WELLBUTRIN XL 150 & 300 mg (bupropion hydrochloride) Extended Release Tablets, USP

WELLBUTRIN XL is a Once Daily medication and should not be confused with other bupropion formulations.

This information is Part III of a three-part “Product Monograph” published when WELLBUTRIN XL was approved for sale in Canada and is designed specifically for Consumers. This is a summary and will not tell you everything about WELLBUTRIN XL. Contact your doctor or pharmacist if you have any questions about the drug.
 
Please read this information before you start to take your medication, even if you have taken this drug before. Keep this information with your medicine in case you need to read it again.

ABOUT THIS MEDICATION
What the medication is used for:
WELLBUTRIN XL has been prescribed to you by your doctor to:

·   Relieve your symptoms of depression (feeling sad, a change in appetite or weight, difficulty concentrating or sleeping, feeling tired, headaches, unexplained aches and pain) OR

·   Prevent autumn-winter seasonal depression in patients with a history of seasonal depression

What it does:
WELLBUTRIN XL is one of a group of drugs called antidepressants.  WELLBUTRIN XL is thought to block reuptake of chemicals in the brain called noradrenaline and dopamine, which are linked with depression.

When it should not be used?
Do not take WELLBUTRIN XL if you:

·   know that you are allergic to Wellbutrin^® SR, bupropion, or any of the other ingredients in WELLBUTRIN XL tablets
·   are taking any other medicines which contain bupropion such as WELLBUTRIN SR or Zyban^®
·   have been diagnosed with epilepsy or have a history of seizures
·   have or have had an eating disorder, for example binge eating (bulimia) or anorexia nervosa
·   are usually a heavy drinker who has just stopped or are about to stop drinking
·   are taking monoamine oxidase (MAO) inhibitor antidepressants (e.g., phenelzine sulphate, moclobemide)
·   are taking the antipsychotic thioridazine 
·   have liver or kidney problems
·   are pregnant or trying to become pregnant,  or if you think that you might be pregnant
·   are breast feeding.

What the medicinal ingredient is:
Bupropion hydrochloride
What the non-medicinal ingredients are:
Denatured ethyl alcohol, ethylcellulose, glyceryl behenate, isopropyl alcohol, methylacrylic acid copolymer dispersion, N-butyl alcohol, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, shellac glaze, silicon dioxide, triethyl citrate, titanium dioxide, red and blue FDC dyes (150 mg) iron oxide black (300 mg)
What dosage forms it comes in:
150 mg and 300 mg once-daily tablets

WARNINGS AND PRECAUTIONS

WELLBUTRIN XL is a Once-Daily medication and should not be confused with other bupropion formulations.

During treatment with these types of medication it is important that you and your doctor have good ongoing communication about how you are feeling.

WELLBUTRIN XL is not for use in children under 18 years of age.

New or Worsened Emotional or Behavioural Problems
Particularly in the first few weeks or when doses are adjusted, a small number of patients taking drugs of this type may feel worse instead of better; for example, they may experience unusual feelings of agitation, hostility or anxiety, or have impulsive or disturbing thoughts such as thoughts of self-harm, or harm to others. Should this happen to you, or to those in your care if you are a caregiver or guardian, consult your doctor immediately. Close observation by a doctor is necessary in this situation.

Important Warning About The Risk Of Seizure
The overall incidence of seizure with WELLBUTRIN® XL in clinical trials at doses up to 450 mg/day was approximately 0.1%.

BEFORE you use WELLBUTRIN XL tell your doctor or pharmacist if you:

·   have ever had any fits or seizures in the past
·   take other medications that may increase your chance of a seizure, 
·   are taking any prescription or over-the-counter medications,  or are planning on taking any prescription or over-the-counter medications during your therapy
·   have, or have had an eating disorder, for example binge eating (bulimia)  or anorexia nervosa
·   have liver problems
·   have kidney problems.
·   take more than the recommended amount of WELLBUTRIN XL tablets. WELLBUTRIN XL tablets should NOT be used if you are taking the smoking cessation aid ZYBAN or any other medications containing bupropion hydrochloride such as WELLBUTRIN SR
·   have diabetes which is treated with insulin or other medications
·   have use over-the-counter diet aids
·   have had a serious head injury
·   drink alcohol.  It is best not to drink alcohol at all or to drink very little while taking WELLBUTRIN XL.  If you drink a lot of alcohol and suddenly stop, you may increase your chance of having a seizure.  Be sure to discuss your use of alcohol with your doctor before you begin taking WELLBUTRIN XL
·   are pregnant, or thinking about becoming pregnant, or are breastfeeding

Driving vehicles or using machinery
WELLBUTRIN XL may impair your ability to perform tasks requiring judgement or motor and cognitive skills.  Until you are reasonably certain that WELLBUTRIN XL does not adversely affect your performance you should refrain from driving an automobile or operating hazardous machinery.

