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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.
BUPROPION EXTENDED-RELEASE (ANTIDEPRESSANT) - ORAL
(bue-PROE-pee-on)
COMMON BRAND NAME(S): Aplenzin, Wellbutrin XL
WARNING: Bupropion is an antidepressant used to treat a variety of conditions, including depression, other mental/mood disorders, and smoking cessation. Antidepressants can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience new or worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. Therefore, it is very important to talk with the doctor about the risks and benefits of antidepressant medication, even if treatment is not for a mental/mood condition. Tell the doctor immediately if you notice new or worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed. If you are using bupropion to quit smoking, stop taking bupropion and contact your doctor immediately if you experience any of the symptoms listed above or if you have any of these symptoms after stopping treatment.
USES: This medication is used to treat depression. It may also be used to prevent autumn-winter seasonal depression (seasonal affective disorder). This medication can improve your mood and feelings of well-being. It may work by restoring the balance of certain natural chemicals (neurotransmitters) in the brain.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. This medication may also be used to treat attention deficit hyperactivity disorder (ADHD), or to help people quit smoking by decreasing your cravings and nicotine withdrawal effects. It may also be used in combination with other mood stabilizers to treat bipolar disorder (depressive phase).
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 once daily in the morning, with or without food. If nausea occurs, you may take this drug with food. It is important to take your dose at the same time each day, 24 hours apart or as directed by your doctor. Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of serious 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. Since this drug may cause sleeplessness at first, it is best not to take it near bedtime. Your dose may be slowly increased to limit side effects such as sleeplessness, and to decrease the risk of seizures. Do not take more or less medication than prescribed. Taking more than the recommended dose of bupropion will increase your risk of having a seizure. There are 2 forms of extended release bupropion (bupropion hydrochloride and bupropion hydrobromide). The usual maximum dose is 450 milligrams per day of bupropion hydrochloride or 522 milligrams of bupropion hydrobromide. The maximum dose depends on your medical condition and response to treatment. Ask your pharmacist for more details or if you have any questions. Do not stop taking this medication without notifying your doctor. Your dose may need to be gradually decreased. Use this medication regularly in order to get the most benefit from it. It may take 4 weeks or more before the full effects of this medication are noticed. Tell your doctor if your condition does not improve or worsens.
SIDE EFFECTS: See also the Warning section. Dry mouth, sore throat, nausea, vomiting, stomach/abdominal pain, flushing, headache, loss of appetite, constipation, trouble sleeping, increased sweating, strange taste in mouth, joint aches, dizziness, or blurred vision may 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., agitation, anxiety, confusion, hallucinations, nervousness, restlessness), 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.
PRECAUTIONS: See also How to Use and Warning Sections 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: seizures or conditions that increase your risk of seizures (including brain/head injury, brain tumors, arteriovenous malformation, eating disorders such as 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 can cause a higher risk of seizures. Before using this medication, tell your doctor or pharmacist your medical history, especially of: alcohol/drug dependence, diabetes, heart disease, high blood pressure, personal or family history of psychiatric disorder (e.g., bipolar/manic-depressive disorder), personal or family history of suicide thoughts/attempts, kidney problems, liver problems, intention to quit smoking. This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit or avoid consumption of alcoholic beverages. Alcohol can increase your risk of seizures and dizziness. Do not take this medicine with any other product containing bupropion (e.g., drugs to help quit smoking) 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. 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 drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring. To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval. Some products that may interact with this drug include: amantadine, certain x-ray dyes (including iomeprol), levodopa, nicotine products (such as patches, gum, spray), regular use of sedatives (such as alprazolam), stimulants, tamoxifen, warfarin. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication and for two weeks before and after treatment. In some cases a serious (possibly fatal) drug interaction may occur. Other medications can affect the removal of bupropion from your body, which may affect how bupropion works. Examples include cyclophosphamide, orphenadrine, thiotepa, antiplatelet drugs (including clopidogrel, ticlodipine), anti-seizure drugs (such as carbamazepine, phenobarbital, phenytoin), HIV drugs (such as efavirenz, ritonavir), rifamycins (such as rifampin), among others. Bupropion can speed up the removal of other drugs from your body, which may affect how they work. Examples of affected drugs include citalopram, antiarrhythmics (such as propafenone, flecainide), antidepressants (such as desipramine, paroxetine, fluoxetine, sertraline), antipsychotics (such as haloperidol, thioridazine), beta-blockers (such as metoprolol), among others. Also report the use of drugs which might increase seizure risk (decrease seizure threshold) when combined with bupropion such as phenothiazines (e.g., chlorpromazine), tricyclic antidepressants (e.g., amitriptyline), corticosteroids (e.g., prednisone), or theophylline among others. Consult your doctor or pharmacist for details. Large amounts of caffeine or 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/nonprescription/herbal drug labels for caffeine and other stimulants (e.g., ephedra). Consult your doctor or pharmacist. This medication may interfere with certain laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug. This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.
