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BUPROPION HYDROCHLORIDE (bupropion hydrochloride extended-release tablets- xl tablet, extended release


  1. Patient Information
  2. Roorkee - 247661, Indiamarketed By:
  3. 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?
  4. 3. How Can I Watch For And Try To Prevent Suicidal Thoughts And Actions In Myself Or A Family Member?
  5. 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:
  6. What Else Do I Need To Know About Antidepressant Medicines?
  7. Talk To Your Healthcare Provider Or Your Family Member S Healthcare Provider About:
  8. When You Try To Quit Smoking, With Or Without Bupropion You May Have Symptoms That May Be Due To Nicotine Withdrawal, Including:
  9. Seizures: There Is A Chance Of Having A Seizure (convulsion, Fit) With Bupropion Hydrochloride Extended-release Tablets (xl), Especially In People:
  10. Manufactured By:
  11. Marketed By:

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 tablets (XL) 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 Tablets (XL)? is available for bupropion hydrochloride extended-release tablets (XL). 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 tablets (XL).

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 health 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 Eventsand Suicide Risk in Smoking Cessation Treatment

Although bupropion hydrochloride extended-release tablets (XL) 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 hydrochloride extended-release tablets (XL) and contact a healthcare professional if they experience such symptoms[seeWarnings and Precautions (5.2)andAdverse Reactions (6.2)].

Severe Allergic Reactions


Educate patients on the symptoms of hypersensitivity and to discontinue bupropion hydrochloride extended-release tablets (XL) if they have a severe allergic reaction.

Seizure

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

Angle-Closure Glaucoma


Patients should be advised that taking bupropion hydrochloride extended-release tablets (XL) 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 tablets (XL) contains the same active ingredient (bupropion) found in ZYBAN, which is used as an aid to smoking cessation treatment, and that bupropion hydrochloride extended-release tablets (XL) should not be used in combination with ZYBAN or any other medications that contain bupropion hydrochloride (such as WELLBUTRIN SR, the sustained-release formulation, WELLBUTRIN, the immediate-release formulation, and APLENZIN, a bupropion hydrobromide formulation). 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 tablets (XL) 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 tablets (XL) do not adversely affect their performance, they should refrain from driving an automobile or operating complex, hazardous machinery. Bupropion hydrochloride extended-release tablets (XL) treatment 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 tablets (XL) and other drugs may affect each other s metabolism.

Pregnancy

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

Precautions for Nursing Mothers

Communicate with the patient and pediatric healthcare provider regarding the infant s exposure to bupropion through human milk. Instruct patients to immediately contact the infant s healthcare provider if they note any side effect in the infant that concerns them or is persistent.

Administration Information

Instruct patients to swallow bupropion hydrochloride extended-release tablets (XL) whole so that the release rate is not altered. 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 tablets (XL) should be swallowed whole and not crushed, divided, or chewed. Bupropion hydrochloride extended-release tablets (XL) should be administered in the morning and may be taken with or without food.

*All brands mentioned are trademarks of their respective owners and are not trademarks of Jubilant Generics Limited.

Rx Only

Roorkee - 247661, Indiamarketed By: 

Jubilant Cadista Pharmaceuticals Inc.
Salisbury, MD 21801, USA

Revision:04/2019

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 ofsuicidal 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 tablets (XL) 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 (XL) are not a treatment for quitting smoking, it contains the same active ingredient (bupropion hydrochloride) as ZYBANwhich 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
  • 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 effects 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 (XL) 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 (XL). In many people, these symptoms went away after stopping bupropion hydrochloride extended-release tablets (XL), but in some people symptoms continued after stopping bupropion hydrochloride extended-release tablets (XL). It is important for you to follow-up with your healthcare provider until your symptoms go away.Before taking bupropion hydrochloride extended-release tablets (XL),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 HydrochlorideExtended-Release Tablets (XL)?

Seizures: There Is A Chance Of Having A Seizure (convulsion, Fit) With Bupropion Hydrochloride Extended-release Tablets (xl), 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 tablets (XL). For more information,

Bupropion hydrochloride extended-release tablets (XL) 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.

Quitting smoking can lower your chances of having lung disease, heart disease, or getting certain types of cancer that are related to smoking.

Who should not take
bupropion hydrochlorideextended-release tablets (XL)?