Effects on Pregnancy and Newborns
Post-marketing reports indicate that some newborns whose mother took an SSRI (selective serotonin reuptake inhibitor) or other newer anti-depressant, such as WELLBUTRIN XL, during pregnancy have developed complications at birth requiring prolonged hospitalization, breathing support and tube feeding. Reported symptoms include: feeding and/or breathing difficulties, seizures, tense or overly relaxed muscles, jitteriness and constant crying.

In most cases, the newer anti-depressant was taken during the third trimester of pregnancy. These symptoms are consistent with either a direct adverse effect of the anti-depressant on the baby, or possibly a discontinuation syndrome caused by sudden withdrawal from the drug.  These symptoms normally resolve over time. However, if your baby experiences any of these symptoms, contact your doctor as soon as you can.

If you are pregnant and taking an SSRI, or other newer anti-depressant, you should discuss the risks and benefits of the various treatment options with your doctor. It is very important that you do NOT stop taking these medications without first consulting with your doctor.

INTERACTIONS WITH THIS MEDICATION

If you are taking or have recently been taking other medicines for depression called monoamine oxidase inhibitors (MAO-Is) tell your doctor before taking WELLBUTRIN XL.
 
You should tell your doctor if you are taking or have recently taken any medications (prescription, non-prescription or natural herbal) especially:

·   other antidepressants such as citalopram, paroxetine, venlafaxine
·   the antipsychotic thioridazine
·   other medications for mental illness such as haloperidol and risperidone
·   medicines for Parkinson’s disease such as levodopa, amantadine or
     orphenadrine
·   medicines used for epilepsy (such as carbamazepine, phenytoin, or
     phenobarbitone)
·   cyclophosphamide or ifosfamide, drugs mainly used to treat cancer
·   drugs called beta blockers to treat heart conditions
·   medicines  to regulate heart rhythm
·   clopidogrel or ticlopidine, drugs used to reduce blood clots
·   nicotine patches to help you stop smoking
·   In general, drinking alcoholic beverages should be kept to a minimum
    or avoided completely while taking WELLBUTRIN XL.

PROPER USE OF THIS MEDICATION
Usual dose:
How to take WELLBUTRIN XL:

·   WELLBUTRIN XL is formulated to be taken as a single tablet,
    once-daily.

Major Depressive Disorder:

Dosing with WELLBUTRIN XL Tablets should begin at 150 mg/day given as a single daily dose in the morning.  The dose of WELLBUTRIN XL may be increased to the 300mg/day maximum dose after 1 week.  The usual adult target dose for WELLBUTRIN XL Tablets is 300 mg/day, given once daily in the morning.

Prevention of Seasonal Depression:

Dosing with WELLBUTRIN XL Tablets should begin at 150 mg/day given as a single daily dose in the morning.  The dose of WELLBUTRIN XL may be increased to the 300mg/day maximum dose after 1 week.  The usual adult target dose for WELLBUTRIN XL Tablets is 300 mg/day, given once daily in the morning. For patients taking 300 mg/day during the autumn-winter season, the dose should be reduced to 150 mg/day for 2 weeks prior to discontinuation.

· Take your WELLBUTRIN XL tablet at the same time each day.  If you have any problems with your dosing routine, contact your doctor or pharmacist
· Swallow your WELLBUTRIN XL tablet whole, with fluids. Do not divide, chew or crush tablets
· Take only the recommended dose prescribed by your doctor.  Never increase the dose of WELLBUTRIN XL that you or those in your care are taking, unless your doctor tells you to 
· The effects of your medication may not be noticeable in the first few days of treatment, and significant improvement may take several weeks. If you are concerned that your medicine is not working, discuss this with your doctor
· You should talk to your doctor before you stop taking your medication on your own.

Remember: This medicine has been prescribed only for you.  Do not give it to anybody else, as they may experience undesirable effects, which may be serious.

