17.2 FDA-Approved Medication Guide

                                                                                                  Medication Guide

                                                                                           Escitalopram Tablets
                                                                                              (ES-sye-TAL-oh-pram)

 

Read the Medication Guide that comes with escitalopram 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 healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or want to learn more about.

Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

Do not stop escitalopram tablets without first talking to your healthcare provider. Stopping escitalopram tablets too quickly may cause serious symptoms including:

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anxiety, irritability, high or low mood, feeling restless or changes in sleep habits

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headache, sweating, nausea, dizziness

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electric shock-like sensations, shaking, confusion

 

What are escitalopram tablets?
Escitalopram tablet is a prescription medicine used to treat depression. It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider.
Escitalopram tablets are also used to treat:

Who should not take escitalopram tablets?
Do not take escitalopram tablets if you:

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are allergic to escitalopram or citalopram or any of the ingredients in escitalopram tablets. See the end of this Medication Guide for a complete list of ingredients in escitalopram tablets.

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Take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or a pharmacist if you are not sure if you take an MAOI, including linezolid.

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Do not take an MAOI within 2 weeks of stopping escitalopram tablets unless directed to do so by your physician.

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Do not start escitalopram tablets if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.

People who take escitalopram tablets close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:

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high fever

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uncontrolled muscle spasms

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stiff muscles

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rapid changes in heart rate or blood pressure

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confusion

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loss of consciousness (pass out)

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Do not take escitalopram tablets with Orap ® (pimozide) because taking these two drugs together can cause serious heart problems.

 

What should I tell my healthcare provider before taking escitalopram tablets? Ask if you are not sure.
Before starting escitalopram tablets, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Escitalopram tablets and some medicines may interact with each other, may not work as well, or may cause serious side effects.

Your healthcare provider or pharmacist can tell you if it is safe to take escitalopram tablets with your other medicines. Do not start or stop any medicine while taking escitalopram tablets without talking to your healthcare provider first.

How should I take escitalopram tablets?

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Take escitalopram tablets exactly as prescribed. Your healthcare provider may need to change the dose of escitalopram tablets until it is the right dose for you.

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Escitalopram tablets may be taken with or without food.

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If you miss a dose of escitalopram tablets, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of escitalopram tablets at the same time.

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If you take too much escitalopram tablets, call your healthcare provider or poison control center right away, or get emergency treatment.

 

What should I avoid while taking escitalopram tablets?
Escitalopram tablets can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how escitalopram tablets affects you. Do not drink alcohol while using escitalopram tablets.

Other side effects in children and adolescents include:

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increased thirst

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abnormal increase in muscle movement or agitation

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nose bleed

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difficult urination

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heavy menstrual periods

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possible slowed growth rate and weight change.

Your child’s height and weight should be monitored during treatment with escitalopram tablets.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of escitalopram tablets. For more information, ask your healthcare provider or pharmacist.

CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088.

How should I store escitalopram tablets?

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Store escitalopram tablets at 68°F to 77°F (20°C to 25°C); excursions permitted to 59°F to 86°F (15°C to 30°C).[see USP Controlled Room Temperature].

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Keep escitalopram tablets bottle closed tightly.

Keep escitalopram tablets and all medicines out of the reach of children.

 

General information about escitalopram tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use escitalopram tablets for a condition for which it was not prescribed. Do not give escitalopram tablets to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about escitalopram tablets. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about escitalopram tablets that is written for healthcare professionals.

For more information, go to www.accordhealthcare.us or call Accord Healthcare Inc. at 1-866-941-7875.

 

What are the ingredients in escitalopram tablets?

Active ingredient: escitalopram oxalate
Inactive ingredients:

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

Coumadin ® is registered trademark of Bristol-Myers Squibb Company.
Jantoven ® is registered trademark of Upsher-Smith Laboratories, Inc.
Orap ® is registered trademark of Teva Pharmaceuticals USA

Medication guide available at www.accordhealthcare.us/medication-guides.

Manufactured For:
Accord Healthcare, Inc.,
1009 Slater Road,
Suite 210-B,
Durham, NC 27703,
USA.

 

Manufactured By:
Intas Pharmaceuticals Limited,
Ahmedabad -380054, India.

10 0653 3 697356

Issued May 2019