Bupropion Hydrochloride SR (Page 9 of 10)

16 HOW SUPPLIED/STORAGE AND HANDLING

Product: 50090-1150

NDC: 50090-1150-0 60 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE, PLASTIC

NDC: 50090-1150-1 30 TABLET, FILM COATED, EXTENDED RELEASE in a BOTTLE

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

Suicidal Thoughts and Behaviors
Instruct patients, their families, and/or their caregivers to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Advise families and caregivers of patients to observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient’s prescriber or healthcare professional, especially if they are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication [see Boxed Warning, Warnings and Precautions (5.1)].

Neuropsychiatric Adverse Events and Suicide Risk in Smoking Cessation Treatment
Inform patients that some patients have experienced changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, aggression, hostility, agitation, anxiety, and panic, as well as suicidal ideation and suicide when attempting to quit smoking while taking bupropion hydrochloride extended-release tablets (SR). Instruct patients to discontinue bupropion hydrochloride extended-release tablets (SR) and contact a healthcare professional if they experience such symptoms [see Warnings and Precautions (5.2), Adverse Reactions (6.2)].

Severe Allergic Reactions
Educate patients on the symptoms of hypersensitivity and to discontinue bupropion hydrochloride extended-release tablets (SR) if they have a severe allergic reaction to bupropion hydrochloride extended-release tablets (SR).

Seizure
Instruct patients to discontinue bupropion hydrochloride extended-release tablets (SR) and not restart it if they experience a seizure while on treatment. Advise patients that the excessive use or abrupt discontinuation of alcohol, benzodiazepines, antiepileptic drugs, or sedatives/hypnotics can increase the risk of seizure. Advise patients to minimize or avoid use of alcohol.

Angle-Closure Glaucoma
Patients should be advised that taking bupropion hydrochloride extended-release tablets (SR) can cause mild pupillary dilation, which in susceptible individuals, can lead to an episode of angle-closure glaucoma. Pre-existing glaucoma is almost always open-angle glaucoma because angle-closure glaucoma, when diagnosed, can be treated definitively with iridectomy. Open-angle glaucoma is not a risk factor for angle-closure glaucoma. Patients may wish to be examined to determine whether they are susceptible to angle closure, and have a prophylactic procedure (e.g., iridectomy), if they are susceptible [see Warnings and Precautions (5.7)].

Bupropion-Containing Products
Educate patients that bupropion hydrochloride extended-release tablets (SR) contains the same active ingredient (bupropion hydrochloride) found in WELLBUTRIN ® , WELLBUTRIN SR ® , and WELLBUTRIN XL ® , which are used to treat depression and that bupropion hydrochloride extended-release tablets (SR) should not be used in conjunction with any other medications that contain bupropion (such as WELLBUTRIN ® , the immediate-release formulation; WELLBUTRIN SR ® , the sustained-release formulation; WELLBUTRIN XL ® or FORFIVO XL ® , the extended-release formulations; and APLENZIN ® , the extended-release formulation of bupropion hydrobromide). In addition, there are a number of generic bupropion HCl products for the immediate-, sustained-, and extended-release formulations.

Potential for Cognitive and Motor Impairment
Advise patients that any CNS-active drug like bupropion hydrochloride extended-release tablets (SR) may impair their ability to perform tasks requiring judgment or motor and cognitive skills. Advise patients that until they are reasonably certain that bupropion hydrochloride extended-release tablets (SR) does not adversely affect their performance, they should refrain from driving an automobile or operating complex, hazardous machinery. Bupropion hydrochloride extended-release tablets (SR) may lead to decreased alcohol tolerance.

Concomitant Medications
Counsel patients to notify their healthcare provider if they are taking or plan to take any prescription or over-the-counter drugs because bupropion hydrochloride extended-release tablets (SR) and other drugs may affect each others’ metabolisms.

Pregnancy
Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during therapy.

Precautions for Nursing Mothers
Advise patients that bupropion hydrochloride extended-release (SR) is present in human milk in small amounts.

