DESCRIPTION

Bupropion hydrochloride extended-release tablets (XL), an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines. It is designated as (±)-1-(3-chlorophenyl)-2-[(1,1-dimethylethyl)amino]-1propanone hydrochloride. The molecular weight is 276.2. The molecular formula is C H ClNO•HCl. Bupropion hydrochloride powder is white, crystalline, and highly soluble in water. It has a bitter taste and produces the sensation of local anesthesia on the oral mucosa. The structural formula is: 1318

Bupropion hydrochloride extended-release tablets (XL) are supplied for oral administration as 150 mg and 300 mg, white to off-white extended-release tablets. Each tablet contains the labeled amount of bupropion hydrochloride and the inactive ingredients: colloidal silicon dioxide, ethylcellulose, hydroxypropyl cellulose, methacrylic acid copolymer, microcrystalline cellulose, stearic acid, talc, titanium dioxide, hydrochloric acid and triethyl citrate. The tablets are printed with edible black ink. USP drug release test is pending.

CLINICAL PHARMACOLOGY

INDICATIONS AND USAGE

Bupropion hydrochloride extended-release tablets (XL) are indicated for the treatment of major depressive disorder. Major Depressive Disorder:

The efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of inpatients and in one 6-week controlled trial of outpatients whose diagnoses corresponded most closely to the Major Depression category of the APA Diagnostic and Statistical Manual (DSM) (see ). CLINICAL TRIALS

A major depressive episode (DSM-IV) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt, or suicidal ideation.

The efficacy of bupropion in maintaining an antidepressant response for up to 44 weeks following 8 weeks of acute treatment was demonstrated in a placebo-controlled trial with the sustained-release formulation of bupropion (see ). Nevertheless, the physician who elects to use bupropion hydrochloride extended-release tablets (XL) for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient. CLINICAL TRIALS

Bupropion hydrochloride extended-release tablets (XL) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder. Seasonal Affective Disorder:

The efficacy of bupropion hydrochloride extended-release tablets (XL) for the prevention of seasonal major depressive episodes was established in 3 controlled trials of adult outpatients with a history of major depressive disorder with an autumn-winter seasonal pattern as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria (see ). CLINICAL TRIALS

Seasonal affective disorder is characterized by recurrent major depressive episodes, most commonly occurring during the autumn and/or winter months. Episodes may last up to 6 months in duration, typically beginning in the autumn and remitting in the springtime. Although patients with seasonal affective disorder may have depressive episodes during other times of the year, the diagnosis of seasonal affective disorder requires that the number of seasonal episodes substantially outnumber the number of non-seasonal episodes during the individual's lifetime.

CONTRAINDICATIONS

Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with a seizure disorder.

Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients treated with ZYBAN (bupropion hydrochloride extended-release tablets (SR); WELLBUTRIN (bupropion hydrochloride tablets), the immediate-release formulation; WELLBUTRIN SR (bupropion hydrochloride extended-release tablets (SR)), the sustained-release formulation; or any other medications that contain bupropion because the incidence of seizure is dose dependent. ®*®*®*

Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa because of a higher incidence of seizures noted in patients treated for bulimia with the immediate-release formulation of bupropion.

Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients undergoing abrupt discontinuation of alcohol or sedatives (including benzodiazepines).

The concurrent administration of bupropion hydrochloride extended-release tablets (XL) and a monoamine oxidase (MAO) inhibitor is contraindicated. At least 14 days should elapse between discontinuation of an MAO inhibitor and initiation of treatment with bupropion hydrochloride extended-release tablets (XL).

Bupropion hydrochloride extended-release tablets (XL) are contraindicated in patients who have shown an allergic response to bupropion or the other ingredients that make up bupropion hydrochloride extended-release tablets (XL).

WARNINGS

PRECAUTIONS

ADVERSE REACTIONS

(See also and ). WARNINGSPRECAUTIONS

Bupropion hydrochloride extended-release tablets (XL) have been demonstrated to have similar bioavailability both to the immediate-release formulation of bupropion and to the sustained-release formulation of bupropion (see ). The information included under this subsection is based primarily on data from controlled clinical trials with the sustained-release formulation of bupropion. Major Depressive Disorder:CLINICAL PHARMACOLOGY

In placebo-controlled clinical trials, 9% and 11% of patients treated with 300 and 400 mg/day, respectively, of the sustained-release formulation of bupropion and 4% of patients treated with placebo discontinued treatment due to adverse events. The specific adverse events in these trials that led to discontinuation in at least 1% of patients treated with either 300 mg/day or 400 mg/day of the sustained-release formulation of bupropion, and at a rate at least twice the placebo rate are listed in Table 6. Adverse Events Leading to Discontinuation of Treatment With the Immediate-Release or Sustained-Release Formulation of Bupropion:

