SERTRALINE HYDROCHLORIDE - sertraline hydrochloride solution, concentrate 
Aurobindo Pharma Limited

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Medication Guide

Sertraline Hydrochloride Oral Solution USP

(ser' tra leen hye'' droe klor' ide)

What is the most important information I should know about sertraline hydrochloride oral solution?


Sertraline hydrochloride oral solution and other antidepressant medicines may cause serious side effects. Call your healthcare provider right away if you have any of the following symptoms, or call 911 if there is an emergency.


1. Suicidal thoughts or actions:


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:


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



3. Increased chance of bleeding: sertraline hydrochloride oral solution 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.

4. Manic episodes. Symptoms may include:



5. Seizures or convulsions.

6. Glaucoma (angle-closure glaucoma). Many antidepressant medicines including sertraline hydrochloride oral solution may cause a certain type of eye problem
     called angle-closure glaucoma. Call your healthcare provider if you have eye pain, changes in your vision, or 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.


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 sertraline hydrochloride oral solution without first talking to your healthcare provider. Stopping sertraline hydrochloride oral solution too quickly may cause serious symptoms including:



What is Sertraline Hydrochloride Oral Solution?


Sertraline hydrochloride oral solution is a prescription medicine used to treat:



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.


Sertraline hydrochloride oral solution is safe and effective in treating children with OCD age 6 to 17 years.


It is not known if sertraline hydrochloride oral solution is safe and effective for use in children under 6 years of age with OCD or children with other behavior health conditions.


Talk to your healthcare provider if you do not think that your condition is getting better with sertraline hydrochloride oral solution treatment.


Who should not take sertraline hydrochloride oral solution?

Do not take sertraline hydrochloride oral solution if you:



People who take sertraline hydrochloride oral solution 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 sertraline hydrochloride oral solution?

Before starting sertraline hydrochloride oral solution, tell your healthcare provider:




Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.


Sertraline hydrochloride oral solution 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 sertraline hydrochloride oral solution with your other medicines. Do not start or stop any medicine while taking sertraline hydrochloride oral solution without talking to your healthcare provider first.


How should I take sertraline hydrochloride oral solution?




If you take too much sertraline hydrochloride oral solution, call your healthcare provider or poison control center right away, or go to the nearest hospital emergency room right away.


What should I avoid while taking sertraline hydrochloride oral solution?

Sertraline hydrochloride oral solution 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 sertraline hydrochloride oral solution affects you. Do not drink alcohol while you take sertraline hydrochloride oral solution.


What are the possible side effects of sertraline hydrochloride oral solution?

Sertraline hydrochloride oral solution may cause serious side effects, including:



The most common side effects in adults who take sertraline hydrochloride oral solution include:



The most common side effects in children and adolescents who take include abnormal increase in muscle movement or agitation, nose bleeds, urinary incontinence, aggressive reaction, possible slowed growth rate, and weight change. Your child’s height and weight should be monitored during treatment with sertraline hydrochloride oral solution.


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 sertraline hydrochloride oral solution. 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 sertraline hydrochloride oral solution?



Keep sertraline hydrochloride oral solution and all medicines out of the reach of children.


General information about the safe and effective use of sertraline hydrochloride oral solution

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


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


For more information call Aurobindo Pharma USA, Inc. at 1-866-850-2876.


What are the ingredients in sertraline hydrochloride oral solution?

Active ingredient: sertraline hydrochloride


Inactive ingredients: alcohol (12%), natural peppermint flavor, propylene glycol and purified water.


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


Dispense with Medication Guide available at: www.aurobindousa.com/product-medication-guides


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

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

Revised: 02/2017

Revised: 2/2017
Aurobindo Pharma Limited