Ramelteon 8mg Tablets

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.

RAMELTEON - ORAL

(ra-MEL-tee-on)

COMMON BRAND NAME(S): Rozerem

USES: This medication is used to treat sleeplessness (insomnia). It helps you fall asleep faster so you can get a full night\'s rest. Sleep is important for your ability to function, think clearly, and remain alert. Lack of sleep can cause problems such as depression, heart disease and accidents. Getting enough sleep allows your mind and body to repair itself and increases your energy throughout the day. Ramelteon works like a natural substance called melatonin that is produced by your body. It helps regulate your sleep-wake cycle (circadian rhythm).

HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking ramelteon 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, 30 minutes before bedtime, or as directed by your doctor. Do not take ramelteon with or immediately after a high-fat meal because fat can affect how well this drug works. The manufacturer directs not to break the tablet before taking it. However, many similar drugs (immediate-release tablets) can be broken. Follow your doctor\'s directions on how to take this medication. Do not take a dose of this medication unless you have time for a full night\'s sleep that lasts at least 7 to 8 hours. Your dosage is based on your medical condition and response to therapy. Do not increase your dose or take it more frequently than prescribed. Inform your doctor if you have any changes in mood (e.g., feelings of depression), if you continue to have trouble falling asleep, or if your insomnia worsens.

SIDE EFFECTS: Dizziness, tiredness, or daytime drowsiness may occur. If any of these effects persist or worsen, notify 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. Some people who take sleep medications have reported getting out of bed and sleep-walking, driving, eating, talking on the phone, or doing other activities while not fully awake. Often, they have no memory of these activities. This problem can be dangerous to you or others. If you have or think you have this problem, tell your doctor right away. Your risk is increased if you use alcohol or other medications that can make you drowsy. Tell your doctor right away if any of these unlikely but serious side effects occur: decreased sexual desire, missed menstrual periods, nipple discharge, difficulty becoming pregnant. Tell your doctor right away if any of these rare but very serious side effects occur: mental/mood changes (e.g., depression, strange thoughts, thoughts of suicide). A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. 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 or at www.fda.gov/medwatch. 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 ramelteon, tell your doctor or pharmacist if you are allergic to it; 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 a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have: severe liver disease. Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (bronchitis, emphysema, sleep apnea), liver disease. This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Alcohol may increase the risk of this drug\'s side effects and can worsen sleeping problems. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Because of the possible risk to the infant (such as unusual sleepiness or difficulty feeding), ask your doctor if you should pump and discard your breast milk during treatment and for 25 hours after a dose of this medication to lessen the risk of these effects in your baby. Get medical help right away if you notice any unusual symptoms in your baby. 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. A product that may interact with this drug is: fluvoxamine. Other medications can affect the removal of ramelteon from your body, which may affect how ramelteon works. Examples include azole antifungals (such as fluconazole, ketoconazole), rifamycins (such as rifampin), among others. Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), other drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others. Laboratory tests (e.g., hormone levels) may be performed if you have certain side effects. Consult your doctor for more details. Lifestyle changes that can help you get to sleep include reducing stress, not smoking, avoiding caffeine and alcoholic beverages for at least 4 to 6 hours before bedtime, listening to relaxing music, and doing relaxation exercises. Get up and go to bed at the same time each day. Don\'t take naps during the day, and make sure your bedroom is quiet and comfortable.

MISSED DOSE: Not applicable.

STORAGE: Store at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Keep container tightly closed. Do not store in the bathroom. Keep all medicines 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 for more details about how to safely discard your product.

Information last revised January 2019. Copyright(c) 2019 First Databank, Inc.