DULOXETINE - duloxetine capsule, delayed release 
Ajanta Pharma Limited

----------

Medication Guide

Duloxetine Delayed-Release Capsules

(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 belongs 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 capsule stoo 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 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].


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 1-855-664-7744.


What are the ingredients in duloxetine delayed-release capsules?

Active ingredient: duloxetine hydrochloride, USP

Inactive ingredients:

sugar spheres, hypromellose,  sucrose, talc, methacrylic acid copolymer dispersion, and triethyl citrate.

The capsule shell contains gelatin, FD&C Red No. 3 (40 mg), FD&C Blue No. 1 (40 mg), FD&C Blue No. 2 (20 mg, 30 mg, 60 mg), titanium dioxide, and sodium lauryl sulfate.

For 20 mg, 30 mg, 40 mg  (body & cap) and 60 mg (body only) strengths, imprinting black ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, potassium hydroxide, and purified water.

For 60 mg (cap only) strength, imprinting white ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, purified water, potassium hydroxide, and titanium dioxide. 

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

All trademarks are the properties of their respective owners.

Medication Guide revised: 11/2019

Marketed by:

Ajanta Pharma USA Inc.

Bridgewater, NJ 08807.

Made un INDIA.

Revised: 11/2019
Ajanta Pharma Limited