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BUDEPRION- bupropion hydrochloride tablet, extended release


  1. Patient Information
  2. Important: Be Sure To Read The Three Sections Of This Medication Guide. The First Section Is About The Risk Of Suicidal Thoughts And Actions With Antidepressant Medicines; The Second Section Is About The Risk Of Changes In Thinking And Behavior, Depression And Suicidal Thoughts Or Actions With Medicines Used To Quit Smoking; And The Third Section Is Entitled What Other Important Information Should I Know About Bupropion Hydrochloride Extended-release Tablets (xl)?
  3. This Section Of The Medication Guide Is Only About The Risk Of Suicidal Thoughts And Actions With Antidepressant Medicines.talk To Your Doctor Or Your Family Member S Healthcare Provider About:
  4. What Is The Most Important Information I Should Know About Antidepressant Medicines, Depression And Other Serious Mental Illnesses, And Suicidal Thoughts Or Actions?
  5. How Can I Watch For And Try To Prevent Suicidal Thoughts And Actions In Myself Or A Family Member?
  6. Call A Healthcare Provider Right Away If You Or Your Family Member Has Any Of The Following Symptoms, Especially If They Are New, Worse, Or Worry You:
  7. What Else Do I Need To Know About Antidepressant Medicines?
  8. If You, Your Family Member, Or Your Caregiver Notice Agitation, Hostility, Depression Or Changes In Thinking Or Behavior That Are Not Typical For You, Or You Have Any Of The Following Symptoms, Stop Taking Bupropion And Call Your Healthcare Provider Right Away:
  9. Seizures: There Is A Chance Of Having A Seizure (convulsion, Fit) With Bupropion Hydrochloride Extended-release Tablets (xl), Especially In People:
  10. Who Should Not Take Bupropion Hydrochloride Extended-release Tablets (xl)? Do Not Take Bupropion Hydrochloride Extended-release Tablets (xl) If You:
  11. What Should I Avoid While Taking Bupropion Hydrochloride Extended-release Tablets (xl)?
  12. What Are Possible Side Effects Of Bupropion Hydrochloride Extended-release Tablets (xl)?
  13. How Should I Store Bupropion Hydrochloride Extended-release Tablets (xl)?
  14. What Are The Ingredients In Bupropion Hydrochloride Extended-release Tablets (xl)?
  15. Manufactured By:
  16. Manufactured For:
  17. Revised: 1/2013document Id:

Patient Information 

BUDEPRION XL

(buPROPion hydrochloride extended-release tablets USP (XL))

Read this Medication Guide carefully before you start using bupropion hydrochloride extended-release tablets (XL) and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about bupropion hydrochloride extended-release tablets (XL), ask your doctor or pharmacist.

Important: Be Sure To Read The Three Sections Of This Medication Guide. The First Section Is About The Risk Of Suicidal Thoughts And Actions With Antidepressant Medicines; The Second Section Is About The Risk Of Changes In Thinking And Behavior, Depression And Suicidal Thoughts Or Actions With Medicines Used To Quit Smoking; And The Third Section Is Entitled What Other Important Information Should I Know About Bupropion Hydrochloride Extended-release Tablets (xl)? 

Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions

This Section Of The Medication Guide Is Only About The Risk Of Suicidal Thoughts And Actions With Antidepressant Medicines.talk To Your Doctor Or Your Family Member S Healthcare Provider About: 

  • all risks and benefits of treatment with antidepressant medicines
  • all treatment choices for depression or other serious mental illness

What Is The Most Important Information I Should Know About Antidepressant Medicines, Depression And Other Serious Mental Illnesses, And Suicidal Thoughts Or Actions? 

  1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
  2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions.These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.

How Can I Watch For And Try To Prevent Suicidal Thoughts And Actions In Myself Or A Family Member? 

  • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
  • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
  • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

Call A Healthcare Provider Right Away If You Or Your Family Member Has Any Of The Following Symptoms, Especially If They Are New, Worse, Or Worry You: 

thoughts about suicide or dyingtrouble sleeping (insomnia)
attempts to commit suicidenew or worse irritability
new or worse depressionacting aggressive, being angry, or violent
new or worse anxietyacting on dangerous impulses
feeling very agitated or restlessan extreme increase in activity and talking (mania)
panic attacksother unusual changes in behavior or mood

What Else Do I Need To Know About Antidepressant Medicines? 

  • Never stop an antidepressant medicine without first talking to a healthcare provider.Stopping an antidepressant medicine suddenly can cause other symptoms.
  • Antidepressants are medicines used to treat depression and other illnesses.It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
  • Antidepressant medicines have other side effects.Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
  • Antidepressant medicines can interact with other medicines.Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
  • Not all antidepressant medicines prescribed for children are FDA approved for use in children.Talk to your child s healthcare provider for more information.

Bupropion hydrochloride extended-release tablets (XL) have not been studied in children under the age of 18 and are not approved for use in children and teenagers.

