Patient Medication Information: uses, side effects, how to take - Wellbutrin SR (Biovail Pharmaceuticals Canada Division of Biovail)
What the medication is used for:
WELLBUTRIN® 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:
WELLBUTRIN® SR is one of a group of drugs called antidepressants. WELLBUTRIN® 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 WELLBUTRIN® SR if you:
know that you are allergic to bupropion, the medical
ingredient, or any of the other ingredients in WELLBUTRIN® SR tablets.
are taking any other medicines which contain
bupropion, such as WELLBUTRIN® XL 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.
- 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:
Carnauba wax, cysteine hydrochloride, hydroxpropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide, edible black ink. The 100 mg tablet contains Blue No.1 Lake and polysorbate 80. The 150 mg tablet contains FD&C Blue No. 2 Lake, FD&C Red No. 40 lake, and polysorbate 80.
What dosage forms it comes in:
100 mg and 150 mg tablets
WELLBUTRIN® 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.
WELLBUTRIN® 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 ABOUT THIS MEDICATION
WARNINGS AND PRECAUTIONS
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 WELLBUTRIN® SR is at risk of a fit (a seizure or convulsion).
BEFORE you use WELLBUTRIN® 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
WELLBUTRIN® SR tablets. WELLBUTRIN® SR 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 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 WELLBUTRIN® 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 WELLBUTRIN® SR.
are pregnant, or thinking about becoming pregnant,
or are breastfeeding
Driving vehicles or using machinery:
WELLBUTRIN® SR may impair your ability to perform tasks requiring judgement or motor and cognitive skills. Until you are reasonably certain that WELLBUTRIN® 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 WELLBUTRIN® SR, 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.
If you are taking or have recently been taking other medicines for depression called monoamine oxidase inhibitors (MAOIs) tell your doctor before taking WELLBUTRIN® 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
INTERACTIONS WITH THIS MEDICATION
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 WELLBUTRIN® SR.
Usual dose:
How to take WELLBUTRIN® SR
The usual starting dose for adults 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 WELLBUTRIN® SR must not exceed 150 mg. Doses of
WELLBUTRIN® SR greater than 150 mg/day should be administered b.i.d preferably with at least 8 hours between successive doses.
Take your WELLBUTRIN® SR tablet at the same
time each day. If you have any problems with your dosing routine, contact your doctor or pharmacist.
Swallow your WELLBUTRIN® 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 WELLBUTRIN® 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:
WELLBUTRIN® 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, 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.
Like all medications, WELLBUTRIN® 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 WELLBUTRIN® 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 SIDE EFFECTS AND WHAT TO DO ABOUT
PROPER USE OF THIS MEDICATION
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. Do not discontinue your medication on your own. 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”)] | T∗ | ||
| 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] | T∗ | ||
| SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | ||||
| Talk with your doctor or pharmacist | ||||
| 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] | T∗ | ||
| Very Rare | Poor Blood Glucose control | T | ||
| Very Rare | Inability to urinate | T | ||
| Very Rare | Hallucinations, delusions, paranoid ideation [sensing or believing thing that are not there] | T | ||
| Very Rare | Aggression | T∗ | ||
See Warnings and Precautions | New or Worsened Emotional or Behavioural Problems | T∗ | ||
See Warnings and Precautions | Rises in Blood Pressure | T | ||
*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 WELLBUTRIN® 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 WELLBUTRIN® SR contact your doctor or pharmacist.
- Keep all medication out of the reach of children.
Store WELLBUTRIN® SR at room temperature
(15-30°C).
- Keep container tightly closed.
If your doctor tells you to stop taking
WELLBUTRIN® SR 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: 866-234-2345 toll-free fax 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
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 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.