ZOLOFT- sertraline hydrochloride tablet, film coated 
ZOLOFT- sertraline hydrochloride solution, concentrate 
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Medication Guide

ZOLOFT (ZOH-loft)
(sertraline hydrochloride)
(Tablets and Oral Concentrate (solution))

Read the Medication Guide that comes with ZOLOFT 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 ZOLOFT?

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

1.
Suicidal thoughts or actions:
  • ZOLOFT and other antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment or when the dose is changed.
  • Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
  • Watch for these changes and call your healthcare provider right away if you notice:
    • New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
    • Pay particular attention to such changes when ZOLOFT is started or when the dose is changed.

    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:
    • attempts to commit suicide
    • acting on dangerous impulses
    • acting aggressive or violent
    • thoughts about suicide or dying
    • new or worse depression
    • new or worse anxiety or panic attacks
    • feeling agitated, restless, angry or irritable
    • trouble sleeping
    • an increase in activity or talking more than what is normal for you
    • other unusual changes in behavior or mood

Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. ZOLOFT may be associated with these serious side effects:
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: ZOLOFT 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 ZOLOFT without first talking to your healthcare provider. Stopping ZOLOFT too quickly may cause serious symptoms including:

What is ZOLOFT?

ZOLOFT 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. ZOLOFT is also used to treat:

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

Who should not take ZOLOFT?

Do not take ZOLOFT if you:

What should I tell my healthcare provider before taking ZOLOFT? Ask if you are not sure.

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

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

How should I take ZOLOFT?

What should I avoid while taking ZOLOFT?

ZOLOFT 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 ZOLOFT affects you. Do not drink alcohol while using ZOLOFT.

What are the possible side effects of ZOLOFT?

ZOLOFT may cause serious side effects, including:

Common possible side effects in people who take ZOLOFT 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 ZOLOFT. 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 ZOLOFT?

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

General information about ZOLOFT

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

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

For more information about ZOLOFT call 1-800-438-1985 or go to www.pfizer.com

What are the ingredients in ZOLOFT?

Active ingredient: sertraline hydrochloride

Inactive ingredients

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

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LAB-0540-4.0

May 2014

Revised: 8/2014
Document Id: df3c47b3-55be-4acb-a2f3-2b674f4b5b03
Set id: fe9e8b7d-61ea-409d-84aa-3ebd79a046b5
Version: 32
Effective Time: 20140826
 
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