Aplenzin (bupropion hydrobromide)

Medication Guide
• acting aggressive, being angry, or violent • an extreme increase in activity and talking (mania) Read this Medication Guide for APLENZIN before you start taking • seeing or hearing things that are not there (hallucinations) it and each time you get a refill. There may be new information. This • feeling people are against you (paranoia) Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk • other unusual changes in behavior or mood with your healthcare provider if there is something you do not When you try to quit smoking, with or without bupropion, you understand or want to learn more about.
may have symptoms that may be due to nicotine withdrawal, What is the most important information I should know about
including urge to smoke, depressed mood, trouble sleeping, APLENZIN?
irritability, frustration, anger, feeling anxious, difficulty concen- APLENZIN and other antidepressant medicines may cause serious trating, restlessness, decreased heart rate, and increased ap- petite or weight gain. Some people have even experienced 1. Suicidal thoughts or actions:
suicidal thoughts when trying to quit smoking without medica- • APLENZIN and other antidepressant medicines may
tion. Sometimes quitting smoking can lead to worsening of increase suicidal thoughts or actions in some children,
mental health problems that you already have, such as depres- teenagers, or young adults within the first few months of
treatment or when the dose is changed.
Before taking bupropion, tell your healthcare provider if you • Depression or other serious mental illnesses are the most have ever had depression or other mental illnesses. You should important causes of suicidal thoughts or actions.
also tell your healthcare provider about any symptoms you had • Watch for these changes and call your healthcare provider during other times you tried to quit smoking, with or without • New or sudden changes in mood, behavior, actions, 3. Seizures. There is a chance of having a seizure (convul-
thoughts, or feelings, especially if severe.
sion, fit) with Aplenzin, especially in people:
• Pay particular attention to such changes when APLENZIN is started or when the dose is changed.
Keep all follow-up visits with your healthcare provider and call The chance of having seizures increases with higher doses of between visits if you are worried about symptoms.
Aplenzin. For more information, see the sections ″Who should Call your healthcare provider right away if you have any of
not take Aplenzin?″ and ″What should I tell my healthcare the following symptoms, or call 911 if an emergency,
provider before using Aplenzin?″ Tell your healthcare provider especially if they are new, worse, or worry you:
about all of your medical conditions and all the medicines you Do not take any other medicines while you are using
Aplenzin unless your healthcare provider has said it is okay
to take them.
If you have experienced a seizure while taking Aplenzin,
• new or worse anxiety or panic attacks stop taking the tablets and call your healthcare provider
• feeling agitated, restless, angry or irritable right away. Do not take Aplenzin again if you have a seizure.
4. Hypertension (high blood pressure). Some patients may get
• an increase in activity or talking more than what is normal high blood pressure, sometimes severe, while taking Aplenzin.
The chance of high blood pressure may be increased if you • other unusual changes in behavior or mood also use nicotine replacement therapy (for example, a nicotine 2. Quitting Smoking, Quit-Smoking Medications, Changes in
Thinking and Behavior, Depression, and Suicidal
Thoughts or Actions
5. Severe allergic reactions. Stop taking Aplenzin and call
Although Aplenzin is not a treatment for quitting smoking, it your healthcare provider right away if you have any of the
contains the same active ingredient (bupropion) as ZYBAN® following reactions:
which is used to help patients quit smoking.
This section of the Medication Guide is only about the risk of changes in thinking and behavior, depression and suicidal • swelling of the face, tongue, eyes or mouth or swollen thoughts or actions with drugs used to quit smoking.
Some people have had changes in behavior, hostility, agitation, • rash, itchy welts (hives) or blisters, alone or with fever or depression, suicidal thoughts or actions while taking bupropion to help them quit smoking. These symptoms can develop during 6. Unusual thoughts or behaviors. Some patients may have
treatment with bupropion or after stopping treatment with bu- unusual thoughts or behaviors while taking Aplenzin,
including delusions (believe you are someone else), hal-
Stop taking bupropion and call your healthcare provider right lucinations (seeing or hearing things that are not there),
away or call 911 if an emergency, if you, your family member, paranoia (feeling that people are against you), or feeling
or your caregiver notice agitation, hostility, depression, or confused. If this happens to you, call your healthcare
changes in thinking or behavior that are not typical for you, or provider.
7. Manic episodes:
How should I take APLENZIN?
• Take APLENZIN exactly as prescribed by your healthcare What is APLENZIN?
provider. Your healthcare provider may need to change the APLENZIN is a prescription medicine used to treat depression. It dose of APLENZIN until it is the right dose for you.
is important to talk with your healthcare provider about the risks of • Do not chew, cut, or crush Aplenzin tablets. You must
treating depression and also the risks of not treating it. You should swallow the tablets whole. Tell your healthcare provider if
discuss all treatment choices with your healthcare provider.
you cannot swallow medicine tablets.
Talk to your healthcare provider if you do not think that your • Take Aplenzin at the same time each day.
condition is getting better with APLENZIN treatment.
• Take your doses of Aplenzin at least 24 hours apart.
Who should not take APLENZIN?
• APLENZIN may be taken with or without food.
• If you miss a dose, do not take an extra tablet to make up for • have or had a seizure disorder or epilepsy.
the dose you forgot. Wait and take your next tablet at the • drink a lot of alcohol and abruptly stop drinking, or use regular time. This is very important. Too much Aplenzin can
medicines called sedatives (these make you sleepy) or ben- increase your chance of having a seizure.
zodiazepines and you stop using them all of a sudden.
