BUPROPION HYDROCHLORIDE (SR)- bupropion hydrochloride tablet, extended release 
RPK Pharmaceuticals, Inc.

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                                              MEDICATION GUIDE
            BUPROPION hydrochloride extended-release tablets USP (SR)
                                  (bue proe' pee on hye'' droe klor' ide)

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.

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 the risk of 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?

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      •   trouble sleeping (insomnia)
 •   attempts to commit suicide             •   new or worse irritability
 •   new or worse depression                •   acting aggressive, being angry, or violent
 •   new or worse anxiety                      •   acting on dangerous impulses
 •   feeling very agitated or restless      •   an extreme increase in activity and talking (mania)
 •   panic attacks                                  •   other unusual changes in behavior or mood

What else do I need to know about antidepressant medicines?

It is not known if bupropion hydrochloride extended-release tablets (SR) are safe and effective in children under the age of 18.

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.

Talk to your healthcare provider or your family member’s healthcare provider about:

• all risks and benefits of quit-smoking medicines

• all treatment choices for quitting smoking

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                                                                        • trouble sleeping

• frustration                                                                              • feeling anxious

• restlessness                                                                            • increased appetite

• depressed mood                                                                     • irritability

• anger                                                                                      • difficulty concentrating

• decreased heart rate                                                               • 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.

Some people have had serious side effect while taking bupropion to help them quit smoking, including: New or worse mental health problems, such as changes in behavior or thinking, aggression, hostility, agitation, depression, or suicidal thoughts or actions. Some people had these symptoms when they began taking bupropion, and others developed them after several weeks of treatment, or after stopping bupropion. These symptoms happened more often in people who had a history of mental health problems before taking bupropion than in people without a history of mental health problems.

Stop taking bupropion hydrochloride extended-release tablets (SR), and call your healthcare provider right away if you, your family, or caregiver notice any of these symptoms. Work with your healthcare provider to decide whether you should continue to take bupropion hydrochloride extended-release tablets (SR). In many people, these symptoms went away after stopping bupropion hydrochloride extended-release tablets (SR), but in some people symptoms continued after stopping bupropion hydrochloride extended-release tablets (SR). It is important for you to follow-up with your healthcare provider until your symptoms go away. Before taking bupropion hydrochloride extended-release tablets (SR), tell your healthcare provider if you have ever had depression 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 bupropion.

What Other Important Information Should I Know About bupropion hydrochloride extended-release tablets (SR)?

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 healthcare provider before taking bupropion hydrochloride extended-release tablets (SR)?” Tell your healthcare provider about all of your medical conditions and all the medicines you take. Do not take any other medicines while you are taking bupropion hydrochloride extended-release tablets (SR) unless your healthcare provider 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 healthcare provider right away. Do not take bupropion hydrochloride extended-release tablets (SR) again if you have a seizure.

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

Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

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

Bupropion hydrochloride extended-release tablets (SR) are 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 healthcare provider before taking bupropion hydrochloride extended-release tablets (SR)?

Tell your healthcare provider 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.”

Tell your healthcare provider about all the medicines you take, including prescription, over-the-counter medicines, vitamins, and herbal supplements. Many medicines increase your chances of having seizures or other serious side effects if you take them while you are taking bupropion hydrochloride extended-release tablets (SR).

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. See the sections at the beginning of this Medication Guide for information about serious side effects of bupropion.

The most common side effects of bupropion hydrochloride extended-release tablets (SR) include:

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

These are not all the possible side effects of bupropion hydrochloride extended-release tablets (SR). 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 Cipla Ltd. at 1-866-604-3268

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

Keep bupropion hydrochloride extended-release tablets (SR) and all medicines out of the reach of children.

General Information about the safe and effective use of bupropion hydrochloride extended-release tablets (SR).

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use bupropion hydrochloride extended-release tablets (SR) for a condition for which it was not prescribed. Do not give bupropion hydrochloride extended-release tablets (SR) to other people, even if they have the same symptoms you have. It may harm them.


If you take a urine drug screening test, bupropion hydrochloride extended-release tablets (SR) may make the test result positive for amphetamines. If you tell the person giving you the drug screening test that you are taking bupropion hydrochloride extended-release tablets (SR), they can do a more specific drug screening test that should not have this problem.


This Medication Guide summarizes important information about bupropion hydrochloride extended-release tablets (SR). If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about bupropion hydrochloride extended-release tablets (SR) that is written for healthcare professionals.


For more information about bupropion hydrochloride extended-release tablets (SR) call Cipla Ltd. at 1-866-604-3268

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

Active ingredient: bupropion hydrochloride.


Inactive ingredients: microcrystalline cellulose, colloidal silicon dioxide, hydroxy propyl methyl cellulose, diluted hydrochloric acid, magnesium stearate, hypromellose, titanium dioxide, polyethylene glycol and polysorbate 80. In addition, the 100 mg-tablet contains FD&C Blue No. 1 Aluminum lake, the 150 mg- tablet contains FD&C Blue No. 2 Aluminum lake and FD&C Red No. 40 Aluminum lake and the 200 mg-tablet contains FD&C Red No. 40 Aluminum lake.


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


*All brand names mentioned are registered trademark of their respective owners and are not of Cipla Limited.


Manufactured for:

Cipla USA, Inc.
1560 Sawgrass Corporate Parkway, Suite 130
Sunrise, FL 33323

Manufactured by:
InvaGen Pharmaceuticals, Inc.
(a subsidiary of Cipla Ltd.)
Hauppauge, NY 11788

Revised: 10/2017

Revised: 10/2018
RPK Pharmaceuticals, Inc.