BUPROPION HYDROCHLORIDE- bupropion hydrochloride tablet, extended release
Actavis South Atlantic LLC
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buPROPion Hydrochloride Extended-Release Tablets (XL)
Rx Only
Read this Medication Guide carefully before you start using bupropion hydrochloride extended-release tablets (XL) and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about bupropion hydrochloride extended-release tablets (XL), ask your doctor 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 bupropion hydrochloride extended-release tablets (XL) ?”
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 doctor 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 a 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 | • trouble sleeping (insomnia) |
• attempts to commit suicide | • new or worse irritability |
• new or worse depression | • acting aggressive, being angry, or violent |
• new or worse anxiety | • acting on dangerous impulses |
• feeling very agitated or restless | • an extreme increase in activity and talking (mania) |
• panic attacks | • other unusual changes in behavior or mood |
What else do I need to know about antidepressant medicines?
Bupropion hydrochloride extended-release tablets (XL) has not been studied in children under the age of 18 and is not approved for use in children and teenagers.
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 bupropion hydrochloride extended-release tablets (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 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:
• thoughts about suicide or dying | • an extreme increase in activity and talking (mania) |
• attempts to commit suicide | • abnormal thoughts or sensations |
• new or worse depression | • seeing or hearing things that are not there (hallucinations) |
• new or worse anxiety | • feeling people are against you (paranoia) |
• panic attacks | • feeling confused |
• feeling very agitated or restless | • other unusual changes in behavior or mood |
• acting aggressive, being angry, or violent | |
• acting on dangerous impulses |
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 doctor 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 bupropion hydrochloride extended-release tablets (XL)?
The chance of having seizures increases with higher doses of bupropion hydrochloride extended-release tablets (XL). For more information, see the sections “Who should not take bupropion hydrochloride extended-release tablets (XL)?” and “What should I tell my doctor before using bupropion hydrochloride extended-release tablets (XL)?” Tell your doctor about all of your medical conditions and all the medicines you take. Do not take any other medicines while you are using bupropion hydrochloride extended-release tablets (XL) unless your doctor has said it is okay to take them.
If you have a seizure while taking bupropion hydrochloride extended-release tablets (XL), stop taking the tablets and call your doctor right away. Do not take bupropion hydrochloride extended-release tablets (XL) again if you have a seizure.
What are bupropion hydrochloride extended-release tablets (XL)?
Bupropion hydrochloride extended-release tablets (XL) are a prescription medicine used to treat adults with a certain type of depression called major depressive disorder and for prevention of autumn-winter seasonal depression (seasonal affective disorder).
Who should not take bupropion hydrochloride extended-release tablets (XL)?
Do not take bupropion hydrochloride extended-release tablets (XL) if you:
What should I tell my doctor before using bupropion hydrochloride extended-release tablets (XL)?
How should I take bupropion hydrochloride extended-release tablets (XL)?
What should I avoid while taking bupropion hydrochloride extended-release tablets (XL)?
What are possible side effects of bupropion hydrochloride extended-release tablets (XL)?
Bupropion hydrochloride extended-release tablets (XL) can cause serious side effects. Read this entire Medication Guide for more information about these serious side effects.
Common side effects reported in studies of major depressive disorder include weight loss, loss of appetite, dry mouth, skin rash, sweating, ringing in the ears, shakiness, stomach pain, agitation, anxiety, dizziness, trouble sleeping, muscle pain, nausea, fast heartbeat, sore throat, and urinating
more often. In studies of seasonal affective disorder, common side effects included weight loss, constipation, and gas.
If you have nausea, take your medicine with food. If you have trouble sleeping, do not take your medicine too close to bedtime.
These are not all the side effects of bupropion hydrochloride extended-release tablets (XL). For a complete list, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store bupropion hydrochloride extended-release tablets (XL)?
General Information about bupropion hydrochloride extended-release tablets (XL).
This Medication Guide summarizes important information about bupropion hydrochloride extended-release tablets (XL). For more information, talk with your doctor. You can ask your doctor or pharmacist for information about bupropion hydrochloride extended-release tablets (XL) that is written for health professionals. For more information call Actavis at 1-800-432-8534.
What are the ingredients in bupropion hydrochloride extended-release tablets (XL)?
Active ingredient: bupropion hydrochloride, USP
Inactive ingredients: copovidone, hydroxypropyl cellulose, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, methacrylic acid copolymer type C, triethyl citrate, colloidal anhydrous silica, sodium bicarbonate, sodium lauryl sulfate, povidone, purified water, and hydrochloric acid (NF).
*The following are registered trademarks of their respective manufacturers:
WELLBUTRIN®, WELLBUTRIN SR, ®ZYBAN®, PARNATE/GlaxoSmithKline; NARDIL®/Warner Lambert Company; MARPLAN®/Oxford Pharmaceutical Services, Inc.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured by:
CMIC CMO USA Corporation
Cranbury, New Jersey 08512
Distributed by:
Actavis South Atlantic LLC
13800 N.W. 2nd Street, Suite 190
Sunrise, FL 33325 USA
221873
(MG 221874)