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).

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).

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 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 or 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.

Changes in Thinking and Behavior When Taking Bupropion to Quit Smoking

Although WELLBUTRIN XL is not a treatment for quitting smoking, some people have had changes in behavior, hostility, agitation, depression, suicidal thoughts or actions while talking bupropion to help them quit smoking. These symptoms can develop during treatment or after stopping treatment. If symptoms occur such as agitation, hostility, depression or changes in thinking or behavior that are not typical for you, stop taking bupropion and call your healthcare provider right away.

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 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 (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 for the following problems. You may want to undergo an eye examination to see if you are at risk:
  • 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 ZYBAN (used to help people stop smoking), APLENZIN®, FORFIVO XL, WELLBUTRIN or WELLBUTRIN SR. 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) or 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; and 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: Dry mouth, Nervousness, Constipation, Headache, Nausea and vomiting, Trouble sleeping, Dizziness, Shakiness (tremor), Fast heartbeat, and Heavy sweating.
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.
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.
Wellbutrin XL is a registered trademark of GlaxoSmithKline LLC used under license. All other product/brand names are trademarks of their respective owners.
©  2016 Valeant Pharmaceuticals North America LLC

WXL.0092.USA.15

  •  INDICATION
    • 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).

  •  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 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 or 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.

      Changes in Thinking and Behavior When Taking Bupropion to Quit Smoking

      Although WELLBUTRIN XL is not a treatment for quitting smoking, some people have had changes in behavior, hostility, agitation, depression, suicidal thoughts or actions while talking bupropion to help them quit smoking. These symptoms can develop during treatment or after stopping treatment. If symptoms occur such as agitation, hostility, depression or changes in thinking or behavior that are not typical for you, stop taking bupropion and call your healthcare provider right away.

      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 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 (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 for the following problems. You may want to undergo an eye examination to see if you are at risk:
      • 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 ZYBAN (used to help people stop smoking), APLENZIN®, FORFIVO XL, WELLBUTRIN or WELLBUTRIN SR. 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) or 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; and 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: Dry mouth, Nervousness, Constipation, Headache, Nausea and vomiting, Trouble sleeping, Dizziness, Shakiness (tremor), Fast heartbeat, and Heavy sweating.
      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.
      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.
      Wellbutrin XL is a registered trademark of GlaxoSmithKline LLC used under license. All other product/brand names are trademarks of their respective owners.
      © 2016 Valeant Pharmaceuticals North America LLC
      WXL.0092.USA.15