Drugs & Vitamins

Ramelteon Active Ingredients: Ramelteon Representative Names: Rozerem Available Product Images: What are Ramelteon tablets? What should I tell my health care provider before I take this medicine? How should this medicine be used? What if I miss a dose? What drug(s) may interact with Ramelteon? What side effects may I notice from receiving Ramelteon? What should I watch for while taking Ramelteon? Where can I keep my medicine? What are Ramelteon tablets? (Back to top) RAMELTEON (Rozerem™) is used to help you fall asleep faster if you experience sleeplessness (insomnia). It is specifically used to help people who have trouble falling asleep, rather than those who might wake up too early or too often at night. Sleep medicines should not be taken for long periods of time, except on your prescriber's advice. Do not share your medicine with anyone else. Generic ramelteon 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: •are a frequent user of alcohol or have a history of drug abuse •attempted suicide or thoughts of harming yourself •breathing difficulty, such as chronic obstructive pulmonary disease (COPD), untreated asthma, or sleep apnea •depression, bipolar disease (manic depression), or other mental health or behavior disorders •difficulty staying asleep •increased prolactin concentrations (hyperprolactinemia) •lactose intolerant •liver disease or a history of liver disease •an unusual reaction to ramelteon, other medicines, foods, dyes, or preservatives •pregnant or trying to get pregnant •breast-feeding How should this medicine be used? (Back to top) Follow the directions on the prescription label, or talk to your health care professional. Swallow ramelteon tablets whole with a drink of water. Only take this medicine within 30 minutes before you are ready to go to bed. After you take ramelteon, limit your activities to those required to get ready for bed. Avoid taking ramelteon with or immediately after eating any high fat meals or snacks. High fat foods may alter the absorption of ramelteon into your blood stream. The sleep promoting effects of ramelteon may be affected. Do not drink alcoholic beverages with ramelteon. Do not drive, operate machinery or engage in other dangerous activities after you have taken ramelteon prior to bedtime. 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) This does not apply. Ramelteon should only be taken immediately before getting into bed or after getting in bed and having trouble falling asleep. Do not take double or extra doses. Do not take an extra dose in the middle of the night if you wake up after falling asleep. What drug(s) may interact with Ramelteon? (Back to top) Many medicines may interact with ramelteon, if you have a question concerning other medicines you may be taking, talk with your pharmacist, prescriber, or other health care professional. Do not take ramelteon with this medicine: •fluvoxamine (Luvox®) Other medicines that may interact with ramelteon: •alcohol and alcoholic beverages •amiodarone •antiretroviral protease inhibitors (medicines used for HIV, AIDS) •barbiturate medicines for inducing sleep or treating seizures (convulsions) •chloramphenicol •ciprofloxacin, erythromycin, enoxacin, norfloxacin (antibiotics) •clopidogrel •cyclosporine •dalfopristin; quinupristin •diltiazem •disulfiram •ethinyl estradiol (in some birth control pills) •kava kava •fluconazole, itraconazole, ketoconazole, miconazole, voriconazole (antifungals) •fluorouracil, 5-FU •gemfibrozil •imatinib, STI-571 •isoniazid, INH •leflunomide •melatonin •metronidazole •mexiletine •mifepristone, RU-486 •rifampin •some sulfonamide medications •tacrine •troleandomycin •valerian •verapamil •zileuton •certain medications for depression, anxiety, or other emotional or psychiatric problems 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 receiving Ramelteon? (Back to top) Side effects that you should report to your prescriber or health care professional as soon as possible: •allergic reaction (itchy, watery eyes, rash, difficulty breathing, swelling of face, tongue, or throat) •breast milk production or discharge from nipples •decreased sex drive •extreme tiredness or weakness •joint or muscle pain •mental depression or worsening of depression •missed monthly period (for women) •sleepwalking or performing other activities while asleep •suicidal thoughts •worsening of insomnia Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome): •bad taste •daytime sleepiness •diarrhea •dizziness •headache •nausea What should I watch for while taking Ramelteon? (Back to top) Visit your prescriber or health care professional for regular checks on your progress. If your insomnia (inability to fall asleep) gets worse after you start taking ramelteon or you notice any different emotions or behaviors (like anxiety, depression, excessive excitement, or mania), you should contact your health care provider immediately. In women: If you experience any irregularities in your menstrual cycle (your monthly period) or if your periods stop, contact your health care provider. If you experience galactorrhea (breast milk), you should also contact your prescriber. If you experience a decreased sexual drive (decreased libido) or problems with fertility, you should contact your health care provider. Do not drive, use machinery, or do anything that needs mental alertness until you know how ramelteon affects you. To reduce dizzy or fainting spells, do not sit or stand up quickly, especially if you are an older patient. Alcohol can increase the drowsy or dizzy effects. Avoid alcoholic drinks. Sleep medicines sometimes cause a type of memory loss, in which the person may not remember what has happened in the several hours after taking the medication. This type of memory loss is usually not a problem since this medicine is taken at bedtime; however there have been reports of driving or performing other activities while asleep after taking a sleep medicine. Be sure to talk to your doctor if you think you are having memory problems while on this medication. If you are going to have surgery, tell your prescriber or health care professional that you are taking ramelteon. If you smoke tobacco, you may affect the amount of ramelteon in your body. Ask your prescriber or health care professional for help to stop smoking. 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 15—30 degrees C (59—86 degrees F) in the original container. Keep the container tightly closed and protected from moisture and humidity. Throw away any unused medicine after the expiration date. Last Updated:03/26/2007 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.