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.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

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. Keep a regular sleep schedule by going to bed at about the same time each night. Avoid caffeine-containing drinks in the evening hours. Talk to your doctor if you still have trouble sleeping within 7 to 10 days of using this medicine. This may mean there is another cause for your sleep problems.

After taking this medicine for sleep, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may have no memory of the event. Activities such as driving a car ("sleep-driving"), making and eating food, talking on the phone, sexual activity, and sleep-walking have been reported. Call your doctor right away if you find out you have done any of these activities. Do not take this medicine if you drink alcohol or have taken another medicine for sleep, since your risk of doing these sleep-related activities will be increased.

Do not take this medicine unless you are able to stay in bed for a full night (7 to 8 hours) before you must be active again. You may have a decrease in mental alertness the day after use, even if you feel that you are fully awake. Tell your doctor if you will need to perform activities requiring full alertness, such as driving, the next day. Do not stand or sit up quickly after taking this medicine, especially if you are an older patient. This reduces the risk of dizzy or fainting spells.

If you or your family notice any changes in your behavior, such as new or worsening depression, thoughts of harming yourself, anxiety, other unusual or disturbing thoughts, or memory loss, call your doctor right away.

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.