Patient Medication Information: uses, side effects, how to take - Teva-Bupropion XL
Serious warnings and precautions box
Self-harm or suicide:
New or worsened emotional or behaviour problems:
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What TEVA-BUPROPION XL is used for:
TEVA-BUPROPION XL is used in adults to:
- relieve the symptoms of depression (feeling sad, a change in appetite or weight, difficulty concentrating or sleeping, feeling tired, headaches, unexplained aches and pain); or
- prevent reoccurring episodes of depression in fall and winter (major depressive illness with an autumn-winter seasonal pattern).
How TEVA-BUPROPION XL work:
TEVA-BUPROPION XL belongs to a group of medicines called antidepressants. TEVA-BUPROPION XL is thought to block reuptake of chemicals in the brain called noradrenaline and dopamine. This helps to relieve your symptoms of depression.
The ingredients in TEVA-BUPROPION XL are:
Medicinal ingredients: Bupropion hydrochloride
Non-Medicinal ingredients: Ethyl cellulose, Hydroxypropyl Cellulose, Hypromellose, Iron Oxide Black, Isopropyl Alcohol, Methacrylic Acid Copolymer, Propylene Glycol, Silicified Microcrystalline Cellulose, Stearic Acid, Talc, Titanium Dioxide, and Triethyl Citrate
TEVA-BUPROPION XL comes in the following dosage forms:
Extended-release tablets: 150 mg and 300 mg of bupropion hydrochloride.
Do not use TEVA-BUPROPION XL if:
- you are allergic to bupropion or any of the other ingredients in TEVA-BUPROPION XL tablets.
- you are taking any other medicines which contain bupropion hydrochloride, such as bupropion hydrochloride sustained-release tablets, ZYBAN®, or CONTRAVE®.
- you have been diagnosed with epilepsy or have a history of seizures.
you have or have had an eating disorder, such as:
- bulimia (binge eating and throwing up so you don’t gain weight);
- anorexia (eating very little).
- you are a heavy drinker, have recently stopped drinking alcohol, and have withdrawal symptoms.
- you have suddenly stopped taking benzodiazepines or other sedatives (medicines used to treat anxiety and sleep disorders) and have withdrawal symptoms.
- you are taking or have recently taken in the last 14 days monoamine oxidase inhibitor (MAOI) antidepressants, such as phenelzine, moclobemide, and tranylcypromine.
- you are taking or have recently taken in the last 14 days thioridazine (an antipsychotic medicine that is typically used to treat schizophrenia and psychosis).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TEVA-BUPROPION XL. Talk about any health conditions or problems you may have, including if you:
are at a higher risk of seizures. This includes if you:
- have ever had any fits or seizures in the past, especially if you have ever had a seizure while taking medicines containing bupropion, such as bupropion hydrochloride sustained-release tablets, ZYBAN®, and CONTRAVE®.
- have had a serious head injury.
- have or have had a tumour in your brain or spinal cord.
- have liver problems.
- are addicted to opioids, cocaine or other drugs that stimulate your central nervous system.
- excessively drink alcohol. It is best not to drink alcohol at all. If you drink a lot of alcohol and suddenly stop, you may increase your risk of having a seizure. Be sure to discuss your use of alcohol with your healthcare professional before you start taking TEVA-BUPROPION XL
- have diabetes and take insulin or other medicines to control your blood sugar.
take other medications that may increase your risk of having a seizure, such as:
- medicines used to treat depression or other mental disorders (e.g., serotonergic agents);
- medicines used to treat psychotic symptoms;
- medicines used to treat malaria;
- lithium, a medicine used to treat bipolar disorder;
- amantadine, a medicine used to treat Parkinson’s Disease;
- theophylline, a medicine used to treat asthma and other lung diseases;
- steroids, which are medicines used to treat inflammation;
- some antibiotics (e.g., quinolones);
- over-the-counter stimulants (e.g., diphenhydramine, dextromethorphan, or pseudoephedrine); or
- diet aids.
- have bipolar disorder.
- are using nicotine patches to help you stop smoking.
- have recently had a heart attack or have heart disease.
- are taking tamoxifen, a medicine used to treat breast cancer.
- are 65 years of age or older.
- are taking medicines that are known to lower the level of sodium in your blood (e.g., thiazide diuretics, a type of “water pill”).
