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Sleeping Aid >> Rozerem

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    Generic Name: Ramelteon (ram-EL-tee-on)
    Brand Name: Rozerem

    Rozerem is taken for:

    Treating insomnia. It might and be taken for other conditions as determined by your physician.

    Rozerem in a melatonin agonist. It works by acting on the melatonin receptors in the brain, which helps cause sleep.

    Do NOT use Rozerem if:

    • you are allergic to any ingredient in Rozerem
    • you have severe liver problems
    • you are taking fluvoxamine

    Contact your physician or health care provider right away if any of these apply to you.

    Before taking Rozerem :

    Some medical conditions might interact with Rozerem . Tell your physician or pharmacist if you have any medical conditions, especially if any of the following apply to you:

    • if you are pregnant, planning to become pregnant, or are breast-feeding
    • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
    • if you have allergies to medicines, foods, or other substances
    • if you have liver problems, heart disease, difficulty breathing while sleeping, severe lung problems (eg, chronic obstructive pulmonary disease [COPD]), mental or mood problems (eg, depression), or you have a history of alcohol abuse or suicidal thoughts or behaviors

    Some MEDICINES MIGHT INTERACT with Rozerem . Tell your health care provider if you are taking any other medicines, especially any of the following:

    • Fluvoxamine or imidazoles (eg, ketoconazole) because the side effects of Rozerem might be increased
    • Rifampin because its effectiveness might be decreased

    This might not be a complete list of all interactions that might occur. Ask your health care provider if Rozerem might interact with other medicines that you use. Check with your health care provider before you start, stop, or change the dose of any medicine.

    How to use Rozerem :

    Use Rozerem as directed by your physician. Check the label on the medicine for exact dosing instructions.

    • Rozerem might be taken with or without food. If stomach upset occurs, use with food to reduce stomach irritation.
    • Do not use Rozerem with or immediately after a high-fat meal.
    • Use Rozerem within 30 minutes prior to going to bed.
    • If you miss a dose of Rozerem and you are taking 1 dose every day at bedtime, skip the missed dose. Do not use the dose in the morning or use 2 doses at one time.

    Ask your health care provider any questions you might have about how to use Rozerem .

    Important safety information:

    • Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Rozerem . Taking Rozerem alone, with certain other medicines, or with alcohol might lessen your ability to drive or perform other potentially dangerous tasks.
    • Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Rozerem . Rozerem will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
    • Rozerem is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
    • PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Rozerem , discuss with your physician the benefits and risks of taking Rozerem during pregnancy. It is unknown if Rozerem is excreted in breast milk. Do not breast-feed while taking Rozerem .

    When sleep medicines are taken every night for more than a few weeks, they might lose their effectiveness to help you sleep. This is known as TOLERANCE. Sleep medicines should generally be taken only for short periods of time, such as a few days and generally no longer than 1 or 2 weeks. If your sleep problems continue, contact your physician.

    Possible side effects of Rozerem :

    All medicines might cause side effects, however many people have no, or minor, side effects. Check with your physician if any of these most GENERAL side effects persist or become bothersome:

    Diarrhea; dizziness; drowsiness; fatigue; nausea: tiredness.

    Seek medical attention right away if any of these SEVERE side effects occur:

    Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); absence of a menstrual cycle; decreased sex drive; fever; hallucinations; headache; rough heartbeat; mental or mood changes; muscle aches; muscle or joint pain; pounding in the chest; problems with fertility; suicidal thoughts or behaviors; unexplained breast milk production; vision changes; worsening of depression; worsening of sleeplessness.

    This is not a complete list of all side effects that might occur. If you have questions or need medical advice about side effects, contact your physician or health care provider. You might report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

    If OVERDOSE is suspected:

    Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

    Proper storage of Rozerem :

    Store Rozerem at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Store Rozerem out of the reach of children and away from pets.

    General information:

    • If you have any questions about Rozerem , please talk with your physician, pharmacist, or other health care provider.
    • Rozerem is to be taken only by the patient for whom it is prescribed. Do not share it with other people.
    • If your symptoms do not improve or if they become worse, check with your physician.

    This information is a summary only. It does not contain all information about Rozerem . If you have questions about the medicine you are taking or would like more information, check with your physician, pharmacist, or other health care provider.

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