Table 6. Treatment Discontinuations Due to Adverse Events in Placebo-Controlled Trials for Major Depressive Disorder

Adverse Event Term	Bupropion Hydrochloride Sustained-Release Formulation	Bupropion Hydrochloride Sustained-Release Formulation	Placebo
	300 mg/day	400 mg/day
	(n = 376)	(n = 114)	(n = 385)
Rash	2.4%	0.9%	0.0%
Nausea	0.8%	1.8%	0.3%
Agitation	0.3%	1.8%	0.3%
Migraine	0.0%	1.8%	0.3%

In clinical trials with the immediate-release formulation of bupropion, 10% of patients and volunteers discontinued due to an adverse event. Events resulting in discontinuation, in addition to those listed above for the sustained-release formulation of bupropion, include vomiting, seizures, and sleep disturbances.

Table 7 enumerates treatment-emergent adverse events that occurred among patients treated with 300 and 400 mg/day of the sustained-release formulation of bupropion and with placebo in controlled trials. Events that occurred in either the 300 or 400 mg/day group at an incidence of 1% or more and were more frequent than in the placebo group are included. Reported adverse events were classified using a COSTART-based Dictionary. Adverse Events Occurring at an Incidence of 1% or More Among Patients Treated With Immediate and Sustained Release Formulations of Bupropion:

Accurate estimates of the incidence of adverse events associated with the use of any drug are difficult to obtain. Estimates are influenced by drug dose, detection technique, setting, physician judgments, etc. The figures cited cannot be used to predict precisely the incidence of untoward events in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. These incidence figures also cannot be compared with those obtained from other clinical studies involving related drug products as each group of drug trials is conducted under a different set of conditions.

Finally, it is important to emphasize that the tabulation does not reflect the relative severity and/or clinical importance of the events. A better perspective on the serious adverse events associated with the use of bupropion is provided in the and sections. WARNINGSPRECAUTIONS

Table 7. Treatment-Emergent Adverse Events in Placebo-Controlled Trials for Major Depressive Disorder *

Body System/ Adverse Event	Bupropion Hydrochloride Sustained-Release Formulation 300 mg/day (n=376)	Bupropion Hydrochloride Sustained-Release Formulation 400 mg/day (n=114)	Placebo (n=385)
Adverse events that occurred in at least 1% of patients treated with either 300 or 400 mg/day of the sustained-release formulation of bupropion, but equally or more frequently in the placebo group, were: abnormal dreams, accidental injury, acne, appetite increased, back pain, bronchitis, dysmenorrhea, dyspepsia, flatulence, flu syndrome, hypertension, neck pain, respiratory disorder, rhinitis, and tooth disorder. *
Incidence based on the number of female patients. †
- Hyphen denotes adverse events occurring in greater than 0 but less than 0.5% of patients.
Body (General)
Headache	26%	25%	23%
Infection	8%	9%	6%
Abdominal pain	3%	9%	2%
Asthenia	2%	4%	2%
Chest pain	3%	4%	1%
Pain	2%	3%	2%
Fever	1%	2%	-
Cardiovascular
Palpitation	2%	6%	2%
Flushing	1%	4%	-
Migraine	1%	4%	1%
Hot flashes	1%	3%	1%
Digestive
Dry mouth	17%	24%	7%
Nausea	13%	18%	8%
Constipation	10%	5%	7%
Diarrhea	5%	7%	6%
Anorexia	5%	3%	2%
Vomiting	4%	2%	2%
Dysphagia	0%	2%	0%
Musculoskeletal
Myalgia	2%	6%	3%
Arthralgia	1%	4%	1%
Arthritis	0%	2%	0%
Twitch	1%	2%	-
Nervous  system
Insomnia	11%	16%	6%
Dizziness	7%	11%	5%
Agitation	3%	9%	2%
Anxiety	5%	6%	3%
Tremor	6%	3%	1%
Nervousness	5%	3%	3%
Somnolence	2%	3%	2%
Irritability	3%	2%	2%
Memory decreased	-	3%	1%
Paresthesia	1%	2%	1%
Central nervous     system stimulation	2%	1%	1%
Respiratory
Pharyngitis	3%	11%	2%
Sinusitis	3%	1%	2%
Increased cough	1%	2%	1%
Skin
Sweating	6%	5%	2%
Rash	5%	4%	1%
Pruritus	2%	4%	2%
Urticaria	2%	1%	0%
Special senses
Tinnitus	6%	6%	2%
Taste perversion	2%	4%	-
Blurred vision or diplopia	3%	2%	2%
Urogenital
Urinary frequency	2%	5%	2%
Urinary urgency	-	2%	0%
Vaginal hemorrhage †	0%	2%	-
Urinary tract infection	1%	0%	-

