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IMPORTANT WARNING

WELLBUTRIN® (WELL byu-trin)

(bupropion hydrochloride) Tablets

Read this Medication Guide carefully before you start taking WELLBUTRIN and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment. If you have any questions about WELLBUTRIN, ask your healthcare provider or pharmacist.

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 WELLBUTRIN?”

• 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. Talk to your healthcare provider or your family member’s healthcare provider about:

• All risks and benefits of treatment with antidepressant medicines
• All treatment choices for depression or other serious mental illness

What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?

• Antidepressant medicines 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 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.
• 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:

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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 WELLBUTRIN 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 WELLBUTRIN 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 changes in behavior, hostility, agitation, depression, suicidal thoughts or actions while taking bupropion to help them quit smoking. These symptoms can develop during treatment with bupropion or after stopping treatment with bupropion.

• If you, your family member, or your caregiver notice agitation, hostility, depression, or changes in thinking or behavior that are not typical for you, or you have any of the following symptoms, stop taking bupropion and call your healthcare provider right away:

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This image is provided by the National Library of Medicine.

• 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, and increased appetite or 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.

• Before taking bupropion, tell your healthcare provider if you have ever had depression or other mental illnesses. 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?

• Seizures: There is a chance of having a seizure (convulsion, fit) with WELLBUTRIN, especially in people:

with certain medical problems. who take certain medicines.

• The chance of having seizures increases with higher doses of WELLBUTRIN. For more information, see the sections “Who should not take WELLBUTRIN?” and “What should I tell my healthcare provider before taking WELLBUTRIN?” 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 WELLBUTRIN unless your healthcare provider has said it is okay to take them.

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

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

• Manic episodes. Some people may have periods of mania while taking WELLBUTRIN, including:

• Greatly increased energy

• Severe trouble sleeping

• Racing thoughts

• Reckless behavior

• Unusually grand ideas

• Excessive happiness or irritability

• Talking more or faster than usual

• If you have any of the above symptoms of mania, call your healthcare provider.

• Unusual thoughts or behaviors. Some patients have unusual thoughts or behaviors while taking WELLBUTRIN, 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.

• Severe allergic reactions. Some people can have severe allergic reactions to WELLBUTRIN. Stop taking WELLBUTRIN 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.

What is WELLBUTRIN?

WELLBUTRIN is a prescription medicine used to treat adults with a certain type of depression called major depressive disorder.

Who should not take WELLBUTRIN?

• Do not take WELLBUTRIN 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 SR®, or WELLBUTRIN XL®. Bupropion is the same active ingredient that is in WELLBUTRIN.

• 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 unless directed to do so by your healthcare provider.

• do not start WELLBUTRIN 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, bupropion, or to any of the inactive ingredients. See the end of this Medication Guide for a complete list of ingredients in WELLBUTRIN.

What should I tell my healthcare provider before taking WELLBUTRIN?

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

problems. See “Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions.”

• 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 passes into your milk in small amounts

• Tell your healthcare provider about all the medicines you take, including prescription, over-the-counter medicines, vitamins, and herbal supplements. Many medicines increase your chances of having seizures or other serious side effects if you take them while you are taking WELLBUTRIN.