WELLBUTRIN- bupropion hydrochloride tablet, film coated
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:
What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?
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:
What else do I need to know about antidepressant medicines?
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:
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?
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.
If you have any of the above symptoms of mania, call your healthcare provider.
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
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:
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.
How should I take WELLBUTRIN?
What should I avoid while taking WELLBUTRIN?
What are possible side effects of WELLBUTRIN?
See “What Other Important Information Should I Know About WELLBUTRIN?”
WELLBUTRIN can cause serious side effects.
The most common side effects of WELLBUTRIN include:
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. For more information, ask your healthcare provider or pharmacist.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1‑800-FDA-1088.
You may also report side effects to GlaxoSmithKline at 1-888-825-5249.
How should I store WELLBUTRIN?
Keep WELLBUTRIN and all medicines out of the reach of children.
General Information about WELLBUTRIN.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use WELLBUTRIN for a condition for which it was not prescribed. Do not give WELLBUTRIN to other people, even if they have the same symptoms you have. It may harm them.
If you take a urine drug screening test, WELLBUTRIN may make the test result positive for amphetamines. If you tell the person giving you the drug screening test that you are taking WELLBUTRIN, they can do a more specific drug screening test that should not have this problem.
This Medication Guide summarizes important information about WELLBUTRIN. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about WELLBUTRIN that is written for healthcare professionals.
For more information about WELLBUTRIN, go to www.wellbutrin.com or call 1-888-825-5249.
What are the ingredients in WELLBUTRIN?
Active ingredient: bupropion hydrochloride.
Inactive ingredients: 75‑mg tablet – D&C Yellow No. 10 Lake, FD&C Yellow No. 6 Lake, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide; 100‑mg tablet – FD&C Red No. 40 Lake, FD&C Yellow No. 6 Lake, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, polyethylene glycol, talc, and titanium dioxide.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL, and ZYBAN are registered trademarks of the GSK group of companies.
The other brands listed are trademarks of their respective owners and are not trademarks of the GSK group of companies. The makers of these brands are not affiliated with and do not endorse the GSK group of companies or its products.
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