Medication Guide

8423101/0923

Sertraline Tablets, USP
(SIR-trah-leen)

What is the most important information I should know about sertraline tablets?
Sertraline tablets 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:

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Sertraline tablets and other antidepressant medicines may increase suicidal thoughts or actions in some people 24 years of age and younger, especially within the first few months of treatment or when the dose is changed.

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Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.

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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.

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Pay particular attention to such changes when sertraline tablets are started or when the dose is changed.

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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:

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attempts to commit suicide

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acting on dangerous impulses

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acting aggressive or violent

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thoughts about suicide or dying

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new or worse depression

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new or worse anxiety or panic attacks

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feeling agitated, restless, angry or irritable

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trouble sleeping

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an increase in activity or talking more than what is normal for you

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other unusual changes in behavior or mood

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

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agitation, hallucinations, coma, or other changes in mental status

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nausea, vomiting, or diarrhea

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racing heartbeat, high or low blood pressure

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sweating or fever

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coordination problems or muscle twitching (overactive reflexes)

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muscle rigidity

3. Increased chance of bleeding: Sertraline tablets 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:

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greatly increased energy

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severe trouble sleeping

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excessive happiness or irritability

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racing thoughts

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reckless behavior

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unusually grand ideas

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talking more or faster than usual

5. Seizures or convulsions.

6. Glaucoma (angle-closure glaucoma). Many antidepressant medicines including sertraline tablets 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:

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Headache

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weakness or feeling unsteady

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confusion, problems concentrating or thinking, memory problems

9. Sexual problems (dysfunction). Taking serotonin and norepinephrine reuptake inhibitors (SSRIs), including Sertraline, may cause sexual problems.
Symptoms in males may include:

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Delayed ejaculation or inability to have an ejaculation

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Decreased sex drive

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Problems getting or keeping an erection

Symptoms in females may include:

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Decreased sex drive

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Delayed orgasm or inability to have an orgasm

Talk to your healthcare provider if you develop any changes in your sexual function or if you have any questions or concerns about sexual problems during treatment with Sertraline. There may be treatments your healthcare provider can suggest.

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

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anxiety, irritability, high or low mood, feeling restless or changes in sleep habits

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headache, sweating, nausea, dizziness

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electric shock-like sensations, shaking, confusion

What are sertraline tablets?
Sertraline tablets are a prescription medicine used to treat:

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Major Depressive Disorder (MDD)

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Obsessive Compulsive Disorder (OCD)

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Panic Disorder

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Posttraumatic Stress Disorder (PTSD)

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Social Anxiety Disorder

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Premenstrual Dysphoric Disorder (PMDD)

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 tablets are safe and effective in treating children with OCD age 6 to 17 years.

It is not known if sertraline tablets are 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 tablets treatment.

Who should not take sertraline tablets?
Do not take sertraline tablets if you:

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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.

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have taken an MAOI within 2 weeks of stopping sertraline tablets unless directed to do so by your healthcare provider.

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have stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider.

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take any other medicines that contain sertraline (such as sertraline HCl or sertraline hydrochloride.

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take the antipsychotic medicine pimozide (Orap ®) because this can cause serious heart problems.

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are allergic to sertraline or any of the ingredients in sertraline tablets. See the end of this Medication Guide for a complete list of ingredients in sertraline tablets.

People who take sertraline 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:

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high fever

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uncontrolled muscle spasms

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stiff muscles

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rapid changes in heart rate or blood pressure

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confusion

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loss of consciousness (pass out)

What should I tell my healthcare provider before taking sertraline tablets?
Before starting sertraline tablets, tell your healthcare provider:

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if you have:

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liver problems

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kidney problems

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a history of a stroke

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heart problems

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or have had seizures or convulsions

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high blood pressure

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bipolar disorder or mania

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low sodium levels in your blood

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or have had bleeding problems

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are pregnant or plan to become pregnant. Your baby may have withdrawal symptoms after birth or may be at increased risk for a serious lung problem at birth. Talk to your healthcare provider about the benefits and risks of taking sertraline tablets during pregnancy.

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are breastfeeding or plan to breastfeed. A small amount of sertraline may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking sertraline tablets.

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

How should I take sertraline tablets?

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Take sertraline tablets exactly as prescribed. Your healthcare provider may need to change the dose of sertraline until it is the right dose for you.

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Sertraline tablets may be taken with or without food.

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If you miss a dose of sertraline, 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 at the same time.

If you take too many sertraline tablets, 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 tablets?
Sertraline 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 tablets affects you. Do not drink alcohol while you take sertraline tablets.

What are the possible side effects of sertraline tablets?
Sertraline tablets may cause serious side effects, including:

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See “What is the most important information I should know about sertraline tablets?”

The most common side effects in adults who take sertraline tablets include:

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nausea, loss of appetite, diarrhea, or indigestion

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change in sleep habits including increased sleepiness or insomnia

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increased sweating

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sexual problems including decreased libido and ejaculation failure

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tremor or shaking

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feeling tired or fatigued

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agitation

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anxiety

The most common side effects in children and adolescents who take sertraline tablets 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 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 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 tablets?

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Store sertraline tablets at room temperature, 68°F to 77°F (20°C to 25°C).

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

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

For more information about sertraline tablets call Cipla Ltd. at 1-866-604-3268.
For more information about the packaging or labeling, call American Health Packaging at 1‐800‐707‐4621.

What are the ingredients in sertraline tablets?
Active ingredient: sertraline hydrochloride, USP

Inactive ingredients: dibasic calcium phosphate dihydrate, hydroxypropyl cellulose, microcrystalline cellulose, magnesium stearate, opadry green (titanium dioxide, hypromellose 3cP, hypromellose 6cP, Macrogol/Peg 400, polysorbate 80, D&C Yellow #10 Aluminum Lake, and FD&C Blue # 2/Indigo Carmine Aluminum Lake for 25 mg tablet), opadry light blue (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, FD&C Blue #2/ Indigo Carmine Aluminum Lake and polysorbate 80 for 50 mg tablet), opadry yellow (hypromellose 3cP, hypromellose 6cP, titanium dioxide, Macrogol/Peg 400, polysorbate 80, Iron Oxide Yellow, Iron Oxide Red for 100 mg tablet) and sodium starch glycolate.

Disclaimer: Other brands listed are the registered trademarks of their respective owner and are not trademarks of Cipla.

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

Distributed by:
American Health Packaging
Columbus, OH 43217

Distributed By:

Cardinal Health

Dublin, OH 43017

L54347330124

L54670480124

8423101/0923