Medication Guide
Bupropion Hydrochloride Extended-Release Tablets
(SR)
Read this Medication Guide carefully before you start using bupropion
hydrochloride extended-release tablets (SR) 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 (SR),
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
(SR)?”
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
- nw or worse depression
- new or worse anxiety
- feeling very agitated or restless
- panic attacks
- trouble sleeping (incomnia)
- 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 hydrochloride extended-release tablets (SR) 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 (SR) 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:
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 (SR)?
Seizures: There is a chance of having a seizure (convulsion,
fit) with bupropion hydrochloride extended-release tablets (SR), especially in
people:
- with certain medical problems.
- who take certain medicines.
The chance of having seizures increases with higher doses of bupropion
hydrochloride extended-release tablets (SR). For more information, see the
sections “Who should not take bupropion hydrochloride extended-release tablets
(SR)?” and “What should I tell my doctor before using bupropion hydrochloride
extended-release tablets (SR)?” 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 (SR) unless your doctor has said it is okay to take them.
If you have a seizure while taking bupropion hydrochloride
extended-release tablets (SR), stop taking the tablets and call your doctor
right away. Do not take bupropion hydrochloride extended-release tablets
(SR) again if you have a seizure.
-
High blood pressure (hypertension). Some people get high
blood pressure, that can be severe, while taking bupropion hydrochloride
extended-release tablets (SR). 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
reaction to bupropion hydrochloride extended-release tablets (SR). Stop taking
bupropion hydrochloride extended-release tablets (SR) 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 hydrochloride
extended-release tablets (SR), 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 hydrochloride extended-release tablets
(SR)?
Bupropion hydrochloride extended-release tablets (SR) are a prescription
medicine used to treat adults with a certain type of depression called major
depressive disorder.
Who should not take bupropion hydrochloride extended-release
tablets (SR)?
Do not take bupropion hydrochloride extended-release tablets
(SR) 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 XL® Extended-Release Tablets.
Bupropion is the same active ingredient that is in bupropion
hydrochloride extended-release tablets (SR).
- 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
extended-release tablets (SR), bupropion, or to any of the inactive ingredients.
See the end of this leaflet for a complete list of ingredients in bupropion
hydrochloride extended-release tablets (SR).
What should I tell my doctor before using bupropion
hydrochloride extended-release tablets (SR)?
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 hydrochloride extended-release tablets (SR) can harm your
unborn baby.
-
are breastfeeding. Bupropion hydrochloride
extended-release tablets (SR) passes through your milk. It is not known if
bupropion hydrochloride extended-release tablets (SR) 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
hydrochloride extended-release tablets (SR).
How should I take bupropion hydrochloride extended-release
tablets (SR)?
- Take bupropion hydrochloride extended-release tablets (SR) exactly as
prescribed by your doctor.
-
Do not chew, cut, or crush bupropion hydrochloride
extended-release tablets (SR). If you do, the medicine will be released
into your body too quickly. If this happens you may be more likely to get side
effects including seizures. You must swallow the tablets whole. Tell your doctor if you cannot swallow medicine tablets.
- Take bupropion hydrochloride extended-release tablets (SR) at the same time
each day.
- Take your doses of bupropion hydrochloride extended-release tablets (SR) at
least 8 hours apart.
- You may take bupropion hydrochloride extended-release tablets (SR) 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 hydrochloride
extended-release tablets (SR) can increase your chance of having a seizure.
- If you take too much bupropion hydrochloride extended-release tablets (SR),
or overdose, call your local emergency room or poison control center right away.
-
Do not take any other medicines while using bupropion
hydrochloride extended-release tablets (SR) unless your doctor has told you it
is okay.
- It may take several weeks for you to feel that bupropion hydrochloride
extended-release tablets (SR) is working. Once you feel better, it is important
to keep taking bupropion hydrochloride extended-release tablets (SR) exactly as
directed by your doctor. Call your doctor if you do not feel bupropion
hydrochloride extended-release tablets (SR) is working for you.
- Do not change your dose or stop taking bupropion hydrochloride
extended-release tablets (SR) without talking with your doctor first.
What should I avoid while taking bupropion hydrochloride
extended-release tablets (SR)?
- Do not drink a lot of alcohol while taking bupropion hydrochloride
extended-release tablets (SR). 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 bupropion
hydrochloride extended-release tablets (SR) affect you. Bupropion hydrochloride
extended-release tablets (SR) can impair your ability to perform these tasks.
What are possible side effects of bupropion hydrochloride
extended-release tablets (SR)?
Bupropion hydrochloride extended-release tablets (SR) 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 hydrochloride extended-release
tablets (SR) are 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.
These are not all the side effects of bupropion hydrochloride
extended-release tablets (SR). 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 (SR)?
- Store bupropion hydrochloride extended-release tablets (SR) at room
temperature. Store out of direct sunlight. Keep bupropion hydrochloride
extended-release tablets (SR) in its tightly closed bottle.
- bupropion hydrochloride extended-release tablets (SR) tablets may have an
odor.
General Information about bupropion hydrochloride
extended-release tablets (SR).
Medicines are sometimes prescribed for purposes other than those listed in a
Medication Guide. Do not use bupropion hydrochloride extended-release tablets
(SR) for a condition for which it was not prescribed. Do not give bupropion
hydrochloride extended-release tablets (SR) to other people, even if they have
the same symptoms you have. It may harm them. Keep bupropion hydrochloride
extended-release tablets (SR) out of the reach of children.
This Medication Guide summarizes important information about bupropion
hydrochloride extended-release tablets (SR). For more information, talk with
your doctor. You can ask your doctor or pharmacist for information about
bupropion hydrochloride extended-release tablets (SR) that is written for health
professionals.
What are the ingredients in bupropion hydrochloride
extended-release tablets (SR)?
Active ingredient: bupropion hydrochloride.