- have kidney problems.
have or have had a speech disorder where you stammer or stutter (dysphemia). Taking TEVA-
- BUPROPION XL may cause your speech disorder to come back or worsen.
Other warnings you should know about:
TEVA-BUPROPION XL can cause serious side effects, including:
Seizures (fits): Your risk of seizures increases when you take TEVA-BUPROPION XL, especially:
- if your dose of TEVA-BUPROPION XL increases;
- if you do not take TEVA-BUPROPION XL as prescribed;
- if you take certain medicines at the same time;
- if you are already at higher than usual risk of seizures.
Angle-closure glaucoma (eye pain caused by increased pressure in the eyes): TEVA-BUPROPION XL can cause an acute attack of glaucoma. Having your eyes examined before you take TEVA-BUPROPION XL could help identify if you are at risk of having angle-closure glaucoma. Get immediate medical help if you experience:
- eye pain;
- changes in vision;
- swelling or redness in or around the eye.
- Liver disorders: This includes hepatitis (inflammation of the liver) and jaundice (yellowing of the skin and eyes).
Severe allergic reactions:
- TEVA-BUPROPION XL may cause an allergic reaction. Symptoms may include skin rash, hives, swelling of the face or throat, muscle pain, joint pain, difficulty breathing, severe skin reactions, chest pain, or fever.
- If you have an allergic reaction while taking TEVA-BUPROPION XL, your symptoms may not go away even after you stop taking it.
Severe skin reactions: Taking TEVA-BUPROPION XL may cause serious skin reactions. This includes Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening, and erythema multiforme. The following symptoms may be related to these skin reactions:
Early warnings for patients:
- fever
- severe skin rash
- swelling, swollen lymph glands
- flu-like feeling
- itching
- body aches
- blisters and peeling skin that may start in and around the mouth, nose, eyes, and genitals and spread to other areas of the body
Later developments:
- yellow skin or eyes
- shortness of breath
- dry cough
- chest pain or discomfort
- feeling thirsty
- urinating less often, less urine
Stop taking TEVA-BUPROPION XL and contact your healthcare professional immediately if you experience these symptoms.
- Hallucinations, delusions, paranoia (sensing or believing things that are not there).
- Mania: Antidepressants, such as TEVA-BUPROPION XL, may trigger manic episodes in patients with bipolar disorder during the depressed state of their illness or psychosis in other susceptible patients.
- Hypertension (high blood pressure): Your healthcare professional may monitor your blood pressure, especially if you are using nicotine patches while you are taking TEVA-BUPROPION XL.
- Hyponatremia (low sodium in the blood).
Serotonin toxicity (also known as serotonin syndrome): TEVA-BUPROPION XL can cause serotonin toxicity, a rare but potentially life-threatening condition. It can cause serious changes in how your brain, muscles and digestive system work. It is more likely to develop serotonin toxicity when you start taking TEVA-BUPROPION XL or when your dose is increased. It may also occur if you take TEVA-BUPROPION XL with certain antidepressants or migraine medications.
Serotonin toxicity symptoms include:
- fever, sweating, shivering, diarrhea, nausea, vomiting,
- muscles shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination, flushing,
- fast heartbeat, changes in blood pressure,
- confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, anxiety, and coma.
Systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE):
TEVA-BUPROPION XL has been associated with new or worsening symptoms in patients susceptible to SLE and CLE. These are autoimmune diseases where your body’s immune system attacks your own tissues and organs. Talk to your healthcare professional right away if you have blotchy rashes mainly on the face, fatigue, joint pain, swelling in the joints, muscle pain, rash, swelling, fever, nausea, or loss of appetite.
- Brugada syndrome (serious heart problem): TEVA-BUPROPION XL may reveal a hidden heart problem you did not know you had, a problem called Brugada syndrome. Brugada syndrome can be serious and cause sudden death. Get immediate medical help if you experience fainting, dizziness, heart palpitations or abnormal heartbeat while taking TEVA-BUPROPION XL
Before you start taking TEVA-BUPROPION XL, tell your healthcare professional if you:
- have Brugada syndrome.
- have unexplained fainting, or a family history of Brugada syndrome or unexplained sudden death before 45 years of age. This could mean you may have Brugada syndrome.
See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.
Alcohol: TEVA-BUPROPION XL lowers your alcohol tolerance. This means you may feel the effects of alcohol when taking less alcohol than usual. Drinking alcohol while taking TEVA-BUPROPION XL may increase your risk of having seizures and allergic reactions. It is best not to drink alcohol at all while taking TEVA-BUPROPION XL to avoid side effects.
