APLENZIN ER- bupropion hydrobromide  tablet, extended release 



Aplenzin (a-plen-zin)
(bupropion hydrobromide extended-release tablets)

Read this Medication Guide carefully before you start using Aplenzin and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about Aplenzin, ask your doctor or pharmacist.

IMPORTANT: Be sure to read both sections of this Medication Guide. The first section is about the risk of suicidal thoughts and actions with antidepressant medicines; the second section is entitled "What other important information should I know about Aplenzin?"


This section of the Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member's, healthcare provider about:

What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?

Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high 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.
How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
  • Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
  • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
  • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call a healthcare provider right away if you or your family member has 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?

Aplenzin has not been studied in children under the age of 18 and is not approved for use in children and teenagers.


There is a chance of having a seizure (convulsion, fit) with Aplenzin, especially in people:

The chance of having seizures increases with higher doses of Aplenzin. For more information, see the sections "Who should not take Aplenzin?" and "What should I tell my doctor before using Aplenzin?" Tell your doctor about all of your medical conditions and all the medicines you take. Do not take any other medicines while you are using Aplenzin unless your doctor has said it is okay to take them.

If you have a seizure while taking Aplenzin, stop taking the tablets and call your doctor right away. Do not take Aplenzin again if you have a seizure.

What is Aplenzin?

Aplenzin is a prescription medicine used to treat adults with a certain type of depression called major depressive disorder.

Who should not take Aplenzin?

Do not take Aplenzin if you:

What should I tell my doctor before using Aplenzin?

How should I take Aplenzin?

What should I avoid while taking Aplenzin?

What are possible side effects of Aplenzin?

Common side effects reported in studies of major depressive disorder 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 have nausea, take your medicine with food. If you have trouble sleeping, do not take your medicine too close to bedtime.

Tell your doctor right away about any side effects that bother you.

These are not all the side effects of Aplenzin. For a complete list, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or contact BTA Pharmaceuticals at (1-866-246-8245 (option 3).

How should I store Aplenzin?

General Information about Aplenzin.

This Medication Guide summarizes important information about Aplenzin. For more information, talk with your doctor. You can ask your doctor or pharmacist for information about Aplenzin that is written for health professionals or you can call toll-free [800-633-1610].

What are the ingredients in Aplenzin?

Active ingredient: bupropion hydrobromide.

Inactive ingredients: ethylcellulose, glyceryl behenate, polyvinyl alcohol, polyethylene glycol, povidone, and dibutyl sebacate. Carnauba wax is included in the 174 mg and 348 mg strengths.The tablets are printed with edible black ink.

The following are registered trademarks of their respective manufacturers: WELLBUTRIN®/GlaxoSmithKline, WELLBUTRIN SR®/GlaxoSmithKline, WELLBUTRIN XL®/GlaxoSmithKline, ZYBAN®/GlaxoSmithKline; PROZAC®/Eli Lilly and Company; ZOLOFT®/Pfizer Pharmaceuticals; LUVOX®/Solvay Pharmaceuticals, Inc.; ANAFRANIL®/Mallinckrodt Inc.; NARDIL®/Warner Lambert Company; MARPLAN®/Oxford Pharmaceutical Services, Inc.

Rx only

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: 2/2011