DULOXETINE- duloxetine capsule, delayed release 
Inventia Healthcare Private Limited

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                                                                                                                                                  Medication Guide

                                                                                                                                 DULOXETINE (doo-LOX-e-teen)

                                                                                                                                     delayed-release capsules USP

Read this Medication Guide before you start taking duloxetine delayed-release capsule USP 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 capsule USP 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 delayed-release capsule USP?

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

Duloxetine delayed-release capsule USP is also used to treat or manage:

Who should not take duloxetine delayed-release capsule USP?

Do Not take duloxetine delayed-release capsule USP if you:

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 or intravenous methylene blue.

People who take duloxetine delayed-release capsule USP 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 capsule USP?").

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

Before starting duloxetine delayed-release capsule USP, 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 capsule USP 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 capsule USP with any other medicine that contain duloxetine.

How should I take duloxetine delayed-release capsule USP?

What should I avoid while taking duloxetine delayed-release capsule USP?

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

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

Common possible side effects in people who take duloxetine delayed-release capsule USP 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 capsule USP may:

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

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

12.sexual problems (dysfunction). Taking serotonin and norepinephrine reuptake inhibitors(SNRIs), including duloxetine delayed-release capsule USP, may cause sexual problems.

Talk to your healthcare provider if you develop any changes in your sexual function or if youhave any questions or concerns about sexual problems during treatment with duloxetine delayed-release capsule USP.There may be treatments your healthcare provider can suggest.

The most common side effects of duloxetine delayed-release capsule USP include:

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

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

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

Keep duloxetine delayed-release capsule USP and all medicines out of the reach of children.

General information about the safe and effective use of duloxetine delayed-release capsule USP

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use duloxetine delayed-release capsule USP for a condition for which it was not prescribed. Do not give duloxetine delayed-release capsule USP 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 capsule USP. 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 capsule USP that is written for healthcare professionals.

For more information, go to www.inventiahealthcare.com.

What are the ingredients in duloxetine delayed-release capsule USP?

Active ingredient: Duloxetine hydrochloride USP

Inactive ingredients:

Delayed-release Capsules: Gelatin, hypromellose, hypromellose phthalate, sucrose, sugar spheres, talc, titanium dioxide and triethyl citrate. The 20 mg capsules also contain FD & C Blue 2 and Iron Oxide Yellow and 60 mg capsules contains FD & C Blue 2. The 20 mg, 30 mg and 60 mg capsules are imprinted with black and grey ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution. Grey ink also contains titanium dioxide.

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

*Trademarks are the property of their respective owners.

Medication guide revised: 10/2021

Manufactured By:

Inventia Healthcare Limited

F1-F1/1-F75/1, Additional Ambernath M.I.D.C.,

Ambernath (East)-421506,

Dist. Thane, Maharashtra, India

Revised: 10/2021
Inventia Healthcare Private Limited