RAMELTEON

(ram EL tee on) Brand: Rozerem

What is the most significant information I must know about ramelteon?

• You must not use this medicine if you are allergic to ramelteon, or if you have severe liver disease.

• You must not take ramelteon if you are also taking the antidepressant fluvoxamine (Luvox).

• Till taking ramelteon, speak your doctor if you have liver malady, sleep apnea, a breathing mess such as chronic obstructive pulmonary malady, or a history of depression, mental diseases, or suicidal thoughts.

• Take ramelteon 30 minutes till your usual bedtime. After you take ramelteon, avoid doing anything another than getting ready for bed.

• Avoid taking ramelteon together with or just after eating a high-fat meal. This will create it harder for your body to absorb the medication.

• Some people using this medication have engaged in activity such as driving, eating, or making telephone calls and later having no memory of the activity. If this happens to you, stop taking ramelteon and conversation with your doctor about other treatment for your sleep disorder.

What is ramelteon?

• Ramelteon is a sedative, also called a hypnotic. It works by affecting determined substances in your body that help regulate your "sleep-wake cycle."

• Ramelteon is used to treat insomnia that is associated with having trouble falling asleep.

• Unlike some another sleep medications, ramelteon is not known to be habit-forming.

• Ramelteon may also be used for purposes not listed in this medicine guide.

What must I discuss with my healthcare provider till taking ramelteon?

• You must not use this medicine if you are allergic to ramelteon, or if you have severe liver disease.

• You must not take ramelteon if you are also taking the antidepressant fluvoxamine (Luvox).

• To create certain you can safely take ramelteon, speak your doctor if you have any of these another conditions:

· liver disease;

· sleep apnea (breathing stops while you are asleep);

· a breathing mess such as chronic obstructive pulmonary malady (COPD); or

· a history of depression, mental diseases, or suicidal thoughts.

• FDA pregnancy category C. It is not known whether ramelteon will harm an unborn child. Speak your doctor if you are pregnant or plan to become pregnant while using this medication.

• It is not known whether ramelteon passes into breast milk or if it could harm a nursing child. Do not use this medicine without telling your doctor if you are breast-feeding a baby.

• Ramelteon may affect the levels of male or female hormones (testosterone or prolactin). This may affect menstrual periods in women, sexual desire in men, or fertility (ability to have children) in either a man or a woman.

How must I take ramelteon?

• Take exactly as predesigned by your doctor. Do not take in larger or less amounts or for longer than recommended. Follow the directions on your prescription label.

• Take this medicine with a full glass of water.

• Take ramelteon 30 minutes till your usual bedtime. After you take ramelteon, avoid doing anything another than getting ready for bed.

• Do not crush, chew, or interrupt the tablet. Swallow it intact.

• Avoid taking ramelteon together with or just after eating a high-fat meal. This will create it harder for your body to absorb the medication.

• Conversation with your doctor if your insomnia does not improve after 7 days of using ramelteon. You may need to be checked for another medical illnesses that may reason insomnia.

• Store at room temperature away from moisture and heat. Hold the bottle tightly closed when not in use.

What happens if I miss a dose?

• Since ramelteon is generally taken as needed, you may not be on a dosing schedule. Ramelteon must be taken only within 30 minutes of your usual bedtime. Do not take extra medication to create up a missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.

What must I avoid while taking ramelteon?

• This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

• Drinking alcohol can magnify determined side effects of ramelteon.

What are the possible side effects of ramelteon?

• Some people using this medication have engaged in activity such as driving, eating, or making telephone calls and later having no memory of the activity. If this happens to you, stop taking ramelteon and conversation with your doctor about other treatment for your sleep disorder.

• Get abnormal medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your person, lips, tongue, or throat.

• Stop taking ramelteon and call your doctor at once if you have a serious side effect such as:

· unusual thoughts or behavior, hallucinations, worsening depression, thoughts about hurting yourself;

· a missed menstrual period;

· nipple discharge; or

· loss of interest in sex.

• Smaller serious side effects may include:

· drowsiness, weary feeling;

· dizziness;

· nausea; or

· worsening sleep problems.

• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect ramelteon?

• Speak your doctor about all another medicines you use, especially:

· donepezil (Aricept);

· doxepin (Sinequan, Silenor);

· methoxsalen (Oxsoralen);

· primaquine or thiabendazole (Mintezol);

· rifampin (Rifadin, Rifater, Rifamate, Rimactane);

· an antibiotic such as ciprofloxacin (Cipro), norfloxacin (Noroxin), or ofloxacin (Floxin);

· heart rhythm medicine such as amiodarone (Cordarone, Pacerone) or mexiletine (Mexitil); or

· an antifungal medicine such as fluconazole (Diflucan) or ketoconazole (Nizoral).

• This list is not complete and another drugs may interact with ramelteon. Speak your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal commodity. Do not start a new medicine without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about ramelteon.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.