BUPROPION HCL XL ORAL (WELLBUTRIN XL) SUICIDALITY AND ANTIDEPRESSANT DRUGS * You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment. * Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. ****************************************************************** BOXED WARNING: Clinical Worsening and Suicide Risk Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) with major depressive disorder (MDD) and other psychiatric disorders. 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 with antidepressants compared to placebo in adults aged 65 and older. The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality. Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers. BEFORE USING THIS MEDICINE: Tell your doctor if you are having any of the following conditions: TOP KIDNEY DISEASE; LIVER PROBLEMS; ANOREXIA; SEIZURES; HEART CONDITION or HIGH BLOOD PRESSURE. * Inform your Doctor or Pharmacist if you are allergic to any prescription or non-prescription medicine; taking other medicines or have other medical problems; pregnant, planning a pregnancy, or breastfeeding. * Check with your Doctor, Pharmacists, or Nurse if information in this leaflet causes you special concern or if you want additional information about your medicine and its use. HOW MEDICINE IS ADMINISTERED? TOP Use this medicine exactly as directed on the label, unless instructed differently by your doctor * Patient should read specific "MEDICATION GUIDE" provided with this medicine before starting treatment and each time their prescription is renewed. * DO NOT EXCEED recommended dosage. * This medicine can be taken with or without food, REGARDLESS of meal times. If stomach upset occurs, take with food. * Swallow whole, unless otherwise directed by your physician. DO NOT crush or chew. * Take regularly as prescribed, even during symptom-free periods. * Do not take this medicine after the evening meal or less than 4 hours before bedtime (not later than 6 pm). WARNINGS/PRECAUTIONS: TOP * STOP TAKING MEDICINE & GET EMERGENCY HELP IMMEDIATELY IF A HYPERSENSITIVITY OR ANAPHYLACTIC REACTION occurs: (see symptoms below):- * Be alert to the emergence of anxiety, panic attack, confusion, irritability, worsening of depression, and suicidal ideas. * Contact your doctor right away if you develop PSYCHIATRIC SYMPTOMS (severe depression, anger, thoughts of suicide). Close supervision is necessary. * The risk of suicide attempt is inherent in psychotic illnesses and in patients with substance abuse. Close supervision is necessary. * shortness of breath, fast or irregular breathing, fever, joint pain, fast pulse, lightheadedness or fainting, swelling of face, hives, & itching. * There are no adequate or well-controlled safety studies in pregnant women. NOTIFY YOUR DOCTOR IF PREGNANT or intend to become pregnant. * Because of INTERACTIONS, report the use of any other prescription or nonprescription medicines, including natural/herbal remedies, to your doctor. * CAUTION: Do not drive or operate machinery until you are reasonably certain that this medicine will not adversely affect your ability to do so safely. * DO NOT DRINK alcoholic beverages or take alcohol-containing preparations while being treated with this medicine. * EXTENDED RELEASE TABLET: The extended release coating is not absorbed in the stomach and may visible in the stool. This is normal. ADVERSE REACTIONS: Stop taking this medicine and get emergency help IMMEDIATELY if you experience: Jerkings of face, trunk, or extremities; Severe allergic reaction. Stop taking this medicine and notify your doctor AS SOON AS POSSIBLE if you experience: Hallucinations; Itching; Skin rash. Other Common Side Effects: TOP Headache; Dry mouth; Nausea; Difficulty falling asleep; Weight loss; Decreased appetite; Sweating; Ringing in ears; Dizziness; Jitteriness; Shakiness; Stomach discomfort or pain; Sore throat; High blood pressure; Constipation. Other Common Side Effects: If symptoms are mild but do not go away or are bothersome, check with your doctor. IF ANY OF THE ABOVE SIDE EFFECTS IS SEVERE, CALL YOUR DOCTOR IMMEDIATELY. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. This leaflet has been developed by CliniDATA Source, Inc. based primarily on labeling information provided by the manufacturer. The information does not cover all possible uses, actions, precautions, side effects, or interactions of this medicine. It is not intended as medical advice for individual patients. Copyright © CliniDATA Source, Inc. 03/14. All rights reserved