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OLEPTRO™ is indicated for the treatment of major depressive disorder (MDD) in adults.

Important Safety Information for Patients
The following information does not include everything you should know about OLEPTRO™. For more complete information about the use of OLEPTRO™, please see the enclosed Medication Guide. Read the Medication Guide that comes with OLEPTRO™ before you start taking this medication and each time you get a refill. There may be new information.
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Oleptro or any other antidepressant in a child, adolescent or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Oleptro is not approved for use in pediatric patients.
What is the most important information I should know about OLEPTRO™?

  1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults
    within the first few months of treatment.


  2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have or have a family history of bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.

  3. How can I watch for and try to prevent suicidal thoughts and actions?

    • Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings.
      This is especially important when an antidepressant medicine is started or when the dose is changed.


    • Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts or feelings.

    • Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

    Call a healthcare provider right away if you have any of the following symptoms, especially if they are new,
    worse, or worry you:


    • Thoughts about suicide or dying

    • Attempts to commit suicide

    • New or worse depression

    • New or worse anxiety

    • Feeling very agitated or restless

    • Panic attacks

    • Trouble sleeping (insomnia)

    • New or worse irritability

    • Acting aggressive, being angry or violent

    • Acting on dangerous impulses

    • An extreme increase in activity and talking (mania)

    • Other unusual changes in behavior or mood

    What else do I need to know about antidepressant medicines?

    • Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.

    • Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider, not just the use of antidepressants.

    • Antidepressant medicines have other side effects. Talk to your healthcare provider about the side effects of your medicines.

    • Antidepressant medicines can interact with other medicines. Know all of the medicines that you take. Keep a list of all medicines to show your healthcare provider. Do not start new medicines without first checking with your healthcare provider.

  4. OLEPTRO™ is not approved for use in children. Talk to your healthcare provider for more information.

  5. What should I tell my healthcare provider before taking OLEPTRO™?

    Before you take OLEPTRO™, tell your healthcare provider if you:

    • Have heart problems, including QT prolongation (irregular or fast heartbeat or fainting) or a family history of it

    • Have ever had a heart attack

    • Have bipolar disorder

    • Have liver or kidney problems

    • Have other serious medical conditions

    • Are pregnant or plan to become pregnant. OLEPTRO™ may harm your unborn baby

    • Are breastfeeding or plan to breastfeed. It is not known if OLEPTRO™ passes into your breast milk

    • Have taken a Monoamine Oxidase Inhibitor (MAOI) or if you have stopped taking an MAOI in the last 2 weeks

    Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Using OLEPTRO™ with certain other medicines can affect each other, causing serious side effects.

    What should I avoid while taking OLEPTRO™?

    • Do not stop taking OLEPTRO™ without talking to your healthcare professional

    • Do not drive, operate heavy machinery, or do other dangerous activities until you know how OLEPTRO™ affects you. OLEPTRO™ can slow your thinking and motor skills.

    • Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking OLEPTRO™ until you talk with your healthcare provider. OLEPTRO™ may make your sleepiness or dizziness worse if you take it with alcohol or other medicines that cause sleepiness or dizziness.

    What are the possible side effects of OLEPTRO™?

    OLEPTRO™ can cause serious side effects or death.

    Serious side effects include:


    • Serotonin syndrome. Symptoms of serotonin syndrome include agitation, hallucinations, problems with coordination, fast heartbeat, tight muscles, trouble walking, nausea, vomiting, and diarrhea

    • Feeling high or in a very good mood, then becoming irritable, or having too much energy, feeling like you have to keep talking or do not sleep (mania)

    • Irregular or fast heartbeat or fainting (QT prolongation)

    • Low blood pressure. You feel dizzy or faint when you change positions (go from sitting to standing)

    • Unusual bruising or bleeding

    • Erection lasting for more than 6 hours (priapism)

    • Low sodium in your blood (hyponatremia). Symptoms of hyponatremia include headache, feeling weak, feeling confused, trouble concentrating, memory problems and feeling unsteady when you walk

    Get medical help right away, if you have any of the symptoms listed above.

    The most common side effects of OLEPTRO™ include sleepiness, dizziness, constipation and blurry vision.

    Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of OLEPTRO™.

    You are encouraged to report side effects to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

    Please see full Prescribing Information and Medication Guide.
© 2010, Angelini Labopharm. All rights reserved. This website is intended for use by patients and healthcare professionals in the United States only. For more information on OLEPTRO™, consult your doctor or other healthcare professional or call 1-877-345-6177.