• If you take too much Aplenzin, or overdose, call your local • have taken within the last 14 days medicine for depression emergency room or poison control center right away.
called a monoamine oxidase inhibitor (MAOI).
• The Aplenzin tablet is covered by a shell that slowly releases • have or had an eating disorder such as anorexia nervosa or the medicine inside your body. You may notice something in your stool that looks like a tablet. This is normal. This is the • are allergic to the active ingredient in Aplenzin, bupropion hydrobromide, or to any of the inactive ingredients. See the end • Do not take any other medicines while using Aplenzin
of this leaflet for a complete list of ingredients in Aplenzin.
unless your healthcare provider has told you it is okay.
What should I tell my healthcare provider before taking
• If you are taking Aplenzin for the treatment of major depressive APLENZIN? Ask if you are not sure.
disorder, it may take several weeks for you to feel that Aplenzin Before starting APLENZIN, tell your healthcare provider if you: is working. Once you feel better, it is important to keep taking • have ever had depression, suicidal thoughts or actions, or Aplenzin exactly as directed by your healthcare provider. Call other mental health problems. See section ЉAntidepressant
your healthcare provider if you do not feel Aplenzin is working Medicines, Depression, and Other Mental Illnesses, and
Suicidal Thoughts or Actions.Љ
• Do not change your dose or stop taking Aplenzin without first • Tell your healthcare provider about your medical condi-
talking with your healthcare provider.
tions. Tell your healthcare provider if you:
What should I avoid while taking APLENZIN?
• are pregnant or plan to become pregnant. It is not known APLENZIN can cause sleepiness or may affect your ability to make if Aplenzin can harm your unborn baby.
decisions, think clearly, or react quickly. You should not drive, • are breastfeeding. Aplenzin passes through your milk. It is operate heavy machinery, or do other dangerous activities until you not known if Aplenzin can harm your baby.
know how APLENZIN affects you. Do not drink alcohol while using • have liver problems, especially cirrhosis of the liver.
What are the possible side effects of APLENZIN?
• have an eating disorder such as anorexia nervosa or APLENZIN may cause serious side effects, including all of those described in the section entitled ″What is the most important information I should know about APLENZIN?″ • have had a seizure (convulsion, fit).
Common possible side effects in people who take APLENZIN • have a tumor in your nervous system (brain or spine).
• have had a heart attack, heart problems, or high blood • are a diabetic taking insulin or other medicines to control • nausea. If you have nausea take your medicine with food.
• feeling anxious or trouble sleeping. If you have trouble sleep- • abuse prescription medicines or street drugs.
ing, do not take your medicine too close to bedtime.
Tell your healthcare provider about all the medicines that you
take, including prescription and non-prescription medicines, vita-
mins, and herbal supplements. APLENZIN and some medicines may interact with each other, may not work as well, may increase your chances of having seizures or cause other serious side Your healthcare provider or pharmacist can tell you if it is safe to take APLENZIN with your other medicines. Do not start or stop any medicine while taking APLENZIN without first talking to your Tell your healthcare provider if you have any side effect that bothersyou or that does not go away. These are not all the possible side If you take APLENZIN, you should not take any other medicines effects of APLENZIN. For more information, ask your healthcare ZYBAN®,
WELLBUTRIN® Tablets, WELLBUTRIN® SR Sustained-
CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE
Release Tablets, or WELLBUTRIN XL® Extended-Release
EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT
Tablets. Bupropion is the same active ingredient that is in
1-800-FDA-1088.
You may also report side effects to Valeant Pharmaceuticals
North America LLC at 1-877-361-2719.
How should I store APLENZIN?
• Store APLENZIN at room temperature between 59°F and 86°F • Keep APLENZIN away from direct sunlight.
• Keep APLENZIN bottle closed tightly.
Keep APLENZIN and all medicines out of the reach of children.
General information about APLENZIN
Medicines are sometimes prescribed for purposes other than those
listed in a Medication Guide. Do not use APLENZIN for a condition
for which it was not prescribed. Do not give APLENZIN to other
people, even if they have the same condition. It may harm them.
If you take a urine drug screening test, APLENZIN may make the
test result positive for amphetamines. If you tell the person giving
you the drug screening test that you are taking APLENZIN, they can
do a more specific drug screening test that should not have this
problem.
This Medication Guide summarizes the most important information
about APLENZIN. If you would like more information, talk with your
healthcare provider. You may ask your healthcare provider or
pharmacist for information about APLENZIN that is written for
healthcare professionals.
For more information about APLENZIN call 1-800-633-1610 or go
to www.APLENZIN.com.
What are the ingredients in APLENZIN?
Active ingredient: bupropion hydrobromide
Inactive ingredients: ethylcellulose, glyceryl behenate, polyvinyl
alcohol, polyethylene glycol, povidone, and dibutyl sebacate. Car-
nauba wax is included in the 174 mg and 348 mg strengths. The
tablets are printed with edible black ink.
The following are registered trademarks of their respective manu-
facturers: WELLBUTRIN®/GlaxoSmithKline; WELLBUTRIN XL®/
GlaxoSmithKline; ZYBAN®/GlaxoSmithKline; KALETRA®/Abbott
Laboratories
This Medication Guide has been approved by the U.S. Food andDrug Administration.
Manufactured by:Valeant Pharmaceuticals International, Inc.
Steinbach, MBCanada R5G 1Z7 Manufactured for:sanofi-aventis U.S. LLCBridgewater, NJ 08807Made in Canada Aplenzin® is a registered trademark of sanofi-aventis U.S. LLC

Source: http://www.aplenzin.com/docs/pdf/Aplenzin_Med_Guide_06-11.pdf