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BUPROPION- bupropion hydrochloride tablet, extended releaseBUPROPION- bupropion hydrochloride tablet, extended release


  1. 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?
  2. What Is The Most Important Information I Should Know About Antidepressant Medicines, Depression And Other Serious Mental Illnesses, And Suicidal Thoughts Or Actions?
  3. 3. How Can I Watch For And Try To Prevent Suicidal Thoughts And Actions In Myself Or A Family Member?
  4. 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:
  5. What Else Do I Need To Know About Antidepressant Medicines?
  6. Talk To Your Healthcare Provider Or Your Family Members Healthcare Provider About:
  7. When You Try To Quit Smoking, With Or Without Bupropion You May Have Symptoms That May Be Due To Nicotine Withdrawal, Including:
  8. 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:
  9. Seizures: There Is A Chance Of Having A Seizure (convulsion, Fit) With Bupropion Hydrochloride Extended-release (sr) Tablets, Especially In People:
  10. Who Should Not Take Bupropion Hydrochloride Extended-release (sr) Tablets?
  11. What Should I Avoid While Taking Bupropion Hydrochloride Extended-release (sr) Tablets?
  12. What Are Possible Side Effects Of Bupropion Hydrochloride Extended-release (sr) Tablets?
  13. Manufactured By:
  14. Distributed By:
  15. Patient Information
  16. Suicidal Thoughts And Behaviors:
  17. Neuropsychiatric Adverse Events And Suicide Risk In Smoking Cessation Treatment:
  18. Severe Allergic Reactions:
  19. Seizure:
  20. Angle-closure Glaucoma:
  21. Bupropion-containing Products:
  22. Potential For Cognitive And Motor Impairment:
  23. Concomitant Medications:
  24. Pregnancy:
  25. Precautions For Nursing Mothers:
  26. Storage Information:
  27. Administration Information:

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

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? 

Never stop an antidepressant medicine without first talking to a healthcare provider.Stopping an antidepressant medicine suddenly can cause other symptoms.
Antidepressants are medicines used to treat depression and other illnesses.It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
Antidepressant medicines have other side effects.Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
Antidepressant medicines can interact with other medicines.Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.

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: 

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

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.

Seizures: There Is A Chance Of Having A Seizure (convulsion, Fit) With Bupropion Hydrochloride Extended-release (sr) Tablets, Especially In People: 

with certain medical problems.
who take certain medicines.
The chance of having seizures increases with higher doses of Bupropion Hydrochloride Extended-release (SR) tablets. For more information,

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

have or had a seizure disorder or epilepsy.
have or had an eating disorder such as anorexia nervosa or bulimia.
are taking any other medicines that contain bupropion, ZYBAN(used to help people stop smoking), WELLBUTRIN (bupropion hydrochloride tablets), Bupropion hydrochloride extended-release (XL) tablets, APLENZIN, or FORFIVO XL.Bupropion is the same active ingredient that is in Bupropion Hydrochloride Extended-release (SR) tablets.
drink a lot of alcohol and abruptly stop drinking, or use medicines called sedatives (these make you sleepy), benzodiazepines, or anti-seizure medicines, and you stop using them all of a sudden.
take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
do not take an MAOI within 2 weeks of stopping Bupropion Hydrochloride Extended-release (SR) tablets unless directed to do so by your healthcare provider.
do not start Bupropion Hydrochloride Extended-release (SR) tablets if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider.
are allergic to the active ingredient in Bupropion Hydrochloride Extended-release (SR) tablets, bupropion, or to any of the inactive ingredients.

Tell your healthcare provider if you have ever had depression, suicidal thoughts or actions, or other mental health problems.

Take Bupropion Hydrochloride Extended-release (SR) tablets exactly as prescribed by your healthcare provider. Do not change your dose or stop taking Bupropion Hydrochloride Extended-release (SR) tablets without talking to your healthcare provider first.
Swallow Bupropion Hydrochloride Extended-release (SR) tablets whole. Do not chew, cut, or crush Bupropion Hydrochloride Extended-release (SR) tablets.If you do, the medicine will be released into your body too quickly. If this happens you may be more likely to get side effects including seizures.Tell your healthcare provider if you cannot swallow tablets.
Bupropion Hydrochloride Extended-release (SR) tablets may have an odor. This is normal.
Take Bupropion Hydrochloride Extended-release (SR) tablets at the same time each day.
Take your doses of Bupropion Hydrochloride Extended-release (SR) tablets at least 8 hours apart.
You may take Bupropion Hydrochloride Extended-release (SR) tablets with or without food.
If you miss a dose, do not take an extra dose to make up for the dose you missed. Wait and take your next dose at the regular time.This is very important.Too much Bupropion Hydrochloride Extended-release (SR) tablets can increase your chance of having a seizure.
If you take too much Bupropion Hydrochloride Extended-release (SR) tablets, or overdose, call your local emergency room or poison control center right away.
Do not take any other medicines while taking Bupropion Hydrochloride Extended-release (SR) tablets unless your healthcare provider has told you it is okay.
If you are taking Bupropion Hydrochloride Extended-release (SR) tablets for the treatment of major depressive disorder, it may take several weeks for you to feel that Bupropion Hydrochloride Extended-release (SR) tablets are working. Once you feel better, it is important to keep taking Bupropion Hydrochloride Extended-release (SR) tablets exactly as directed by your healthcare provider. Call your healthcare provider if you do not feel Bupropion Hydrochloride Extended-release (SR) tablets are working for you.

What Should I Avoid While Taking Bupropion Hydrochloride Extended-release (sr) Tablets? 

