17.2 FDA-Approved Medication Guide

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

•   agitation, hallucinations, coma or other changes in mental status
•   coordination problems or muscle twitching (overactive reflexes)
•   racing heartbeat, high or low blood pressure
•   sweating or fever
•   nausea, vomiting, or diarrhea
•   muscle rigidity

3. Severe  allergic  reactions:

• trouble breathing
• swelling of the face, tongue, eyes or mouth
• rash, itchy welts (hives) or blisters, alone or with fever or joint pain

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:

•   greatly increased energy
•   severe trouble sleeping
•   racing thoughts
•   reckless behavior
•   unusually grand ideas
•   excessive happiness or irritability
•   talking more or faster than usual

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:

•   headache
•   weakness or feeling unsteady
•   confusion, problems concentrating or thinking or memory problems

9.  Visual problems

•   eye pain
•   changes in vision
•   swelling or redness in or around the eye

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:

•   anxiety, irritability, high or low mood, feeling restless or changes in sleep habits
•   headache, sweating, nausea, dizziness
•   electric shock-like sensations, shaking, confusion

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:

•   Major Depressive Disorder (MDD)
•   Generalized Anxiety Disorder (GAD)

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:

• are allergic to escitalopram oxalate or citalopram hydrobromide or any of the ingredients in escitalopram tablets. See the end of this Medication Guide for a complete list of ingredients in escitalopram tablets.
• take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
• Do not take an MAOI within 2 weeks of stopping escitalopram tablets unless directed to do so by your physician.
• 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:

•   high fever
•   uncontrolled muscle spasms
•   stiff muscles
•   rapid changes in heart rate or blood pressure
•   confusion
•   loss of consciousness (pass out)
•   take the antipsychotic medicine pimozide (Orap ®) because taking this drug with escitalopram tablets 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:

•   Are taking certain drugs such as:
•   Triptans used to treat migraine headache
•   Medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, SSRIs, SNRIs, or antipsychotics
•   tramadol
•   Over-the-counter supplements such as tryptophan or St. John's Wort
•   have liver problems
•   have kidney problems
•   have heart problems
•   have or had seizures or convulsions
•   have bipolar disorder or mania
•   have low sodium levels in your blood
•   have a history of a stroke
•   have high blood pressure
•   have or had bleeding problems
•   are pregnant or plan to become pregnant. It is not known if escitalopram tablets will harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating depression during pregnancy
•   are breast-feeding or plan to breast-feed. Some escitalopram oxalate may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking escitalopram tablets.

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?

•   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.
•   Escitalopram tablets may be taken with or without food.
•   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.
•   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 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 :

•   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 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 FDA AT 1-800-FDA-1088.

How  should  I  store  escitalopram  tablets?

• Store escitalopram tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
• 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 about escitalopram tablets call 1-269-544-2299.

What  are  the  ingredients  in  escitalopram  tablets?

Active ingredient: escitalopram oxalate, USP

Inactive ingredients:

•   Tablets : cellulose microcrystalline, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, povidone and talc. The film coating contains hypromellose, polyethylene glycol 400 and titanium dioxide.

Trademarks are the property of their respective owners.

Manufactured by:

TORRENT PHARMACEUTICALS LTD., Indrad-382 721, Dist. Mehsana, INDIA.

For:

     TORRENT PHARMA INC., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920.

8053133                                                                                       Revised January 2015

                                                            OR

Manufactured by:

TORRENT PHARMACEUTICALS LTD., Bharuch-392130, INDIA.

For:

TORRENT PHARMA INC., Basking Ridge, NJ 07920.

8055813                                                                                     Revised July 2015

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