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 using BUPROBAN® 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 BUPROBAN®, ask your doctor 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.

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 notice 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:

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 health problems. You should also tell your doctor 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. Talk to your doctor, 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?

  1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
  2. 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.
  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 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:

What else do I need to know about antidepressant medicines?

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

What Other Important Information Should I Know About BUPROBAN®?

What is BUPROBAN®?

BUPROBAN® is a prescription medicine to help people quit smoking. Studies have shown that more than one third of people quit smoking for at least 1 month while taking BUPROBAN® and participating in a patient support program. For many patients, BUPROBAN® reduces withdrawal symptoms and the urge to smoke. 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.

Who should not take BUPROBAN®?

Do not take BUPROBAN® if you:

What should I tell my doctor before using BUPROBAN®?

Tell your doctor if you have ever had depression, suicidal thoughts or actions, or other mental health problems. You should also tell your doctor 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®?

How long should I take BUPROBAN®?

Most people should take BUPROBAN® for at least 7 to 12 weeks. Some people may need to take BUPROBAN® for a longer period of time to assist in their smoking cessation efforts. Follow your doctor's instructions.

When should I stop smoking?

It takes about 1 week for BUPROBAN® to start working. For your best chance of quitting, you should not stop smoking until you have been taking BUPROBAN® for 1 week. You should set a date to stop smoking during the second week you're taking BUPROBAN®.

Can I smoke while taking BUPROBAN®?

It is not physically dangerous to smoke and use BUPROBAN® at the same time. But you will seriously lower your chance of breaking your smoking habit if you smoke after the date you set to stop smoking.

Can BUPROBAN® be used at the same time as nicotine patches?

Yes, BUPROBAN® and nicotine patches can be used at the same time but should only be used together under the supervision of your doctor. Using BUPROBAN® and nicotine patches together may raise your blood pressure, sometimes severely. Tell your doctor if you are planning to use nicotine replacement therapy because your doctor should check your blood pressure regularly.

Do not smoke at any time if you are using a nicotine patch or any other nicotine product along with BUPROBAN®. It is possible to get too much nicotine and have serious side effects.

What should I avoid while taking BUPROBAN®?

What are possible side effects of BUPROBAN®?

BUPROBAN® can cause serious side effects. Read this entire Medication Guide for more information about these serious side effects.

The most common side effects of BUPROBAN® are dry mouth and trouble sleeping. These side effects are generally mild and often disappear after a few weeks. If you have trouble sleeping, do not take BUPROBAN® too close to bedtime.

These are not all the side effects of BUPROBAN®. 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.

How should I store BUPROBAN®?

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. Keep BUPROBAN® out of the reach of children.

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®. For more information, talk with your doctor. You can ask your doctor or pharmacist for information about BUPROBAN® that is written for health professionals.

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.


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The following are registered trademarks of their respective manufacturers: NARDIL®/Warner Lambert Company; MARPLAN®/Oxford Pharmaceutical Services, Inc.

Revised: 03/2013
 
TEVA Pharmaceuticals USA Inc