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|Wellbutrin XL Extended-Release Tablets

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Wellbutrin XL Extended-Release Tablets

Generic Name: Bupropion Extended-Release Tablets (bue-PROE-pee-on)
Brand Name: Wellbutrin XL

Antidepressants may increase the risk of suicidal thoughts or actions in children and teenagers. The risk may be greater during the first few months that patients take Wellbutrin XL Extended-Release Tablets. Be sure that the benefits of using Wellbutrin XL Extended-Release Tablets outweigh the risks. Talk with the patient"s doctor if you have any questions.

Family and caregivers must closely observe patients who take Wellbutrin XL Extended-Release Tablets. It is important to keep in close contact with the patient"s doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior.

Wellbutrin XL Extended-Release Tablets is used for:

Treating depression and seasonal affective disorder (SAD). It may also be used for other conditions as determined by your doctor.

Wellbutrin XL Extended-Release Tablets is an antidepressant. It works in the brain to treat depression. Exactly how it works is not known.

Do NOT use Wellbutrin XL Extended-Release Tablets if:

you are allergic to any ingredient in Wellbutrin XL Extended-Release Tablets
you are taking any other medicine that contains bupropion
you have a history of an eating disorder (eg, anorexia, bulimia) or seizures (eg, epilepsy)
you are suddenly stopping the use of alcohol or sedatives (eg, benzodiazepines) after long-term use
you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using Wellbutrin XL Extended-Release Tablets:

Some medical conditions may interact with Wellbutrin XL Extended-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you or a family member has a history of bipolar disorder (manic depression), other mental or mood problems (eg, depression), suicidal thoughts or attempts, or alcohol or substance abuse
if you have diabetes, kidney problems, high blood pressure, heart problems (eg, congestive heart failure), or a recent heart attack
if you have a history of seizure, head injury, tumor in the brain or spinal cord, or liver problems (eg, cirrhosis)

Some MEDICINES MAY INTERACT with Wellbutrin XL Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Amantadine, antipsychotics (eg, haloperidol, risperidone), corticosteroids (eg, prednisone), insulin, levodopa, MAOIs (eg, phenelzine), nicotine patches, oral hypoglycemics (eg, glipizide), other antidepressants (eg, fluoxetine, amitriptyline), sympathomimetics (eg, pseudoephedrine), theophylline, or tiagabine because they may increase the risk of Wellbutrin XL Extended-Release Tablets"s side effects
Carbamazepine, phenobarbital, or phenytoin because they may decrease Wellbutrin XL Extended-Release Tablets"s effectiveness
Antiarrhythmics (eg, propafenone, flecainide), beta-blockers (eg, metoprolol), phenothiazines (eg, thioridazine), selective serotonin reuptake inhibitor (SSRI) antidepressants (eg, fluoxetine), or tricyclic antidepressants (eg, nortriptyline) because the risk of their side effects may be increased by Wellbutrin XL Extended-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Wellbutrin XL Extended-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Wellbutrin XL Extended-Release Tablets:

Use Wellbutrin XL Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Wellbutrin XL Extended-Release Tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Wellbutrin XL Extended-Release Tablets refilled.
Take Wellbutrin XL Extended-Release Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
Swallow Wellbutrin XL Extended-Release Tablets whole. Do not break, crush, or chew before swallowing.
Several weeks may pass before your symptoms improve. Do not stop taking Wellbutrin XL Extended-Release Tablets without checking with your doctor.
Take your doses at the same times each day at least 6 hours apart unless directed otherwise by your doctor. This may help to decrease the risk of seizures with Wellbutrin XL Extended-Release Tablets.
Continue to take Wellbutrin XL Extended-Release Tablets even if you feel well. Do not miss any doses.
If you miss a dose of Wellbutrin XL Extended-Release Tablets, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Wellbutrin XL Extended-Release Tablets.

Important safety information:

Wellbutrin XL Extended-Release Tablets may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Wellbutrin XL Extended-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are taking Wellbutrin XL Extended-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
Wellbutrin XL Extended-Release Tablets may increase your risk of seizures. Your risk may be greater if you also have certain medical conditions, use certain medicines, or if you drink large amounts of alcohol. Talk to your doctor to see if you may have a greater risk of seizures while taking Wellbutrin XL Extended-Release Tablets.
If you already drink alcohol or use sedatives, do not suddenly stop them without first checking with your doctor. Suddenly stopping them may increase your seizure risk.
Do not take decongestants (eg, pseudoephedrine), stimulants, or diet pills while you are taking Wellbutrin XL Extended-Release Tablets without first checking with your doctor. They may increase your risk of seizures.
The risk of seizures may be greater if you take Wellbutrin XL Extended-Release Tablets in high doses or for a long time. Do NOT take more than the recommended dose, change your dose, or use Wellbutrin XL Extended-Release Tablets for longer than prescribed without checking with your doctor.
Children and teenagers who take Wellbutrin XL Extended-Release Tablets may be at increased risk for suicidal thoughts or actions. Adults may also be affected. The risk may be greater in patients who have had suicidal thoughts or actions in the past. The risk may also be greater in patients who have had bipolar (manic-depressive) illness, or if their family members have had it. Watch patients who take Wellbutrin XL Extended-Release Tablets closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
You may notice the tablet shell in your stool. This is normal and not a cause for concern.
If you have trouble sleeping, you may be taking your dose too close to bedtime. Talk with your doctor about changing your dosing schedule.
Wellbutrin XL Extended-Release Tablets contains the same ingredients as Zyban, a medicine used to help stop smoking. Do not take Wellbutrin XL Extended-Release Tablets if you are also taking Zyban. Discuss any questions or concerns with your doctor.
Use Wellbutrin XL Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects.
Wellbutrin XL Extended-Release Tablets should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Wellbutrin XL Extended-Release Tablets while you are pregnant. Wellbutrin XL Extended-Release Tablets is found in breast milk. Do not breast-feed while taking Wellbutrin XL Extended-Release Tablets.

Possible side effects of Wellbutrin XL Extended-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Agitation; anxiety; constipation; dizziness; drowsiness; dry mouth; flushing; gas; headache; increased sweating; increased urination; loss of appetite; nausea; nervousness; restlessness; stomach pain; taste changes; trouble sleeping; vomiting; weakness; weight changes.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or other vision changes; chest pain; confusion; changes in sexual desire or ability; delusions; fainting; fast or irregular heartbeat; fever, chills, or sore throat; hallucinations; hearing problems; joint or muscle pain; menstrual changes; new or worsening concentration problems, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well-being, inability to sit still, or other unusual or severe mental or mood changes; red, swollen, blistered, or peeling skin; seizures; severe headache or dizziness; severe or persistent anxiety, agitation, restlessness, or trouble sleeping; shortness of breath; suicidal thoughts or attempts; tremor; unusual swelling; worsening depression.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include chest pain; fast, slow, or irregular heartbeat; fever; hallucinations; loss of consciousness; rigid or painful muscles; seizures; severe dizziness; slow or difficult breathing.

Proper storage of Wellbutrin XL Extended-Release Tablets:

Store Wellbutrin XL Extended-Release Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tight, light-resistant container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep this medicine out of the reach of children and away from pets.

General information:

If you have any questions about Wellbutrin XL Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
Wellbutrin XL Extended-Release Tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Wellbutrin XL Extended-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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