Additional events to those listed in Table 7 that occurred at an incidence of at least 1% in controlled clinical trials of the immediate-release formulation of bupropion (300 to 600 mg/day) and that were numerically more frequent than placebo were: cardiac arrhythmias (5% vs 4%), hypertension (4% vs 2%), hypotension (3% vs 2%), tachycardia (11% vs 9%), appetite increase (4% vs 2%), dyspepsia (3% vs 2%), menstrual complaints (5% vs 1%), akathisia (2% vs 1%), impaired sleep quality (4% vs 2%), sensory disturbance (4% vs 3%), confusion (8% vs 5%), decreased libido (3% vs 2%), hostility (6% vs 4%), auditory disturbance (5% vs 3%), and gustatory disturbance (3% vs 1%).

Adverse events from Table 7 occurring in at least 5% of patients treated with the sustained-release formulation of bupropion and at a rate at least twice the placebo rate are listed below for the 300 and 400 mg/day dose groups. Incidence of Commonly Observed Adverse Events in Controlled Clinical Trials:

Anorexia, dry mouth, rash, sweating, tinnitus, and tremor. 300 mg/day of the Sustained-Release Formulation:

Abdominal pain, agitation, anxiety, dizziness, dry mouth, insomnia, myalgia, nausea, palpitation, pharyngitis, sweating, tinnitus, and urinary frequency. 400 mg/day of the Sustained-Release Formulation:

In placebo-controlled clinical trials, 9% of patients treated with the extended-release formulation of bupropion and 5% of patients treated with placebo discontinued treatment due to adverse events. The adverse events in these trials that led to discontinuation in at least 1% of patients treated with the extended-release formulation of bupropion and at a rate numerically greater than the placebo rate are insomnia (2% vs <1%) and headache (1% vs <1%). Seasonal Affective Disorder: Adverse Events Leading to Discontinuation of Treatment With Bupropion Hydrochloride Extended-Release Tablets (XL):

Table 8 enumerates treatment-emergent adverse events that occurred among patients treated with the extended-release formulation of bupropion for up to approximately 6 months in 3 placebo-controlled trials. Events that occurred at an incidence of 2% or more and were more frequent than in the placebo group are included. Reported adverse events were classified using a MedDRA-based Dictionary. Adverse Events Occurring at an Incidence of 2% or More Among Patients Treated With Bupropion Hydrochloride Extended-Release Tablets (XL):

Accurate estimates of the incidence of adverse events associated with the use of any drug are difficult to obtain. Estimates are influenced by drug dose, detection technique, setting, physician judgments, etc. The figures cited cannot be used to predict precisely the incidence of untoward events in the course of usual medical practice where patient characteristics and other factors differ from those that prevailed in the clinical trials. These incidence figures also cannot be compared with those obtained from other clinical studies involving related drug products as each group of drug trials is conducted under a different set of conditions; e.g., different patient populations, different treatment durations.

Finally, it is important to emphasize that the tabulation does not reflect the relative severity and/or clinical importance of the events. A better perspective on the serious adverse events associated with the use of bupropion is provided in the WARNINGS and PRECAUTIONS sections.

Table 8. Treatment-Emergent Adverse Events in Placebo-Controlled Trials of Seasonal Affective Disorder *

System Organ Class/ Preferred Term	Bupropion Hydrochloride Extended-Release Formulation  (n=537)	Placebo (n=511)
Adverse events that occurred in at least 2% of patients treated with the extended-release formulation of bupropion, but equally or more frequently in the placebo group, were: abdominal pain upper, arthralgia, back pain, diarrhea, dyspepsia, fatigue, gastroenteritis viral, hyperhidrosis, influenza, irritability, migraine, nasal congestion, neck pain, palpitations, pharyngolaryngeal pain, sinus congestion. *
Gastrointestinal Disorder
Dry Mouth	26%	15%
Nausea	13%	8%
Constipation	9%	2%
Flatulence	6%	3%
Abdominal pain	2%	<1%
Nervous System Disorders
Headache	34%	26%
Dizziness	6%	5%
Tremor	3%	<1%
Infections and Infestations
Nasopharyngitis	13%	12%
Upper respiratory tract infection	9%	8%
Sinusitis	5%	4%
Psychiatric Disorders
Insomnia	20%	13%
Anxiety	7%	5%
Abnormal dreams	3%	2%
Agitation	2%	<1%
Musculoskeletal and Connective Tissue Disorders
Myalgia	3%	3%
Pain in extremity	2%	2%
Respiratory, Thoracic and Mediastinal Disorders
Cough	4%	3%
General Disorders and Administration Site Conditions
Feeling jittery	3%	2%
Skin and Subcutaneous Tissue Disorders
Rash	3%	2%
Metabolism and Nutrition Disorders
Decreased appetite	4%	1%
Reproductive System and Breast Disorders
Dysmenorrhea	2%	<1%
Ear and Labyrinth Disorders
Tinnitus	3%	<1%
Vascular Disorders
Hypertension	2%	0%

