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 (DR) capsules USP are a prescription medicine used to treat or manage:

  • Major Depressive Disorder 
  • Generalized Anxiety Disorder
  • Diabetic Peripheral Neuropathic Pain
  • Chronic Muscleoskeletal Pain

IMPORTANT SAFETY INFORMATION 

You should not take duloxetine DR capsules if you are taking a monoamine oxidase inhibitor (MAOI).   Ask your healthcare provider or pharmacist if you are taking an MAOI, including the antibiotic linezolid.  You should not start duloxetine DR 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 DR capsules, unless directed by your physician.  People who take duloxetine DR capsules close in time to an MAOI may have serious or even life‐threatening side effects. Get medical help right away if you develop high fever, uncontrolled muscle spasms, stiff muscles, rapid changes in heart rate or blood pressure, confusion, or loss of consciousness (pass out).

Duloxetine DR 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 DR 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 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, 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 DR capsules, tell your physician if you have:

  • heart problems or high blood pressure
  • diabetes (duloxetine DR capsule use may worsen the control of blood sugar in diabetic patients)
  • liver or kidney problems
  • glaucoma
  • or had seizures or convulsions
  • bipolar disorder or mania
  • low sodium levels in your blood
  • delayed stomach emptying
  • or had bleeding problems

Call your healthcare provider right away (or call 911 if it's an emergency) if you have any of the following symptoms which may be associated with serious side effects, including liver damage, serotonin syndrome, abnormal bleeding, severe skin reactions, manic episodes, visual problems, seizures or convulsions, changes in blood pressure, low salt levels in the blood, problems with urination, and changes in appetite or weight. 

  • 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
  • Racing heartbeat, high or low blood pressure
  • Sweating or fever
  • Nausea, vomiting, or diarrhea
  • Muscle rigidity, tremor, or seizures
  • Itching, flushing
  • Abnormal bleeding
  • Skin blisters or peeling rash, sores in the mouth, or hives
  • Greatly increased energy
  • Racing thoughts or severe trouble sleeping
  • Unusually grand ideas or reckless behavior
  • Excessive happiness or irritability
  • Talking more or faster than usual
  • Eye pain, changes in vision, or swelling or redness in or around the eye
  • Headache, feeling dizzy or faint upon standing
  • Confusion or problems concentrating or thinking or memory problems
  • Decreased urine flow or output

Duloxetine DR 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 DR capsules affect you. Use of duloxetine DR capsules concomitantly with heavy alcohol intake may be associated with severe liver injury. Avoid heavy alcohol use while taking duloxetine DR capsules. Tell your healthcare provider about all the medicines that you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Duloxetine DR 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 or supplement while taking duloxetine DR capsules without talking to your healthcare provider first. If you take duloxetine DR capsules, you should not take any other medicines that contain duloxetine. Do not stop taking your duloxetine DR capsules without first talking to your healthcare provider, as this may cause serious symptoms.

It is not known if duloxetine DR 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 DR capsules. Duloxetine DR 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 DR 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 DR capsules.

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