RAMELTEON- ramelteon tablet, film coated
i3 Pharmaceuticals, LLC
Read the Medication Guide that comes with Ramelteon Tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment.
What is the most important information I should know about Ramelteon Tablets?
Ramelteon Tablets may cause severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you get these symptoms after taking Ramelteon Tablets.
After taking Ramelteon Tablets, 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 not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with Ramelteon Tablets. Activities may include:
Call your doctor right away if you find out that you have done any of the above activities after taking Ramelteon Tablets.
1. Take Ramelteon Tablets exactly as prescribed
2. Do not take Ramelteon Tablets if you:
WHAT ARE RAMELTEON TABLETS?
Ramelteon Tablets are a hypnotic (sleep) medicine. Ramelteon Tablets are used in adults for the treatment of the symptom of trouble falling asleep from insomnia.
Ramelteon Tablets are not for children.
Who should not take Ramelteon Tablets?
Do not take Ramelteon Tablets if you are allergic to anything in it. See the end of this Medication Guide for a complete list of ingredients in Ramelteon Tablets.
Do not take Ramelteon Tablets if you are currently taking Luvox (fluvoxamine).
Ramelteon Tablets may not be right for you. Before starting Ramelteon Tablets, tell your doctor about all of your health conditions, including if you:
Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Medicines can interact with each other, sometimes causing serious side effects.
Do not take Ramelteon Tablets with:
Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.
How should I take Ramelteon Tablets?
What are the possible side effects of Ramelteon Tablets?
Possible serious side effects of Ramelteon Tablets include:
decreased interest in sex
• problems getting pregnant
• irregular menstrual periods or no menstrual periods
• leakage of milk from the nipples of a person who is not breastfeeding
Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using Ramelteon Tablets. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
The most common side effects of Ramelteon Tablets are:
These are not all the side effects of Ramelteon Tablets. Ask your doctor or pharmacist for more information.
How should I Store Ramelteon Tablets?
General Information about Ramelteon Tablets
This Medication Guide summarizes the most important information about Ramelteon Tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Ramelteon Tablets that is written for healthcare professionals. For more information about Ramelteon Tablets, please call i3 Pharmaceuticals, LLC at 1-844-874-7353.
What are the ingredients in Ramelteon Tablets?
Active Ingredient: ramelteon
Inactive Ingredients: lactose monohydrate, pregelatinized starch, hydroxypropyl cellulose, crospovidone, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc and iron oxide yellow.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured and Distributed by:
i3 Pharmaceuticals, LLC
200 Park Avenue, Warminster, PA 18974