Medication Guide Duloxetine (doo-LOX-e-teen) Delayed-release Capsules, USP Rx Only

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:

• in some children, teenagers, or young adults within the Duloxetine Delayed-release Capsules and other antidepressant medicines may increase suicidal thoughts or actionsfirst few months of treatment or when the dose is changed.
• Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
• Watch for these changes and call your healthcare provider right away if you notice:
  • New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
  • Pay particular attention to such changes when Duloxetine Delayed-release Capsules are started or when the dose is changed.

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:

• attempts to commit suicide
• acting on dangerous impulses
• acting aggressive or violent
• thoughts about suicide or dying
• new or worse depression
• new or worse anxiety or panic attacks
• feeling agitated, restless, angry or irritable
• trouble sleeping
• an increase in activity or talking more than what is normal for you
• other unusual changes in behavior or mood

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:

• itching
• right upper abdominal pain
• dark urine
• hepatitis with yellow skin or eyes
• enlarged liver
• increased liver enzymes

3. Serotonin Syndrome -This condition can be life-threatening and 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

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. 4. Abnormal bleeding:®®

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. 5. Severe skin reactions:

6. 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

7. Seizures or convulsions

Monitor your blood pressure before starting and throughout treatment. Duloxetine Delayed-release Capsules may: 8. Changes in blood pressure.

• 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.

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

Symptoms may include:

• headache
• weakness or feeling unsteady
• confusion, problems concentrating or thinking or memory problems

10. Problems with urination include:

• decreased urine flow
• unable to pass any urine

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

Stopping Duloxetine Delayed-release Capsules too quickly or changing from another antidepressant too quickly may result in serious symptoms including: Do not stop Duloxetine Delayed-release Capsules without first talking to your healthcare provider.

• anxiety, irritability
• feeling tired or problems sleeping
• headache, sweating, dizziness
• electric shock-like sensations
• vomiting, nausea, diarrhea

What are Duloxetine Delayed-release Capsules?

Duloxetine Delayed-release Capsules are 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 are also used to treat or manage:

• Major Depressive Disorder (MDD)
• Generalized Anxiety Disorder (GAD)
• Diabetic Peripheral Neuropathic Pain (DPNP)
• Chronic Musculoskeletal Pain

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:

• have uncontrolled narrow-angle glaucoma
• 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.
• Do not take an MAOI within 5 days of stopping Duloxetine Delayed-release Capsules unless directed to do so by your physician.
• Do not start Duloxetine Delayed-release Capsules if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician.
  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:
  • high fever
  • uncontrolled muscle spasms
  • stiff muscles
  • rapid changes in heart rate or blood pressure
  • confusion
  • loss of consciousness (pass out)
• take Mellaril (thioridazine) 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:

• Are taking certain drugs such as:
  • Triptans used to treat migraine headache
  • Medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclics, lithium, buspirone, SSRIs, SNRIs or MAOIs
  • Tramadol and fentanyl
  • Cimetidine
  • The antibiotics ciprofloxacin, enoxacin
  • Medicine to control heart rate such as propafenone, flecainide, quinidine
  • Theophylline
  • The blood thinner warfarin (Coumadin , Jantoven ) ®®
  • Non-steroidal anti-inflammatory drug (NSAID), like ibuprofen, naproxen or aspirin.
  • Over-the-counter supplements such as tryptophan or St. John's Wort
• have heart problems or high blood pressure
• have diabetes (Duloxetine Delayed-release Capsules treatment worsens the control of blood sugar in some patients with diabetes)
• have liver problems
• have kidney problems
• have glaucoma
• have or had seizures or convulsions
• have bipolar disorder or mania
• have low sodium levels in your blood
• have delayed stomach emptying
• have or had bleeding problems
• are pregnant or plan to become pregnant. It is not known if Duloxetine Delayed-release Capsules will harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating depression or other conditions with Duloxetine Delayed-release Capsules during pregnancy.
• are breast-feeding or plan to breast-feed. Some duloxetine may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking Duloxetine Delayed-release Capsules.

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. Tell your healthcare provider about all the medicines that you take,

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?

• Take Duloxetine Delayed-release Capsules exactly as prescribed. Your healthcare provider may need to change the dose of Duloxetine Delayed-release Capsules until it is the right dose for you.
• Do not open, break or chew the capsule; it must be swallowed whole.
• Duloxetine Delayed-release Capsules may be taken with or without food.
• If you miss a dose of Duloxetine Delayed-release Capsules, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Duloxetine Delayed-release Capsules at the same time.
• If you take too many Duloxetine Delayed-release Capsules, call your healthcare provider or poison control center right away, or get emergency treatment.
• When switching from another antidepressant to Duloxetine Delayed-release Capsules your doctor may want to lower the dose of the initial antidepressant first to potentially avoid side effects.

What should I avoid while taking Duloxetine Delayed-release Capsules?

• Duloxetine Delayed-release Capsules can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how Duloxetine Delayed-release Capsules affects you.
• Use of Duloxetine Delayed-release Capsules concomitantly with heavy alcohol intake may be associated with severe liver injury. Avoid heavy alcohol use 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:

nausea dry mouth sleepiness fatigue

loss of appetite increased sweating dizziness

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-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 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 they were 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.

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?

 

duloxetine hydrochloride, USP Active ingredient:

 

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 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. Inactive ingredients:

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

Trademarks are the property of their respective owners.

Revised: 06/2014

Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487 Manufactured for:

Laboratorios Dr. Esteve, S.A., Martorelles (Barcelona), Spain Manufactured by:

706454-04