Taro-Bupropion XL: Uses, Side Effects and Dosage

Serious Warnings and Precautions

New or worsened emotional or behaviour problems:

• When you first start taking TARO-BUPROPION XL or when your dose is adjusted, you may feel worse instead of better. This can include new or worsened feelings of agitation, hostility, anxiety, or impulsivity.
• It is important that you and your healthcare professional talk regularly during your treatment about how you are feeling.

• You may find it helpful to tell a relative or close friend that you are depressed. Ask them to read this leaflet. You might ask them to tell you if they:

  • think your depression is getting worse, or
  • are worried about changes in your behaviour.
• If your depression worsens or you experience changes in your behaviour, tell your healthcare professional right away. Do not stop taking your medicine as it takes time for TARO-BUPROPION XL to work.

Self-harm or suicide

• Antidepressants, such as TARO-BUPROPION XL, can increase the risk of suicidal thoughts or actions.
• If you have thoughts of harming or killing yourself at any time, tell your healthcare professional or go to a hospital right away. You will be closely monitored by a healthcare professional in this situation.

What is TARO-BUPROPION XL used for?

TARO-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 does TARO-BUPROPION XL work?

TARO-BUPROPION XL belongs to a group of medicines called antidepressants. TARO-BUPROPION XL is thought to block reuptake of chemicals in the brain called noradrenaline and dopamine. This helps to relieve your symptoms of depression.

What are the ingredients in TARO-BUPROPION XL?

Medicinal ingredient: Bupropion Hydrochloride.

Non-medicinal ingredients: Ethylcellulose, glyceryl behenate, hydroxypropyl cellulose, hypromellose, iron oxide black, lactose monohydrate, methylacrylic acid copolymer dispersion, polyethylene glycol, povidone, propylene glycol, shellac glaze, silicon dioxide, stearic acid, and triethyl citrate.

TARO-BUPROPION XL comes in the following dosage forms:

Extended-release tablets: 150 mg and 300 mg of bupropion hydrochloride.

Do not use TARO-BUPROPION XL if:

• you are allergic to bupropion, or any of the other ingredients in TARO-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 TARO-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:
• are taking other medicines containing bupropion, such as bupropion hydrochloride sustained-release tablets, Zyban®, and Contrave®.
• have ever had any fits or seizures in the past.
• 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 TARO-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 TARO-BUPROPION XL may cause your speech disorder to come back or worsen.

Other warnings you should know about:

TARO-BUPROPION XL can cause serious side effects, including:

• Seizures (fits): Your risk of seizures increases when you take TARO-BUPROPION XL, especially:

  • if your dose of TARO-BUPROPION XL increases;
  • if you do not take TARO-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)
• Liver disorders: This includes hepatitis (inflammation of the liver) and jaundice (yellowing of the skin and eyes).

• Severe allergic reactions:

  • TARO-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 TARO-BUPROPION XL, your symptoms may not go away even after you stop taking it.
• Hallucinations, delusions, paranoia (sensing or believing things that are not there).
• Mania: Antidepressants, such as TARO-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 TARO-BUPROPION XL.
• Hyponatremia (low sodium in the blood).

• Serotonin toxicity (also known as serotonin syndrome): TARO-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 TARO-BUPROPION XL or when your dose is increased. It may also occur if you take TARO-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.

• Severe skin reactions: Taking TARO-BUPROPION XL may cause serious skin reactions. This includes Stevens-Johnson Syndrome (SJS), acute generalised exanthematous pustulosis (AGEP), and erythema multiforme. Stop taking TARO-BUPROPION XL and

  • • severe skin rash;
    • peeling of the skin;
    • blisters around the mouth, eyes or genitals;
    • itching;
    • chest pain;
    • swelling;
    • shortness of breath;
    • body aches;
    • fever.

Systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE): TARO-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): TARO-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 TARO-BUPROPION XL.

  Before you start taking TARO-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: TARO-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 TARO-BUPROPION XL may increase your risk of having seizures and allergic reactions. It is best not to drink alcohol at all while taking TARO-BUPROPION XL to avoid side effects.

Misuse: TARO-BUPROPION XL is intended for oral use only. Taking TARO-BUPROPION XL by any other route may lead to seizure, overdose or even death.

Driving and using machines:

TARO-BUPROPION XL may impair your ability to do tasks requiring judgement, thinking, or motor skills. You should not drive or use machines until you know how TARO-BUPROPION XL affects you.

Pregnancy:

• If you are pregnant, your healthcare professional will determine if TARO-BUPROPION XL is right for you. They will also discuss the risks of birth defects and complications after birth if you take TARO-BUPROPION XL during pregnancy.

• If you have been prescribed TARO-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 TARO-BUPROPION XL. It is very important that you do not stop taking TARO-BUPROPION XL without first consulting with your healthcare professional.

Breastfeeding: TARO-BUPROPION XL passes into breastmilk and could harm a breastfed baby. You and your healthcare professional will decide if you should take TARO-BUPROPION XL or breastfeed. You should not do both.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with TARO-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 TARO-BUPROPION XL:

• TARO-BUPROPION XL extended-release tablets should not be confused with other bupropion formulations.
• Take TARO-BUPROPION XL exactly as directed by your healthcare professional. It should be taken once daily at the same time each day, typically in the morning. If you have any problems with your dosing routine, contact your healthcare professional.
• TARO-BUPROPION XL must be taken orally. Swallow your TARO-BUPROPION XL tablet whole, with fluids. Do not divide, chew or crush tablets.
• Never increase the dose of TARO-BUPROPION XL unless your doctor 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 TARO-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 TARO-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.

.

Missed Dose:

If you forget or miss a dose of TARO-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.

What are possible side effects from using TARO-BUPROPION XL?

These are not all the possible side effects you may have when taking TARO-BUPROPION XL. If you experience any side effects not listed here, tell your healthcare professional.

The side effects of TARO-BUPROPION XL may include:

• Very common side effects (may affect more than 1 in 10 people)

  • constipation,
  • dry mouth,
  • headache,
  • insomnia (a sleeping disorder that makes it hard to fall asleep),
  • ringing in ears.

• Common side effects (may affect up to 1 in 10 people)

  • 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

Serious side effects and what to do about them

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

Storage:

• Store TARO-BUPROPION XL at 15°C to 30°C.
• Keep container tightly closed.
• If your doctor tells you to stop taking TARO-BUPROPION XL, please return any leftover medicine to your pharmacist.
• Keep out of reach and sight of children.

If you want more information about TARO-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 website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug- products/drug-product-database.html); or by calling the manufacturer Sun Pharma Canada Inc., at 1-866-840-1340.

Sun Pharma Canada Inc.

Brampton, ON

L6T 1C1

Last Revised: APR 4, 2025

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