Medguide

Medguide

Medication Guide

Bupropion Hydrochloride Extended-Release Tablets USP (XL)

Read this Medication Guide carefully before you start using bupropion hydrochloride extended-release tablets (XL) 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 (XL), ask your doctor or pharmacist.

IMPORTANT: Be sure to read both sections of this Medication Guide. The first section is about the risk of suicidal thoughts and actions with antidepressant medicines; the second section is entitled “What other important information should I know about bupropion hydrochloride extended-release tablets (XL)?”

Antidepressant Medicines, Depression and Other Serious Mental Illnesses,
and Suicidal Thoughts or Actions

Read the Medication Guide that comes with you or your family member’s antidepressant medicine.

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 (XL) have not been studied in children under the age of 18 years and are not approved for use in children and teenagers.

What other important information should I know about bupropion hydrochloride extended-release tablets (XL)?

There is a chance of having a seizure (convulsion, fit) with bupropion hydrochloride extended-release tablets (XL), 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 (XL). For more information, see the sections “Who should not take bupropion hydrochloride extended-release tablets (XL)?” and “What should I tell my doctor before using bupropion hydrochloride extended-release tablets (XL)?” 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 (XL) unless your doctor has said it is okay to take them.

If you have a seizure while taking bupropion hydrochloride extended-release tablets (XL), stop taking the tablets and call your doctor right away. Do not take bupropion hydrochloride extended-release tablets (XL) again if you have a seizure.

What are bupropion hydrochloride extended-release tablets (XL)?

Bupropion hydrochloride extended-release tablets (XL) 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 (XL)?

Do not take bupropion hydrochloride extended-release tablets (XL) 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 bupropion hydrochloride tablets or bupropion hydrochloride sustained-release tablets. Bupropion is the same active ingredient that is in bupropion hydrochloride extended-release tablets (XL).

• 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 (XL), 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 (XL).

What should I tell my doctor before using bupropion hydrochloride extended-release tablets (XL)?

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

• are pregnant or plan to become pregnant. It is not known if bupropion hydrochloride extended-release tablets (XL)can harm your unborn baby.

• are breastfeeding. Bupropion hydrochloride extended-release tablets (XL)passes through your milk. It is not known if bupropion hydrochloride extended-release tablets (XL)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 (XL).

How should I take bupropion hydrochloride extended-release tablets (XL)?

• Take bupropion hydrochloride extended-release tablets (XL) exactly as prescribed by your doctor.

• Do not chew, cut, or crush bupropion hydrochloride extended-release tablets (XL). You must swallow the tablets whole. Tell your doctor if you cannot swallow medicine tablets.

• Take bupropion hydrochloride extended-release tablets (XL) at the same time each day.

• Take your doses of bupropion hydrochloride extended-release tablets (XL)at least 24 hours apart.

• You may take bupropion hydrochloride extended-release tablets (XL)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 (XL) can increase your chance of having a seizure.

• If you take too much bupropion hydrochloride extended-release tablets (XL), or overdose, call your local emergency room or poison control center right away.

• The bupropion hydrochloride extended-release tablet (XL) is covered by a shell that slowly releases the medicine inside your body. You may notice something in your stool that looks like a tablet. This is normal. This is the empty shell passing from your body.

• Do not take any other medicines while using bupropion hydrochloride extended-release tablets (XL) unless your doctor has told you it is okay.

• If you are taking bupropion hydrochloride extended-release tablets (XL) for the treatment of major depressive disorder, it may take several weeks for you to feel that bupropion hydrochloride extended-release tablets (XL) is working. Once you feel better, it is important to keep taking bupropion hydrochloride extended-release tablets (XL) exactly as directed by your doctor. Call your doctor if you do not feel bupropion hydrochloride extended-release tablets (XL) is working for you.

• Do not change your dose or stop taking bupropion hydrochloride extended-release tablets (XL) without talking with your doctor first.

What should I avoid while taking bupropion hydrochloride extended-release tablets (XL)?

• Do not drink a lot of alcohol while taking bupropion hydrochloride extended-release tablets (XL).  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 (XL) affects you. Bupropion hydrochloride extended-release tablets (XL) can impair your ability to perform these tasks.

  What are possible side effects of bupropion hydrochloride extended-release tablets (XL)?

• Seizures. Some patients get seizures while taking bupropion hydrochloride extended-release tablets (XL). If you have a seizure while taking bupropion hydrochloride extended-release tablets (XL), stop taking the tablets and call your doctor right away. Do not take bupropion hydrochloride extended-release tablets (XL) again if you have a seizure.

• Hypertension (high blood pressure). Some patients get high blood pressure, sometimes severe, while taking bupropion hydrochloride extended-release tablets (XL). 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 bupropion hydrochloride extended-release tablets (XL) 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 (XL), 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.

  Common side effects reported in studies of major depressive disorder include weight loss, 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.

  Tell your doctor right away about any side effects that bother you.

  These are not all the side effects of bupropion hydrochloride extended-release tablets (XL). For a complete list, ask your doctor or pharmacist.

  How should I store bupropion hydrochloride extended-release tablets (XL)?

• Store bupropion hydrochloride extended-release tablets (XL) at room temperature. Store out of direct sunlight. Keep bupropion hydrochloride extended-release tablets (XL) in its tightly closed bottle.

• Bupropion hydrochloride extended-release tablets (XL) may have an odor.

  General Information about bupropion hydrochloride extended-release tablets (XL).

• Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use bupropion hydrochloride extended-release tablets (XL) for a condition for which it was not prescribed. Do not give bupropion hydrochloride extended-release tablets (XL) to other people, even if they have the same symptoms you have. It may harm them. Keep bupropion hydrochloride extended-release tablets (XL)out of the reach of children.

This Medication Guide summarizes important information about bupropion hydrochloride extended-release tablets (XL). For more information, talk with your doctor. You can ask your doctor or pharmacist for information about bupropion hydrochloride extended-release tablets (XL) that is written for health professionals.  To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA at 1-888-493-0857 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

What are the ingredients in bupropion hydrochloride extended-release tablets (XL)?

Active ingredient: bupropion hydrochloride.

Inactive ingredients: dehydrated alcohol, ethylcellulose, hydrochloric acid, hydroxypropylcellulose, methacrylic acid copolymer, povidone, silicon dioxide, hydrogenated vegetable oil and ethyl alcohol. The tablets are printed with edible black ink.

*The following are registered trademarks of their respective manufacturers: PROZAC®/Eli Lilly and Company; ZOLOFT®/Pfizer Pharmaceuticals; LUVOX®/Solvay Pharmaceuticals, Inc.; ANAFRANIL®/Mallinckrodt Inc.; NARDIL®/Warner Lambert Company; MARPLAN®/Oxford Pharmaceutical Services, Inc.; PARNATE®/ GlaxoSmithKline.

Manufactured by:

Anchen Pharmaceuticals, Inc.

Irvine, CA 92618

08/08