This medicine is an antidepressant used for helping certain patients to stop smoking cigarettes. It may also be used for other conditions as determined by your doctor.
Follow the directions for taking this medicine provided by your doctor. This medicine has a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. TAKE THIS MEDICINE by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. SWALLOW THIS MEDICINE WHOLE. Do not break, crush, divide, or chew before swallowing. STORE THIS MEDICINE at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tight, light-resistant container away from heat, moisture, and light. Do not store in the bathroom. KEEP THIS MEDICINE out of the reach of children and away from pets. SEVERAL WEEKS MAY PASS BEFORE YOUR SYMPTOMS IMPROVE. Do not stop taking this medicine without checking with your doctor. It takes about 1 week for this medicine to work. You should begin taking this medicine while you are still smoking. However, you and your doctor should decide on the date that you will stop smoking during the 2nd week of taking this medicine. IF YOU HAVE NOT MADE PROGRESS TOWARDS STOPPING SMOKING BY THE 12TH WEEK, contact your doctor. If you are not able to stop smoking while using this medicine, talk to your doctor to determine why you were not successful. After the reasons have been reduced or eliminated, you should try to stop smoking again. TAKE YOUR DOSES AT THE SAME TIMES EACH DAY AT LEAST 8 HOURS APART unless directed otherwise by your doctor. This may help to decrease the risk of seizures with this medicine. IF YOU HAVE TROUBLE SLEEPING, you may be taking your dose too close to bedtime. Talk with your doctor about changing your dosing schedule. CONTINUE TO TAKE THIS MEDICINE EVEN IF YOU FEEL WELL. Do not miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE, skip the missed dose. Go back to your regular dosing schedule. Do not take more than 1 dose within 8 hours. Do not take 2 doses at once.
WARNING: Although this medicine is not used to treat depression, it contains the same ingredient that is in the antidepressants Aplenzin and Wellbutrin. Antidepressants may increase the risk of suicidal thoughts or actions in children, teenagers, and young adults. However, depression and certain other mental problems may also increase the risk of suicide. Talk with the patient's doctor to be sure that the benefits of using this medicine outweigh the risks. Some patients have also developed depression and certain other mental or mood problems, including suicidal thoughts or actions, while taking this medicine to help them quit smoking. FAMILY AND CAREGIVERS MUST CLOSELY WATCH patients who take this medicine. It is important to keep in close contact with the doctor. Contact the doctor at once if new, worsened, or sudden symptoms such as agitation; hostility; depressed mood; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur. Discuss any questions with the doctor. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE IF you are taking another medicine that contains bupropion or if you are taking or have taken linezolid or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking amantadine, antipsychotics (eg, haloperidol, risperidone), clopidogrel, corticosteroids (eg, prednisone), cyclophosphamide, efavirenz, HIV protease inhibitors (eg, nelfinavir), insulin, levodopa, nicotine patches, oral hypoglycemics (eg, glipizide), orphenadrine, sympathomimetics (eg, pseudoephedrine), tamoxifen, theophylline, thiotepa, tiagabine, ticlopidine, carbamazepine, phenobarbital, phenytoin, rifampin, antiarrhythmics (eg, propafenone, flecainide), beta-blockers (eg, metoprolol), phenothiazines (eg, thioridazine), ritonavir, methylene blue, selective serotonin reuptake inhibitor (SSRI) (eg, fluoxetine), tricyclic antidepressants (eg, nortriptyline), or other antidepressants. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including diabetes, kidney problems, high blood pressure, heart problems (eg, congestive heart failure), recent heart attack, allergies, pregnancy, or breast-feeding. Tell your doctor if you have a history of seizure, head injury, tumor in the brain or spinal cord, or liver problems (eg, cirrhosis). Tell your doctor if you or a family member has a history of bipolar disorder (manic depression), other mental or mood problems (eg, depression), suicidal thoughts or attempts, or alcohol or substance abuse. Tell your doctor if you are taking nonprescription weight loss medicines or stimulants. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have a history of an eating disorder (eg, anorexia, bulimia) or seizures (eg, epilepsy). Tell your doctor if you are suddenly stopping the use of alcohol or sedatives (eg, benzodiazepines) after long-term use. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.
SIDE EFFECTS that may occur while taking this medicine include anxiety; changes in appetite; constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; increased sweating; nausea; nervousness; stomach pain; stuffy nose; trouble sleeping; vomiting; or weight changes. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience blurred vision or other vision changes; chest pain; confusion; changes in sexual desire or ability; dark urine; delusions; fainting; fast or irregular heartbeat; fever or chills; hallucinations; hearing problems or ringing in the ears; joint or muscle pain; menstrual changes; new or worsening mental or mood changes (eg, concentration problems, depression, panic attacks, aggressiveness, agitation, anxiety, impulsiveness, irritability, hostility, exaggerated feeling of well-being, inability to sit still); pale stools; red, swollen, blistered, or peeling skin; seizures; severe headache or dizziness; severe or persistent restlessness or trouble sleeping; severe or persistent nausea, vomiting, or stomach pain; shortness of breath; suicidal thoughts or attempts; tremor; or yellowing of the skin or eyes. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; or unusual hoarseness. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately. Symptoms may include chest pain; fainting; fast, slow, or irregular heartbeat; fever; hallucinations; loss of consciousness; rigid or painful muscles; seizures; severe dizziness or drowsiness; or slow or difficult breathing.
IT IS IMPORTANT TO FOLLOW THE PROGRAM THAT YOUR DOCTOR HAS PRESCRIBED, including behavioral changes, counseling, or support services, in order to stop smoking. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.