WELLBUTRIN XL® (WELL byu-trin)
(bupropion hydrochloride extended-release tablets)
Read the Patient Information that comes with WELLBUTRIN XL before you start taking
PHARMACIST--DETACH HERE AND GIVE LEAFLET TO PATIENT. ALSO
PROVIDE AN APPROVED MEDICATION GUIDE ABOUT USING
ANTIDEPRESSANTS IN CHILDREN AND TEENAGERS.
_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
Patient Information
WELLBUTRIN XL and each time you get a refill. There may be new information. This
leaflet does not take the place of talking with your doctor about your medical condition or your
treatment.
What is the most important information I should know about WELLBUTRIN XL?
There is a chance of having a seizure (convulsion, fit) with WELLBUTRIN XL, especially
in people:
• with certain medical problems.
• who take certain medicines.
The chance of having seizures increases with higher doses of WELLBUTRIN XL. For more
information, see the sections "Who should not take WELLBUTRIN XL?" and "What should I
tell my doctor before using WELLBUTRIN 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 WELLBUTRIN XL unless your doctor has said it is okay to take them.
If you have a seizure while taking WELLBUTRIN XL, stop taking the tablets and call your
doctor right away. Do not take WELLBUTRIN XL again if you have a seizure.
What is important information I should know and share with my family about taking
antidepressants?
Patients and their families should watch out for worsening depression or thoughts of suicide.
Also watch out for sudden or severe changes in feelings such as feeling anxious, agitated,
panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and
hyperactive, not being able to sleep, or other unusual changes in behavior. If this happens,
especially at the beginning of antidepressant treatment or after a change in dose, call your doctor.
A patient Medication Guide will be provided to you with each prescription of
WELLBUTRIN XL entitled "About Using Antidepressants in Children and Teenagers."
WELLBUTRIN XL is not approved for use in children and teenagers.
What is WELLBUTRIN XL?
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WELLBUTRIN XL is a prescription medicine used to treat adults with a certain type of
depression called major depressive disorder.
Who should not take WELLBUTRIN XL?
Do not take WELLBUTRIN XL if you
• have or had a seizure disorder or epilepsy.
• are taking ZYBAN (used to help people stop smoking) or any other medicines that
contain bupropion hydrochloride, such as WELLBUTRIN Tablets or
WELLBUTRIN SR Sustained-Release Tablets. 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 and you stop using them all of a sudden.
• have taken within the last 14 days medicine for depression called a monoamine oxidase
inhibitor (MAOI), such as NARDIL®*(phenelzine sulfate), PARNATE®(tranylcypromine
sulfate), or MARPLAN®*(isocarboxazid).
• have or had an eating disorder such as anorexia nervosa or bulimia.
• are allergic to the active ingredient in WELLBUTRIN XL, bupropion, or to any of the
inactive ingredients. See the end of this leaflet for a complete list of ingredients in
WELLBUTRIN XL.
What should I tell my doctor before using WELLBUTRIN XL?
• Tell your doctor about your medical conditions. Tell your doctor if you
• are pregnant or plan to become pregnant. It is not known if WELLBUTRIN XL can
harm your unborn baby. If you can use WELLBUTRIN XL while you are pregnant, talk
to your doctor about how you can be on the Bupropion Pregnancy Registry.
• are breastfeeding. WELLBUTRIN XL passes through your milk. It is not known if
WELLBUTRIN XL can harm your baby.
• have liver problems, especially cirrhosis of the liver.
• have kidney problems.
• have 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 a lot of alcohol.
• abuse prescription medicines or street drugs.
• Tell your doctor about all the medicines you take, including prescription and nonprescription
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 using
WELLBUTRIN XL.
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WELLBUTRIN XL has not been studied in children under the age of 18 years.
How should I take WELLBUTRIN XL?
• Take WELLBUTRIN XL exactly as prescribed by your doctor.
• Do not chew, cut, or crush WELLBUTRIN XL tablets. You must swallow the tablets
whole. Tell your doctor if you cannot swallow medicine 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 forgot. 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.
• The WELLBUTRIN XL tablet is covered by a shell that slowly releases the medicine inside
your body. You may notice something in your stool that looks like a tablet. This is normal.