Missed Dose:
WELLBUTRIN XL should be taken at the same time each day and no more than one dose should be taken each day.
If your normal administration time has been missed, the dose should be skipped and administration resumed at the normal administration time of the following day.

Overdose
If you take too many tablets, you may increase the risk of a fit or seizure, or other serious effects.  Contact your doctor or the nearest hospital emergency department or Poison Control Center at once, even though you may not feel sick.

SIDE EFFECTS AND WHAT TO DO ABOUT THEM:

Like all medications, WELLBUTRIN XL can cause some side effects.  You may not experience any of them.  For most patients these side effects are likely to be minor and temporary.  However, some may be serious.  Some of these side effects may be dose related.  Consult your doctor if you experience these or other side effects, as the dose may have to be adjusted.

The most common side effects of WELLBUTRIN XL are:
·   dry mouth 
·   nausea 
·   constipation 
·   insomnia 
·   dizziness 
·   anxiety 
·   decreased appetite

Uncommon side effects

These could affect less than one in every 100 people:
·   increased appetite 
·   weight
·   bloating 
·   migraine 

New or Worsened Emotional or Behavioural Problems
A small number of patients taking drugs of this type may feel worse instead of better; for example, they may experience new or worsened feelings of agitation, hostility or anxiety, or thoughts about suicide.  Your doctor should be informed of such changes immediately. Close observation by a doctor is necessary in this situation. See also the WARNINGS AND PRECAUTIONS section. 

Effects on Newborns
Some newborns whose mothers took an SSRI (selective serotonin reuptake inhibitor) or other newer anti-depressant during pregnancy have shown such symptoms as breathing and feeding difficulties, jitteriness and constant crying. If your baby experiences any of these symptoms, contact your doctor as soon as you can.  See WARNINGS AND PRECAUTIONS section for more information.
 
Serious Side Effects

SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM
Symptom / effect		Talk with your doctor or pharmacist		Stop taking drug and call your doctor or pharmacist
					Only if severe	In all cases
Rare	Seizures [loss of consciousness with uncontrollable shaking (“fit”/ “convulsion”)]			v
Very Rare	Severe allergic  reactions (red and lumpy or blistering skin rash, swelling of the face or throat, trouble breathing, collapse, blackout, severe muscle or joint pains)			v
Very Rare	Liver disorders, including hepatitis and jaundice (symptoms include nausea, vomiting, loss of appetite combined with itching, yellowing of the skin or eyes, dark urine)		v	v
Very Rare	Poor blood glucose control	v
Very Rare	Inability to urinate		v
Very Rare	Hallucinations, delusions, paranoid ideation (sensing or believing thing that are not there)		v
Very Rare	Agression		v
See Warnings and Precautions	New or worsened emotional or behavioural problems		v
See Warnings and Precautions	Rises in blood pressure	v

* If you think you have these side effects, it is important that you seek medical advice from your doctor straight away.

The overall incidence of seizure with WELLBUTRIN XL in clinical trials at doses up to 450 mg/day was approximately 0.1%.    

The chance of a seizure happening is higher if you take too much, if you take certain medicines at the same time, if you drink alcohol, or if you are at higher than usual risk of seizures.

This is not a complete list of side effects. For any unexpected effects while taking WELLBUTRIN XL contact your doctor or pharmacist.

HOW TO STORE IT

·   Keep all medication out of the reach of children 
·   Store WELLBUTRIN XL at room temperature (15-30°C)
·   Keep container tightly closed
·   If your doctor tells you to stop taking WELLBUTRIN XL please return any left over medicine to your pharmacist

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs.  If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

Toll-free telephone: 1-866-234-2345
Toll-free fax: 1-866-678-6789
By email: cadrmp@hc-sc.gc.ca
By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness
Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON  K1A 0K9

NOTE: Before contacting Health Canada , you should contact your physician or pharmacist.

MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found at http://www.biovail.com or by contacting the sponsor: 
 
 Biovail Pharmaceuticals Canada
 7150 Mississauga Rd.
 Mississauga, Ontario
 L5N 8M5
 1-866-825-8120.

This document was prepared by Biovail Pharmaceuticals Canada.

Wellbutrin^® XL, Wellbutrin^® SR and Zyban^® are trademarks of the GlaxoSmithKline Group of Companies and are used by Biovail Corporation under license. 

Last Revised: February 4, 2009

Product information on this page is intended for residents of Canada only. Residents of the U.S. should return to the User Profile Selection page and select accordingly.