CYMBALTA- duloxetine hydrochloride capsule, delayed release 
Eli Lilly and Company

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Medication Guide

Cymbalta®
[sim-BALL-tah]
(duloxetine delayed-release capsules)

Read this Medication Guide before you start taking Cymbalta® and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

Talk to your healthcare provider about:

What is the most important information I should know about antidepressant medicines, depression, other serious mental illnesses, and suicidal thoughts or actions?

1. Cymbalta 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.

2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts or actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness).

3. How can I watch for and try to prevent suicidal thoughts and actions?

Call your healthcare provider right away if you have any of the following symptoms or feelings, especially if they are new, worse, or worry you. In an emergency, call 911.

What else do I need to know about antidepressant medicines?

What is Cymbalta?

Cymbalta is a prescription medicine used to treat a certain type of depression called Major Depressive Disorder (MDD). Cymbalta belongs to a class of medicines known as SNRIs (or serotonin-norepinephrine reuptake inhibitors).

Cymbalta is also used to treat or manage:

Who should not take Cymbalta?

Do Not take Cymbalta if you:

People who take Cymbalta close in time to an MAOI may have a serious problem called Serotonin Syndrome (see “What are the possible side effects of Cymbalta?”).

What should I tell my healthcare provider before taking Cymbalta?

Before starting Cymbalta, tell your healthcare provider if you:

Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Cymbalta and some medicines may interact with each other, may not work as well, or may cause serious side effects.

Especially tell your healthcare provider if you take:

Ask your healthcare provider for a list of these medicines if you are not sure.

Do not take Cymbalta with any other medicine that contain duloxetine.

How should I take Cymbalta?

What should I avoid while taking Cymbalta?

What are the possible side effects of Cymbalta?

Cymbalta may cause serious side effects, including: See “What is the most important information I should know about Cymbalta?

Common possible side effects in people who take Cymbalta include:

1. liver damage. Symptoms may include:

2. changes in blood pressure and falls. Monitor your blood pressure before starting and throughout treatment. Cymbalta may:

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

4. abnormal bleeding: Cymbalta 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. severe skin reactions: Cymbalta may cause serious skin reactions that may require stopping its use. This may need to be treated in a hospital and may be life-threatening. Call your healthcare provider right away or get emergency help if you have skin blisters, peeling rash, sores in the mouth, hives or any other allergic reactions.

6. discontinuation symptoms: Do not stop Cymbalta without first talking to your healthcare provider. Stopping Cymbalta too quickly or changing from another antidepressant too quickly may result in serious symptoms including:

7. manic episodes:

8. 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.

9. seizures or convulsions

10. low salt (sodium) levels in the blood. Elderly people may be at greater risk for this. Symptoms may include:

11. problems with urination. Symptoms may include:

The most common side effects of Cymbalta include:

Common possible side effects in children and adolescents who take Cymbalta include:

Side effects in adults may also occur in children and adolescents who take Cymbalta. Children and adolescents should have height and weight monitored during treatment.

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 Cymbalta. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to 1-800-FDA-1088.

How should I store Cymbalta?

Store Cymbalta at room temperature between 68°F to 77°F (20°C to 25°C).

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

General information about the safe and effective use of Cymbalta.

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

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

For more information, call 1-800-545-5979.

What are the ingredients in Cymbalta?

Active ingredient: duloxetine hydrochloride

Inactive ingredients:

FD&C Blue No. 2, gelatin, hypromellose, hydroxypropyl methylcellulose acetate succinate, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow.

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

Coumadin, Jantoven, and Mellaril are trademarks of their respective owners and not trademarks of Eli Lilly and Company.

Medication Guide revised: November 2014

Marketed by: Lilly USA, LLC
Indianapolis, IN 46285, USA

Cymbalta is a registered trademark of Eli Lilly and Company.

Copyright © 2009, 2014, Eli Lilly and Company. All rights reserved.

CYM-0003-MG-20141125

Revised: 11/2014
 
Eli Lilly and Company