Indications

Cymbalta is indicated for the treatment of major depressive disorder (MDD). The efficacy of Cymbalta was established in four short-term 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 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 if you have new or worsening depression symptoms, unusual changes in behavior, 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^® (duloxetine HCl) is not for everyone. Do not take Cymbalta if you:

• have recently taken a type of antidepressant called a monoamine oxidase inhibitor (MAOI) or Mellaril^® (thioridazine)
• have uncontrolled narrow-angle glaucoma (increased eye pressure)

Before taking Cymbalta, talk with your healthcare provider:

• about all your medical conditions, including kidney or liver problems, glaucoma, diabetes, seizures, or if you have bipolar disorder. Cymbalta may worsen a type of glaucoma or diabetes
• about all your prescription and nonprescription medicines. A potentially life-threatening condition has been reported when Cymbalta was taken with certain drugs for migraine, mood, or psychotic disorders
• if you are taking NSAID pain relievers, aspirin, or blood thinners. Use with Cymbalta may increase bleeding risk
• about your alcohol use
• about your blood pressure. Cymbalta can increase your blood pressure. Your healthcare provider should check your blood pressure prior to and while taking Cymbalta
• if you are pregnant or plan to become pregnant during therapy, or are breast-feeding

While taking Cymbalta, talk to your healthcare provider right away:

• if you have itching, right upper-belly pain, dark urine, yellow skin/eyes, or unexplained flu-like symptoms, which may be signs of liver problems. Severe liver problems, sometimes fatal, have been reported
• if you have high fever, confusion and stiff muscles, which may be symptoms of a potentially life-threatening condition
• if you have skin blisters, serious or peeling rash, hives, mouth sores, or any other allergic reaction. These may be serious, possibly life-threatening, skin reactions
• if you experience dizziness or fainting upon standing. This tends to occur in the first week or when increasing the dose, but may occur at any time during treatment
• before you stop Cymbalta or change your dose
• if you experience headache, weakness, confusion, problems concentrating, memory problems, or feel unsteady, which may be signs of low sodium levels
• if you develop problems with urine flow

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

• nausea, dry mouth, sleepiness, fatigue, constipation, dizziness, decreased appetite, and increased sweating

You are encouraged to report negative side effects of Prescription drugs to the FDA. Visit 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 should not 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. Cymbalta should be taken by mouth. Do not open, break or chew capsule; it must be swallowed whole. Cymbalta can be taken with or without food.

Cymbalta is available by prescription only.

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

DD CON ISI 28NOV2011