Do not take
bupropion hydrochlorideextended-release tablets (XL)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, including WELLBUTRIN, WELLBUTRIN SR, APLENZIN, ZYBAN, or FORFIVO XL.Bupropion is the same active ingredient that is in bupropion hydrochloride extended-release tablets (XL).
  • drink a lot of alcohol and abruptly stop drinking, or take medicines called sedatives (these make you sleepy), benzodiazepines, or anti-seizure medicines, and you stop taking 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 hydrochlorideextended-release tablets (XL)unless directed to do so by your healthcare provider.
    • do not start bupropion hydrochlorideextended-release tablets (XL)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 tablets (XL), 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. You should also tell your healthcare provider about any symptoms you had during other times you tried to quit smoking, with or without bupropion hydrochloride extended-release tablets (XL).

    • Start bupropion hydrochloride extended-release tablets (XL) before you stop smoking to give bupropion hydrochloride extended-release tablets (XL) time to build up in your body. It takes about 1 week for bupropion hydrochloride extended-release tablets (XL) to start working.
    • Pick a date to stop smoking that is during the second week you are taking bupropion hydrochloride extended-release tablets (XL).
    • Take bupropion hydrochloride extended-release tablets (XL) exactly as prescribed by your healthcare provider. Do not change your dose or stop taking bupropion hydrochloride extended-release tablets (XL) without talking with your healthcare provider first.
    • Bupropion hydrochloride extended-release tablets (XL) are usually taken for 7 to 12 weeks. Your healthcare provider may decide to prescribe bupropion hydrochloride extended-release tablets (XL) for longer than 12 weeks to help you stop smoking. Follow your healthcare provider s instructions.
    • Swallow bupropion hydrochloride extended-release tablets (XL) whole. Do not chew, cut, or crush bupropion hydrochloride extended-release tablets (XL). 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 tablets (XL) may have an odor. This is normal.
    • Take your doses of bupropion hydrochloride extended-release tablets (XL) at least 8 hours apart.
    • You may take bupropion hydrochloride extended-release tablets (XL) with or without food.
    • It is not dangerous to smoke and take bupropion hydrochloride extended-release tablets (XL) at the same time. But, you will lower your chance of breaking your smoking habit if you smoke after the date you set to stop smoking.
    • You may use bupropion hydrochloride extended-release tablets (XL) and nicotine patches (a type of nicotine replacement therapy) at the same time, following the precautions below.
      • You should only use bupropion hydrochloride extended-release tablets (XL) and nicotine patches together under the care of your healthcare provider. Using bupropion hydrochloride extended-release tablets (XL) and nicotine patches together may raise your blood pressure, and sometimes this can be severe.
      • Tell your healthcare provider if you plan to use nicotine patches. Your healthcare provider should check your blood pressure regularly if you use nicotine patches with bupropion hydrochloride extended-release tablets (XL) to help you quit smoking.
    • 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 tablets (XL) can increase your chance of having a seizure.
    • If you take too much bupropion hydrochloride extended-release tablets (XL), or overdose, call your local emergency room or poison control center right away.

    Do not take any other medicines while takingbupropion hydrochlorideextended-release tablets (XL)unless your healthcare provider has told you it is okay.

    What should I avoid while taking
    bupropion hydrochlorideextended-release tablets (XL)?

    • Limit or avoid using alcohol during treatment with bupropion hydrochloride extended-release tablets (XL). 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 tablets (XL) affects you. Bupropion hydrochloride extended-release tablets (XL) can affect your ability to do these things safely.

    What are possible side effects ofbupropion hydrochlorideextended-release tablets (XL)?

    Bupropion hydrochloride extended-release tablets (XL) can cause serious side effects.

    • Store bupropion hydrochloride extended-release tablets (XL) at 20 C to 25 C (68 F to 77 F); excursions permitted to 15 C to 30 C (59 F to 86 F) [

      Active ingredient: bupropion hydrochloride USP

      Inactive ingredients: cysteine hydrochloride, ethyl cellulose, methacrylic acid copolymer dispersion, polyethylene glycol, polyvinyl alcohol, povidone, silicon dioxide, sodium stearyl fumarate, talc, titanium dioxide and triethyl citrate. The tablets are printed with edible black ink.

      Printing ink contains: ammonium hydroxide, ferric oxide black, propylene glycol, and shellac.

      * All brands mentioned are trademarks of their respective owners and are not trademarks of Jubilant Generics Limited.

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

      Rx Only

Manufactured By: 

Jubilant Generics Limited
Roorkee - 247661, India

Marketed By: 

Jubilant Cadista Pharmaceuticals Inc.
Salisbury, MD 21801, USA

Revision: 04/2019



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