ESCITALOPRAM- escitalopram oxalate tablet, film coated 
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Medguide

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

Read the Medication Guide that comes with escitalopram 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.

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

Escitalopram 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 anemergency. Escitalopram 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 and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin®, Jantoven®), a nonsteroidal 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:

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

What is escitalopram?

Escitalopram 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 is also used to treat:

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

Who should not take escitalopram?

Do not take escitalopram if you:

People who take escitalopram 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? Ask if you are not sure.

Before starting escitalopram, 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 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 with your other medicines. Do not start or stop any medicine while taking escitalopram without talking to your healthcare provider first.

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

How should I take escitalopram?

  • Take escitalopram exactly as prescribed. Your healthcare provider may need to change the dose of escitalopram until it is the right dose for you.
  • Escitalopram may be taken with or without food.
  • If you miss a dose of escitalopram, 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 at the same time.
  • If you take too much escitalopram, call your healthcare provider or poison control center right away, or get emergency treatment.

What should I avoid while taking escitalopram?

Escitalopram 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 affects you. Do not drink alcohol while using escitalopram.

What are the possible side effects of escitalopram?

Escitalopram 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?

Common possible side effects in people who take escitalopram include:

  • Nausea
  • Sleepiness
  • Weakness
  • Dizziness
  • Feeling anxious
  • Trouble sleeping
  • Sexual problems
  • Sweating
  • Shaking
  • Not feeling hungry
  •  Dry mouth
  • Constipation
  • Infection
  • Yawning

Other side effects in children and adolescents include:

  • increased thirst
  • abnormal increase in muscle movement or agitation
  • nose bleed
  • difficult urination
  • heavy menstrual periods
  • possible slowed growth rate and weight change. Your child’s height and weight should be monitored during treatment with escitalopram.

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. 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?

  • Store escitalopram at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
  • Keep escitalopram bottle closed tightly.

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

General information about escitalopram

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use

escitalopram for a condition for which it was not prescribed. Do not give escitalopram to other people, even if they have the same condition. It may harm them.

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

For more information about escitalopram call Teva Pharmaceuticals Medical Affairs at 1-888-838-2872.

What are the ingredients in escitalopram?

Active ingredient: escitalopram oxalate, USP

Inactive ingredients: corn starch, croscarmellose sodium, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol and titanium dioxide.

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

Manufactured In India By:

CIPLA LTD.

Kurkumbh, India

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. A 12/2012

All trademarks are the property of their respective owners.

Revised: 09/2013
 
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