ESZOPICLONE

Main information

  • Trade name:
  • ESZOPICLONE- eszopiclone tablet, coated
  • Composition:
  • ESZOPICLONE 3 mg
  • Administration route:
  • ORAL
  • Prescription type:
  • PRESCRIPTION DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ESZOPICLONE- eszopiclone tablet, coated
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone administered at bedtime decreased sleep latency and improved sleep maintenance.   The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). Eszopiclone tablets are contraindicated in patients with known hypersensitivity to eszopiclone. Hypersensitivity reactions include anaphylaxis and angioedema [see Warnings and Precautions (5.3) ]. Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Eszopiclone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.   Oral administration of eszopiclone to pregnant rats (62.5, 125, or 250 mg/ kg/ day) and rabbits
  • Product summary:
  • Eszopiclone tablets, 1 mg are light blue colored, film coated, round, biconvex beveled edge tablets debossed with “RDY” on one side and “629” on other side and are supplied in bottles of 30’s, 100’s  and 500’s.   Bottles of 30                                                               NDC 55111-629-30 Bottles of 100                                                             NDC 55111-629-01 Bottles of 500                                                             NDC 55111-629-05   Eszopiclone tablets, 2 mg are white colored, film coated, round, biconvex beveled edge tablets debossed with “RDY” on one side and “619” on other side and are supplied in bottles of 30’s, 90’s, 100’s , 500’s and unit dose package of 90 (9 x 10).  Bottles of 30                                                               NDC 55111-619-30 Bottles of 90                                                               NDC 55111-619-90 Bottles of 100                                                             NDC 55111-619-01 Bottles of 500                                                             NDC 55111-619-05 Unit dose package of 90 (9 x 10)                               NDC 55111-619-09   Eszopiclone tablets, 3 mg are dark blue colored, film coated, round, biconvex beveled edge tablets debossed with “RDY” on one side and “617” on other side and are supplied in bottles of 30’s, 90’s, 100’s , 500’s and unit dose package of 90 (9 x 10).  Bottles of 30                                                               NDC 55111-617-30 Bottles of 90                                                               NDC 55111-617-90 Bottles of 100                                                             NDC 55111-617-01 Bottles of 500                                                             NDC 55111-617-05 Unit dose package of 90 (9 x 10)                               NDC 55111-617-09   Store at 20°-25°C (68°-77°F); [see USP Controlled Room Temperature].

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • Abbreviated New Drug Application
  • Authorization number:
  • 70518-0815-0
  • Last update:
  • 26-05-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

REMEDYREPACK INC.

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MEDICATION GUIDE

Eszopiclone Tablets, Coated C-IV

(ES-zoe-PIK-lone)

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?

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 that you may not know are happening to you.These

side effects include:

sleepiness during the day

not thinking clearly

act strangely, confused, or upset

"sleep-walking" or doing other activities when you are asleep like:

eating

talking

having sex

driving a car

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.

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

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:

trouble falling asleep

waking up often during the night

Eszopiclone is not for children.

Eszopiclone 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

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 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 tablets 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 do 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, 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 20°-25°C (68°-77°F); [see USP Controlled Room Temperature].

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 it was not prescribed.

Do not share eszopiclone tablets with other people, even if you think they have the same

symptoms that you have. It 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.

For customer service, call 1-866-733-3952.

To report side effects, call 1-888-375-3784.

For medical information, call 1-888-375-3784.

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 and titanium

dioxide. In addition, both the 1 mg and 3 mg tablets contain FD&C Blue #2 and triacetin.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Rx Only

Manufactured by:

Dr. Reddy’s Laboratories Limited

Bachupally – 500 090 INDIA

Revised: 0217

Dispense with Medication Guide available at:www.drreddys.com/medguide/eszopiclonetabs.pdf

Revised: 11/2017

Document Id: 5d060412-185b-6f49-e053-2991aa0ad476

34391-3

Set id: 6bed0820-bd3a-4dce-b763-f6156df23bf7

Version: 1

Effective Time: 20171102

REMEDYREPACK INC.