This is the empty shell passing from your body.
• Do not take any other medicines while using WELLBUTRIN XL unless your doctor has
told you it is okay.
• It may take several weeks for you to feel that WELLBUTRIN XL is working. Once you feel
better, it is important to keep taking WELLBUTRIN XL exactly as directed by your doctor.
Call your doctor if you do not feel WELLBUTRIN XL is working for you.
• Do not change your dose or stop taking WELLBUTRIN XL without talking with your doctor
first.
What should I avoid while taking WELLBUTRIN XL?
• Do not drink a lot of alcohol while taking WELLBUTRIN XL. If you usually drink a lot of
alcohol, talk with your doctor before suddenly stopping. If you suddenly stop drinking
alcohol, you may increase your chance of having seizures.
• Do not drive a car or use heavy machinery until you know how WELLBUTRIN XL affects
you. WELLBUTRIN XL can impair your ability to perform these tasks.
What are possible side effects of WELLBUTRIN XL?
• Seizures. Some patients get seizures while taking WELLBUTRIN XL. If you have a seizure
while taking WELLBUTRIN XL, stop taking the tablets and call your doctor right
away. Do not take WELLBUTRIN XL again if you have a seizure.
• Hypertension (high blood pressure). Some patients get high blood pressure, sometimes
severe, while taking WELLBUTRIN XL. The chance of high blood pressure may be
increased if you also use nicotine replacement therapy (for example, a nicotine patch) to help
you stop smoking.
• Severe allergic reactions. Stop WELLBUTRIN XL and call your doctor right away if
you get a rash, itching, hives, fever, swollen lymph glands, painful sores in the mouth or
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around the eyes, swelling of the lips or tongue, chest pain, or have trouble breathing. These
could be signs of a serious allergic reaction.
• Unusual thoughts or behaviors. Some patients 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 doctor.
The most common side effects of WELLBUTRIN XL are 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.
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 doctor right away about any side effects that bother you.
These are not all the side effects of WELLBUTRIN XL. For a complete list, ask your doctor or
pharmacist.
How should I store WELLBUTRIN XL?
• Store WELLBUTRIN XL at room temperature. Store out of direct sunlight. Keep
WELLBUTRIN XL in its tightly closed bottle.
• WELLBUTRIN XL tablets may have an odor.
General Information about WELLBUTRIN XL.
• Medicines are sometimes prescribed for conditions that are not mentioned in patient
information leaflets. Do not use WELLBUTRIN XL for a condition for which it was not
prescribed. Do not give WELLBUTRIN XL to other people, even if they have the same
symptoms you have. It may harm them. Keep WELLBUTRIN XL out of the reach of
children.
This leaflet summarizes important information about WELLBUTRIN XL. For more information,
talk with your doctor. You can ask your doctor or pharmacist for information about
WELLBUTRIN XL that is written for health professionals or you can visit
www.wellbutrin-xl.com or call toll-free 888-825-5249.
What are the ingredients in WELLBUTRIN XL?
Active ingredient: bupropion hydrochloride.
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Inactive ingredients: ethylcellulose aqueous dispersion (NF), glyceryl behenate, methacrylic acid
copolymer dispersion (NF), polyvinyl alcohol, polyethylene glycol, povidone, silicon dioxide,
and triethyl citrate. The tablets are printed with edible black ink.
*The following are registered trademarks of their respective manufacturers: Nardil®/Warner
Lambert Company; Marplan®/Oxford Pharmaceutical Services, Inc.
Manufactured by:
Biovail Corporation
Mississauga, ON L5N 8M5, Canada for
GlaxoSmithKline
Research Triangle Park, NC 27709
©2005, GlaxoSmithKline. All rights reserved.
January 2005 RL-2163
WELLBUTRIN XL® (WELL byu-trin) |
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Depression Forums - A Depression & Mental Health Community Support Group > DEPRESSION & ANXIETY MEDICATIONS - LOOKING FOR ANSWERS > Wellbutrin® - (also marketed as Zyban® & Bupropion)
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Dec 18 2005, 07:31 PM