Adverse events from Table 8 that occurred in at least 5% of patients treated with the extended-release formulation of bupropion and at a rate at least twice the placebo rate were constipation and flatulence. Incidence of Commonly Observed Adverse Events in Controlled Clinical Trials:

Adverse events with onset during the 2 weeks following down-titration of the extended-release formulation of bupropion from 300 mg/day to 150 mg/day were reported by 14% of patients compared to 18% of patients who continued on placebo. Adverse Events During Taper or Following Discontinuation of the Extended-Release Formulation of Bupropion:

Adverse events with onset during the 2 weeks following discontinuation of the extended-release formulation of bupropion were reported by 9% of patients compared with 12% of patients following discontinuation of placebo.

DRUG ABUSE AND DEPENDENCE

OVERDOSAGE

DOSAGE AND ADMINISTRATION

MEDICATION GUIDE

BuPROPion Hydrochloride Extended-Release Tablets (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 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 (XL)?” 

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 doctor, 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. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions. 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.

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?

• Stopping an antidepressant medicine suddenly can cause other symptoms. Never stop an antidepressant medicine without first talking to a healthcare provider.

• 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. Antidepressants are medicines used to treat depression and other illnesses.

• Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member. Antidepressant medicines have other side effects.

• 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. Antidepressant medicines can interact with other medicines.

• Talk to your child’s healthcare provider for more information. Not all antidepressant medicines prescribed for children are FDA approved for use in children.

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

Seisures: 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.

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

• 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. High blood pressure (hypertension). Some people get high blood pressure, that can be severe, while taking bupropion hydrochloride extended-release tablets (XL).

• 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. Severe allergic reactions. Some people have severe allergic reactions to bupropion hydrochloride extended-release tablets (XL). Stop taking bupropion hydrochloride extended-release tablets (XL) and call your doctor right away if

• 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. Unusual thoughts or behaviors.

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 and for prevention of autumn-winter seasonal depression (seasonal affective 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.

• Bupropion is the same active ingredient that is in bupropion hydrochloride extended-release tablets (XL). are taking ZYBAN (used to help people stop smoking) or any other medicines that contain bupropion hydrochloride, such as WELLBUTRIN (bupropion hydrochloride tablets) or WELLBUTRIN SR (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, 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 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 medical conditions including if you

  • It is not known if bupropion can harm your unborn baby. are pregnant or plan to become pregnant.

  • Bupropion passes through your milk. It is not known if bupropion can harm your baby. are breastfeeding.

  • especially cirrhosis of the liver. have liver problems,

  • 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.

  • 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). Tell your doctor about all the medicines you take,

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

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

• 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. Do not chew, cut, or crush bupropion hydrochloride extended-release tablets (XL).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. Too many bupropion hydrochloride extended-release tablets (XL) can increase your chance of having a seizure. This is very important.

• If you take too many bupropion hydrochloride extended-release tablets (XL), 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 (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) are 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) are working for you.

• If you are taking bupropion hydrochloride extended-release tablets (XL) for the prevention of seasonal major depressive episodes associated with seasonal affective disorder, it is important to keep taking WELLBUTRIN XL through the autumn-winter season, or as directed by your doctor.

• 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) affect 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)?

Bupropion hydrochloride extended-release tablets (XL) can cause serious side effects. Read this entire Medication Guide for more information about these serious side effects.

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.In studies of seasonal affective disorder, common side effects included weight loss, constipation, and gas.

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.

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 (XL)?

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

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

Active ingredient: bupropion hydrochloride. Inactive ingredients: colloidal silicon dioxide, ethylcellulose, hydroxypropyl cellulose, methacrylic acid copolymer, microcrystalline cellulose, stearic acid, talc, titanium dioxide, hydrochloric acid and triethyl citrate. The tablets are printed with edible black ink.

The following are registered trademarks of their respective manufacturers: NARDIL /Warner Lambert Company; PARNATE /GlaxoSmithKline; MARPLAN /Oxford Pharmaceutical Services, Inc.; ZYBAN /GlaxoSmithKline; WELLBUTRIN /GlaxoSmithKline; WELLBUTRIN SR /GlaxoSmithKline. *®®®®®®

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

Manufactured by: Corona, CA 92880 USA
Watson Laboratories, Inc.

Distributed by: Corona, CA 92880 USA
Watson Pharma, Inc.

Revised: August 2010 174662-3

Bupropion HCL XL 150mg Tablet