Bupropion Hydrochloride (Smoking Deterrent), Oral

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KEY POINTS

• This medicine is taken by mouth to help people stop smoking. Take it exactly as directed.
• This medicine may increase suicidal thoughts or actions in some people.
• This medicine may cause unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• You should not take certain other medicines while you are taking this medicine. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: smoking deterrent

Generic and brand names: bupropion hydrochloride, oral; Buproban; Zyban

What is this medicine used for?

This medicine is taken by mouth to help people stop smoking.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Do not take this medicine if you:

• Have ever had a seizure disorder, head injury, stroke, or brain tumor
• Are taking any other medicine that also contains bupropion
• Have or have had an eating disorder such as bulimia or anorexia nervosa
• Are taking an MAO inhibitor (Do not take this medicine and an MAO inhibitor within 14 days of each other.)

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• Diabetes
• Glaucoma
• Heart disease, angina, or a heart attack
• High blood pressure
• Kidney or liver disease
• Mental health problems such as depression, bipolar disorder, or thoughts of suicide
• Problems with alcohol or drug abuse
• Problems with low sodium levels in the blood

Also tell your provider if you drink alcohol or take any other medicines regularly, such as sedatives, stimulants, antianxiety medicines, barbiturates, antiseizure medicines, or weight-loss medicines. The risk of seizures is increased if you stop taking certain medicines suddenly or if you drink a lot of alcohol and suddenly stop.

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I take it?

Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Taking too much may increase the risk of side effects. Do not stop taking this medicine without your healthcare provider's approval.

Check with your healthcare provider before using this medicine in children under age 18.

This medicine is usually started while you are still smoking because you need to take it for 1 week to build an effective level of medicine in your blood. Set a target date to stop smoking (usually within the second week of taking this medicine).

Treatment with this medicine usually lasts for 7 to 12 weeks but may take longer, depending on your response. It is important that you receive counseling and support during treatment and for some time after.

This medicine comes as sustained-release tablets. Do not crush or chew the tablets. Swallow them whole. You may take this medicine with or without food. If you have trouble sleeping, do not take your medicine too close to bedtime. Talk with your healthcare provider about this.

Do not take nicotine replacement medicines without your healthcare provider's approval. Taking this medicine with nicotine replacement medicines may increase your risk of side effects. Do not smoke if you use a nicotine replacement product while taking this medicine. Talk with your healthcare provider about this.

What if I miss a dose?

All doses should be taken 8 hours apart. If you miss a dose, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: dizziness, vomiting, seizures, tremors, hallucinations (seeing or hearing things that are not there), muscle stiffness, fainting, fast or irregular heartbeat, trouble breathing, coma.

What should I watch out for?

Although this medicine is not used to treat depression, it contains the same active ingredient as some other antidepressant medicines. Antidepressant medicines may increase suicidal thoughts or actions, especially in some children, teenagers, and young adults, within the first few months of treatment or at times of dose changes. Also, some people have had changes in behavior, hostility, agitation, depression, suicidal thoughts or actions while taking this medicine to help them quit smoking. Call your healthcare provider right away if you notice: new or increased thoughts of suicide changes in mood or behavior such as becoming irritable or anxious. These symptoms can develop during treatment or after stopping treatment with this medicine. Talk with your healthcare provider about this.

Do not take this medicine if you are also taking Aplenzin, Forfivo XL, Wellbutrin, Wellbutrin XL, or Wellbutrin SR for depression. Also, do not take this medicine if you are also taking bupropion/naltrexone (Contrave) for weight management. They contain the same ingredient, and increase the risk of an overdose or seizures.

Your healthcare provider will want to see you regularly while you are taking this medicine. Keep all appointments.

This medicine may trigger angle-closure glaucoma. Contact your provider right away if you have eye pain, vision changes, or redness and swelling in or around your eye.

When you stop smoking, there may be a change in how certain medicines work for you. Talk to your healthcare provider if you are taking medicine that reduces the chance of blood clots, bronchodilators, or diabetes medicines.

This medicine increases the effects of alcohol and other drugs that slow down your nervous system. Do not drink alcohol or take other medicines unless your healthcare provider approves.