Misuse: TEVA-BUPROPION XL is intended for oral use only. Taking TEVA-BUPROPION XL by any other route may lead to seizure, overdose or even death.
Driving and using machines: TEVA-BUPROPION XL may impair your ability to do tasks requiring judgement, thinking, or motor skills. You should not drive, use machines or do any activities that require alertness or physical coordination until you know how TEVA-BUPROPION XL affects you.
Pregnancy:
- If you are pregnant, your healthcare professional will determine if TEVA-BUPROPION XL is right for you. They will also discuss the risks of birth defects and complications after birth if you take TEVA-BUPROPION XL during pregnancy.
If you have been prescribed TEVA-BUPROPION XL during pregnancy, be ready to seek immediate medical help for your newborn if they:
- have trouble breathing or feeding;
- have muscle stiffness, or floppy muscles (like a rag doll);
- have seizures (fits);
- are shaking (jitteriness);
- are constantly crying.
- Tell your healthcare professional right away if you become pregnant while taking TEVA-BUPROPION XL. It is very important that you do not stop taking TEVA-BUPROPION XL without first consulting with your healthcare professional.
Breastfeeding: TEVA-BUPROPION XL passes into breastmilk and could harm a breastfed baby. You and your healthcare professional will decide if you should take TEVA-BUPROPION XL or breastfeed. You should not do both.
Laboratory drug testing: If you take a urine drug screening test, TEVA-BUPROPION XL may give a positive test result for amphetamines. Tell the laboratory technician that you are taking TEVA-BUPROPION XL. They can do a more specific drug screening test for you.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
Serious drug interactions
Serious drug interactions with TEVA-BUPROPION XL include:
Do not take TEVA-BUPROPION XL if you are taking any of these medicines. Ask your healthcare professional if you are unsure. |
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The following may also interact with TEVA-BUPROPION XL:
- medicines used to treat depression and other mental illnesses, such as citalopram, paroxetine, venlafaxine, nortriptyline, imipramine, desipramine, fluoxetine, sertraline, haloperidol, or risperidone.
- medicines used to treat Parkinson’s Disease, such as levodopa, amantadine, or orphenadrine.
- medicines used to prevent epilepsy or seizures, such as carbamazepine, phenytoin, or phenobarbital.
- medicines used to treat cancer, such as cyclophosphamide or ifosfamide.
- medicines used to treat HIV infection, such as ritonavir, lopinavir, or efavirenz.
- beta blockers, which are used to lower your blood pressure. This includes metoprolol, bisoprolol, or carvedilol.
- medicines used to regulate your heart rhythm, such as propafenone, or flecainide.
- medicines used to reduce blood clots, such as ticlopidine or clopidogrel.
- nicotine patches, which are used to help you stop smoking.
- tamoxifen, a medicine used to treat breast cancer.
- digoxin, a medicine used to treat various heart conditions.
- theophylline, a medicine used to treat asthma and other lung diseases.
- lithium, a medicine used to treat bipolar disorder.
- steroids, which are used to treat inflammation, such as prednisone.
- alcoholic beverages.
How to take TEVA-BUPROPION XL:
- TEVA-BUPROPION XL extended-release tablets should not be confused with other bupropion formulations.
- Take TEVA-BUPROPION XL exactly as directed by your healthcare professional. It should be taken once daily with or without food at the same time each day, typically in the morning. If you have any problems with your dosing routine, contact your healthcare professional.
- TEVA-BUPROPION XL must be taken orally. Swallow your TEVA-BUPROPION XL tablet whole, with fluids. Do not divide, chew or crush tablets.
- Never increase the dose of TEVA-BUPROPION XL unless your healthcare professional tells you to.
The effects of your medication may not be noticeable in the first few days of treatment, and improvement may take several weeks. If you are concerned that your medicine is not working:
- continue taking your medicine as it takes time for TEVA-BUPROPION XL to work, and
- discuss this with your healthcare professional.
- You should talk to your healthcare professional before you stop taking your medication on your own. You may experience unwanted side effects if you suddenly stop taking TEVA-BUPROPION XL.
Usual dose:
Your healthcare professional will determine the right dose for you given your condition.
- The usual adult dose is one 150 mg tablet once daily, usually taken in the morning.
- Your dose may be increased to one 300 mg tablet once daily after 1 week.