Limit or avoid using alcohol during treatment with Bupropion Hydrochloride Extended-release (SR) tablets. If you usually drink a lot of alcohol, talk with your healthcare provider before suddenly stopping. If you suddenly stop drinking alcohol, you may increase your chance of having seizures.
Do not drive a car or use heavy machinery until you know how Bupropion Hydrochloride Extended-release (SR) tablets affect you. Bupropion Hydrochloride Extended-release (SR) tablets can affect your ability to do these things safely.

What Are Possible Side Effects Of Bupropion Hydrochloride Extended-release (sr) Tablets? 

Bupropion Hydrochloride Extended-release (SR) tablets can cause serious side effects.

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

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Bupropion Hydrochloride Extended-release (SR) tablets and counsel them in its appropriate use.

A patient Medication Guide about Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions, Quitting Smoking, Quit-Smoking Medications, Changes in Thinking and Behavior, Depression, and Suicidal Thoughts or Actions, and What Other Important Information Should I Know About Bupropion Hydrochloride Extended-release (SR) Tablets? is available for Bupropion Hydrochloride Extended-release (SR) tablets. Instruct patients, their families, and their caregivers to read the Medication Guide and assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.

Advise patients regarding the following issues and to alert their prescriber if these occur while taking Bupropion Hydrochloride Extended-release (SR) tablets.

Suicidal Thoughts And Behaviors: 

Instruct patients, their families, and/or their caregivers to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Advise families and caregivers of patients to observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient s prescriber or healthcare professional, especially if they are severe, abrupt in onset, or were not part of the patient s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.

Neuropsychiatric Adverse Events And Suicide Risk In Smoking Cessation Treatment: 

Although Bupropion Hydrochloride Extended-release (SR) tablets are not indicated for smoking cessation treatment, it contains the same active ingredient as ZYBANwhich is approved for this use. Inform patients that some patients have experienced changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation and suicide when attempting to quit smoking while taking bupropion. Instruct patients to discontinue bupropion and contact a healthcare professional if they experience such symptoms[see Warnings and Precautions (5.2), Adverse Reactions (6.2)].

Severe Allergic Reactions: 

Educate patients on the symptoms of hypersensitivity and to discontinue Bupropion Hydrochloride Extended-release (SR) tablets if they have a severe allergic reaction.

Seizure: 

Instruct patients to discontinue and not restart Bupropion Hydrochloride Extended-release (SR) tablets if they experience a seizure while on treatment. Advise patients that the excessive use or abrupt discontinuation of alcohol, benzodiazepines, antiepileptic drugs, or sedatives/hypnotics can increase the risk of seizure. Advise patients to minimize or avoid use of alcohol.

As the dose is increased during initial titration to doses above 150 mg per day, instruct patients to take Bupropion Hydrochloride Extended-release (SR) tablets in 2 divided doses, preferably with at least 8 hours between successive doses, to minimize the risk of seizures.

Angle-closure Glaucoma: 

Patients should be advised that taking Bupropion Hydrochloride Extended-release (SR) tablets can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle-closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible[seeWarnings and Precautions (5.7)].

Bupropion-containing Products: 

Educate patients that Bupropion Hydrochloride Extended-release (SR) tablets contain the same active ingredient (bupropion hydrochloride) found in ZYBAN, which is used as an aid to smoking cessation treatment, and that Bupropion Hydrochloride Extended-release (SR) tablets should not be used in combination with ZYBAN or any other medications that contain bupropion (such as WELLBUTRIN, the immediate-release formulation and Bupropion hydrochloride extended-release (XL) tablets or FORFIVO XL, the extended- release formulations, and APLENZIN, the extended-release formulation of bupropion hydrobromide). In addition, there are a number of generic bupropion HCl products for the immediate-, sustained-, and extended-release formulations.

Potential For Cognitive And Motor Impairment: 

Advise patients that any CNS-active drug like Bupropion Hydrochloride Extended-release (SR) tablets may impair their ability to perform tasks requiring judgment or motor and cognitive skills. Advise patients that until they are reasonably certain that Bupropion Hydrochloride Extended-release (SR) tablets do not adversely affect their performance, they should refrain from driving an automobile or operating complex, hazardous machinery. Bupropion Hydrochloride Extended-release (SR) tablets may lead to decreased alcohol tolerance.

Concomitant Medications: 

Counsel patients to notify their healthcare provider if they are taking or plan to take any prescription or over-the-counter drugs because Bupropion Hydrochloride Extended-release (SR) tablets and other drugs may affect each others metabolisms.

Pregnancy: 

Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during therapy.

Precautions For Nursing Mothers: 

Advise patients that Bupropion Hydrochloride is present in human milk in small amounts.

Storage Information: 

Store at 20 C to 25 C (68 F to 77 F) [see USP Controlled Room Temperature]. Keep the tablets dry and out of the light.

Administration Information: 

Instruct patients to swallow Bupropion Hydrochloride Extended-release (SR) tablets whole so that the release rate is not altered. Do not chew, divide, or crush tablets; they are designed to slowly release drug in the body. When patients take more than 150 mg per day, instruct them to take Bupropion Hydrochloride Extended-release (SR) tablets in 2 doses at least 8 hours apart, to minimize the risk of seizures. Instruct patients if they miss a dose, not to take an extra tablet to make up for the missed dose and to take the next tablet at the regular time because of the dose-related risk of seizure. Instruct patients that Bupropion Hydrochloride Extended-release (SR) tablets may have an odor. Bupropion Hydrochloride Extended-release (SR) tablets can be taken with or without food.

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

You may report side effects to Solco Healthcare US LLC. at 1-866-257-2597 or FDA at 1-800-FDA-1088.



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