MEDICATION GUIDE BUPROPION HYDROCHLORIDE TABLETS, USP
Read this Medication Guide carefully before you start using
bupropion hydrochloride tablets 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, 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
Tablets?”
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, 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, and young adults within the first few
months of treatment.
-
Depression and 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 the healthcare provider right away to report new or sudden changes in
mood, behavior, thoughts, or feelings.
- Keep all follow-up visits with the healthcare provider as scheduled. Call
the healthcare provider between visits as needed, especially if you have
concerns about symptoms.
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
- attempts to commit suicide
- new or worse depression
- new or worse anxiety
- feeling very agitated or restless
- panic attacks
- trouble sleeping (insomnia)
- new or worse irritability
- acting aggressive, being angry, or violent
- acting on dangerous impulses
- an extreme increase in activity and talking (mania)
- other unusual changes in behavior or mood
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.
-
Not all antidepressant medicines prescribed for children
are FDA approved for use in children. Talk to your child’s healthcare
provider for more information.
Bupropion 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 tablets are 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
- attempts to commit suicide
- new or worse depression
- new or worse anxiety
- panic attacks
- feeling very agitated or restless
- acting aggressive, being angry, or violent
- acting on dangerous impulses
- an extreme increase in activity and talking (mania)
- abnormal thoughts or sensations
- seeing or hearing things that are not there (hallucinations)
- feeling people are against you (paranoia)
- feeling confused
- other unusual changes in behavior or mood
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 Tablets?
Seizures: There is a chance of having a seizure (convulsion,
fit) with bupropion, especially in people:
- with certain medical problems.
- who take certain medicines.
The chance of having seizures increases with higher doses of bupropion. For
more information, see the sections “Who should not take bupropion?” and “What
should I tell my doctor before using bupropion?” 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 unless your doctor has
said it is okay to take them.
If you have a seizure while taking bupropion, stop taking
the tablets and call your doctor right away. Do not take bupropion again
if you have a seizure.
-
High blood pressure (hypertension). Some people get high
blood pressure, that can be severe, while taking bupropion. 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.
-
Severe allergic reactions: Some people have severe allergic
reactions to bupropion. Stop taking bupropion and call your doctor 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.
-
Unusual thoughts or behaviors. Some patients have
unusual thoughts or behaviors while taking bupropion, 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.
What is bupropion?
Bupropion is a prescription medicine used to treat adults with a certain type
of depression called major depressive disorder.
Who should not take bupropion?
Do not take bupropion 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 SR®* Sustained-Release
Tablets or WELLBUTRIN XL®* Extended-Release Tablets.
Bupropion is the same ingredient that is in bupropion hydrochloride
tablets, USP.
- 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 bupropion hydrochloride tablets,
bupropion, or to any of the inactive ingredients. See the end of this leaflet
for a complete list of ingredients in bupropion hydrochloride tablets.
What should I tell my doctor before using bupropion?
Tell your doctor 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 doctor about your other medical conditions
including if you:
-
are pregnant or plan to become pregnant. It is not
known if bupropion can harm your unborn baby.
-
are breast-feeding. Bupropion passes through your
milk. It is not known if bupropion 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 non-prescription 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 bupropion.
How should I take bupropion?
- Take bupropion exactly as prescribed by your doctor.
- Take bupropion at the same time each day.
- Take your doses of bupropion at least 6 hours apart.
- You may take bupropion 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 bupropion can increase your
chance of having a seizure.
- If you take too much bupropion, or overdose, call your local emergency room
or poison control center right away.
-
Do not take any other medicines while using bupropion
unless your doctor has told you it is okay.
- It may take several weeks for you to feel that bupropion is working. Once
you feel better, it is important to keep taking bupropion exactly as directed by
your doctor. Call your doctor if you do not feel bupropion is working for you.
- Do not change your dose or stop taking bupropion without talking with your
doctor first.
What should I avoid while taking bupropion?
- Do not drink a lot of alcohol while taking bupropion. 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 risk of having seizures.
- Do not drive a car or use heavy machinery until you know how bupropion
affects you. Bupropion can impair your ability to perform these tasks.
What are possible side effects of bupropion?
Bupropion can cause serious side effects. Read this entire Medication Guide
for more information about these serious side effects.
The most common side effects of bupropion are nervousness, constipation,
trouble sleeping, dry mouth, headache, nausea, vomiting, and shakiness
(tremor).
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. 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?
- Store bupropion hydrochloride tablets at room temperature. Store out of
direct sunlight. Keep bupropion hydrochloride tablets in its tightly closed
bottle.
General Information about bupropion.
- Medicines are sometimes prescribed for purposes other than those listed in a
Medication Guide. Do not use bupropion for a condition for which it was not
prescribed. Do not give bupropion to other people, even if they have the same
symptoms you have. It may harm them. Keep bupropion out of the reach of
children.
This Medication Guide summarizes important information about bupropion. For
more information, talk to your doctor. You can ask your doctor or pharmacist for
information about bupropion that is written for health professionals.
What are the ingredients in bupropion hydrochloride tablets?
Active ingredient: bupropion hydrochloride, USP.
Inactive ingredients: anhydrous lactose, colloidal silicon dioxide,
crospovidone, hydrochloric acid, hypromellose, microcrystalline cellulose,
polydextrose, polyethylene glycol, stearic acid, titanium dioxide and triacetin.
In addition, the 75 mg tablets contain synthetic red iron oxide and synthetic
yellow iron oxide and the 100 mg tablets contain FD&C Blue No. 2 Aluminum
Lake and FD&C Yellow No. 6 Aluminum Lake.
*The following are registered trademarks of their respective manufacturers:
NARDIL®/Warner Lambert Company, MARPLAN®/Oxford Pharmaceutical Services, Inc., PARNATE®/GlaxoSmithKline, ZYBAN®/GlaxoSmithKline, and WELLBUTRIN® SR
and WELLBUTRIN® XL/GlaxoSmithKline.
This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505
REVISED JULY 2009
MG:BUPR:R3
Physicians Total Care, Inc.