Storage Information
Instruct patients to store bupropion hydrochloride extended-release tablets (SR) at room temperature, between 68°F and 77°F (20°C to 25°C) and keep the tablets dry and out of the light.

Administration Information
Instruct patients to swallow bupropion hydrochloride extended-release tablets (SR) whole so that the release rate is not altered. Do not chew, divide, or crush tablets; they are designed to slowly release drug in the body. When patients take more than 150 mg per day, instruct them to take bupropion hydrochloride extended-release tablets (SR) in 2 doses at least 8 hours apart, to minimize the risk of seizures. Instruct patients if they miss a dose, not to take an extra tablet to make up for the missed dose and to take the next tablet at the regular time because of the dose-related risk of seizure. Bupropion hydrochloride extended-release tablets (SR) can be taken with or without food. Advise patients that bupropion hydrochloride extended-release tablets (SR) may have an odor.

Brands listed are the trademarks of their respective owners.

Manufactured by:
Actavis Laboratories FL, Inc.
Fort Lauderdale, FL 33314 USA

Distributed by:
Actavis Pharma, Inc.Parsippany, NJ 07054 USA

Rev. B 4/2021

MEDICATION GUIDE

BuPROPion Hydrochloride ( bue proe’ pee on hye” droe klor’ ide)

Extended-Release Tablets (SR)

IMPORTANT: Be sure to read the three sections of this Medication Guide. The first section is about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with medicines used to quit smoking; the second section is about the risk of suicidal thoughts and actions with antidepressant medicines; and the third section is entitled “What Other Important Information Should I Know About Bupropion Hydrochloride Extended-Release Tablets (SR)?”

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. Talk to your healthcare provider or your family member’s healthcare provider about:

  • all risks and benefits of quit-smoking medicines.
  • all treatment choices for quitting smoking.

When you try to quit smoking, with or without bupropion hydrochloride extended-release tablets (SR), you may have symptoms that may be due to nicotine withdrawal, including:
  • urge to smoke
  • frustration
  • restlessness
  • depressed mood
  • anger
  • decreased heart rate
  • trouble sleeping
  • feeling anxious
  • increased appetite
  • irritability
  • difficulty concentrating
  • 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.

Some people have had serious side effects while taking bupropion hydrochloride extended-release tablets (SR) to help them quit smoking, including:

New or worse mental health problems, such as changes in behavior or thinking, aggression, hostility, agitation, depression, suicidal thoughts or actions. Some people had these symptoms when they began taking bupropion hydrochloride extended-release tablets (SR), and others developed them after several weeks of treatment, or after stopping bupropion hydrochloride extended-release tablets (SR). These symptoms happened more often in people who had a history of mental health problems before taking bupropion hydrochloride extended-release tablets (SR) than in people without a history of mental health problems.

Stop taking bupropion hydrochloride extended-release tablets (SR) and call your healthcare provider right away if you, your family, or caregiver notices any of these symptoms. Work with your healthcare provider to decide whether you should continue to take bupropion hydrochloride extended-release tablets (SR). In many people, these symptoms went away after stopping bupropion hydrochloride extended-release tablets (SR), but in some people symptoms continued after stopping bupropion hydrochloride extended-release tablets (SR). It is important for you to follow-up with your healthcare provider until your symptoms go away. Before taking bupropion hydrochloride extended-release tablets (SR), tell your healthcare provider if you have ever had depression or other mental health problems. You should also tell your healthcare provider about any symptoms you had during other times you tried to quit smoking, with or without bupropion hydrochloride extended-release tablets (SR).

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

Although bupropion hydrochloride extended-release tablets (SR) are not a treatment for depression, it contains bupropion, the same active ingredient as the antidepressant medications WELLBUTRIN ® , WELLBUTRIN SR ® , and WELLBUTRIN XL ® .

This section of the Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines.

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, or young adults within the first few months of treatment.

2. Depression or 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 your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
  • Keep all follow-up visits with your healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call your 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
  • trouble sleeping (insomnia)
  • attempts to commit suicide
  • new or worse irritability
  • new or worse depression
  • acting aggressive, being angry, or violent
  • new or worse anxiety
  • acting on dangerous impulses
  • feeling very agitated or restless
  • an extreme increase in activity and talking (mania)
  • panic attacks
  • 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.

