ESZOPICLONE- eszopiclone tablet, film coated
Lupin Pharmaceuticals, Inc.
Read the Medication Guide that comes with eszopiclone 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 eszopiclone tablets?
Complex sleep behaviors that have caused serious injury and death. 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 (complex sleep behaviors). The next morning, you may not remember that you did anything during the night. These activities may occur with eszopiclone tablets whether or not you drink alcohol or take other medicines that make you sleepy.
Reported activities and behaviors include:
The morning after you take eszopiclone tablets your ability to drive safely and think clearly may be decreased.
Do not take eszopiclone tablets if you:
drank alcohol that evening or before bed
take other medicines that can make you sleepy. Talk to your doctor about all of your medicines. Your doctor will tell you if you can take eszopiclone tablets with your other medicines.
cannot get a full night's sleep
Eszopiclone tablet is a sedative-hypnotic (sleep) medicine. Eszopiclone tablet is used in adults for the treatment of a sleep problem called insomnia. Symptoms of insomnia include:
Eszopiclone tablet is 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.
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?
Possible serious side effects of eszopiclone tablets include:
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. You may also report side effects to Lupin Pharmaceuticals, Inc. at 1-800-399-2561.
How should I store 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.
Active Ingredient: eszopiclone
Inactive Ingredients: colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, hypromellose, lactose monohydrate, polyethylene glycol, povidone, pregelatinized starch, magnesium stearate and titanium dioxide. In addition, both the 1 mg and 3 mg tablets contain FD&C Blue #2.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Lupin Pharmaceuticals, Inc.
Baltimore, Maryland 21202
Goa 403 722
Revised: October 2019 ID#: 262264