ESCITALOPRAM - escitalopram oxalate tablet, film coated 
Aurobindo Pharma Limited

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Read the Medication Guide that comes with escitalopram 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 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.

What is the most important information I should know about escitalopram tablets?


Escitalopram tablets and other antidepressant medicines may cause serious side effects, including:


1. Suicidal thoughts or actions:



Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.


Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:



Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Escitalopram tablets may be associated with these serious side effects:

2. Serotonin Syndrome. This condition can be life-threatening and may include:



3. Severe allergic reactions:



4. Abnormal bleeding: Escitalopram tablets and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a non-­steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin.


5. Seizures or convulsions


6. Manic episodes:



7. Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.

8. Low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:


9. Visual problems


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:


What are escitalopram tablets?


Escitalopram tablets are 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:



Talk to your healthcare provider if you do not think that your condition is getting better with escitalopram tablets treatment.


Who should not take escitalopram tablets?


Do not take escitalopram tablets if you:



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:




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.


If you take escitalopram tablets, you should not take any other medicines that contain escitalopram oxalate or citalopram hydrobromide including: Celexa.

How should I take escitalopram tablets?



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 affect you. Do not drink alcohol while using escitalopram tablets.

What are the possible side effects of escitalopram tablets?


Escitalopram tablets may cause serious side effects, including all of those described in the section entitled “What is the most important information I should know about escitalopram tablets?”


Common possible side effects in people who take escitalopram tablets include:



Other side effects in children and adolescents include:



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?



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. They 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 about escitalopram tablets call 1-866-850-2876.


What are the ingredients in escitalopram tablets?


Active ingredient: escitalopram oxalate


Inactive ingredients: butylated hydroxyl anisole, butylated hydroxy toluene, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, silicified microcrystalline cellulose, and talc. The film coating contains hypromellose, polyethylene glycol 400, and titanium dioxide.


Coumadin® is a registered trademark of Bristol Myers Squibb.

Jantoven® is a registered trademark of Upsher-Smith Laboratories Inc.

Orap® is a registered trademark of Teva Pharmaceuticals USA.


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


Manufactured for:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 072, India

Revised: 08/2014

Revised: 08/2014
 
Aurobindo Pharma Limited