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APLENZIN- bupropion hydrobromide tablet, extended release


  1. Patient Information
  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. 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 Member S 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 Had Serious Side Effects While Taking Bupropion To Help Them Quit Smoking, Including:
  9. Seizures: There Is A Chance Of Having A Seizure (convulsion, Fit) With Aplenzin, Especially In People:
  10. The Chance Of Having Seizures Increases With Higher Doses Of Aplenzin. For More Information, Andwhat Should I Tell My Healthcare Provider Before Taking Aplenzin?
  11. Do Not Take Aplenzin If You:
  12. What Should I Avoid While Taking Aplenzin?
  13. What Are Possible Side Effects Of Aplenzin?
  14. What Are The Ingredients In Aplenzin?
  15. Manufactured For:
  16. Bridgewater, Nj 08807 Usaby:
  17. Revised: 5/2017document Id:

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 APLENZIN 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 APLENZIN? is available for APLENZIN. 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 APLENZIN.

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 Events and Suicide Risk in Smoking Cessation Treatment

Although APLENZIN is 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 APLENZIN and contact a healthcare professional if they experience such symptoms[

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? 

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 APLENZIN is 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 APLENZIN is not a treatment for quitting smoking, it contains the same active ingredient (bupropion) 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
depressed mood
trouble sleeping
irritability
frustration
anger
feeling anxious
difficulty concentrating
restlessness
decreased heart rate
increased appetite
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 APLENZIN 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 APLENZIN. In many people, these symptoms went away after stopping APLENZIN, but in some people symptoms continued after stopping APLENZIN. It is important for you to follow up with your healthcare provider until your symptoms go away. Before taking APLENZIN, 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 Aplenzin, Especially In People: 

o
with certain medical problems
o
who take certain medicines.

The Chance Of Having Seizures Increases With Higher Doses Of Aplenzin. For More Information, Andwhat Should I Tell My Healthcare Provider Before Taking Aplenzin? 

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 APLENZIN unless your healthcare provider has said it is okay to take them.

If you have a seizure while taking APLENZIN, stop taking the tablets and call your healthcare provider right away.Do not take APLENZIN again if you have a seizure.

High blood pressure (hypertension). Some people get high blood pressure that can be severe, while taking APLENZIN.The chance of high blood pressure may be higher if you also use nicotine replacement therapy (such as a nicotine patch) to help you stop smoking (

APLENZIN 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.

Do Not Take Aplenzin 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, WELLBUTRIN XL, ZYBAN, or FORFIVO XL.Bupropion is the same active ingredient that is in APLENZIN.
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.
o
do not take an MAOI within 2 weeks of stopping APLENZIN unless directed to do so by your healthcare provider.
o
do not start APLENZIN 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 APLENZIN, 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 APLENZIN.

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

Do not take any other medicines while taking APLENZIN unless your healthcare provider has told you it is okay.

What Should I Avoid While Taking Aplenzin? 

Limit or avoid using alcohol during treatment with APLENZIN. 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 APLENZIN affects you. APLENZIN can affect your ability to do these things safely.

What Are Possible Side Effects Of Aplenzin? 

APLENZINcan cause serious side effects.

Store APLENZIN at room temperature between 59 F and 86 F (15 C to 30 C).

Keep APLENZIN and all medicines out of the reach of children.

General information about the safe and effective use of APLENZIN.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use APLENZIN for a condition for which it was not prescribed. Do not give APLENZIN to other people, even if they have the same symptoms you have. It may harm them.
If you take a urine drug screening test, APLENZIN may make the test result positive for amphetamines. If you tell the person giving you the drug screening test that you are taking APLENZIN, they can do a more specific drug screening test that should not have this problem.

This Medication Guide summarizes important information about APLENZIN. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about APLENZIN that is written for health professionals.

For more information about APLENZIN, go to www.APLENZIN.com or call1-800-321-4576.

What Are The Ingredients In Aplenzin? 

Active ingredient: bupropion hydrobromide

Inactive ingredients: ethylcellulose, glyceryl behenate, polyvinyl alcohol, polyethylene glycol, povidone, and dibutyl sebacate. Carnauba wax is included in the 174 mg and 348 mg strengths. The tablets are printed with edible black ink.