Quitting Smoking, Quit-Smoking Medications, Changes in Thinking and Behavior, Depression, and Suicidal Thoughts or Actions

This section of the Medication Guide is only about the risk of changes in thinking and behavior, depression and suicidal thoughts or actions with drugs used to quit smoking.

Although bupropion hydrochloride extended-release tablets (XL) are not a treatment for quitting smoking, it contains the same active ingredient (bupropion hydrochloride) as ZYBAN*which is used to help patients quit smoking.

Some people have had changes in behavior, hostility, agitation, depression, suicidal thoughts or actions while taking bupropion to help them quit smoking. These symptoms can develop during treatment with bupropion or after stopping treatment with bupropion.

If You, Your Family Member, Or Your Caregiver Notice Agitation, Hostility, Depression Or Changes In Thinking Or Behavior That Are Not Typical For You, Or You Have Any Of The Following Symptoms, Stop Taking Bupropion And Call Your Healthcare Provider Right Away: 

thoughts about suicide or dyingan extreme increase in activity and talking (mania)
attempts to commit suicideabnormal thoughts or sensations
new or worse depression

Seizures: There Is A Chance Of Having A Seizure (convulsion, Fit) With Bupropion Hydrochloride Extended-release Tablets (xl), Especially In People: 

  • with certain medical problems.
  • who take certain medicines.

The chance of having seizures increases with higher doses of bupropion hydrochloride extended-release tablets (XL). For more information,

Bupropion hydrochloride extended-release tablets (XL) are a prescription medicine used to treat adults with a certain type of depression called major depressive disorder and for prevention of autumn-winter seasonal depression (seasonal affective disorder).

Who Should Not Take Bupropion Hydrochloride Extended-release Tablets (xl)? Do Not Take Bupropion Hydrochloride Extended-release Tablets (xl) If You: 

  • have or had a seizure disorder or epilepsy.
  • are taking ZYBAN*(used to help people stop smoking) or any other medicines that contain bupropion hydrochloride, such as WELLBUTRIN*(bupropion hydrochloride tablets) or WELLBUTRIN SR(bupropion hydrochloride extended-release tablets (SR)).Bupropion is the same active ingredient that is in bupropion hydrochloride extended-release tablets (XL).
  • drink a lot of alcohol and abruptly stop drinking, or use medicines called sedatives (these make you sleepy) or benzodiazepines and you stop using them all of a sudden.
  • have taken within the last 14 days medicine for depression called a monoamine oxidase inhibitor (MAOI), such as NARDIL*(phenelzine sulfate), PARNATE*(tranylcypromine sulfate), or MARPLAN*(isocarboxazid).
  • have or had an eating disorder such as anorexia nervosa or bulimia.
  • are allergic to the active ingredient in bupropion hydrochloride extended-release tablets (XL), bupropion, or to any of the inactive ingredients.

    • Tell your doctor if you have ever had depression, suicidal thoughts or actions, or other mental health problems.

      • Take bupropion hydrochloride extended-release tablets (XL) exactly as prescribed by your doctor.
      • Do not chew, cut, or crush bupropion hydrochloride extended-release tablets (XL).If you do, the medicine will be released into your body too quickly. If this happens you may be more likely to get side effects including seizures. You must swallow the tablets whole.Tell your doctor if you cannot swallow medicine tablets.
      • Take bupropion hydrochloride extended-release tablets (XL) at the same time each day.
      • Take your doses of bupropion hydrochloride extended-release tablets (XL) at least 24 hours apart.
      • You may take bupropion hydrochloride extended-release tablets (XL) with or without food.
      • If you miss a dose, do not take an extra tablet to make up for the dose you forgot. Wait and take your next tablet at the regular time.This is very important.Too much bupropion hydrochloride extended-release tablets (XL) can increase your chance of having a seizure.
      • If you take too much bupropion hydrochloride extended-release tablets (XL), or overdose, call your local emergency room or poison control center right away.
      • The bupropion hydrochloride extended-release tablet (XL) is covered by a shell that slowly releases the medicine inside your body. You may notice something in your stool that looks like a tablet. This is normal. This is the empty shell passing from your body.
      • Do not take any other medicines while using bupropion hydrochloride extended-release tablets (XL) unless your doctor has told you it is okay.
      • If you are taking bupropion hydrochloride extended-release tablets (XL) for the treatment of major depressive disorder, it may take several weeks for you to feel that bupropion hydrochloride extended-release tablets (XL) are working. Once you feel better, it is important to keep taking bupropion hydrochloride extended-release tablets (XL) exactly as directed by your doctor. Call your doctor if you do not feel bupropion hydrochloride extended-release tablets (XL) are working for you.
      • If you are taking bupropion hydrochloride extended-release tablets (XL) for the prevention of seasonal major depressive episodes associated with seasonal affective disorder, it is important to keep taking bupropion hydrochloride extended-release tablets (XL) through the autumn-winter season, or as directed by your doctor.
      • Do not change your dose or stop taking bupropion hydrochloride extended-release tablets (XL) without talking with your doctor first.

What Should I Avoid While Taking Bupropion Hydrochloride Extended-release Tablets (xl)? 

