Abilify

(aripiprazole)

This summary of the Package Insert contains risk and safety information for patients about ABIUFY. This summary does not include all information about ABILIFY and is not meant to take the place of discussions with your healthcare professional about your treatment. Please read this important information carefully before you start taking ABILIFY and discuss any questions about ABILIFY with your healthcare professional. Name

ABILIFY® (o-Bll-T-fl) (aripiprazole) (olr-ri-PIP-ra-zall)

What is ABILIFY (aripiprazole)?

ABILIFY is a prescription medicine used alone or with lithium or divalproex to treat manic or mixed episodes of Bipolar I Disorder in adults or pediatric patients (10 to 17 years). What is Bipolar I Disorder? Bipolar I Disorder is an illness with symptoms thought to be caused by an imbalance of brain chemicals. People who have Bipolar I Disorder tend to experience extreme mood swings, along with other specific symptoms and behaviors. These mood swings, or "episodes," can take three forms: manic, depressive, or mixed episodes. Common symptoms of a manic episode are: feeling extremely happy, being very irritable and anxious, talking too fast and too much, and having more energy and needing less sleep than usual. Common symptoms of a depressive episode Include: feelings of overwhelming sadness or emptiness, low energy, a loss of interest in things, trouble concentrating, changes in sleep or appetite, and thoughts of dying or suicide. A mixed episode Includes symptoms that are both manic and depressive. Who should NOT take ABILIFY? People who are allergic to ABILIFY or to any substance that is in it. Allergic reactions have ranged from rash, hives and itching to difficulty breathing and swelling of the face, lips, or tongue. Please talk with your healthcare professional. What is the most important information that I should know about ABILIFY? Elderly patients, diagnosed with psychosis as a result of dementia (for example, an inability to perform daily activities as a result of increased memory loss), and who are treated with antipsychotic medicines including ABILIFY, are at an Increased risk of death when compared to patients who are treated with a placebo (sugar pill). ABILIFY is not approved for the treatment of patients with dementia-related psychosis. Some medicines can increase suicidal thoughts and behaviors in children, teens, and young adults. Serious mental illnesses are themselves associated with an increase in the risk of suicide. When taking ABILIFY call your doctor right away if you have new or worsening mood symptoms, unusual changes in behavior, or thoughts of suicide. Patients and their caregivers should be especially observant within the first few months of treatment or after a change in dose. Serious side effects can occur with any antipsychotic medicine, including ABILIFY. Tell your healthcare professional right away if you have any conditions or side effects, including the following:

Stroke or ministroke in elderly patients with dementia: An increased risk of stroke and ministroke has been reported In clinical studies of elderly patients with dementia (for example, increased memory loss and inability to perform daily activities). ABILIFY is not approved for treating patients with dementia. Neuroleptic malignant syndrome (NMS): Very high fever, rigid muscles, shaking, confusion, sweating, or increased heart rate and blood pressure may be signs of NMS, a rare but serious side effect that could be fatal. Tardive dyskinesia (TD): Abnormal or uncontrollable movements of face, tongue, or other parts of body may be signs of a serious condition known as TD, which may be permanent.

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