Indication: WELLBUTRIN XL® (hydrochloride extended-release tablets) is a prescription medicine used to treat adults with a certain type of depression called major depressive disorder, and for the prevention of autumn-winter seasonal depression (seasonal affective disorder).

Proven Effectiveness in Treating Depression
Provided Efficacy Similar to SSRIs in Major Depressive Disorder
  • In 5 head-to-head studies, with more than 1,900 cumulative patients, bupropion was found to be similarly effective as the SSRIs Lexapro, Zoloft, and Prozac*1-5
    • - Based on HAM-D-17 total score analysis at treatment week 8
    • - Studies evaluated the mean change in HAM-D scores and were   conducted using bupropion HCl sustained-release tablets.
American Psychiatric Association practice guidelines state that effectiveness of antidepressants is generally comparable, so choosing an antidepressant is typically based on other factors, including anticipated side effects.6
Common Side Effects
  • WELLBUTRIN XL may cause serious side effects. The most common side effects of WELLBUTRIN XL include:

    • Dry mouth
    • Nervousness
    • Constipation
    • Headache
    • Nausea and vomiting
    • Trouble sleeping
    • Dizziness
    • Shakiness (tremor)
    • Fast heartbeat
    • Heavy sweating

  • 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 WELLBUTRIN XL. For more information, ask your healthcare provider or pharmacist.

A Common Problem With Depression Treatment

Risk of Sexual Side Effects With Some Antidepressants

Antidepressant use is associated with a number of possible side effects, including sexual side effects (such as loss of sex drive, inability to become aroused or difficulty achieving sexual satisfaction), which can affect both men and women.1-4

  • Sexual side effects may start early-problems may appear within a week of starting treatment with some antidepressants4
  • Significantly fewer patients taking WELLBUTRIN XL® had difficulty achieving sexual satisfaction compared with patients taking LEXAPRO (escitalopram). In fact, among patients taking bupropion SR, this problem was not statistically different than with placebo (sugar pill)4
  • Problems achieving sexual satisfaction were significantly more common among patients taking PROZAC (fluoxetine), than among those taking bupropion SR or placebo (sugar pill)1,5
  • In an 8 week study, patients treated with bupropion SR were significantly less likely to experience a loss in sexual desire than patients taking ZOLOFT (sertraline)3
  • Your doctor can't help if you don't speak up about sexual side effects-in one study of 344 patients, 58% of the patients taking the most commonly prescribed antidepressants were having sexual side effects when asked by their doctor, but only 14% had mentioned them to their doctor.6† There's no need to be shy-the American Psychiatric Association encourages doctors to discuss sexual side effects with patients to help determine a cause and a solution to the problem7
  • †Only the following SSRIs were included in this study: fluoxetine, fluvoxamine, paroxetine, sertraline. Sexual dysfunction includes loss of sex drive, inability to become aroused, and problems achieving sexual satisfaction.
SmartCoat Technology
How to take WELLBUTRIN XL®
  • Take WELLBUTRIN XL exactly as prescribed by your healthcare provider.
  • Do not chew, cut, or crush WELLBUTRIN XL tablets.
  • Take WELLBUTRIN XL at the same time each day.
  • Take your doses of WELLBUTRIN XL at least 24 hours apart.
  • You may take WELLBUTRIN XL with or without food.
  • If you miss a dose, do not take an extra tablet to make up for the dose you missed. Wait and take your next tablet at the regular time. This is very important. Too much WELLBUTRIN XL can increase your chance of having a seizure
  • If you take too much WELLBUTRIN XL, or overdose, call your local emergency room or poison control center right away.
  • Do not take any other medicines while using WELLBUTRIN XL unless your healthcare provider has told you it is okay.
  • Do not change your dose or stop taking WELLBUTRIN XL without first talking with your healthcare provider.

INDICATION

WELLBUTRIN XL® (bupropion hydrochloride extended-release tablets) is a prescription medicine used to treat adults with a certain type of depression called major depressive disorder, and for the prevention of autumn-winter seasonal depression (seasonal affective disorder).

IMPORTANT SAFETY INFORMATION

WARNING: CHANGES IN THINKING AND BEHAVIOR, DEPRESSION, AND SUICIDAL THOUGHTS OR ACTIONS

Suicidal Thoughts or Actions and Antidepressant Drugs

Antidepressants may increase the risk of suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment. Depression or other serious mental illnesses are the most important causes of suicidal thoughts and actions. People who have (or have a family history of) bipolar illness, or suicidal thoughts or actions may have a particularly high risk. Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if symptoms such as anxiety, irritability, impulsivity, trouble sleeping, aggressive behavior or suicidal thoughts are new, worse or worry you. WELLBUTRIN XL has not been evaluated for use in patients under the age of 18.

