DULOXETINE  DELAYED-RELEASE- duloxetine hydrochloride capsule, delayed release pellets 
Breckenridge Pharmaceutical, Inc.

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MEDICATION GUIDE
Duloxetine (doo-LOX-e-teen)
Delayed-Release Capsules, USP
Rx Only

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?
    • Pay close attention to any changes in mood, behavior, actions, thoughts, or feelings, especially sudden changes. This is very important when an antidepressant medicine is started or when the dose is changed.
    • Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
      • Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

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 contains 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:
  • itching
  • right upper abdominal pain
  • dark urine
  • yellow skin or eyes
  • enlarged liver
  • increased liver enzymes
2.
changes in blood pressure and falls. Monitor your blood pressure before starting and throughout treatment. Duloxetine delayed-release capsules may:
  • increase your blood pressure.
  • decrease your blood pressure when standing and cause dizziness or fainting, mostly when first starting Duloxetine delayed-release capsules or when increasing the dose.
  • increase risk of falls, especially in elderly.
3.
Serotonin Syndrome: This condition can be life-threatening and symptoms may include:
  • agitation, hallucinations, coma or other changes in mental status
  • coordination problems or muscle twitching (overactive reflexes)
  • racing heartbeat, high or low blood pressure
  • sweating or fever
  • nausea, vomiting, or diarrhea
  • muscle rigidity
  • dizziness
  • flushing
  • tremor
  • seizures
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:
  • anxiety
  • irritability
  • feeling tired or problems sleeping
  • headache
  • sweating
  • dizziness
  • electric shock-like sensations
  • vomiting or nausea
  • diarrhea
7.
manic episodes:
  • greatly increased energy
  • severe trouble sleeping
  • racing thoughts
  • reckless behavior
  • unusually grand ideas
  • excessive happiness or irritability
  • talking more or faster than usual
8.
visual problems:
  • eye pain
  • changes in vision
  • swelling or redness in or around the eye

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:
  • headache
  • weakness or feeling unsteady
  • confusion, problems concentrating or thinking or memory problems
11.
problems with urination. Symptoms may include:
  • decreased urine flow
  • unable to pass any urine

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 68°F to 77°F (20°C to 25°C).

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 about Duloxetine delayed-release capsules, contact Breckenridge Pharmaceutical, Inc. at 1-800-367-3395.

What are the ingredients in Duloxetine delayed-release capsules, USP?

Active ingredient: duloxetine hydrochloride, USP

Inactive ingredients: ammonium hydroxide, black iron oxide, hypromellose, methacrylic acid copolymer dispersion (methacrylic acid-ethyl acrylate copolymer, polysorbate 80, sodium lauryl sulfate), potassium hydroxide, propylene glycol, shellac, sucrose, sugar spheres (maize starch, sucrose), talc, titanium dioxide, triethylcitrate, and hard gelatin capsules (gelatin, titanium dioxide). The 20 mg hard gelatin capsule colorant is yellow iron oxide. The 30 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, and FD&C Yellow No. 10. The 40 mg hard gelatin capsule colorants are FD&C Blue No. 2, red iron oxide, and yellow iron oxide. The 60 mg hard gelatin capsule colorants are FD&C Blue No. 1, FD&C Yellow No. 6, FD&C Yellow No.10, and yellow iron oxide.

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

Trademarks are the property of their respective owners.

Revised: 01/2021

Manufactured for:
Breckenridge Pharmaceutical, Inc.,
Berlin, CT 06037

Manufactured by:
Towa Pharmaceutical Europe, S.L.
Martorelles (Barcelona), Spain

Revised: 1/2021
Breckenridge Pharmaceutical, Inc.