SERTRALINE HYDROCHLORIDE- sertraline hydrochloride tablet, film coated 
Cardinal Health

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Medication Guide

SERTRALINE HYDROCHLORIDE TABLETS USP (ser′ tra leen)

25 mg, 50 mg and 100 mg

Rx only

Read the Medication Guide that comes with sertraline hydrochloride tablets 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 tablets?

Sertraline hydrochloride tablets and other antidepressant medicines may cause serious side effects, including:

1. Suicidal thoughts or actions:

Sertraline 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 tablets are 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 tablets 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: Sertraline 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 sertraline hydrochloride tablets without first talking to your healthcare provider. Stopping sertraline hydrochloride 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 sertraline hydrochloride tablets?

Sertraline hydrochloride tablets are 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 tablets are also used to treat:

Major Depressive Disorder (MDD)
Obsessive Compulsive Disorder (OCD)
Panic Disorder
Posttraumatic Stress Disorder (PTSD)
Social Anxiety Disorder
Premenstrual Dysphoric Disorder (PMDD)

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

Who should not take sertraline hydrochloride tablets?

Do not take sertraline hydrochloride tablets if you:

are allergic to sertraline or any of the ingredients in sertraline hydrochloride tablets. See the end of this Medication Guide for a complete list of ingredients in sertraline hydrochloride tablets.
take the antipsychotic medicine pimozide (Orap®) because this can cause serious heart problems.
take Antabuse®(disulfiram) (if you are taking the liquid form of sertraline) due to the alcohol content.
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 sertraline hydrochloride tablets unless directed to do so by your physician.
Do not start sertraline hydrochloride tablets if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.

People who take sertraline hydrochloride 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)

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

Before starting sertraline hydrochloride tablets, tell your healthcare provider if you:

• Are taking certain drugs such as:

   ▪ Medicines used to treat migraine headaches such as:

triptans

   ▪ Medicines used to treat mood, anxiety, psychotic or thought disorders, such as:

tricyclic antidepressants
lithium
diazepam
SSRIs
SNRIs
antipsychotic drugs
valproate

   ▪ Medicines used to treat seizures such as:

phenytoin

   ▪ Medicines used to treat pain such as:

tramadol

   ▪ Medicines used to thin your blood such as:

warfarin

   ▪ Medicines used to control your heartbeat such as :

  propafenone
  flecainide
  digitoxin

   ▪ Medicines used to treat type II diabetes such as:

          tolbutamide

   ▪ Cimetidine used to treat heartburn

   ▪ Over-the-counter medicines or supplements such as:

Aspirin or other NSAIDs
tryptophan
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 sertraline 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 sertraline may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking sertraline hydrochloride tablets.

Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Sertraline hydrochloride 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 sertraline hydrochloride tablets with your other medicines. Do not start or stop any medicine while taking sertraline hydrochloride tablets without talking to your healthcare provider first.

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

How should I take sertraline hydrochloride tablets?

Take sertraline hydrochloride tablets exactly as prescribed. Your healthcare provider may need to change the dose of sertraline hydrochloride tablets until it is the right dose for you.
Sertraline hydrochloride tablets may be taken with or without food.
If you miss a dose of sertraline hydrochloride 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 sertraline hydrochloride tablets at the same time.
If you take too much sertraline hydrochloride tablets, call your healthcare provider or poison control center right away, or get emergency treatment.

What should I avoid while taking sertraline hydrochloride tablets?

Sertraline hydrochloride 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 sertraline affects you. Do not drink alcohol while using sertraline hydrochloride tablets.

What are the possible side effects of sertraline hydrochloride tablets?

Sertraline hydrochloride tablets may cause serious side effects, including:

See "What is the most important information I should know about sertraline hydrochloride tablets?"
Feeling anxious or trouble sleeping

Common possible side effects in people who take sertraline hydrochloride tablets include:

nausea, loss of appetite, diarrhea or indigestion
change in sleep habits including increased sleepiness or insomnia
increased sweating
sexual problems including decreased libido and ejaculation failure
tremor or shaking
feeling tired or fatigued
agitation

Other side effects in children and adolescents include:

abnormal increase in muscle movement or agitation
nose bleed
urinating more often
urinary incontinence
aggressive reaction
heavy menstrual periods
possible slowed growth rate and weight change. Your child's height and weight should be monitored during treatment with sertraline hydrochloride 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 sertraline hydrochloride 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 THE FDA AT 1-800-FDA-1088.

How should I store sertraline hydrochloride tablets?

Store sertraline hydrochloride tablets at room temperature, between 20° to 25°C (68° to 77°F).
Keep sertraline hydrochloride tablets bottle closed tightly.

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

General information about sertraline hydrochloride tablets

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

For more information about sertraline hydrochloride tablets call Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or visit at www.lupinpharmaceuticals.com.

What are the ingredients in sertraline hydrochloride tablets?

Active ingredient: sertraline hydrochloride

Inactive ingredients: D&C Yellow #10 (in 25 mg tablet), dibasic calcium phosphate anhydrous, FD&C Blue #1 (in 25 mg tablet), FD&C Blue #2 (in 50 mg tablet), FD&C Red #40 (in 25 mg tablet), hydroxypropyl cellulose, hypromellose, iron oxide yellow (in 100 mg tablet), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide

The brands listed are trademarks of their respective owners and are not trademarks of Lupin Pharmaceuticals, Inc. The makers of these brands are not affiliated with and do not endorse Lupin Pharmaceuticals, Inc. or its products.

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

Manufactured for:

Lupin Pharmaceuticals, Inc.

Baltimore, Maryland 21202

United States

MADE IN INDIA

Revised: October 2014                                                                                       ID#: 238577

Sertraline Tablets USP, 25 mg, 50 mg and 100 mg are available from Cardinal Health in cards of 28 tablets and in cards of 30 tablets.

Cardinal Health

Zanesville, OH 43701

IT47586600814

Revised: 11/2014
 
Cardinal Health