SERTRALINE HYDROCHLORIDE - sertraline hydrochloride tablet, film coated 
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

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SERTRALINE (SER-tra-line) HYDROCHLORIDE
(sertraline hydrochloride)
(Tablets and Oral Concentrate (solution))

Read the Medication Guide that comes with SERTRALINE HYDROCHLORIDE 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?

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

1.
Suicidal thoughts or actions:
  • SERTRALINE HYDROCHLORIDE 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 SERTRALINE HYDROCHLORIDE 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. SERTRALINE HYDROCHLORIDE may be associated with these serious side effects:
2.
Serotonin Syndrome or Neuroleptic Malignant Syndrome-like reactions. 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: SERTRALINE HYDROCHLORIDE 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

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

What is SERTRALINE HYDROCHLORIDE?

SERTRALINE HYDROCHLORIDE 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 is also used to treat:

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

Who should not take SERTRALINE HYDROCHLORIDE?

Do not take SERTRALINE HYDROCHLORIDE if you:

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

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

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

How should I take SERTRALINE HYDROCHLORIDE?

What should I avoid while taking SERTRALINE HYDROCHLORIDE?

SERTRALINE HYDROCHLORIDE 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 affects you. Do not drink alcohol while using SERTRALINE HYDROCHLORIDE.

What are the possible side effects of SERTRALINE HYDROCHLORIDE?

SERTRALINE HYDROCHLORIDE may cause serious side effects, including:

Common possible side effects in people who take SERTRALINE HYDROCHLORIDE 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. 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?

Keep SERTRALINE HYDROCHLORIDE and all medicines out of the reach of children.

General information about SERTRALINE HYDROCHLORIDE

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SERTRALINE HYDROCHLORIDE for a condition for which it was not prescribed. Do not give SERTRALINE HYDROCHLORIDE 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. If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about SERTRALINE HYDROCHLORIDE that is written for healthcare professionals.

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

What are the ingredients in SERTRALINE HYDROCHLORIDE?

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-0541-1.0

September 2011

Revised: 12/2011
 
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC