ESZOPICLONE - eszopiclone tablet, film coated
Aphena Pharma Solutions - Tennessee, LLC
Eszopiclone (ES-zoe-PIK-lone) Tablets, Coated C-IV
Read the Medication Guide that comes with eszopiclone tablets before you start taking them 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 eszopiclone tablets?
After taking eszopiclone 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 eszopiclone tablets. Reported activities include:
Call your doctor right away if you find out that you have done any of the above activities after taking eszopiclone tablets.
1. Take eszopiclone tablets exactly as prescribed
2. Do not take eszopiclone tablets if you:
WHAT ARE ESZOPICLONE TABLETS?
Eszopiclone tablets are a sedative-hypnotic (sleep) medicine. Eszopiclone tablets are used in adults for the treatment of a sleep problem called insomnia. Symptoms of insomnia include:
Eszopiclone tablets are not for children.
Eszopiclone tablets are a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep eszopiclone tablets in a safe place to prevent misuse and abuse. Selling or giving away eszopiclone tablets may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.
Who should not take eszopiclone tablets?
Do not take eszopiclone tablets if you are allergic to anything in it.
See the end of this Medication Guide for a complete list of ingredients in eszopiclone tablets.
Eszopiclone tablets may not be right for you. Before starting eszopiclone 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 eszopiclone tablets with other medicines that can make you sleepy.
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 eszopiclone tablets?
What are the possible side effects of eszopiclone tablets?
Possible serious side effects of eszopiclone tablets include:
Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using eszopiclone tablets.
The most common side effects of eszopiclone tablets are:
These are not all the side effects of eszopiclone tablets. Ask your doctor or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I Store eszopiclone tablets?
General Information about eszopiclone tablets
This Medication Guide summarizes the most important information about eszopiclone tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about eszopiclone tablets that is written for healthcare professionals.
For customer support or for medical information please call the AvKARE Customer Response Line at 1-855-361-3993. You may report side effects to FDA at 1-800-FDA-1088 or to AvKARE at 1-855-361-3993.
What are the ingredients in eszopiclone tablets?
Active Ingredient: eszopiclone.
Inactive Ingredients: colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide. Additionally, the 1 mg tablet contains FD&C blue #1/aluminum lake; the 2 mg tablet contains polysorbate; and the 3 mg tablet contains FD&C blue #2/aluminum lake.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Pulaski, TN 38478
Mfg. Rev. A 10/13
AV 05/14 (P)