Dom-Bupropion SR: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Dom-BUPROPION SR 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)

What it does:

Dom-BUPROPION SR is one of a group of drugs called antidepressants. Dom-BUPROPION SR 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 Dom-BUPROPION SR if you:

• know that you are allergic to bupropion, the medical

  ingredient, or any of the other ingredients in Dom-BUPROPION SR tablets.

• are taking any other medicines which contain

  bupropion, such as bupropion sustained release, bupropion extended release or bupropion immediate release.

• 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.

  • 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: 100 mg: carboxyvinyl polymer, colloidal silicon dioxide, FD&C Blue # 1, hypromellose, iron oxide black, glyceryl behenate, lactose anhydrous, magnesium stearate, polyethylene glycol, polyethylene oxide and titanium dioxide.

150 mg: carboxyvinyl polymer, colloidal silicon dioxide, glyceryl behenate, lactose anhydrous, polyethylene glycol, magnesium stearate, polyethylene oxide, polyvinyl alcohol, talc and titanium dioxide. In addition, the 150 mg tablet contains also FD&C Red # 40 and FD&C Blue # 2

What dosage forms it comes in:

Tablets: 100 mg and 150 mg

WARNINGS AND PRECAUTIONS

Dom-BUPROPION SR is a Twice 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.

Dom-BUPROPION SR 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. Do not discontinue your medication on your own.

Important Warning about the Risk of Seizures:

• At the maximum recommended dose of 300 mg per

  day, approximately 1 in every 1000 people taking the maximum dose of Dom-BUPROPION SR is at risk of a fit (a seizure or convulsion).

BEFORE you use Dom-BUPROPION SR 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, including drugs for depression and some antibiotics.

• 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

  bupropion sustained release tablets. Dom-BUPROPION SR tablets should NOT be used if you are taking the smoking cessation aid ZYBAN or any other medications containing bupropion hydrochloride.

• have diabetes which is treated with insulin or other

  medications.

• have used 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 Dom-BUPROPION SR. 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 Dom-BUPROPION SR.

• are pregnant, or thinking about becoming pregnant,

  or are breastfeeding.

Driving vehicles or using machinery:

Dom-BUPROPION SR may impair your ability to perform tasks requiring judgement or motor and cognitive skills.

Until you are reasonably certain that Dom-BUPROPION SR 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 bupropion sustained release, 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 (MAOIs) tell your doctor before taking Dom-BUPROPION SR.

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.
• medicines used to reduce blood clots (such as ticlopidine or clopidogrel).
• nicotine patches to help you stop smoking.
• In general, drinking alcoholic beverages should be kept to a minimum or avoided completely while taking Dom-BUPROPION SR.

PROPER USE OF THIS MEDICATION

Usual dose:

How to take Dom-BUPROPION SR

• The usual adult starting dose for sustained release

  bupropion is one 100 mg or 150 mg tablet once daily. Patients may have a dosage increase after one week to 300 mg daily. In order to minimize the risk of seizures (see WARNINGS) single doses of sustained release bupropion must not exceed 150 mg. Doses of sustained release bupropion greater than 150 mg/day should be administered b.i.d preferably with at least 8 hours between successive doses.

• Take your Dom-BUPROPION SR tablet at the same

  time each day. If you have any problems with your dosing routine, contact your doctor or pharmacist.

• Swallow your Dom-BUPROPION SR 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 Dom-BUPROPION SR 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:

Dom-BUPROPION SR should be taken at the same time each day and no more than the recommended 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(s), or other serious effects, including irregular heartbeat, which may be life threatening..

SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medications, Dom-BUPROPION SR 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 Dom-BUPROPION SR are:

• headache
• dry mouth
• nausea
• constipation
• insomnia
• dizziness
• shakiness
• ringing in the ears

Uncommon side effects

These could affect less than one in every 100 people:

• Increased appetite
• Weight increase
• 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 antidepressant 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

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

Approximately 1 in every 1000 people taking the maximum dose of Dom-BUPROPRION SR is at risk of a fit (a seizure or convulsion). 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 Dom-BUPROPION SR contact your doctor or pharmacist.

HOW TO STORE IT

• Keep all medication out of the reach of children.

  • Store between 15°C and 30 °C in a dry place away from direct sunlight. Protect from moisture.
  • Keep container tightly closed.
  • If your doctor tells you to stop talking Dom-BUPROPION SR please return any left over medicine to your pharmacist.

REPORTING SUSPECTED SIDE EFFECTS

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

$ Report online at www.healthcanada.gc.ca/medeffect $ Call toll-free at 1-866-234-2345

$ Complete a Canada Vigilance Reporting Form and:

• Fax toll-free to 1-866-678-6789, or

• Mail to: Canada Vigilance Program Health Canada

  Postal Locator 0701E Ottawa, Ontario

  K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect^™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effect, please contact your health care provider. The Canada Vigilance Program does not provide medical advice.

MORE INFORMATION

You may need to read this package insert again. Please do not throw it away until you have finished your medicine.

This document plus the full product monograph, prepared for health professionals can be obtained by contacting Dominion Pharmacal, at 1-888-550-6060.

Dominion Pharmacal

Montreal Quebec

H4P 2T4

Last revised February 13, 2014