Manufactured For: 

Valeant Pharmaceuticals North America LLC

Bridgewater, Nj 08807 Usaby: 

Valeant Pharmaceuticals International, Inc.
Steinbach, MB R5G 1Z7, Canada

APLENZIN is a trademark of Valeant Pharmaceuticals International,
Inc. or its affiliates. All other product/brand names are the
trademarks of their respective owners.

Valeant Pharmaceuticals North America LLC

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

9386805

20001960

Revised: 05/2017

---------------------------------------------
PRINCIPAL DISPLAY PANEL - 174 mg Tablet Bottle Label

NDC 0187-5810-30
RXONLY

ONCE DAILY
Aplenzin
(bupropion hydrobromide)
Extended-Release Tablets

174 mg

WARNING: Do not use with other
medicines that contain bupropion.

Federal Law requires dispensing of Aplenzin with
the Medication Guide attached to this bottle.

30Tablets

174mg 30

PRINCIPAL DISPLAY PANEL - 348 mg Tablet Bottle Label

NDC 0187-5811-30
RXONLY

ONCE DAILY
Aplenzin
(bupropion hydrobromide)
Extended-Release Tablets

348 mg

WARNING: Do not use with other
medicines that contain bupropion.

Federal Law requires dispensing of Aplenzin with
the Medication Guide attached to this bottle.

30Tablets

348 mg 30

PRINCIPAL DISPLAY PANEL - 522 mg Tablet Bottle Label

NDC 0187-5812-30
RXONLY

ONCE DAILY
Aplenzin
(bupropion hydrobromide)
Extended-Release Tablets

522 mg

WARNING: Do not use with other
medicines that contain bupropion.

Federal Law requires dispensing of Aplenzin with
the Medication Guide attached to this bottle.

30Tablets

522 mg 30
APLENZIN
bupropion hydrobromide tablet, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0187-5810
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BUPROPION HYDROBROMIDE(UNII: E70G3G5863) (BUPROPION - UNII:01ZG3TPX31)BUPROPION HYDROBROMIDE174 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
CARNAUBA WAX(UNII: R12CBM0EIZ)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
Product Characteristics
ColorWHITE (white to off-white)Scoreno score
ShapeROUNDSize8mm
FlavorImprint CodeBR;174
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-5810-077 in 1 BOTTLE; Type 0: Not a Combination Product04/23/2008
2NDC:0187-5810-3030 in 1 BOTTLE; Type 0: Not a Combination Product04/23/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02210804/23/2008
APLENZIN
bupropion hydrobromide tablet, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0187-5811
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BUPROPION HYDROBROMIDE(UNII: E70G3G5863) (BUPROPION - UNII:01ZG3TPX31)BUPROPION HYDROBROMIDE348 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
CARNAUBA WAX(UNII: R12CBM0EIZ)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
Product Characteristics
ColorWHITE (white to off-white)Scoreno score
ShapeROUNDSize9mm
FlavorImprint CodeBR;348
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-5811-077 in 1 BOTTLE; Type 0: Not a Combination Product04/23/2008
2NDC:0187-5811-3030 in 1 BOTTLE; Type 0: Not a Combination Product04/23/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02210804/23/2008
APLENZIN
bupropion hydrobromide tablet, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0187-5812
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BUPROPION HYDROBROMIDE(UNII: E70G3G5863) (BUPROPION - UNII:01ZG3TPX31)BUPROPION HYDROBROMIDE522 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
DIBUTYL SEBACATE(UNII: 4W5IH7FLNY)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
Product Characteristics
ColorWHITE (white to off-white)Scoreno score
ShapeROUNDSize11mm
FlavorImprint CodeBR;522
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-5812-077 in 1 BOTTLE; Type 0: Not a Combination Product04/23/2008
2NDC:0187-5812-3030 in 1 BOTTLE; Type 0: Not a Combination Product04/23/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02210804/23/2008
Labeler -Valeant Pharmaceuticals North America LLC (042230623)
Registrant -Valeant Pharmaceuticals International, Inc. (245141858)
Establishment
NameAddressID/FEIBusiness Operations
Valeant Pharmaceuticals International, Inc.253292734MANUFACTURE(0187-5810, 0187-5811, 0187-5812)

Revised: 5/2017document Id: 

b67ab478-b218-470d-8ba5-e33cd58bc38dSet id: 6494d2d9-0ce4-4126-b1c7-49684395942bVersion: 10Effective Time: 20170504Valeant Pharmaceuticals North America LLC



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