DULOXETINE - duloxetine capsule, delayed release 
Ascend Laboratories, LLC

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Medication Guide

Duloxetine Delayed-Release Capsules USP

(doo-LOX-e-teen)

Read this Medication Guide before you start taking duloxetine 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 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 duloxetine?

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

Duloxetine is also used to treat or manage:

Who should not take Duloxetine?

Do Not take Duloxetine if you:

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

What should I tell my healthcare provider before taking duloxetine?

Before starting duloxetine, 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 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 with any other medicine that contain duloxetine.

How should I take Duloxetine?


What should I avoid while taking Duloxetine?


What are the possible side effects of duloxetine?

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

Common possible side effects in people who take duloxetine include:

1. liver damage. Symptoms may include:


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


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


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



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


Side effects in adults may also occur in children and adolescents who take duloxetine. 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. For more information, ask your healthcare provider or pharmacist.


Call your doctor for medical advice about side effects. You may report side effects to 1800-FDA-1088.


How should I store Duloxetine Delayed-Release Capsules USP?

Store Duloxetine Delayed-Release Capsules USP at room temperature between 68°F to 77°F (20°C to 25°C).


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

General information about the safe and effective use of duloxetine.


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

What are the ingredients in Duloxetine Delayed-Release Capsules USP?


Active ingredient: duloxetine hydrochloride


Inactive ingredients:

FD&C Blue No.2, gelatin, hypromellose, hydroxypropyl cellulose, sugar spheres, hypromellose phthalates, talc, titanium dioxide, and triethyl citrate. The 20 and 60 mg capsules also contain iron oxide yellow. The printing ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, potassium hydroxide, black iron oxide (for 20 mg and 30 mg strengths), titanium dioxide and purified water.


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 Ascend Laboratories LLC.

Manufactured by:

Alkem Laboratories Ltd.

Mumbai - 400 013, INDIA.


Distributed by:

Ascend Laboratories, LLC

Parsippany, NJ 07054 

Revised: December, 2019
PT2473-02

Revised: 12/2019
Ascend Laboratories, LLC