ESZOPICLONE- eszopiclone tablet
Hikma Pharmaceuticals USA Inc.
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Eszopiclone Tablets (ES-zoe-PIK-lone), coated CIV
Read the Medication Guide that comes with eszopiclone 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 eszopiclone?
Eszopiclone may cause serious side effects, including:
Complex sleep behaviors that have caused serious injury and death. After taking eszopiclone, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing (complex sleep behaviors). The next morning, you may not remember that you did anything during the night. These activities may occur with eszopiclone whether or not you drink alcohol or take other medicines that make you sleepy.
The morning after you take eszopiclone your ability to drive safely and think clearly may be decreased. You also may experience sleepiness during the day.
Do not take eszopiclone if you:
What is eszopiclone?
Eszopiclone is a sedative-hypnotic (sleep) medicine. Eszopiclone is used in adults for the treatment of a sleep problem called insomnia. Symptoms of insomnia include:
Eszopiclone is not for children.
Eszopiclone is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep eszopiclone in a safe place to prevent misuse and abuse. Selling or giving away eszopiclone 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?
Eszopiclone may not be right for you. Before starting eszopiclone, 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 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?
What are the possible side effects of eszopiclone?
Possible serious side effects of eszopiclone 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.
The most common side effects of eszopiclone are:
These are not all the side effects of eszopiclone. 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?
General Information about eszopiclone
This Medication Guide summarizes the most important information about eszopiclone. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about eszopiclone that is written for healthcare professionals.
For product information call 1-800-962-8364.
What are the ingredients in Eszopiclone Tablets, USP?
Active Ingredient: eszopiclone, USP
Inactive Ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose (anhydrous), magnesium stearate, microcrystalline cellulose, and Opadry II (White). Opadry II (White) contains hypromellose, polydextrose, polyethylene glycol, titanium dioxide and triacetin.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Distr. by: Hikma
Pharmaceuticals USA Inc.
Berkeley Heights, NJ 07922
C50000543/01
Revised September 2020