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, loss of consciousness.
NOTES: Psychiatric/medical checkups (and possibly laboratory and/or medical tests such as blood pressure monitoring) must be done periodically to monitor your progress and check for side effects. Consult your doctor for more details. Do not share this medication with others.
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. Taking too much of this medication can increase your chance of having a seizure.
STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59 and 86 degrees F (15-30 degrees C) is permitted. 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.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854- 1166 (USA) or 1-800-668-1507 (Canada).
Information last revised September 2012. Copyright(c) 2012 First Databank, Inc.
Prescription Return Policy
We are prevented by law from accepting returns for any prescription medication. If you need to dispose of any medication, please follow the steps below...
FDA Guidelines on Proper Methods of Disposing of Unused Medicine
For guidelines on proper methods of disposing of unused medicines, consult the following FDA link: www.fda.gov/ForConsumers/ConsumerUpdates/ucm101653.htm
As a general rule of thumb, do not flush prescription drugs down the toilet or drain unless the label or accompanying patient information specifically instructs you to do so. For information on drugs that should be flushed visit the FDA’s website.
To dispose of prescription drugs not labeled to be flushed, you may be able to take advantage of community drug take-back programs or other programs, such as household hazardous waste collection events, that collect drugs at a central location for proper disposal. Call your city or county government’s household trash and recycling service and ask if a drug take-back program is available in your community.
If a drug take-back or collection program is not available:
1. Take your prescription drugs out of their original containers.
2. Mix drugs with an undesirable substance, such as cat litter or used coffee grounds.
3. Put this mixture into a disposable container with a lid, such as an empty margarine tub, or into a sealable bag.
4. Conceal or remove any personal information, including Rx number, on the empty containers by covering it with black permanent marker or duct tape, or by scratching it off.
5. Place the sealed container with the mixture, and the empty drug containers, in the trash.
Shipping Policy
Although we strive to fill your medication as quickly as possible, we are not an urgent facility. Please obtain a local fill of your medication if you have an emergency or urgent needs to ensure no disruption with your medical therapy.
All orders ship from Titusville, FL. We offer 100% FREE shipping on all orders. We ship orders Monday through Friday. We only ship to valid street addresses within the state of Florida. No Post Office boxes.
For all orders, you can expect the following shipping times: 1-2 business days.
Please note that prescription items cannot be shipped until a valid, verified prescription is on file. In addition to the shipping times stated above, please add up to 1-2 business days of processing time to all orders.
Offer to Counsel
If you have any questions regarding this prescription or any other medication, please feel free to contact us at info@atyourdoorpharmacy.com or during store counseling hours (Mon-Fri, 9am-6pm, Eastern) at (407) 476-1721.
Health Insurance Portability & Accountability Act
At Your Door is committed to protecting your privacy. As a healthcare provider, we know that your trust in us is of central importance. This policy discloses our information use and policies and procedures in detail. Please read it to learn more about the ways we protect the information we collect and to find out how you can limit the information about you that is shared. If At Your Door should change its information practices, we will provide you notice of any material changes.
Strict Security Measures
At Your Door takes the security of information very seriously and has established security standards and procedures to prevent unauthorized access to patient information. We maintain physical, electronic, and procedural safeguards to comply with federal standards to guard patient information.
The following are ways AtYourDoorPharmacy.com will use and disclosure your Personal Health Information (PHI). Every allowable use or disclosure may not be listed:
For Treatment AtYourDoorPharmacy.com will use and disclose PHI to coordinate and manage your healthcare in order to dispense your prescription medication.
