Drugs & Vitamins

Modafinil Active Ingredients: Modafinil Representative Names: Provigil Available Product Images: What are modafinil tablets? What should I tell my health care provider before I take this medicine? How should I take this medicine? What if I miss a dose? What drug(s) may interact with modafinil? What side effects may I notice from taking modafinil? What should I watch for while taking modafinil? Where can I keep my medicine? What are modafinil tablets? (Back to top) MODAFINIL (Provigil®) is a medication that helps to promote alertness during daytime hours. Modafinil helps to improve the symptoms of a condition called narcolepsy. Narcolepsy makes people fall into a sudden deep sleep at odd times; this excessive sleepiness can interfere with the ability to participate in daytime activities. Modafinil has also been used to treat fatigue associated with other sleep disorders. Federal law prohibits giving this medication to any person other than the person for whom it was prescribed. Generic modafinil tablets are not yet available. What should I tell my health care provider before I take this medicine? (Back to top) They need to know if you have any of these conditions: •if you frequently drink alcohol containing beverages •if you have a history of drug or alcohol abuse or rehabilitation •heart disease (including heart valve problems, irregular heart beat, recent heart attack, or unstable chest pain) •high blood pressure •kidney disease •liver disease •mental illness •an unusual or allergic reaction to modafinil, other medicines, foods, dyes, or preservatives •use some method of birth control •pregnant or trying to get pregnant •breast-feeding How should I take this medicine? (Back to top) Take modafinil tablets by mouth. Take your daily dose in the morning hours to get the best effects during the day; taking the medication in the afternoon or evening might interfere with your night-time sleep. Follow the directions on the prescription label regarding how to take this medicine. Swallow the tablets with a drink of water. Take your doses at regular intervals. Do not take your medicine more often than directed. Remember: Your prescription for modafinil is only for you. You should never share or give your modafinil prescription to anyone else. Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed. What if I miss a dose? (Back to top) 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 drug(s) may interact with modafinil? (Back to top) Modafinil can potentially interact with a variety of medications. Doses of your other medications may need to be adjusted or you may have to be monitored more closely. •alcohol-containing beverages •antidepressants and other medications for the treatment of mood problems •antifungal medications (like itraconazole or ketoconazole) •barbiturates (like phenobarbital) •birth control pills or other hormone-containing birth control devices or implants •caffeine •carbamazepine •cimetidine •cyclosporine •dextroamphetamine, methylphenidate, or other stimulants •doxercalciferol •grapefruit juice •guarana •linezolid •phenytoin •some antibiotics (like rifampin, erythromycin, clarithromycin) •theophylline •warfarin Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines. What side effects may I notice from taking modafinil? (Back to top) Side effects that you should report to your prescriber or health care professional as soon as possible: Rare: •chest pain •diarrhea (severe), or vomiting •difficulty breathing or shortness of breath •heart palpitations, irregular heartbeat, or a fast heartbeat •increased blood pressure, particularly if you have high blood pressure •skin rash, itching, hives, or other allergic reactions •sore throat, fever, or chills •tremor or shaking movements Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome): More common: •headache •nausea, mild diarrhea, or stomach upset •nervousness Less common: •decreased appetite •depressed or elevated mood, anxiety, or other changes in your moods or emotions •dizziness •dry mouth or skin •trouble sleeping at night What should I watch for while taking modafinil? (Back to top) The use of modafinil needs careful supervision. Patients with narcolepsy can be helped, but not cured, by modafinil treatment. Visit your prescriber or health care professional for regular checks on your progress. The full effects of modafinil may not be seen right away. Do not stop taking except on your prescriber's advice. Modafinil may affect your concentration, function, or may hide signs that you are tired. Try to maintain a regular sleeping pattern. Until you know how modafinil affects you, do not drive, use machinery, or do any activity that needs mental alertness. Because alcohol may interfere with your response to modafinil or your alertness, it is recommended that you avoid alcohol-containing beverages while on this medication. Modafinil can decrease the effectiveness of certain contraceptives including birth control pills and implantable hormonal contraceptives. If you are using this type of birth control while taking modafinil you should either: 1) use an alternate birth control method; or 2) use another effective birth control method together with your current contraceptive. You should also continue to follow this advice for 1 month after you stop treatment with modafinil. You may wish to discuss birth control options with your health care provider. Some patients with narcolepsy may experience temporary moments of limpness or loss of muscle tone as a regular problem of their condition. These episodes are called cataplexy. This problem may occur when the person laughs, gets excited, or experiences other emotions. Modafinil usually does not increase or decrease the occurrence of these episodes. It is unknown if modafinil's effects will be increased by the use of other stimulants, like caffeine. Caffeine is available in many foods, beverages, and medications. Ask your prescriber if you should limit or change your intake of caffeine-containing products while on modafinil. Do not take any non-prescription medications without the advice of your health care provider or pharmacist. If you are going to have surgery, notify your health care provider that you are on this medication. Where can I keep my medicine? (Back to top) Keep out of the reach of children in a container that small children cannot open. Store at room temperature between 20—25 degrees C (68—77 degrees F). Keep container tightly closed. Throw away any unused medicine after the expiration date. Last Updated:08/30/2005 CLINICAL PHARMACOLOGY© GOLD STANDARD MULTIMEDIA INC, ALL RIGHTS RESERVED

Note: The above information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist, or other healthcare professional. It should not be construed to indicate that the use of the product is safe, appropriate, or effective for you. Consult your healthcare professional before taking the product.