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

Although WELLBUTRIN XL is not a treatment for quitting smoking, it contains the same active ingredient (bupropion hydrochloride) as ZYBAN which is used to help patients quit smoking. 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 WELLBUTRIN 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 WELLBUTRIN XL. In many people, these symptoms went away after stopping WELLBUTRIN XL, but in some people symptoms continued after stopping WELLBUTRIN XL. It is important for you to follow-up with your healthcare provider until your symptoms go away. Before taking WELLBUTRIN 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 WELLBUTRIN XL?


  • Seizures: There is a chance of having a seizure (convulsion, fit) with WELLBUTRIN XL, especially in people with certain medical problems or who take certain medicines. Do not take any other medicines while you are taking WELLBUTRIN XL unless your healthcare provider has said it is okay to take them. If you have a seizure while taking WELLBUTRIN XL, stop taking the tablets and call your healthcare provider right away.

  • High blood pressure (hypertension): Some people get high blood pressure, that can be severe, while taking WELLBUTRIN XL.

  • Manic episodes: Some people may have periods of mania while taking WELLBUTRIN XL. If you have any of the following symptoms of mania, call your healthcare provider:
  • greatly increased energy
  • severe trouble sleeping
  • racing thoughts
  • reckless behavior
  • unusually grand ideas
  • excessive happiness or irritability
  • talking more or faster than usual

  • Unusual thoughts or behaviors: Some patients may have unusual thoughts or behaviors while taking WELLBUTRIN XL, including delusions (e.g. believe you are someone else), hallucinations (seeing or hearing things that are not there), paranoia (feeling that people are against you), or feeling confused. If this happens to you, call your healthcare provider.

  • Visual problems: Some people are at risk of glaucoma if they take Wellbutrin. You should see an eye doctor to determine whether you are at risk prior to starting therapy. If you experience any of the following symptoms you should see an eye doctor:
  • eye pain
  • changes in vision
  • swelling or redness in or around the eye

  • Severe allergic reactions: Some patients have severe allergic reactions to WELLBUTRIN XL. Stop taking WELLBUTRIN XL and call your healthcare provider right away if you get a rash, itching, hives, fever, swollen lymph glands, painful sores in the mouth or around the eyes, swelling of the lips or tongue, chest pain, or have trouble breathing. These could be signs of a serious allergic reaction.

Do not take WELLBUTRIN 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 or WELLBUTRIN SR, APLENZIN®, ZYBAN, FORFIVO XL. Bupropion is the same active ingredient that is in WELLBUTRIN XL.
  • 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 WELLBUTRIN XL unless directed to do so by
    your healthcare provider.
  • do not start WELLBUTRIN 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 WELLBUTRIN XL, bupropion hydrochloride, or to any of the inactive ingredients.
Before taking Wellbutrin XL tell your healthcare provider if you have ever had depression, suicidal thoughts or actions, or other mental health problems or any symptoms you had during other times you tried to quit smoking with or without WELLBUTRIN XL. Also, tell your healthcare provider about your other medical conditions, including if you:
  • have liver problems, especially cirrhosis of the liver.
  • have kidney problems.
  • have, or have had, an eating disorder such as anorexia nervosa or bulimia.
  • have had a head injury.
  • have had a seizure (convulsion, fit).
  • have a tumor in your nervous system (brain or spine).
  • have had a heart attack, heart problems, or high blood pressure.
  • are a diabetic taking insulin or other medicines to control your blood sugar.
  • drink alcohol.
  • abuse prescription medicines or street drugs.
  • are pregnant or plan to become pregnant.
  • are breastfeeding. WELLBUTRIN XL passes into your milk in small amounts.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Many medicines increase your chances of having seizures or cause other serious side effects if you take them while you are using WELLBUTRIN XL.
WELLBUTRIN XL may cause serious side effects. The most common side effects of WELLBUTRIN XL include: trouble sleeping, stuffy nose, dry mouth, dizziness, feeling anxious, nausea, constipation, and joint aches.
Read the Medication Guide carefully before you start using WELLBUTRIN XL. If you have any questions about WELLBUTRIN XL, ask your healthcare provider or pharmacist.
Click here for full Prescribing Information, including Medication Guide and Boxed Warning regarding suicidal thoughts and actions; Please see full Prescribing Information including Medication Guide and Boxed Warning regarding suicidal thoughts and actions [location].
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also contact Valeant Customer Service at 1-800-556-1937.


© 2018 Valeant Pharmaceuticals North America LLC

WXL.0055.USA.18

  •  INDICATION
    • INDICATION

      WELLBUTRIN XL® (bupropion
      hydrochloride extended-release tablets) is a prescription medicine used to treat adults with a certain type of depression called major depressive disorder, and for the prevention of autumn-winter seasonal depression (seasonal affective disorder).