For Payment AtYourDoorPharmacy.com will use and disclose PHI to receive payment for our services. We may disclose your PHI to other HIPAA covered entities or business associates who may need it for their processing of your healthcare payments.
For Healthcare Operations AtYourDoorPharmacy.com will use and disclose PHI for administrative purposes to evaluate and improve the quality of care we provide you.
We may also use or disclose PHI for the following purposes
Business associates AtYourDoorPharmacy.com may provide some services through contracts with HIPAA compliant business associates. The business associates must enter into a confidentiality agreement to protect your PHI from unauthorized use and disclosure.
Communication with individuals involved in your care If you do not object, AtYourDoorPharmacy.com may disclose PHI to a friend or family member who is involved in your care.
Parents or legal guardians If you are a minor, we may release your PHI to your parents or legal guardians when we are permitted or required to do so under federal and applicable state law.
Health related communications AtYourDoorPharmacy.com may contact you to provide refill reminders or other health-related services that may be of interest to you as permitted by law.
As required by law We may disclose PHI when required to do so by federal, state or local law.
Law enforcement We may disclose PHI for law enforcement purposes, in response to a subpoena or other legal process.
Public Health As required by law, we may disclose PHI about you to public health authorities to prevent or control a serious threat to the health and safety of another person. We may also disclose PHI for the purpose of reporting adverse events and product recalls
Health Oversight Activities We may disclose PHI to an oversight agency for activities authorized by law. These activities would include pharmacy investigations, audits, credentialing and inspections required for our licensure. These are governmental agencies who monitor the health care system who are subject to government regulation and civil right laws.
Judicial and administrative proceedings We may disclose your PHI in response to a subpoena, court or administrative order, or other lawful process, but only if efforts were made to notify you about the request or to obtain an order protecting the requested PHI as required by law.
Coroners, medical examiners, and funeral directors We may disclose PHI to a coroner or medical examiner. This may be necessary to identify a deceased person or determine the cause of death. We may also disclose PHI to funeral directors as necessary with applicable laws so they may carry out their duties.
Organ, eye and tissue donation We may disclose PHI, consistent with applicable law to organizations who engage in organ procurement or transplant to facilitate the donation.
Research Under certain circumstances, we may disclose PHI for research purposes. Before disclosing PHI we would either remove information that personally identifies you or obtain your written authorization.
Military and Veterans Under certain circumstances, we may disclose to military authorities PHI or armed forces personnel.
National Security We may disclose PHI to authorized federal officials for intelligence, counterintelligence, and other national security activities authorized by law.
Correctional Institution We may disclose PHI of an inmate to the institution when necessary for your health or the health and safety of others.
Workers’ compensation We may disclose your PHI to comply with Workers’ Compensation Laws or other similar programs.
Individual Rights
In most cases, you have the right to look at or get a copy of health information about you that we use to make decisions about your care. You also have the right to receive a list of instances where we have disclosed health information about you for reasons other than treatment, payment, or related administrative purposes. If you believe that information in your record is incorrect or if important information is missing, you have the right to request that we correct or add the missing information. We will take precautions to prevent inappropriate or non-essential use or distribution of patient information when transmitted via the Internet and while the pharmacy possesses such information. You may request in writing that we not use or disclose your information for treatment payment and administrative purposes except when specifically authorized by you, when required by law, or in emergencies. We will consider your request but are not legally required to accept it.
Other Uses and Disclosures of your PHI
We are required by law to protect the privacy of your information, provide this notice of our information practices, and follow the information practices described in this notice. AtYourDoorPharmacy.com will request written authorization from you before using or disclosing your PHI for purposes not included in this document or as otherwise permitted or required by law. If you provide authorization and want to revoke this authorization at any time, or have any questions or complaints, this can be done in writing at any time by sending a written request to:
Atyourdoorpharmacy.com
Attn: Privacy Officer
100 E. Pine St.Suite 110
Orlando, FL
You may also call if you have any questions or complaints, please contact AtYourDoorPharmacy.com at (407) 476-1727
This revocation will not affect any use or disclosure of your PHI allowed by your authorization while it was in effect.