SERTRALINE HYDROCHLORIDE- sertraline hydrochloride tablet 
Aidarex Pharmaceuticals LLC



Sertraline Tablets, USP


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 tablets?

Sertraline hydrochloride 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 tablets 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 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.

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 tablets without first talking to your healthcare provider. Stopping sertraline tablets too quickly may cause serious symptoms including:

What are sertraline tablets?

Sertraline tablets are 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 tablets are also used to treat:

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

Who should not take sertraline tablets?

Do not take sertraline tablets if you:

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:

What should I tell my healthcare provider before taking sertraline tablets?

Ask if you are not sure.

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

● Are taking certain drugs such as:

● triptants

● tricyclic antidepressants

● lithium

● diazepam



● antipsychotic drugs

● valproate

● phenytoin

● tramadol

● warfarin

● propafenone

● flecainide

● digitoxin

● tolbutamide

● 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 tablets.

Tell your healthcare provider about all the medicines that you take, including prescription and non-prescription 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.

 If you take sertraline tabletsyou should not take any other medicines that contain sertraline (sertraline HClsertraline hydrochlorideetc.).

How should I take sertraline tablets?

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 affect you. Do not drink alcohol while using sertraline tablets.

What are the possible side effects of sertraline tablets?

Sertraline tablets may cause serious side effects, including:

Common possible side effects in people who take sertraline tablets 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 tablets. For more information, ask your healthcare provider or pharmacist.


How should I store sertraline tablets?

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

General information about 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

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.

† The brand names mentioned in this Medication Guide are registered trademarks of their respective manufacturers.

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

Manufactured for:

Cipla USA Inc.,

9100 S. Dadeland Blvd., Suite 1500

Miami, FL 33156

Manufactured by:

InvaGen Pharmaceuticals, Inc.

(a subsidiary of Cipla Ltd.)

Hauppauge, NY 11788


Ascent Pharmaceuticals, Inc.

Central Islip, NY 11722

Revised: 07/2016

Revised: 3/2017
Aidarex Pharmaceuticals LLC