BUDEPRION SR- bupropion hydrochloride tablet, extended release 
Cardinal Health

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MEDICATION GUIDE

Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts orActions

Read the Medication Guide that comes with you or your family member’s antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your or your familymember’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 otherserious mental illnesses, and suicidal thoughts oractions?

1. Antidepressant medicines may increase suicidalthoughts or actions in some children, teenagers,and young adults within the first few months oftreatment.

2. Depression and other serious mental illnesses arethe most important causes of suicidal thoughts andactions. Some people may have a particularly highrisk 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.

3. How can I watch for and try to prevent suicidalthoughts 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 treatdepression 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 othermedicines. 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.

This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.

Manufactured By:

IMPAX Laboratories, Inc.

Hayward, CA 94544 USA

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. 06/2007

514-03

IU37361050408

PHARMACIST - DETACH HERE AND GIVE LEAFLET TO PATIENT.

Patient Information

BUDEPRION SR®

(buPROPion HCI Extended-Release Tablets)

Read the Patient Information that comes with BUDEPRION SR® before you starttaking BUDEPRION SR® 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.

BUDEPRION SR® has not been studied in children under the age of 18 and is not approved for use in children and teenagers.

What other important information should I know about BUDEPRION SR®?

There is a chance of having a seizure (convulsion, fit) with BUDEPRION SR®,especially in people:

• with certain medical problems.

• who take certain medicines.

The chance of having seizures increases with higher doses of BUDEPRION SR®.

For more information, see the sections “Who should not take BUDEPRION SR®?” and “What should I tell my doctor before using BUDEPRION SR®?” Tell your doctor about all of your medical conditions and all the medicines you take. Do nottake any other medicines while you are using BUDEPRION SR® unless yourdoctor has said it is okay to take them.

If you have a seizure while taking BUDEPRION SR®, stop taking the tablets and call your doctor right away. Do not take BUDEPRION SR® again if you have a seizure.

What is BUDEPRION SR®?

BUDEPRION SR® is a prescription medicine used to treat adults with a certain type of depression called major depressive disorder.

Who should not take BUDEPRION SR®?

Do not take BUDEPRION 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® [bupropion hydrochloride extended-release Tablets (XL)]. Bupropion is the same active ingredient that is in BUDEPRION 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 BUDEPRION SR®, bupropion, or to any of the inactive ingredients. See the end of this leaflet for a complete list of ingredients in BUDEPRION SR®.

What should I tell my doctor before using BUDEPRION SR®?

Tell your doctor about your medical conditions. Tell your doctor if you:

are pregnant or plan to become pregnant. It is not known if BUDEPRION SR® can harm your unborn baby.

are breastfeeding. BUDEPRION SR® passes through your milk. It is not known if BUDEPRION 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 BUDEPRION SR®.

How should I take BUDEPRION SR®?

• Take BUDEPRION SR® exactly as prescribed by your doctor.

Do not chew, cut, or crush BUDEPRION SR®. You must swallow the tablets whole.

Tell your doctor if you cannot swallow medicine tablets.

• Take BUDEPRION SR® at the same time each day.

• Take your doses of BUDEPRION SR® at least 8 hours apart.

• You may take BUDEPRION 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 BUDEPRION SR® can increase your chance of having a seizure.

• If you take too much BUDEPRION SR®, or overdose, call your local emergency room or poison control center right away.

Do not take any other medicines while using BUDEPRION SR® unless yourdoctor has told you it is okay.

• It may take several weeks for you to feel that BUDEPRION SR® is working. Once you feel better, it is important to keep taking BUDEPRION SR® exactly as directed by your doctor. Call your doctor if you do not feel BUDEPRION SR® is working for you.

• Do not change your dose or stop taking BUDEPRION SR® without talking with your doctor first.

What should I avoid while taking BUDEPRION SR®?

• Do not drink a lot of alcohol while taking BUDEPRION 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 BUDEPRION SR ® affects you. BUDEPRION SR® can impair your ability to perform these tasks.

What are possible side effects of BUDEPRION SR®?

Seizures. Some patients get seizures while taking BUDEPRION SR®. If you have a seizure while taking BUDEPRION SR®, stop taking the tablets and call your doctor right away. Do not take BUDEPRION SR® again if you have a seizure.

Hypertension (high blood pressure). Some patients get high blood pressure, sometimes severe, while taking BUDEPRION SR®. 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 taking BUDEPRION 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 BUDEPRION 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.

The most common side effects of BUDEPRION 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 heart beat, sore throat, and urinating more often.

If you have nausea, you may want to 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 BUDEPRION SR®. For a complete list, ask your doctor or pharmacist.

How should I store BUDEPRION SR®?

• Store BUDEPRION SR® at room temperature. Store out of direct sunlight. Keep BUDEPRION SR® in its tightly closed bottle.

• BUDEPRION SR® may have an odor.

General Information about BUDEPRION SR®.

• Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use BUDEPRION SR® for a condition for which it was not prescribed. Do not give BUDEPRION SR® to other people, even if they have the same symptoms you have. It may harm them. Keep BUDEPRION SR® out of the reach of children.

This leaflet summarizes important information about BUDEPRION SR®. For more information, talk with your doctor. You can ask your doctor or pharmacist for information about BUDEPRION SR® that is written for health professionals.

What are the ingredients in BUDEPRION SR®?

Active ingredient: bupropion hydrochloride.

Inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, magnesium stearate, and microcrystalline cellulose. The 100 mg tablet also contains FD&C red # 40, FD&C yellow # 5, hypromellose, iron oxide yellow, macrogol, polydextrose, titanium dioxide and triacetin. The 150 mg tablet also contains hypromellose, iron oxide yellow, macrogol, polydextrose, titanium dioxide and triacetin.

Rx only

Manufactured By:

IMPAX Laboratories, Inc.

Hayward, CA 94544 USA

Manufactured For:

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

ZYBAN®, WELLBUTRIN®, and WELLBUTRIN XL® are registered trademarks of

GlaxoSmithKline.

Nardil® is a registered trademark of Parke Davis.

Parnate® is a registered trademark of GlaxoSmithKline.

Marplan® is a registered trademark of Oxford Pharmaceutical Services.

Rev. 06/2007

514-03

BUDEPRION SR® 100 mg and 150 mg tablets are available from Cardinal Health in

unit dose packages of 100 tablets.

100 mg, unit dose package of 100 tablets, NDC 55154-8255-4

150 mg, unit dose package of 100 tablets, NDC 55154-8250-4

Cardinal Health

Zanesville OH 43701

IU37361050408

Revised: 1/2018
Cardinal Health