SPL MEDGUIDE

BuPROPion Hydrochloride Extended-release Tablets USP (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.

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?

1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.

2. 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.

3.

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 hydrochloride extended-release tablets (SR) have not been studied in children under the age of 18 and are 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 Zybanwhich 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 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 sectionsWho should not take bupropion hydrochloride extended-release tablets (SR)?andWhat 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 awayif 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 are 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 WellbutrinTablets or Wellbutrin XLExtended-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. SeeAntidepressant 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 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 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 many bupropion hydrochloride extended-release tablets (SR) can increase your chance of having a seizure.

• If you take too many 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) are 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) are 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 their tightly closed bottle.

• Bupropion hydrochloride extended-release tablets (SR) 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.

Inactive ingredients: hydroxypropyl cellulose, microcrystalline cellulose, colloidal silicon dioxide, stearic acid, magnesium stearate, and diluted hydrochloric acid. The film coating contains lactose monohydrate, hydroxypropyl cellulose, titanium dioxide, and polyethylene glycol.

*The following are registered trademarks of their respective manufacturers: Zyban

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