It is not known if bupropion hydrochloride extended-release tablets (SR) are safe and effective in children under the age of 18.

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 healthcare provider before taking bupropion hydrochloride extended-release tablets (SR)?” Tell your healthcare provider about all of your medical conditions and all the medicines you take. Do not take any other medicines while you are taking bupropion hydrochloride extended-release tablets (SR) unless your healthcare provider 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 healthcare provider 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 (see the section of this Medication Guide called “How should I take bupropion hydrochloride extended-release tablets (SR)?”).
  • Manic episodes. Some people may have periods of mania while taking bupropion hydrochloride extended-release tablets (SR), including:
    • Greatly increased energy
    • Severe trouble sleeping
    • Racing thoughts
    • Reckless behavior
    • Unusually grand ideas
    • Excessive happiness or irritability
    • Talking more or faster than usual

If you have any of the above symptoms of mania, call your healthcare provider.

  • 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 healthcare provider.
  • Visual problems.
    • eye pain
    • changes in vision
    • swelling or redness in or around the eye

Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

  • Severe allergic reactions. Some people can have severe allergic reactions to bupropion hydrochloride extended-release tablets (SR). Stop taking bupropion hydrochloride extended-release tablets (SR) and call your healthcare provider 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.
What are bupropion hydrochloride extended-release tablets (SR)?

Bupropion hydrochloride extended-release tablets (SR) are a prescription medicine to help people quit smoking.

Bupropion hydrochloride extended-release tablets (SR) should be used with a patient support program. It is important to participate in the behavioral program, counseling, or other support program your healthcare professional recommends.

Quitting smoking can lower your chances of having lung disease, heart disease, or getting certain types of cancer that are related to smoking.

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.
  • have or had an eating disorder such as anorexia nervosa or bulimia.
  • are taking any other medicines that contain bupropion, including WELLBUTRIN ® , WELLBUTRIN SR ® , WELLBUTRIN XL ® , APLENZIN ® , or FORFIVO XL ® . 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 take medicines called sedatives (these make you sleepy), benzodiazepines, or anti-seizure medicines, and you stop taking them all of a sudden.
  • take a monoamine oxidase inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.
    • do not take an MAOI within 2 weeks of stopping bupropion hydrochloride extended-release tablets (SR) unless directed to do so by your healthcare provider.
    • do not start bupropion hydrochloride extended-release tablets (SR) if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your healthcare provider.
  • 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 Medication Guide for a complete list of ingredients in bupropion hydrochloride extended-release tablets (SR).
What should I tell my healthcare provider before taking bupropion hydrochloride extended-release tablets (SR)?

Tell your healthcare provider if you have ever had depression, suicidal thoughts or actions, or other mental health problems. You should also tell your healthcare provider about any symptoms you had during other times you tried to quit smoking, with or without bupropion hydrochloride extended-release tablets (SR). See “Quitting Smoking, Quit-Smoking Medications, Changes in Thinking and Behavior, Depression, and Suicidal Thoughts or Actions.”

  • Tell your healthcare provider about your other medical conditions, including if you:
    • have liver problems, especially cirrhosis of the liver.
    • have kidney problems.
    • have, or have had, 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 alcohol.
    • abuse prescription medicines or street drugs.
    • are pregnant or plan to become pregnant.
    • are breastfeeding. Bupropion hydrochloride extended-release (SR) passes into your milk in small amounts

