SERTRALINE HYDROCHLORIDE - sertraline hydrochloride solution, concentrate 
Aurobindo Pharma Limited

----------

Medication Guide


Sertraline Hydrochloride Oral Solution USP
(ser' tra leen hye'' droe klor' ide)


Read the Medication Guide that comes with sertraline hydrochloride oral solution 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 sertraline hydrochloride
oral solution?
 
Sertraline hydrochloride oral solution 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. Sertraline hydrochloride oral solution 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: 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.

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 sertraline hydrochloride oral solutio
n 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 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. Sertraline hydrochloride oral solution is also used to treat: 


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? Ask if you are not sure.

Before starting sertraline hydrochloride oral solution, 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. 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.


   If you take sertraline hydrochloride oral solution, you should not take any other medicines that contain sertraline (sertraline hydrochloride etc.).

How should I take sertraline hydrochloride oral solution?



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 using 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: 


Common possible side effects in people who take sertraline hydrochloride oral solution 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 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 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 about sertraline hydrochloride oral solution call 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.

Orap® is a registered trademark of Teva Pharmaceuticals USA.
Coumadin® is a registered trademark of Bristol Myers Squibb.
Jantoven® is a registered trademark of Upsher-Smith Laboratories Inc.
Antabuse® is a registered trademark of Duramed Pharmaceuticals, Inc. and Ayerst, McKenna & Harrison Limited.

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

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

Revised: 10/2014

Revised: 10/2014
 
Aurobindo Pharma Limited