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Prescribing Information  
Medication Guide  
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IMPORTANT SAFETY INFORMATION
Use in Treating Psychiatric Disorders:
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 APLENZIN 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. APLENZIN is not approved for use in pediatric patients.

Use in Smoking Cessation Treatment:
APLENZIN is not approved for smoking cessation treatment, but bupropion under the name of ZYBAN® is approved for this use. Serious neuropsychiatric events, including but not limited to depression, suicidal ideation, suicide attempt, and completed suicide have been reported in patients taking bupropion for smoking cessation.
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Why Aplenzin?
The active ingredient in Aplenzin is bupropion, which has been an effective medicine doctors have trusted in treating depression for over 25 years. Bupropion has been shown to effectively treat depression symptoms. But Aplenzin is made with a different type of salt than other bupropion treatments. So what does that mean to you?
Aplenzin has no generic substitute.
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Aplenzin is one pill a day, even at the highest strength.
The chance of having seizures increases with higher doses of Aplenzin.


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Talk to your doctor to see if Aplenzin is right for you.
 
IMPORTANT SAFETY INFORMATION
Use in Treating Psychiatric Disorders:
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 APLENZIN 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. APLENZIN is not approved for use in pediatric patients.

Use in Smoking Cessation Treatment:
APLENZIN is not approved for smoking cessation treatment, but bupropion under the name of ZYBAN® is approved for this use. Serious neuropsychiatric events, including but not limited to depression, suicidal ideation, suicide attempt, and completed suicide have been reported in patients taking bupropion for smoking cessation.

APLENZIN® is not for everyone and is approved only for adults 18 years of age and older. There is a risk of seizure with APLENZIN which increases with higher doses. Taking more than 450 mg/day increases the chance of serious side effects. Don't use it if you've had a seizure or eating disorder, or if you abruptly stop using alcohol or sedatives. Don't take with Monoamine oxidase inhibitors (MAOIs), or medicines that contain bupropion. When used with a nicotine patch or alone, there is a risk of increased blood pressure, sometimes severe. To reduce risk of serious side effects, tell your doctor if you have liver or kidney problems. Other side effects may include restlessness, delusions, hallucinations, concentration disturbance, confusion, paranoia, itching, rash, hives and fever.

Whether or not you are taking antidepressants, you or your family should call the doctor right away if you have worsening depression, thoughts of suicide, sudden or severe changes in mood or behavior, especially at the beginning of treatment or after a change in dose (see Medication Guide: Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions).

APLENZIN® contains the same active ingredient (bupropion) as ZYBAN® which is used to help patients quit smoking. Some people have had changes in behavior, hostility, agitation, depression, suicidal thoughts or actions while taking bupropion to help them quit smoking. These symptoms can develop during treatment with bupropion or after stopping treatment with bupropion. Stop taking bupropion and call your healthcare provider right away or call 911 if an emergency, if you, your family member, or your caregiver notice agitation, hostility, depression, or changes in thinking or behavior that are not typical for you, or you have any of the following symptoms: thoughts about suicide or dying, attempts to commit suicide, new or worse depression, new or worse anxiety, panic attacks, feeling very agitated or restless, acting aggressive, being angry, or violent, acting on dangerous impulses, an extreme increase in activity and talking (mania), abnormal thoughts or sensations, seeing or hearing things that are not there (hallucinations), feeling people are against you (paranoia), feeling confused, other unusual changes in behavior or mood.

When you try to quit smoking, with or without bupropion, you may have symptoms that may be due to nicotine withdrawal, including urge to smoke, depressed mood, trouble sleeping, irritability, frustration, anger, feeling anxious, difficulty concentrating, restlessness, decreased heart rate, and increased appetite or weight gain. Some people have even experienced suicidal thoughts when trying to quit smoking without medication. Sometimes quitting smoking can lead to worsening of mental health problems that you already have, such as depression. Before taking bupropion, tell your healthcare provider if you have ever had depression or other mental illnesses. You should also tell your healthcare provider about any symptoms you had during other times you tried to quit smoking, with or without bupropion. (see Medication Guide: Quitting Smoking, Quit-Smoking Medications, Changes in Thinking and Behavior, Depression, and Suicidal Thoughts or Actions)

The most common side effects may include weight loss, loss of appetite, dry mouth, skin rash, sweating, ringing in the ears, shakiness, stomach pain, agitation, anxiety, dizziness, trouble sleeping, muscle pain, nausea, fast heartbeat, sore throat, and urinating more often.

If you take a urine drug screening test, Aplenzin may make the test result positive for amphetamines. See Medication Guide.

For specific questions about your health, you should always consult your healthcare professional who is responsible for your care.

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