DULOXETINE - duloxetine hydrochloride capsule, delayed release 
Aurobindo Pharma Limited

----------

Medication Guide


Duloxetine Delayed-Release Capsules USP

(doo lox' e teen)

Read this Medication Guide before you start taking duloxetine delayed-release capsules 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. Duloxetine delayed-release capsules 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 are duloxetine delayed-release capsules?

Duloxetine delayed-release capsules are a prescription medicine used to treat a certain type of depression called Major Depressive Disorder (MDD). Duloxetine delayed-release capsules belong to a class of medicines known as SNRIs (or serotonin-norepinephrine reuptake inhibitors).


Duloxetine delayed-release capsules are also used to treat or manage:


Who should not take duloxetine delayed-release capsules?

Do Not take duloxetine delayed-release capsules if you:



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

What should I tell my healthcare provider before taking duloxetine delayed-release capsules?

Before starting duloxetine delayed-release capsules, 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. Duloxetine delayed-release capsules 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 duloxetine delayed-release capsules with any other medicine that contain duloxetine.


How should I take duloxetine delayed-release capsules?



What should I avoid while taking duloxetine delayed-release capsules?



What are the possible side effects of duloxetine delayed-release capsules?

Duloxetine delayed-release capsules may cause serious side effects, including: See “What is the most important information I should know about duloxetine delayed-release capsules?”


Common possible side effects in people who take duloxetine delayed-release capsules include:


1. liver damage. Symptoms may include:


2. changes in blood pressure and falls. Monitor your blood pressure before starting and throughout treatment. Duloxetine delayed-release capsules may:


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


4. abnormal bleeding: Duloxetine delayed-release capsules 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: Duloxetine delayed-release capsules 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 duloxetine delayed-release capsules without first talking to your healthcare provider. Stopping duloxetine delayed-release capsules 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 duloxetine delayed-release capsules include:


Common possible side effects in children and adolescents who take duloxetine delayed-release capsules include:


Side effects in adults may also occur in children and adolescents who take duloxetine delayed-release capsules. 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 duloxetine delayed-release capsules. 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 duloxetine delayed-release capsules?

Store duloxetine delayed-release capsules at room temperature between 20° to 25°C (68° to 77°F).


Keep duloxetine delayed-release capsules and all medicines out of the reach of children. General information about the safe and effective use of duloxetine delayed-release capsules.

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


For more information, call Aurobindo Pharma USA, Inc. at 1-866-850-2876.


What are the ingredients in duloxetine delayed-release capsules?

Active ingredient: duloxetine hydrochloride


Inactive ingredients: crospovidone, hydroxy propyl cellulose, hypromellose, hypromellose phthalate, methylene chloride, sugar spheres, talc, titanium dioxide, and triethylcitrate. The empty hard gelatin capsule shells contain gelatin, titanium dioxide, and sodium lauryl sulphate. In addition, the 20 mg and 60 mg contain FD&C Blue No. 2 and iron oxide yellow and 30 mg contains FD&C Blue No. 2. The capsules are printed with edible ink containing black iron oxide, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution.


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 Aurobindo Pharma Limited.

Dispense with Medication Guide available at: www.aurobindousa.com/product-medication-guides


Distributed by:
Aurobindo Pharma USA, Inc.
2400 Route 130 North
Dayton, NJ 08810

Manufactured by:
Aurobindo Pharma Limited
Hyderabad–500 038, India

Revised: 01/2018  

Revised: 9/2019
Aurobindo Pharma Limited