Aplenzin (Bupropion Hydrobromide)

Take APLENZIN exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Too much of this medicine can increase your risk of a seizure.

Do not crush, chew, or break an extended-release APLENZIN tablet. Swallow the tablet whole.

You should not change your dose or stop using APLENZIN suddenly, unless you have a seizure while taking this medicine. Stopping suddenly can cause unpleasant withdrawal symptoms.

Do not stop using APLENZIN suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using bupropion.

This medicine can cause you to have a false positive drug screening test. If you provide a urine sample for drug screening, tell the laboratory staff that you are taking bupropion.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of bupropion can be fatal. Overdose symptoms may include muscle stiffness, hallucinations, fast or uneven heartbeat, shallow breathing, or fainting.

What should I avoid while taking APLENZIN?

Drinking alcohol with bupropion may increase your risk of seizures. If you drink alcohol regularly, talk with your doctor before changing the amount you drink. APLENZIN can also cause seizures in people who drink a lot of alcohol and then suddenly quit drinking when they start using the medication.

APLENZIN may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Get emergency medical help if you have any of these signs of an allergic reaction to APLENZIN: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

• mood or behavior changes, unusual thoughts or feelings;
• feeling anxious, restless, or depressed;
• agitation, hostility, aggression;
• impulsive or risk-taking behavior;
• confusion, paranoia, hallucinations, panic; or
• thoughts about suicide or hurting yourself.

Report any new or worsening symptoms to your doctor.

Call your doctor at once if you have:

• a seizure (convulsions);
• a manic episode- racing thoughts, increased energy, reckless behavior, feeling extremely happy or irritable, talking more than usual, severe problems with sleep;
• blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• fast heartbeats;
• severe skin reactionfever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common APLENZIN side effects may include:

• dry mouth, nausea, stomach pain;
• headache, dizziness, ringing in your ears;
• vision changes;
• loss of interest in sex;
• sore throat, muscle pain;
• mild itching or skin rash, increased sweating, increased urination; or
• changes in appetite, weight loss or gain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You should not take APLENZIN if you have seizures, an eating disorder, or if you have suddenly stopped using alcohol, seizure medication, or sedatives. If you take APLENZIN for depression, do not also take Zyban to quit smoking.

Do not use bupropion if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

APLENZIN may cause seizures, especially in people with certain medical conditions or when using certain drugs. Tell your doctor about all of your medical conditions and the drugs you use.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor will need to check your progress at regular visits while you are using APLENZIN. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Before taking this medicine

Do not use APLENZIN if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

You should not take APLENZIN if you are allergic to bupropion, or if you have:

• epilepsy or a seizure disorder;
• an eating disorder such as anorexia or bulimia; or
• if you have suddenly stopped using alcohol, seizure medication, or a sedative (Valium, Nembutal, Seconal, Solfoton, and others).

APLENZIN may cause seizures, especially in people with certain medical conditions. Tell your doctor about all of your medical conditions.

Do not take APLENZIN to treat more than one condition at a time. If you take APLENZIN for depression, do not also take Zyban to quit smoking.

To make sure APLENZIN is safe for you, tell your doctor if you have:

• a history of head injury, seizures, or brain or spinal cord tumor;
• narrow-angle glaucoma;
• heart disease, high blood pressure, history of heart attack;
• diabetes;
• kidney or liver disease (especially cirrhosis); or
• bipolar disorder (manic depression).

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor will need to check your progress at regular visits while you are using APLENZIN. Your family or other caregivers should also be alert to changes in your mood or symptoms.

FDA pregnancy category C. It is not known whether APLENZIN will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

You may have a higher risk of seizures if you use certain other medicines while taking APLENZIN.

Many drugs can interact with bupropion. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with APLENZIN. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

In addition to its needed effects, some unwanted effects may be caused by bupropion (the active ingredient contained in APLENZIN). In the event that any of these side effects do occur, they may require medical attention.