Zyban

• Product Info
• Patient Info
• Prescribing Info

Important Patient Information

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

USES: This medication is used in combination with a stop-smoking program (e.g., support group, counseling) to help you quit smoking. Bupropion can decrease your nicotine withdrawal symptoms (e.g., irritability, anxiety, restlessness) and your urge to smoke. Quitting smoking decreases your risk of heart and lung disease, as well as cancer. This medication belongs to a class of medications known as antidepressants. It is not known exactly how bupropion works to reduce smoking urges. It may work by restoring the balance of certain natural chemicals (neurotransmitters) in the brain.

HOW TO USE: Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using bupropion and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist. Take this medication by mouth, usually twice daily with or without food. If stomach upset occurs, take with food. It is important to take your doses at least 8 hours apart or as directed by your doctor to decrease your risk of seizure. You may have trouble sleeping when you start taking this drug. Do not take your evening dose too close to bedtime. Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects, including seizures. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing. Your dosage is based on your medical condition and response to therapy. Your dose may be slowly increased to limit side effects. Do not take more or less medication than prescribed. Do not take more than 150 milligrams in a single dose. Do not take more than 300 milligrams per day. Taking more than the recommended dose of this medication may increase your risk of having a seizure. It is recommended that you do not try to quit smoking until you have been taking bupropion for 1 week so that the drug can reach a high enough level in your blood. Set a date for quitting, and stop smoking sometime in the second week of taking the drug. If necessary, this medication may be combined with nicotine patches or gum to help you quit smoking. Ask your doctor for more information. The combination of nicotine and this medication may increase your blood pressure. Your doctor may need to monitor your blood pressure closely. Do not smoke at any time if using any nicotine products with this drug. Too much nicotine can cause serious side effects. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day. Tell your doctor if you are not able to stop smoking after 7 to 12 weeks on this medication.

SIDE EFFECTS: Dry mouth and trouble sleeping may occur as your body gets used to the drug. Dizziness, drowsiness, nausea, diarrhea, fatigue, constipation, blurred vision, increased sweating, strange taste in mouth, or stomach pain may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: chest pain, fainting, fast/pounding heartbeat, irregular heartbeat, mental/mood changes (e.g., anxiety, agitation, confusion), muscle aches, ringing in the ears, severe headache, uncontrolled movements (tremor), unusual weight loss or gain. Tell your doctor immediately if any of these rare but very serious side effects occur: muscle pain/tenderness/weakness, change in the amount of urine. This drug may rarely cause seizures. Seek immediate medical attention if you experience a seizure. If you have a seizure while taking bupropion, you should not take this drug again. A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. An empty tablet shell may appear in your stool. This is harmless. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: See also the How to Use and Warnings section. Before taking bupropion, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have or have had: seizures, eating disorders (e.g., bulimia, anorexia nervosa). This medication should not be used if you are suddenly stopping regular use of sedatives (e.g., benzodiazepines such as lorazepam) or alcohol, which may increase your risk of seizures. Before using this medication, tell your doctor or pharmacist your medical history, especially of: alcohol/drug dependence, brain tumor, diabetes, head injury, heart disease (e.g., congestive heart failure, recent heart attack), high blood pressure, kidney problems, liver problems (e.g., cirrhosis), mental/mood disorders (e.g., bipolar disorder, thoughts of suicide). This drug may make you dizzy, drowsy, or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit or avoid alcoholic beverages. Alcohol can increase your risk of dizziness or seizures. Do not take this medicine with any other product that contains bupropion (e.g., antidepressants) since large doses of bupropion are more likely to cause seizures. Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be more sensitive to this drug and to side effects. This medication should be used only when clearly needed during pregnancy. Behavioral therapy and stop-smoking education is preferred for pregnant women who desire to stop smoking. Discuss the risks and benefits with your doctor. Infrequently, newborns whose mothers have used certain newer antidepressants during the last 3 months of pregnancy may develop symptoms including persistent feeding or breathing difficulties, jitteriness, seizures or constant crying. Promptly report any such symptoms to the doctor. However, do not stop taking this medication unless your doctor directs you to do so. This medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first. This drug should not be used with the following medications because very serious interactions may occur: certain x-ray dyes such as iomeprol, sibutramine, thioridazine. If you are currently using any of these medications, tell your doctor or pharmacist before starting bupropion. Avoid taking MAO inhibitors (e.g., furazolidone, isocarboxazid, linezolid, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment and for 2 weeks before and after treatment with this medication. In some cases a serious, possibly fatal, drug interaction may occur. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: amantadine, diabetes medications (e.g., glipizide, glyburide, insulin), HIV drugs (e.g., efavirenz, nelfinavir, ritonavir), levodopa, regular use of sedatives (e.g., benzodiazepines such as lorazepam), stimulants (e.g., amphetamine, cocaine, "ecstasy," ephedrine), warfarin. Also tell your doctor if you are taking any drugs which are affected by certain liver enzymes such as antidepressants (e.g., desipramine, paroxetine, fluoxetine), antipsychotics (e.g., haloperidol), beta-blockers (e.g., metoprolol), antiarrhythmics (e.g., propafenone, flecainide), orphenadrine, thiotepa, cyclophosphamide, carbamazepine, phenobarbital, or phenytoin, among others. Also report the use of drugs which might increase seizure risk (decrease seizure threshold) when combined with bupropion such as corticosteroids (e.g., prednisone), phenothiazines (e.g., chlorpromazine), theophylline, or tricyclic antidepressants (e.g., amitriptyline) among others. Consult your doctor or pharmacist for details Large amounts of caffeine and other stimulants, such as those found in weight loss and cold/sinus medications, can increase the chance of seizures with this drug. Check all prescription and nonprescription/herbal product labels for caffeine and other stimulants (e.g., ephedra). Consult your doctor or pharmacist for more information. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include: seizures, severe confusion, hallucinations, rapid heart rate, and loss of consciousness.

MISSED DOSE: If you miss a dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store the US product at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Store the Canadian product at room temperature between 59-77 degrees F (15-25 degrees C) away from light and moisture. Bupropion tablets may have a strange odor. This is normal, and the medication is still safe to use. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.