  • Do not drink a lot of alcohol while taking bupropion hydrochloride extended-release tablets (XL). If you usually drink a lot of alcohol, talk with your doctor before suddenly stopping. If you suddenly stop drinking alcohol, you may increase your chance of having seizures.
  • Do not drive a car or use heavy machinery until you know how bupropion hydrochloride extended-release tablets (XL) affect you. Bupropion hydrochloride extended-release tablets (XL) can impair your ability to perform these tasks.

What Are Possible Side Effects Of Bupropion Hydrochloride Extended-release Tablets (xl)? 

Bupropion hydrochloride extended-release tablets (XL) can cause serious side effects. Read this entire Medication Guide for more information about these serious side effects.

Common side effects reported in studies of major depressive disorder include weight loss, loss of appetite, dry mouth, skin rash, sweating, ringing in the ears, shakiness, stomach pain, agitation, anxiety, dizziness, trouble sleeping, muscle pain, nausea, fast heartbeat, sore throat, and urinating more often. In studies of seasonal affective disorder, common side effects included weight loss, constipation, and gas.

If you have nausea, take your medicine with food. If you have trouble sleeping, do not take your medicine too close to bedtime.

These are not all the side effects of bupropion hydrochloride extended-release tablets (XL). For a complete list, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or TEVA PHARMACEUTICALS USA at 1-888-838-2872, X6351.

How Should I Store Bupropion Hydrochloride Extended-release Tablets (xl)? 

  • Store bupropion hydrochloride extended-release tablets (XL) at room temperature. Store out of direct sunlight. Keep bupropion hydrochloride extended-release tablets (XL) in its tightly closed bottle.
  • Bupropion hydrochloride extended-release tablets (XL) may have an odor.

General Information about bupropion hydrochloride extended-release tablets (XL).

  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use bupropion hydrochloride extended-release tablets (XL) for a condition for which it was not prescribed. Do not give bupropion hydrochloride extended-release tablets (XL) to other people, even if they have the same symptoms you have. It may harm them. Keep bupropion hydrochloride extended-release tablets (XL) out of the reach of children.

This Medication Guide summarizes important information about bupropion hydrochloride extended-release tablets (XL). For more information, talk with your doctor. You can ask your doctor or pharmacist for information about bupropion hydrochloride extended-release tablets (XL) that is written for health professionals or call 1-888-838-2872, MEDICAL AFFAIRS.

What Are The Ingredients In Bupropion Hydrochloride Extended-release Tablets (xl)? 

Active ingredient: bupropion hydrochloride.

Inactive ingredients: dehydrated alcohol, ethylcellulose, hydrochloric acid, hydroxypropylcellulose, methacrylic acid copolymer, povidone, silicon dioxide, hydrogenated vegetable oil and ethyl alcohol. The tablets are printed with edible black ink.

*The following are registered trademarks of their respective manufacturers: WELLBUTRINand WELLBUTRIN XL/GlaxoSmithKline; ZYBAN/GlaxoSmithKline; PARNATE/ GlaxoSmithKline; NARDIL/Warner Lambert Company; MARPLAN/ Validus Pharmaceuticals LLC; KALETRA/Abbott Laboratories.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Rx only

Manufactured By: 

ANCHEN PHARMACEUTICALS, INC.

Irvine, CA 92618

Manufactured For: 

TEVA PHARMACEUTICALS USA

Sellersville, PA 18960

Rev. E 6/2010

06/10

Bupropion HCL XL 150mg Tablet

Label
BUDEPRION
bupropion hydrochloride tablet, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63629-3762(NDC:0093-5350)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BUPROPION HYDROCHLORIDE(UNII: ZG7E5POY8O) (BUPROPION - UNII:01ZG3TPX31)BUPROPION HYDROCHLORIDE150 mg
Inactive Ingredients
Ingredient NameStrength
ALCOHOL(UNII: 3K9958V90M)
ETHYLCELLULOSES(UNII: 7Z8S9VYZ4B)
HYDROCHLORIC ACID(UNII: QTT17582CB)
HYDROXYPROPYL CELLULOSE(UNII: RFW2ET671P)
POVIDONES(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
Product Characteristics
ColorWHITE (white to off-white)Scoreno score
ShapeROUNDSize7mm
FlavorImprint CodeA101
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63629-3762-190 in 1 BOTTLE
2NDC:63629-3762-230 in 1 BOTTLE
3NDC:63629-3762-328 in 1 BOTTLE
4NDC:63629-3762-460 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07728405/30/2008
Labeler -Bryant Ranch Prepack (171714327)
Registrant -Bryant Ranch Prepack (171714327)
Establishment
NameAddressID/FEIBusiness Operations
Bryant Ranch Prepack171714327REPACK(63629-3762) , RELABEL(63629-3762)

Revised: 1/2013document Id: 

45fa1a0a-5ee3-4cc2-b2cc-d7c12bed54a2Set id: 34743e9d-b87b-4158-8424-eaeb31ae85d5Version: 1000Effective Time: 20130118Bryant Ranch Prepack



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