mania, psychosis), personal or family history of regular use/abuse of drugs/alcohol. Sleep disorders may decrease your ability to react quickly. Though armodafinil helps keep you awake, you still may not be able to safely perform tasks that require quick reactions (e.g., driving). This drug may also make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages. Caution is advised when using this drug in children because they may be more sensitive to the effects of the drug, especially serious rashes. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: alpha blockers (e.g., doxazosin, prazosin), medications for high blood pressure (e.g., beta blockers such as atenolol/metoprolol, clonidine, guanabenz, methyldopa), "blood thinners" (e.g., warfarin), street drugs (e.g., methamphetamine, MDMA/"ecstasy"), drugs that affect liver enzymes that remove armodafinil from the body (e.g., azole antifungals such as itraconazole/ketoconazole, erythromycin, rifamycins such as rifabutin/rifampin, anti-seizure medications such as carbamazepine/phenobarbital). Armodafinil can speed up or slow down the removal of other drugs from your body by affecting certain liver enzymes. These affected drugs may include clomipramine, cyclosporine, diazepam, ethinyl estradiol, omeprazole, phenytoin, propranolol, triazolam. This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication and for 1 month after stopping this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well. Check the labels on all your medicines (e.g., cough-and-cold products, diet aids) because they may contain ingredients (e.g., pseudoephedrine, ephedra/ma huang) that could increase your heart rate or blood pressure. Ask your pharmacist about using those products safely. Avoid drinking large amounts of beverages containing caffeine (e.g., coffee, tea, certain soft drinks). Caffeine can increase the side effects of this medication.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose include: fast/irregular heartbeat, restlessness, hallucinations.

NOTES: Do not share this medication with others. It is against the law. Have your blood pressure checked regularly while taking this medication. Lifestyle changes (e.g., sleeping in a dark/quiet room, avoiding caffeine close to bedtime) may help improve your sleep if you have shift work sleep disorder. Consult your doctor or pharmacist for more details.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up. Do not take missed doses close to bedtime because this drug can interfere with your sleep.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

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