BUPROPION HYDROCHLORIDE - bupropion hydrochloride tablet, film coated, extended release 
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SPL MEDGUIDE

BuPROPion Hydrochloride Extended-release Tablets USP (SR)

Read this Medication Guide carefully before you start using bupropion hydrochloride extended-release tablets (SR) 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 bupropion hydrochloride extended-release tablets (SR), 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 suicidal thoughts and actions with antidepressant medicines; the second section is about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with medicines used to quit smoking; and the third section is entitled “What other important information should I know about bupropion hydrochloride extended-release tablets (SR)?”

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

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?

  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?

Bupropion hydrochloride extended-release tablets (SR) have not been studied in children under the age of 18 and are not approved for use in children and teenagers.

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.

Although bupropion hydrochloride extended-release tablets (SR) are not a treatment for quitting smoking, it contains the same active ingredient (bupropion hydrochloride) 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.

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 bupropion and call your healthcare provider right away:

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 doctor about any symptoms you had during other times you tried to quit smoking, with or without bupropion.

What Other Important Information Should I Know About Bupropion Hydrochloride Extended-release Tablets (SR)?

Seizures: There is a chance of having a seizure (convulsion, fit) with bupropion hydrochloride extended-release tablets (SR), especially in people:

The chance of having seizures increases with higher doses of bupropion hydrochloride extended-release tablets (SR). For more information, see the sections “Who should not take bupropion hydrochloride extended-release tablets  (SR)?” and “What should I tell my doctor before using bupropion hydrochloride extended-release tablets (SR)?” 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 bupropion hydrochloride extended-release tablets (SR) unless your doctor has said it is okay to take them.

If you have a seizure while taking bupropion hydrochloride extended-release tablets (SR), stop taking the tablets and call your doctor right away. Do not take bupropion hydrochloride extended-release tablets (SR) again if you have a seizure.

What are bupropion hydrochloride extended-release tablets (SR)?

Bupropion hydrochloride extended-release tablets (SR) are a prescription medicine used to treat adults with a certain type of depression called major depressive disorder.

Who should not take bupropion hydrochloride extended-release tablets (SR)?

Do not take bupropion hydrochloride extended-release tablets (SR) if you:

What should I tell my doctor before using bupropion hydrochloride extended-release tablets (SR)?

Tell your doctor if you have ever had depression, suicidal thoughts or actions, or other mental health problems. See “Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions.”

How should I take bupropion hydrochloride extended-release tablets (SR)?

What should I avoid while taking bupropion hydrochloride extended-release tablets (SR)?

What are possible side effects of bupropion hydrochloride extended-release tablets (SR)?

Bupropion hydrochloride extended-release tablets (SR) can cause serious side effects. Read this entire Medication Guide for more information about these serious side effects.

The most common side effects of bupropion hydrochloride extended-release tablets (SR) are 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.

These are not all the side effects of bupropion hydrochloride extended-release tablets (SR). 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 bupropion hydrochloride extended-release tablets (SR)?

General Information about bupropion hydrochloride extended-release tablets (SR).

This Medication Guide summarizes important information about bupropion hydrochloride extended-release tablets (SR). For more information, talk with your doctor. You can ask your doctor or pharmacist for information about bupropion hydrochloride extended-release tablets (SR) that is written for health professionals.

What are the ingredients in bupropion hydrochloride extended-release tablets (SR)?

Active ingredient: bupropion hydrochloride.

Inactive ingredients: hydroxypropyl cellulose, microcrystalline cellulose, colloidal silicon dioxide, stearic acid, magnesium stearate, and diluted hydrochloric acid. The film coating contains lactose monohydrate, hydroxypropyl cellulose, titanium dioxide, and polyethylene glycol.

*The following are registered trademarks of their respective manufacturers: Zyban®/GlaxoSmithKline; Nardil®/Warner Lambert Company; Parnate®/ GlaxoSmithKline; Marplan®/Oxford Pharmaceutical Services, Inc.; Wellbutrin®/GlaxoSmithKline; Wellbutrin XL®/GlaxoSmithKline.

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

Manufactured by:
Watson Laboratories, Inc.
Corona, CA 92880 USA

Distributed by:
Watson Pharma, Inc.
Corona, CA 92880 USA

Issued: August 2010

 

Revised: 03/2013
 
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