ESZOPICLONE (Page 6 of 7)

16 HOW SUPPLIED/STORAGE AND HANDLING

Product: 50090-3514

NDC: 50090-3514-0 30 TABLET, FILM COATED in a BOTTLE

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Medication Guide).

Inform patients and their families about the benefits and risks of treatment with eszopiclone. Inform patients of the availability of a Medication Guide and instruct them to read the Medication Guide prior to initiating treatment with eszopiclone and with each prescription refill. Review the eszopiclone Medication Guide with every patient prior to initiation of treatment. Instruct patients or caregivers that eszopiclone should be taken only as prescribed.

Complex Sleep Behaviors

Instruct patients and their families that eszopiclone may cause complex sleep behaviors, including sleep-walking, sleep-driving, preparing and eating food, making phone calls, or having sex while not being fully awake. Serious injuries and death have occurred during complex sleep behavior episodes. Tell patients to discontinue eszopiclone and notify their healthcare provider immediately if they develop any of these symptoms [see Boxed Warning, Warnings and Precautions (5.1)].

CNS Depressant Effects and Next-Day Impairment

Tell patients that eszopiclone can cause next-day impairment even when used as prescribed, and that this risk is increased if dosing instructions are not carefully followed. Caution patients taking the 3 mg dose against driving and other activities requiring complete mental alertness the day after use. Inform patients that impairment can be present despite feeling fully awake. Advise patients that increased drowsiness and decreased consciousness may increase the risk of falls in some patients [see Warnings and Precautions (5.2)].

Severe Anaphylactic and Anaphylactoid Reactions

Inform patients that severe anaphylactic and anaphylactoid reactions have occurred with eszopiclone. Describe the signs/symptoms of these reactions and advise patients to seek medical attention immediately if any of them occur [see Warnings and Precautions (5.4)].

Suicide

Tell patients to immediately report any suicidal thoughts.

Alcohol and Other Drugs

Ask patients about alcohol consumption, medicines they are taking, and drugs they may be taking without a prescription. Advise patients not to use eszopiclone if they drank alcohol that evening or before bed.

Tolerance, Abuse, and Dependence

Tell patients not to increase the dose of eszopiclone on their own, and to inform you if they believe the drug “does not work.”

Administration Instructions

Patients should be counseled to take eszopiclone right before they get into bed and only when they are able to stay in bed a full night (7 to 8 hours) before being active again. Eszopiclone tablets should not be taken with or immediately after a meal. Advise patients NOT to take eszopiclone if they drank alcohol that evening.

Dispense with Medication Guide available at: www.aurobindousa.com/product-medication-guides

MEDICATION GUIDE

Eszopiclone Tablets USP CIV
(es-zoe’-pi-klone)

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?

  • Do not take more eszopiclone tablets than prescribed.

  • Do not take eszopiclone tablets unless you are able to stay in bed a full night (7 to 8 hours) before you must be active again.

  • Take eszopiclone tablets right before you get in bed, not sooner.

Eszopiclone tablets may cause serious side effects, including:

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:

  • doing activities when you are asleep like:
    • making and eating food
    • talking on the phone
    • having sex
    • driving a car (“sleep-driving”)
    • sleep walking

Stop taking eszopiclone tablets and call your healthcare provider right away if you find out that you have done any of the above activities after taking eszopiclone tablets.

The morning after you take eszopiclone tablets your ability to drive safely and think clearly may be decreased. You also may experience sleepiness during the day.

Do not take eszopiclone tablets if you:

  • have ever experienced a complex sleep behavior (such as driving a car, making and eating food, talking on the phone or having sex while not fully awake) after taking eszopiclone tablets.
  • 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

What are eszopiclone tablets?

Eszopiclone tablets are sedative-hypnotic (sleep) medicine. Eszopiclone tablets are used in adults for the treatment of a sleep problem called insomnia. Symptoms of insomnia include:

  • trouble falling asleep
  • waking up often during the night

Eszopiclone tablets are not for children.

Eszopiclone tablets are federally controlled substance (C-IV) because they 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 have ever had a complex sleep behavior happen after taking 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:

  • have a history of depression, mental illness, or suicidal thoughts
  • have a history of drug or alcohol abuse or addiction
  • have liver disease
  • are pregnant, planning to become pregnant, or breastfeeding

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?

  • Take eszopiclone tablets exactly as prescribed. Do not take more eszopiclone tablets than prescribed for you.
  • Take eszopiclone tablets right before you get into bed.
  • Do not take eszopiclone tablets with or right after a meal.
  • Do not take eszopiclone tablets unless you are able to get a full night’s sleep before you must be active again.
  • Call your doctor if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problems.
  • If you take too much eszopiclone or overdose, call your doctor or poison control center right away, or get emergency treatment.

What are the possible side effects of eszopiclone tablets?

Possible serious side effects of eszopiclone tablets include:

  • getting out of bed while not being fully awake and doing an activity that you do not know you are doing. (See “What is the most important information I should know about eszopiclone tablets?”)
  • abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, acting strangely, hallucinations, worsening of depression, and suicidal thoughts or actions.
  • memory loss
  • anxiety
  • 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 eszopiclone tablets.

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:

  • unpleasant taste in mouth, dry mouth
  • drowsiness
  • dizziness
  • headache
  • symptoms of the common cold
  • You may still feel drowsy the next day after taking eszopiclone tablets. Do not drive or do other dangerous activities after taking eszopiclone tablets until you feel fully awake.

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?

  • Store eszopiclone tablets at room temperature, between 68° to 77°F (20° to 25°C).
  • Do not use eszopiclone tablets after the expiration date.
  • Keep eszopiclone tablets and all medicines out of reach of children.

General Information about eszopiclone tablets

  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.
  • Do not use eszopiclone tablets for a condition for which they were not prescribed.
  • Do not share eszopiclone tablets with other people, even if you think they have the same symptoms that you have. They may harm them and is against the law.

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.

  • To report side effects, call Aurobindo Pharma USA, Inc. at 1-866-850-2876.

What are the ingredients in eszopiclone tablets?

Active Ingredient: eszopiclone

Inactive Ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcelac 100 (lactose monohydrate and cellulose, microcrystalline), polyethylene glycol, titanium dioxide, and triacetin. 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.

Dispense with Medication Guide available at: www.aurobindousa.com/product-medication-guides

Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Manufactured by:
Aurobindo Pharma Limited
Hyderabad–500 038, India Revised: 11/2019

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