Mylan-Bupropion XL: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Mylan-Bupropion 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:

Mylan-Bupropion XL is one of a group of drugs called antidepressants. Mylan-Bupropion 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 Mylan-Bupropion XL if you:

• know that you are allergic to bupropion hydrochloride sustained-release tablets, bupropion, or any of the other ingredients in Mylan-Bupropion XL
• are taking any other medicines which contain bupropion such as bupropion hydrochloride sustained-release tablets 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:

Colloidal silicon dioxide, hydrochloric acid, hypromellose, magnesium stearate, microcrystalline cellulose, povidone and stearic acid. Coating: Eudragit L30 D-55, mannitol, polyethylene glycol, polysorbate, polyvinyl alcohol, talc and triethyl citrate.

Ink: hypromellose, iron oxide black, isopropyl alcohol and propylene glycol.

What dosage forms it comes in:

150 mg and 300 mg once daily tablets

WARNINGS AND PRECAUTIONS

Mylan-Bupropion 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.

Mylan Bupropion 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 Seizures:

The overall incidence of seizure with bupropion hydrochloride extended-release tablets in clinical trials at doses up to 450 mg/day was approximately 0.1%.

BEFORE you use Mylan-Bupropion 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, 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 Mylan-Bupropion XL tablets. Mylan-Bupropion XL tablets should NOT be used if you are taking the smoking cessation aid ZYBAN^® or any other medications containing bupropion hydrochloride such as bupropion hydrochloride sustained-release tablets
• 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 Mylan-Bupropion 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 Mylan-Bupropion XL.
• are pregnant, or thinking about becoming pregnant, or are breastfeeding

Driving vehicles or using machinery:

Mylan-Bupropion XL may impair your ability to perform tasks requiring judgement or motor and cognitive skills. Until you are reasonably certain that Mylan-Bupropion 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 bupropion hydrochloride extended-release tablets, 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.

Angle-Closure Glaucoma:

Mylan-Bupropion XL can cause an acute attack of glaucoma. Seek immediate medical attention if you experience eye pain, changes in vision, swelling or redness in or around the eye.

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 Mylan-Bupropion 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.
• digoxin, used to treat congestive heart failure and a fast heart rate or irregular heart rhythm such as atrial fibrillation (sometimes called “a-fib”).
• tamoxifen, a drug to treat breast cancer.
• ritonavir or efavirenz, drugs to treat HIV infection.
• In general, drinking alcoholic beverages should be kept to a minimum or avoided completely while taking Mylan-Bupropion XL.

PROPER USE OF THIS MEDICATION

Usual dose:

How to take Mylan-Bupropion XL

Mylan-Bupropion XL is formulated to be taken as a single tablet, once-daily.

Major Depressive Disorder:

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

Prevention of Seasonal Depression:

Dosing with Mylan-Bupropion XL tablets should begin at 150 mg/day given as a single daily dose in the morning. The dose of Mylan-Bupropion XL may be increased to the 300 mg/day maximum dose after 1 week. The usual adult target dose for Mylan-Bupropion 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 Mylan-Bupropion XL tablet at the same time each day. If you have any problems with your dosing routine, contact your doctor or pharmacist.
• Swallow your Mylan-Bupropion 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 Mylan-Bupropion XL 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:

Mylan-Bupropion 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(s), or other serious effects, including irregular heartbeat, which may be life-threatening.

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SIDE EFFECTS AND WHAT TO DO ABOUT THEM

Like all medications, Mylan-Bupropion 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 Mylan-Bupropion 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 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 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

* 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 bupropion hydrochloride extended-release tablets 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 Mylan-Bupropion XL contact your doctor or pharmacist.

HOW TO STORE IT

• Keep all medication out of the reach of children.
• Store Mylan-Bupropion XL tablets between 15°C and 30°C.
• Keep container tightly closed.
• If your doctor tells you to stop taking Mylan-Bupropion XL please return any leftover medicine to your pharmacist.

Reporting Side Effects

MORE INFORMATION

FOATION

This document can be found at: www.mylan.ca.

The full Product Monograph prepared for health professionals can be obtained by contacting the sponsor, Mylan Pharmaceuticals ULC at: 1-844-596-9526

Etobicoke, Ontario M8Z 2S6

Last revised: August 8, 2017

Mylan Pharmaceuticals ULC Etobicoke, ON M8Z 2S6 1-844-596-9526 www.mylan.ca