Ramelteon Oral tablet

What is this medicine?

RAMELTEON (ram EL tee on) is used to treat insomnia. This medicine helps you to fall asleep.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• depression
• history of a drug or alcohol abuse problem
• liver disease
• lung or breathing disease
• suicidal thoughts
• an unusual or allergic reaction to ramelteon, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Do not break tablets; swallow whole. Follow the directions on the prescription label. It is better to take this medicine on an empty stomach and only when you are ready for bed. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. This medicine should only be taken immediately before going to sleep. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• fluvoxamine
• melatonin

This medicine may also interact with the following medications:

• medicines used to treat fungal infections like ketoconazole, fluconazole, or itraconazole
• rifampin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. If your condition gets worse after you start taking this medicine or you notice any different emotions or behaviors (like anxiety, depression, excessive excitement, or mania), you should contact your health care provider right away.

Do not take this medicine unless you are able to get a full night's sleep before you must be active again. You may not be able to remember things that you do in the hours after you take this medicine. Some people have reported driving, making phone calls, or preparing and eating food while asleep after taking sleep medicine. Take this medicine right before going to sleep. Tell your doctor if you are have any problems with your memory.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breast milk production or discharge
• breathing problems
• joint or muscle pain
• depression, suicidal thoughts
• missed monthly period (for women)
• unusual activities while asleep like driving, eating, making phone calls
• unusually weak or tired
• worsening of insomnia

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• bad taste
• daytime sleepiness
• decreased sex drive
• diarrhea
• headache
• nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep the container tightly closed. Protect from moisture and humidity. Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.