BUPROPION- bupropion hydrochloride tablet, extended release 
REMEDYREPACK INC.

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MEDICATION GUIDE

Bupropion Hydrochloride Extended-release (SR) Tablets, USP
(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 (SR) Tablets?

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?

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?

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 Bupropion Hydrochloride Extended-release (SR) tablets 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.

Talk to your healthcare provider or your family members healthcare provider about:

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

 • frustration

 • restlessness

 • depressed mood

 • anger

 • decreased heart rate

 • trouble sleeping

 • feeling anxious

 • increased appetite

 • irritability

 • difficulty concentrating

 • 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 (SR) tablets 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 (SR) tablets. In many people, these symptoms went away after stopping Bupropion Hydrochloride Extended-release (SR) tablets, but in some people symptoms continued after stopping Bupropion Hydrochloride Extended-release (SR) tablets. It is important for you to follow-up with your healthcare provider until your symptoms go away. Before taking Bupropion Hydrochloride Extended-release (SR) tablets, 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 (SR) Tablets?

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 (SR) tablets?

Bupropion Hydrochloride Extended-release (SR) tablets 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 (SR) tablets?

Do not take Bupropion Hydrochloride Extended-release (SR) tablets if you

What should I tell my healthcare provider before taking Bupropion Hydrochloride Extended-release (SR) tablets?

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.

How should I take Bupropion Hydrochloride Extended-release (SR) tablets?

What should I avoid while taking Bupropion Hydrochloride Extended-release (SR) tablets?

What are possible side effects of Bupropion Hydrochloride Extended-release (SR) tablets?

Bupropion Hydrochloride Extended-release (SR) tablets can cause serious side effects. See the sections at the beginning of this Medication Guide for information about serious side effects of Bupropion Hydrochloride.

The most common side effects of Bupropion Hydrochloride Extended-release (SR) tablets 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 (SR) tablets. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088.

How should I store Bupropion Hydrochloride Extended-release (SR) tablets

Keep Bupropion Hydrochloride Extended-release (SR) tablets and all medicines out of the reach of children.

General Information about the safe and effective use of Bupropion Hydrochloride Extended-release (SR) Tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Bupropion Hydrochloride Extended-release (SR) tablets for a condition for which it was not prescribed.

Do not give Bupropion Hydrochloride Extended-release (SR) tablets 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 (SR) tablets 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 (SR) tablets, 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 (SR) tablets. 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 (SR) tablets that is written for healthcare professionals.

For more information about Bupropion Hydrochloride Extended-release (SR) tablets, call Solco Healthcare US, LLC at 1-866-257-2597.

What are the ingredients in Bupropion Hydrochloride Extended-release (SR) tablets?

Active ingredient: bupropion hydrochloride.

Inactive ingredients: copovidone, glyceryl behenate, hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide. In addition, the 100-mg tablet contains FD&C Blue No. 2 Lake, the 150-mg tablet contains FD&C Blue No. 2 Lake and FD&C Red No. 40 Lake, and the 200-mg tablet contains Iron Oxide Red.

Trademarks are owned by or licensed to the GSK group of companies. The other brands listed are trademarks of their respective owners.

Manufactured by:
Zhejiang Huahai Pharmaceutical Co., Ltd.
Xunqiao, Linhai, Zhejiang 317024, China

Distributed by:
Solco Healthcare US, LLC
Cranbury, NJ 08512, USA

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

Revised: 09/2017

17098-05

Revised: 11/2018
REMEDYREPACK INC.