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Indications

Cymbalta is indicated for the treatment of major depressive disorder (MDD). The efficacy of Cymbalta was established in four short-term trials and one maintenance trial in adults.

Cymbalta is indicated for the treatment of generalized anxiety disorder (GAD). The efficacy of Cymbalta was established in three short-term trials and one maintenance trial in adults.

Cymbalta is indicated for the management of diabetic peripheral neuropathic pain and fibromyalgia.

Cymbalta is indicated for the management of chronic musculoskeletal pain due to chronic osteoarthritis pain and chronic low back pain.

Important Safety Information About Cymbalta^®

The most important information you should know about Cymbalta:

Antidepressants can increase suicidal thoughts and behaviors in children, teens, and young adults. Suicide is a known risk of depression and some other psychiatric disorders. Call your doctor right away or seek emergency help if you have new or worsening depression symptoms; unusual changes in behavior, such as agitation, irritability, impulsivity, or restlessness; or thoughts of suicide. Be especially observant within the first few months of treatment or after a change in dose. Approved only for adults 18 and over.

Cymbalta may be associated with serious side effects. Call your healthcare provider right away or seek emergency help if you experience any of the following:

• Itching, right upper-belly pain, dark urine, yellow skin/eyes, or unexplained flu-like symptoms, which may be signs of life-threatening liver problems. Severe liver problems, some fatal, have been reported
• High fever, confusion, stiff muscles, muscle twitching, or racing heart rate, which may be signs of serotonin syndrome, a potentially life-threatening condition
• Abnormal bleeding, especially if Cymbalta is taken with aspirin, NSAID pain relievers (like ibuprofen or naproxen), or blood thinners
• Serious, possibly life-threatening skin reactions, which may include skin blisters, peeling rash, mouth sores, hives, or other allergic reactions
• Abnormal mood (mania), which may include greatly increased energy, severe trouble sleeping, racing thoughts, talking more or faster than usual, and reckless behavior
• Seizures or convulsions
• Decreased blood pressure upon standing, which can cause dizziness or fainting, mostly when first starting or increasing the dose. Cymbalta can also increase blood pressure. Your healthcare provider should check your blood pressure prior to and while taking Cymbalta
• Headache, weakness or feeling unsteady, confusion, problems concentrating, or memory problems, which may be signs of low sodium levels in the blood. Elderly people may be at greater risk
• Problems with urination, including decreased flow or inability to pass any urine
• Changes in appetite or weight. Children and adolescents should have height and weight monitored

Do not stop Cymbalta or change your dose without talking to your healthcare provider, as you could have side effects.

Cymbalta is not for everyone. Do not take Cymbalta if you:

• Are taking or have recently taken a monoamine oxidase inhibitor (MAOI), including the antibiotic linezolid, or Mellaril^® (thioridazine). Taking Cymbalta close in time to these medicines can cause serious or even life-threatening side effects
• Have uncontrolled narrow-angle glaucoma (eye pain due to increased eye pressure)

Before taking Cymbalta, talk with your healthcare provider:

• About all your medical conditions, including
  • kidney or liver problems, heart problems, or high blood pressure
  • glaucoma or diabetes (Cymbalta may worsen diabetes or a type of glaucoma)
  • seizures/convulsions, mania, or if you have bipolar disorder
  • if you have ever had or been told you have bleeding problems, low sodium levels in your blood, or delayed stomach emptying
• About all prescription and over-the-counter medicines and supplements you take or plan to take, including
  • antibiotics or medicines for migraine, mood, or psychotic disorders, to avoid a potentially life-threatening condition when taken with Cymbalta
  • aspirin, NSAID pain relievers, or blood thinners, because they may increase risk for bleeding
• About your alcohol use (you should not take Cymbalta if you drink heavily)
• If you are pregnant or plan to become pregnant during therapy or are breast-feeding

Most common side effects of Cymbalta (this is not a complete list):

Nausea, dry mouth, sleepiness, fatigue, constipation, decreased appetite, increased sweating, dizziness. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

Other safety information about Cymbalta:

• Cymbalta may cause sleepiness and dizziness. Until you know how Cymbalta affects you, you shouldn't drive a car or operate hazardous machinery
• People age 65 and older who took Cymbalta reported more falls, some resulting in serious injuries

How to take Cymbalta

Take Cymbalta exactly as directed by your healthcare provider. Do not open, break, or chew capsule; swallow it whole. Cymbalta is available by prescription only.

See Prescribing Information, including Boxed Warning about antidepressants and risk of suicide, and Medication Guide.

DD CON ISI 02OCT2012

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