BUPROBAN- bupropion hydrochloride tablet, extended release 
TEVA Pharmaceuticals USA Inc

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MEDICATION GUIDE

BUPROBAN®
[buPROPion HCl Extended-Release Tablets (SR)]

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

IMPORTANT: Be sure to read the three sections of this Medication Guide. The first section is about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with medicines used to quit smoking; the second section is about the risk of suicidal thoughts and actions with antidepressant medicines; and the third section is entitled "What Other Important Information Should I Know About BUPROBAN®?"

Quitting Smoking, Quit-Smoking Medications, Changes in Thinking and Behavior, Depression, and Suicidal Thoughts or Actions

This section of the Medication Guide is only about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with drugs used to quit smoking. Talk to your healthcare provider or your family member's healthcare provider about:

Some people have had changes in behavior, hostility, agitation, depression, suicidal thoughts or actions while taking BUPROBAN® to help them quit smoking. These symptoms can develop during treatment with BUPROBAN® or after stopping treatment with BUPROBAN®.

If you, your family member, or your caregiver notices agitation, hostility, depression, or changes in thinking or behavior that are not typical for you, or you have any of the following symptoms, stop taking BUPROBAN® and call your healthcare provider right away:

  • 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 BUPROBAN®, 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 BUPROBAN®, 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 BUPROBAN®.

Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions

Although BUPROBAN® is not a treatment for depression, it contains bupropion, the same active ingredient as the antidepressant medications WELLBUTRIN®, WELLBUTRIN SR®, and WELLBUTRIN XL®.

This section of the Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines.

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

1.
Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment.
2.
Depression or 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.
3.
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 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 the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call your 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?

It is not known if BUPROBAN® is safe and effective in children under the age of 18.

What other important information should I know about BUPROBAN®?

If you have any of the above symptoms of mania, call your healthcare provider.

What is BUPROBAN®?

BUPROBAN® is a prescription medicine to help people quit smoking.

BUPROBAN® should be used with a patient support program. It is important to participate in the behavioral program, counseling, or other support program your healthcare professional recommends.

Quitting smoking can lower your chances of having lung disease, heart disease, or getting certain types of cancer that are related to smoking.

Who should not take BUPROBAN®?

Do not take BUPROBAN® if you:

What should I tell my healthcare provider before taking BUPROBAN®?

Tell your healthcare provider if you have ever had depression, suicidal thoughts or actions, or other mental health problems. You should also tell your healthcare provider about any symptoms you had during other times you tried to quit smoking, with or without BUPROBAN®. See "Quitting Smoking, Quit-Smoking Medications, Changes in Thinking and Behavior, Depression, and Suicidal Thoughts or Actions."

How should I take BUPROBAN®?

Do not take any other medicines while taking BUPROBAN® unless your healthcare provider has told you it is okay.

What should I avoid while taking BUPROBAN®?

What are possible side effects of BUPROBAN®?

BUPROBAN® can cause serious side effects. See the sections at the beginning of this Medication Guide for information about serious side effects of BUPROBAN®.

The most common side effects of BUPROBAN® include:

If you have trouble sleeping, do not take BUPROBAN® too close to bedtime.

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

These are not all the possible side effects of BUPROBAN®. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to TEVA USA, PHARMACOVIGILANCE at 1-866-832-8537.

How should I store BUPROBAN®?

Keep BUPROBAN® and all medicines out of the reach of children.

General information about BUPROBAN®

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use BUPROBAN® for a condition for which it was not prescribed.

Do not give BUPROBAN® to other people, even if they have the same symptoms you have. It may harm them.

If you take a urine drug screening test, BUPROBAN® may make the test result positive for amphetamines. If you tell the person giving you the drug screening test that you are taking BUPROBAN®, they can do a more specific drug screening test that should not have this problem.

This Medication Guide summarizes important information about BUPROBAN®. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about BUPROBAN® that is written for health professionals.

For more information about BUPROBAN®, call 1-888-838-2872.

What are the ingredients in BUPROBAN®?

Active ingredient: bupropion hydrochloride.

Inactive ingredients: colloidal silicon dioxide, hydroxypropylcellulose, hypromellose, iron oxide yellow, macrogol, magnesium stearate, microcrystalline cellulose, polydextrose, titanium dioxide and triacetin.

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

WELLBUTRIN®, WELLBUTRIN SR®, and WELLBUTRIN XL® are registered trademarks of the GlaxoSmithKline group of companies.

FORFIVO XL™ is a registered trademark of Edgemont Pharmaceuticals, LLC.

APLENZIN® is a registered trademark of sanofi-aventis U.S. LLC.

Manufactured by:
Impax Laboratories, Inc.
Hayward, CA 94544 USA

Manufactured for:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960

530-08
Rev. 04/2014

Revised: 05/2014
 
TEVA Pharmaceuticals USA Inc