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PROVIGIL 200MG TABLETS
Ingredient Name: MODAFINIL (moe-DAF-i-nil)
Drug Manufacturer: CEPHALON
Common Uses: This medicine is an anti-narcoleptic agent used to improve wakefulness in patients with narcolepsy (sudden uncontrollable attacks of daytime sleepiness), sleep apnea, or in patients with shift work sleep disorder. It may also be used to treat other conditions as determined by your doctor.
Before Using This Medicine: Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking cabazitaxel. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking amphetamines or other stimulants (eg, methylphenidate), anticoagulants (eg, warfarin), axitinib, azole antifungals (eg, ketoconazole, itraconazole), certain benzodiazepines (eg, diazepam, midazolam, triazolam), carbamazepine, cyclosporine, hormonal products (eg, birth control pills, certain hormone replacements), hydantoins (eg, phenytoin), a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), phenobarbital, prazosin, propranolol, rifampin, certain tricyclic antidepressants (eg, clomipramine, desipramine), or ulipristal. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including cirrhosis, liver problems, kidney problems, heart problems (eg, chest pain, heart blood vessel problems, recent heart attack), high blood pressure, allergies, pregnancy, or breast-feeding. INFORM YOUR DOCTOR if you have a history of alcohol or other substance abuse, suicidal thoughts or actions, or other mood or mental problems (eg, depression, mania, psychosis). USE OF THIS MEDICINE IS NOT RECOMMENDED if you have a history of developing a rash after taking this medicine or armodafinil; or if you have a history of certain heart or heart valve problems (eg, mitral valve prolapse, left ventricular hypertrophy). Use of this medicine in CHILDREN is not recommended. Discuss with your doctor the risks and benefits of giving this medicine to your child. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.
How to Use This Medicine: Follow the directions for using this medicine provided by your doctor. This medicine has a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. YOUR DOCTOR WILL TELL YOU what time of day to take this medicine. Do not change the time of day you take it without talking to your doctor. This medicine may be taken on an empty stomach or with food. STORE THIS MEDICINE at room temperature between 68 and 77 degrees F (20 and 25 degrees C) in a tightly-closed container, away from heat and light. KEEP THIS MEDICINE out of the reach of children and away from pets. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If you do not remember until late afternoon or evening, skip the missed dose and go back to your regular dosing schedule. Do NOT take 2 doses at once.
Cautions: DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it, to any ingredient in this product, or to any similar medicine (eg, armodafinil). IF YOU EXPERIENCE difficulty breathing; tightness of chest; swelling of eyelids, face, or lips; or if you develop a rash or hives, tell your doctor immediately. Do not take any more doses of this medicine unless your doctor tells you to do so. THIS MEDICINE CANNOT CURE SLEEP DISORDERS and it may not stop all of your sleepiness. Do not change your daily habits without first talking to your doctor. Discuss your level of sleepiness with your doctor at each visit. Do not use this medicine in place of getting enough sleep. Follow your doctor's instructions for good sleep habits and using other treatments. DO NOT EXCEED THE RECOMMENDED DOSE, take more often than prescribed, or take this medicine for longer than prescribed without checking with your doctor. Exceeding the recommended dose or taking this medicine for longer than prescribed may be habit-forming. Laboratory and/or medical tests, including blood pressure checks and liver function, may be performed to monitor your progress or to check for side effects. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are taking this medicine. This medicine may cause dizziness. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. DO NOT DRINK ALCOHOL while you are using this medicine. CHECK WITH YOUR DOCTOR before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using this medicine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness. SERIOUS AND SOMETIMES FATAL SKIN REACTIONS (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis) have been rarely reported with this medicine. Contact your doctor right away if you develop a rash; red, swollen, blistered, or peeling skin; or blisters on the inside of the eyes, nose, or mouth. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. CAUTION IS ADVISED WHEN USING THIS MEDICINE IN THE ELDERLY because they may be more sensitive to the effects of the medicine. FOR WOMEN TAKING BIRTH CONTROL PILLS, this medicine may decrease the effectiveness of your birth control pills. To prevent pregnancy, use an additional form of birth control while you are taking this medicine and for 1 month after stopping this medicine. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. IT IS UNKNOWN IF THIS MEDICINE ISEXCRETED in breast milk. IF YOU ARE OR WILL BE BREAST-FEEDING while you are using this medicine, check with your doctor or pharmacist to discuss the risks to your baby.
Possible Side Effects: SIDE EFFECTS that may occur while taking this medicine include back pain, diarrhea, dizziness, headache, nausea, nervousness, stomach upset, stuffy nose, or trouble sleeping. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience blisters on the inside of the eyes, nose, or mouth; chest pain; confusion; fever, chills, or sore throat; fast or irregular heartbeat; mental or mood changes (eg, aggression, agitation, anxiety, depression, exaggerated sense of well-being, hallucinations, irritability, nervousness); red, blistered, swollen, or peeling skin; severe or persistent headache; shortness of breath; suicidal thoughts or actions; swelling of the hands, ankles, or feet; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, stomach pain, yellowing of the skin or eyes); unusual bruising or bleeding; or unusual tiredness or weakness. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Overdose: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose include agitation; anxiety; chest pain; confusion; diarrhea; excitation; fast or slow heartbeat; hallucinations; nausea; restlessness; severe or persistent headache or dizziness; sleeplessness; tremor.
Additional Information: If your symptoms do not improve or if they become worse, check with your doctor. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.
Copyright 2012 Wolters Kluwer Health, Inc.
Disclaimer - This information is not intended to substitute for professional medical advice. Be sure to contact your physician, pharmacist or other health care provider for more information about this medication. By searching these web site pages, you agree to our terms and conditions of use.