Tell your healthcare provider about all the medicines you take , including prescription, over-the-counter 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 taking bupropion hydrochloride extended-release tablets (SR).
How should I take bupropion hydrochloride extended-release tablets (SR)?
  • Start bupropion hydrochloride extended-release tablets (SR) before you stop smoking to give bupropion hydrochloride extended-release tablets (SR) time to build up in your body. It takes about 1 week for bupropion hydrochloride extended-release tablets (SR) to start working.
  • Pick a date to stop smoking that is during the second week you are taking bupropion hydrochloride extended‑release tablets (SR).
  • Take bupropion hydrochloride extended-release tablets (SR) exactly as prescribed by your healthcare provider. Do not change your dose or stop taking bupropion hydrochloride extended-release tablets (SR) without talking with your healthcare provider first.
  • Bupropion hydrochloride extended-release tablets (SR) are usually taken for 7 to 12 weeks. Your healthcare provider may decide to prescribe bupropion hydrochloride extended-release tablets (SR) for longer than 12 weeks to help you stop smoking. Follow your healthcare provider’s instructions.
  • Swallow bupropion hydrochloride extended-release tablets (SR) whole. 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. Tell your healthcare provider if you cannot swallow tablets.
  • Bupropion hydrochloride extended-release tablets (SR) may have an odor. This is normal.
  • 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.
  • It is not dangerous to smoke and take bupropion hydrochloride extended-release tablets (SR) at the same time. But, you will lower your chance of breaking your smoking habit if you smoke after the date you set to stop smoking.
  • You may use bupropion hydrochloride extended-release tablets (SR) and nicotine patches (a type of nicotine replacement therapy) at the same time, following the precautions below.
    • You should only use bupropion hydrochloride extended-release tablets (SR) and nicotine patches together under the care of your healthcare provider. Using bupropion hydrochloride extended-release tablets (SR) and nicotine patches together may raise your blood pressure, and sometimes this can be severe.
    • Tell your healthcare provider if you plan to use nicotine patches. Your healthcare provider should check your blood pressure regularly if you use nicotine patches with bupropion hydrochloride extended-release tablets (SR) to help you quit smoking.
  • If you miss a dose, do not take an extra dose to make up for the dose you missed. Wait and take your next dose 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 taking bupropion hydrochloride extended-release tablets (SR) unless your healthcare provider has told you it is okay.
What should I avoid while taking bupropion hydrochloride extended-release tablets (SR)?
  • Limit or avoid using alcohol during treatment with bupropion hydrochloride extended-release tablets (SR). If you usually drink a lot of alcohol, talk with your healthcare provider 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) affects you. Bupropion hydrochloride extended-release tablets (SR) can affect your ability to do these things safely.
What are possible side effects of bupropion hydrochloride extended-release tablets (SR)?

Bupropion hydrochloride extended-release tablets (SR) can cause serious side effects. See the sections at the beginning of this Medication Guide for information about serious side effects of bupropion hydrochloride extended-release tablets (SR).

The most common side effects of bupropion hydrochloride extended-release tablets (SR) include:
  • trouble sleeping
  • feeling anxious
  • stuffy nose
  • nausea
  • dry mouth
  • constipation
  • dizziness
  • joint aches
If you have trouble sleeping, do not take bupropion hydrochloride extended-release tablets (SR) too close to bedtime.

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

These are not all the possible side effects of bupropion hydrochloride extended-release tablets (SR). For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Actavis at 1-888-838-2872.
How should I store bupropion hydrochloride extended-release tablets (SR)?
  • Store bupropion hydrochloride extended-release tablets (SR) at room temperature between 68°F and 77°F (20°C to 25°C).
  • Keep bupropion hydrochloride extended-release tablets (SR) dry and out of the light.

Keep bupropion hydrochloride extended-release tablets (SR) and all medicines out of the reach of children.

General information about the safe and effective use of 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.

If you take a urine drug screening test, bupropion hydrochloride extended-release tablets (SR) may make the test result positive for amphetamines. If you tell the person giving you the drug screening test that you are taking bupropion hydrochloride extended-release tablets (SR), they can do a more specific drug screening test that should not have this problem.

This Medication Guide summarizes important information about bupropion hydrochloride extended-release tablets (SR). If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about bupropion hydrochloride extended-release tablets (SR) that is written for health professionals.

For more information about bupropion hydrochloride extended-release tablets (SR), call 1-888-838-2872.

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.

Brands listed are the trademarks of their respective owners.

Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA

Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA

This Medication Guide has been approved by the U.S. Food and Drug Administration. Rev. B 4/2021

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

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