  •  IMPORTANT SAFETY INFORMATION
    • IMPORTANT SAFETY INFORMATION

      WARNING: CHANGES IN THINKING AND BEHAVIOR, DEPRESSION, AND SUICIDAL THOUGHTS OR ACTIONS

      Suicidal Thoughts or Actions and Antidepressant Drugs

      Antidepressants may increase the risk of suicidal thoughts or actions in some children, teenagers, or young adults within the first few months of treatment. Depression or other serious mental illnesses are the most important causes of suicidal thoughts and actions. People who have (or have a family history of) bipolar illness, or suicidal thoughts or actions may have a particularly high risk. Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if symptoms such as anxiety, irritability, impulsivity, trouble sleeping, aggressive behavior or suicidal thoughts are new, worse or worry you. WELLBUTRIN XL has not been evaluated for use in patients under the age of 18.

      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

      Although WELLBUTRIN XL is not a treatment for quitting smoking, it contains the same active ingredient (bupropion hydrochloride) as ZYBAN which is used to help patients quit smoking. 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 WELLBUTRIN 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 WELLBUTRIN XL. In many people, these symptoms went away after stopping WELLBUTRIN XL, but in some people symptoms continued after stopping WELLBUTRIN XL. It is important for you to follow-up with your healthcare provider until your symptoms go away. Before taking WELLBUTRIN 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 WELLBUTRIN XL?
      • Seizures: There is a chance of having a seizure (convulsion, fit) with WELLBUTRIN XL, especially in people with certain medical problems or who take certain medicines. Do not take any other medicines while you are taking WELLBUTRIN XL unless your healthcare provider has said it is okay to take them. If you have a seizure while taking WELLBUTRIN XL, stop taking the tablets and call your healthcare provider right away.
      • High blood pressure (hypertension): Some people get high blood pressure, that can be severe, while taking WELLBUTRIN XL.
      • Manic episodes: Some people may have periods of mania while taking WELLBUTRIN XL. If you have any of the following symptoms of mania, call your healthcare provider:
      • greatly increased energy
      • severe trouble sleeping
      • racing thoughts
      • reckless behavior
      • unusually grand ideas
      • excessive happiness or irritability
      • talking more or faster than usual
      • Unusual thoughts or behaviors: Some patients may have unusual thoughts or behaviors while taking WELLBUTRIN XL, including delusions (e.g. believe you are someone else), hallucinations (seeing or hearing things that are not there), paranoia (feeling that people are against you), or feeling confused. If this happens to you, call your healthcare provider.
      • Visual problems: Some people are at risk of glaucoma if they take Wellbutrin. You should see an eye doctor to determine whether you are at risk prior to starting therapy. If you experience any of the following symptoms you should see an eye doctor:
      • eye pain
      • changes in vision
      • swelling or redness in or around the eye
      • Severe allergic reactions: Some patients have severe allergic reactions to WELLBUTRIN XL. Stop taking WELLBUTRIN XL and call your healthcare provider right away if you get a rash, itching, hives, fever, swollen lymph glands, painful sores in the mouth or around the eyes, swelling of the lips or tongue, chest pain, or have trouble breathing. These could be signs of a serious allergic reaction.
      Do not take WELLBUTRIN 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 or WELLBUTRIN SR, APLENZIN, ZYBAN, FORFIVO XL. Bupropion is the same active ingredient that is in WELLBUTRIN XL.
      • 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 WELLBUTRIN XL unless directed to do so by your healthcare provider.
      • do not start WELLBUTRIN 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 WELLBUTRIN XL, bupropion hydrochloride, or to any of the inactive ingredients.
      Before taking Wellbutrin XL tell your healthcare provider if you have ever had depression, suicidal thoughts or actions, or other mental health problems or any symptoms you had during other times you tried to quit smoking with or without WELLBUTRIN XL. Also, tell your healthcare provider about your other medical conditions, including if you:
      • have liver problems, especially cirrhosis of the liver.
      • have kidney problems.
      • have, or have had, an eating disorder such as anorexia nervosa or bulimia.
      • have had a head injury.
      • have had a seizure (convulsion, fit).
      • have a tumor in your nervous system (brain or spine).
      • have had a heart attack, heart problems, or high blood pressure.
      • are a diabetic taking insulin or other medicines to control your blood sugar.
      • drink alcohol.
      • abuse prescription medicines or street drugs.
      • are pregnant or plan to become pregnant.
      • are breastfeeding. WELLBUTRIN XL passes into your milk in small amounts.
      Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Many medicines increase your chances of having seizures or cause other serious side effects if you take them while you are using WELLBUTRIN XL.
      WELLBUTRIN XL may cause serious side effects. The most common side effects of WELLBUTRIN XL include: trouble sleeping, stuffy nose, dry mouth, dizziness, feeling anxious, nausea, constipation, and joint aches.
      Read the Medication Guide carefully before you start using WELLBUTRIN XL. If you have any questions about WELLBUTRIN XL, ask your healthcare provider or pharmacist.
      Click here for full Prescribing Information, including Medication Guide and Boxed Warning regarding suicidal thoughts and actions; Please see full Prescribing Information including Medication Guide and Boxed Warning regarding suicidal thoughts and actions [location].
      You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also contact Valeant Customer
      Service at 1-800-556-1937.


      © 2018 Valeant Pharmaceuticals North America LLC

      WXL.0055.USA.18