This medicine may make you drowsy or dizzy. Do not drive or operate machinery unless you are fully alert.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine. This medicine may affect the results of certain drug tests.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Seizures, fast or irregular heartbeat, chest pain, trouble breathing, severe dizziness or fainting, thoughts of suicide, changes in mood or behavior, new or worsening depression, hallucinations, confusion, severe headache, tremors, severe drowsiness; severe skin redness, blisters, or peeling; unexplained muscle or joint pain; fever with a rash; eye pain, vision changes, redness or swelling around the eye; yellowing of your skin or eyes, extreme weakness or tiredness; ringing in the ears.

Other: Trouble sleeping, abnormal dreams, dry mouth, mild anxiety, mild dizziness, mild headache, constipation, diarrhea, loss of appetite, mild muscle pain, cough, stuffy or runny nose, stomach pain, nausea, weight changes.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• Amantadine (Symmetrel)
• Amiloride
• Antianxiety medicines such as alprazolam (Xanax), clonazepam (Klonopin), clorazepate (Gen-Xene, Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• Antidepressants such as amitriptyline, citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor), sertraline (Zoloft), trazodone, and venlafaxine (Effexor)
• Antihistamines such as azelastine (Astelin, Astepro), chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), and hydroxyzine (Vistaril)
• Antipsychotic medicines such as aripiprazole (Abilify), chlorpromazine, haloperidol (Haldol), olanzapine (Zyprexa), perphenazine, pimozide (Orap), prochlorperazine (Compro), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), fosphenytoin (Cerebyx), phenytoin (Dilantin, Phenytek), and primidone (Mysoline)
• Atomoxetine (Strattera)
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, and secobarbital (Seconal)
• Beta blockers such as betaxolol, carvedilol (Coreg), metoprolol (Lopressor, Toprol), nebivolol (Bystolic), and pindolol
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Bupropion/naltrexone (Contrave)
• Cancer medicines such as crizotinib (Xalkori), cyclophosphamide (Cytoxan), doxorubicin (Doxil), oxaliplatin (Eloxatin), tamoxifen, and thiotepa
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Dextromethorphan, an ingredient in many cough, cold, or allergy medicines such as Robitussin-DM
• Doxepin (Silenor)
• Eliglustat (Cerdelga)
• Heart medicines such as flecainide, mexiletine, procainamide, and propafenone (Rythmol)
• HIV medicines such as efavirenz (Sustiva), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), nevirapine (Viramune), and ritonavir (Norvir)
• Linezolid (Zyvox)
• Lorcaserin (Belviq)
• Malaria medicines such as artemether/lumefantrine (Coartem), chloroquine, mefloquine, primaquine, and quinine
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines to block or prevent stomach acid such as cimetidine (Tagamet), famotidine (Pepcid), and ranitidine (Zantac)
• Medicines to treat or prevent blood clots such as clopidogrel (Plavix), and warfarin (Coumadin)
• Memantine (Namenda)
• Metformin (Fortamet, Glucophage, Riomet)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), cyclobenzaprine (Amrix), methocarbamol (Robaxin), orphenadrine (Norflex), and tizanidine (Zanaflex)
• Natural remedies such as gotu kola, kava, SAMe, St. John's wort, and valerian
• Other products to help you quit smoking, such as varenicline (Chantix)
• Pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone (Hysingla, Zohydro), hydromorphone (Dilaudid, Exalgo), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), oxycodone/acetaminophen (Percocet, Roxicet), pentazocine (Talwin), tapentadol (Nucynta), and tramadol (ConZip, Ultram)
• Parkinson’s disease medicines such as apomorphine (Apokyn), bromocriptine (Cycloset, Parlodel), levodopa/carbidopa (Duopa, Rytary, Sinemet), pramipexole (Mirapex), and rasagiline (Azilect)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Procarbazine (Matulane)
• Products that contain methylene blue (Hyophen, Prosed DS, Urophen, Uta)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Rifampin (Rifadin)
• Sleeping pills such as flurazepam, temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien, Edluar, Intermezzo)
• Stimulants such as dexmethylphenidate (Focalin), dextroamphetamine (Dexedrine), methamphetamine (Desoxyn), and methylphenidate (Concerta, Daytrana, Metadate, Ritalin)
• Tedizolid (Sivextro)
• Tetrabenazine (Xenazine)
• Theophylline
• Tolterodine (Detrol)

Drinking alcohol while you are taking this medicine may increase its side effects. Ask your healthcare provider about this.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.