- The usual adult target dose is one 300 mg tablet once daily.
Overdose:
The symptoms of an overdose include:
- drowsiness;
- fainting;
- respiratory arrest (breathing stops);
- amnesia (loss of memories);
- seizures;
- irregular heartbeat, which can be life-threatening;
- serotonin syndrome, which is a serious condition that can be life-threatening. See the Serious side effects and what to do about them table for more details.
If you think you, or a person you are caring for, have taken too much TEVA-BUPROPION XL, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
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Missed dose:
If you forget or miss a dose of TEVA-BUPROPION XL, skip the missed dose and take the next dose as scheduled. Do not double the dose to make up for the missed dose.
Possible side effects from using TEVA-BUPROPION XL:
These are not all the possible side effects you may have when taking TEVA-BUPROPION XL. If you experience any side effects not listed here, tell your healthcare professional.
Side effects with TEVA-BUPROPION XL may include:
- constipation,
- dry mouth,
- headache,
- insomnia (a sleeping disorder that makes it hard to fall asleep),
- ringing in ears.
- abnormal dreams,
- acne,
- blocked or stuffy nose,
- decreased weight,
- feeling jittery,
- flatulence,
- hot flush,
- memory loss,
- muscle spasms,
- painful periods or menstrual cramps,
- panic attack,
- shakiness,
- taste is altered,
- thirsty,
- tremor.
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Rare | |||
| Seizures (fits): loss of consciousness with uncontrollable shaking. | √ | ||
Systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE): red blotchy rash mainly on the face which may be accompanied by fatigue, pain or swelling in joints, muscle pain, fever, nausea, or loss of appetite. | √ | ||
| Very Rare | |||
| Aggression | √ | ||
| Angle-closure glaucoma (eye pain caused by increased pressure in the eyes): blurred vision, halos around lights, eye pain and redness, nausea and vomiting, or severe headache. | √ | ||
| Hallucinations, delusions or paranoia (sensing or believing thing that are not there) | √ | ||
| Hypertension (high blood pressure): shortness of breath, fatigue, dizziness, fainting, chest pain or pressure, swelling in your ankles and legs, bluish colour to your lips and skin, racing pulse, or heart palpitations. | √ | ||
| Hyponatremia (low blood sodium): lethargy, confusion, muscular twitching, achy, stiff or uncoordinated muscles, seizure, or coma. | √ | ||
| Inability to urinate | √ | ||
| Liver disorders (including hepatitis and jaundice): yellowing of the skin or eyes, dark urine, pale stools, abdominal pain, nausea, vomiting, loss of appetite, or itching. | √ | ||
| Mania: elevated or irritable mood, talking fast, taking more risks, needing less sleep, or racing thoughts. | √ | ||
New or worsened emotional or behavioural problems: feeling angry, aggressive, worried, agitated, hostile or impulsive, feeling violent, feeling like you are not yourself or that you are less inhibited. | √ | ||
| Poor blood sugar control | √ | ||
| Serotonin toxicity (also known as serotonin syndrome): feeling of agitation or restlessness, flushing, muscle twitching, involuntary eye movements, heavy sweating, high body temperature (above 38°C), or rigid muscles. | √ | ||
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. | √ | ||
Severe skin reactions: any combination of itchy skin rash, redness, blistering and peeling of the skin and/or inside of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, body aches or swollen glands, joint pain, yellowing of the skin or eyes, dark urine, shortness of breath, chest pain or discomfort, feeling thirsty, urinating less often, less urine. | √ | ||
Thoughts of death or suicide: thoughts or actions about hurting or killing yourself or other people. | √ | ||
| Unknown | |||
| Brugada syndrome (serious heart problem): dizziness, fainting, fast heartbeat, palpitations, abnormal heartbeat, seizures (fits), or abnormal breathing while sleeping. | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
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Storage:
- Store TEVA-BUPROPION XL at room temperature (15°C to 30°C)
- Keep container tightly closed.
- If your healthcare professional tells you to stop taking TEVA-BUPROPION XL please return any leftover medicine to your pharmacist.
- Keep out of reach and sight of children.
If you want more information about TEVA-BUPROPION XL:
- Talk to your healthcare professional
- Find the full Product Monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.tevacanada.com; or by calling 1-800-268-4127 ext. 3; or email druginfo@tevacanada.com.
Toronto, Ontario M1B 2K9
