Talk with your doctor about switching to Teva's FDA-approved generic version of Cymbalta® Delayed-Release Capsules to help save you money.

INDICATIONS
Duloxetine delayed-release capsules are a prescription medicine used to treat or manage:

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

IMPORTANT SAFETY INFORMATION 

You should not take duloxetine delayed-release capsules if you have uncontrolled narrow-angle glaucoma or if you are taking a Monoamine Oxidase Inhibitor (MAOI).  Tell  your healthcare provider or pharmacist if you are taking an MAOI, including the antibiotic linezolid.  You should not start duloxetine delayed-release capsules if you stopped taking an MAOI within the last 14 days, and you should not take an MAOI within 5 days of stopping duloxetine delayed-release capsules, unless directed 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)

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.  Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.  Watch for changes in thought or behavior and call your physician 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 physician right away if you have any of the following symptoms, or call 911 if an emergency, especially if symptoms 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, 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

Before starting duloxetine delayed-release capsules, tell your physician if you:

  • have heart problems or high blood pressure
  • have diabetes (duloxetine delayed-release capsule treatment worsens the control of blood sugar in some diabetic patients)
  • have liver or 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

Call your physician right away if you have any of the following symptoms which may be associated with serious side effects, or call 911 if an emergency:

  • right, upper abdominal pain
  • dark urine or yellowing of the eyes or skin
  • agitation, hallucinations, other changes in mental status
  • coordination problems or muscle twitching
  • muscle rigidity, tremor, seizures
  • abnormal bleeding
  • skin blisters or peeling rash, sores in the mouth
  • greatly increased energy
  • racing thoughts
  • unusually grand ideas
  • increased blood pressure
  • feeling dizzy or faint upon standing
  • decreased urine flow or output
  • headache, sweating, electric shock-like sensations, vomiting

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 affect 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.

Taking duloxetine with certain medications, such as fluvoxamine, cimetidine, quinolone, ciprofloxacin, enoxacin, paroxetine, fluoxetine, quinidine, warfarin, aspirin, non-steroidal anti-inflammatory drugs, drugs that affect stomach acidity, theophylline, and desipramine, may result in a drug-drug interaction. 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.  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.

Pregnancy Category C
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 during pregnancy.  Some duloxetine passes into your breast milk.  Talk to your healthcare provider about the best way to feed your baby while taking duloxetine delayed-release capsules.

Duloxetine delayed-release capsules should be swallowed whole and should not be chewed or crushed, nor should the capsules be opened. 

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 does not go away. These are not all the possible side effects of duloxetine delayed-release capsules.

You are encouraged to report side effects of prescription drugs to the FDA.  Visit www.fda.gov/medwatch, or call 800.FDA.1088.
 

PI Rev B 11/2013
MG Rev A 11/2013