DULOXETINE HYDROCHLORIDE 20 MG- duloxetine capsule, delayed release 
DULOXETINE HYDROCHLORIDE 30 MG- duloxetine capsule, delayed release 
DULOXETINE HYDROCHLORIDE 60 MG- duloxetine capsule, delayed release 
Alembic Pharmaceuticals Limited

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Medication Guide

Duloxetine (doo-LOX-e-teen)
Delayed-release Capsules, USP
Read the Medication Guide that comes with duloxetine delayed-release capsules 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 duloxetine delayed-release capsules?

Duloxetine delayed-release capsules 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. Duloxetine delayed-release capsules may be associated with these serious side effects:

2.   Liver damage-symptoms may include:

3. Serotonin Syndrome -This condition can be life-threatening and 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 doctor right away or get emergency help if you have skin blisters, peeling rash, sores in the mouth, hives or any other allergic reactions.

6. Manic episodes:

7. Seizures or convulsions

8. Changes in blood pressure. Monitor your blood pressure before starting and throughout treatment. duloxetine delayed-release capsules may:

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

10. Problems with urination include:

11. Changes in appetite or weight. Children and adolescents should have height and weight monitored during treatment.

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:

What is duloxetine delayed-release capsules?

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

Talk to your healthcare provider if you do not think that your condition is getting better with duloxetine delayed-release capsules treatment.

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 serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:

            because this can cause serious heart rhythm problems or sudden death  
What should I tell my healthcare provider before taking
duloxetine delayed-release capsules? Ask if you are not sure.

            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 non-prescription 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.

Your healthcare provider or pharmacist can tell you if it is safe to take duloxetine delayed-release capsules with your other medicines. Do not start or stop any medicine while taking duloxetine delayed-release capsules without talking to your healthcare provider first.


If you take duloxetine delayed-release capsules, you should not take any other medicines 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 all of those described in the section entitled “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:

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 THE FDA AT 1-800-FDA­1088.


How should I store duloxetine delayed-release capsules?

Store duloxetine delayed-release capsules at room temperature between 59°F and 86°F (15°C to 30°C). Keep duloxetine delayed-release capsules and all medicines out of the reach of children.
General information about 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 condition. 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.

What are the ingredients in duloxetine delayed-release capsules?

Active ingredient: duloxetine hydrochloride

Inactive ingredients:

20mg: shellac, black iron oxide, potassium hydroxide, propylene gylcol, strong ammonia solution


30mg: shellac, titanium dioxide, yellow iron oxide, FD&C Blue No. 2 Aluminum Lake, propylene glycol, strong ammonia solution


60mg: shellac, potassium hydroxide, titanium dioxide, propylene glycol, strong ammonia solution
This Medication Guide has been approved by the U.S. Food and Drug Administration


*The brands listed are trademarks of their respective owners and not trademarks of Alembic Pharmaceuticlas Ltd.


Issued: 06/2014

Revised: 6/2014
Alembic Pharmaceuticals Limited