Mylan-Buprenorphine/Naloxone: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is Mylan-Buprenorphine/Naloxone used for?

Mylan-Buprenorphine/Naloxone is part of a medical, social and psychological treatment program for adults undergoing substitution treatment for problematic opioid drug dependence.

Treatment with Mylan-Buprenorphine/Naloxone sublingual (under the tongue) tablets is intended for use in adults (18 years of age or older) and is voluntary.

Only a qualified doctor can prescribe Mylan-Buprenorphine/Naloxone. The dose of Mylan-Buprenorphine/Naloxone needs to be taken under the daily supervision of a healthcare professional until you are clinically stable and able to safely store Mylan-Buprenorphine/Naloxone take-home doses.

How does Mylan-Buprenorphine/Naloxone work?

Buprenorphine, a component of Mylan-Buprenorphine/Naloxone, works in the brain as other opioid drugs (e.g. morphine, methadone). If you are in withdrawal from opioid drugs, Mylan-Buprenorphine/Naloxone will stop the feelings of withdrawal.

Mylan-Buprenorphine/Naloxone also contains naloxone. When naloxone is injected, it blocks the effects of medicines and drugs like methadone, heroin, and morphine. Naloxone is added to Mylan-Buprenorphine/Naloxone to stop people from injecting (“shooting-up”) Mylan-Buprenorphine/Naloxone tablets. When you use Mylan-Buprenorphine/Naloxone under your tongue (sublingually), as prescribed, the naloxone in Mylan-Buprenorphine/Naloxone should not stop the medicine’s effects. However, if you inject Mylan-Buprenorphine/Naloxone, the naloxone can give you bad withdrawal symptoms.

Do not use Mylan-Buprenorphine/Naloxone if:

• your doctor did not prescribe it for you
• you are allergic to buprenorphine, naloxone, or to any of the ingredients in this product (see below for the complete listing of non-medicinal ingredients).

Talk to your healthcare professional about any health conditions or problems you may have, including if:

• you have severe asthma, trouble breathing, or other breathing problems.
• you have serious problems with your liver.

• you suffer from or have a history of alcoholism.

• you have any heart problems.
• you have bowel blockage or narrowing of the stomach or intestines.
• you have severe pain in your abdomen.
• you have a head injury.
• you are at risk for seizures.
• you are taking or have taken within the past 2 weeks a Monoamine Oxidase inhibitor (MAOi) (such as phenelzine sulphate, tranylcypromine sulphate, moclobemide or selegiline).
• you recently had, or you are going to have, surgery.
• you are pregnant or planning to become pregnant*.

*Pregnancy and breast-feeding: If you are pregnant or planning to become pregnant or you are breast-feeding or planning to breast-feed your baby your doctor will decide if you should use Mylan-Buprenorphine/Naloxone. The buprenorphine ingredient in Mylan-Buprenorphine/Naloxone can be transferred to your baby through breast milk, or while still in the womb. It can then cause life-threatening breathing problems in your unborn baby or nursing infant. It should only be used if the potential benefit justifies the potential risk to the fetus or baby. It is important that you discuss this with your healthcare professional.

What are the ingredients in Mylan-Buprenorphine/Naloxone?

Medicinal ingredients: buprenorphine and naloxone

Non-medicinal ingredients: aspartame, citric acid anhydrous, colloidal silicon dioxide, crospovidone, lactose monohydrate, lemon lime flavour, magnesium stearate, mannitol and sodium citrate.

What dosage forms does it come in?

Mylan-Buprenorphine/Naloxone sublingual tablet 2 mg / 0.5 mg.

Mylan-Buprenorphine/Naloxone sublingual tablet 8 mg / 2 mg.

To help avoid side effects and ensure proper use, talk to your healthcare professional BEFORE you use Mylan-Buprenorphine/Naloxone. Talk about any health conditions or problems you may have, including if you:

• have a history of illicit or prescription drug or alcohol abuse,
• have asthma, other breathing problems, or lung problems,
• have severe kidney, liver, or lung disease,
• have heart disease,
• have low or decrease in blood pressure,
• have past or current depression,
• suffer from chronic or severe constipation,
• have gallbladder problems,
• have pancreas problems,
• have adrenal gland problems, such as Addison’s disease,
• have low thyroid hormone levels (hypothyroidism),
• in men: urinary disorders (especially linked to enlarged prostate),
• in women: if you are pregnant or are planning to become pregnant
• have problems urinating,
• have a curve in your spine that affects your breathing,
• have severe mental problems or hallucinations (seeing or hearing things that are not really there),
• suffer from migraines.

Other warnings you should know about:

Driving and using machines: Before you do tasks which may require special attention, you should wait until you know how you react to Mylan-Buprenorphine/Naloxone. Mylan-Buprenorphine/Naloxone can cause:

• drowsiness
• dizziness or
• light-headedness

This can usually occur after you take your first dose and when your dose is increased.

Drug testing for sport events:

Athletes should be aware that this medicine, due to its active substance, may cause a positive reaction to “anti-doping tests”.

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

Taking Mylan-Buprenorphine/Naloxone with benzodiazepines (medicines used to treat anxiety or sleep disorders) may cause death due to respiratory failure (inability to breathe). Some people have died from respiratory failure because they misused buprenorphine or took it while using a benzodiazepine drug, alcohol or other opioids. While you are being treated with Mylan-Buprenorphine/Naloxone, do not use benzodiazepines unless they have been prescribed by your doctor.

While taking Mylan-Buprenorphine/Naloxone, avoid drinking alcoholic beverages or taking medicines that contain alcohol. This can lead to serious side effects or a fatal overdose.

Pregnancy, nursing, labour and delivery: Opioids can be transferred to your baby through breast milk, or while still in the womb. Mylan-Buprenorphine/Naloxone can then cause life-threatening breathing problems in your unborn baby or nursing infant. Your doctor will determine if the benefits of using Mylan-Buprenorphine/Naloxone, outweigh the risks to your unborn baby or nursing infant.

If you are pregnant and are taking Mylan-Buprenorphine/Naloxone, it is important that you don’t stop taking your medication all of a sudden. If you do, it can cause a miscarriage or a still-birth. If you choose to stop Mylan-Buprenorphine/Naloxone treatment while pregnant, talk to your doctor for guidance. Your doctor will monitor and guide you on how to slowly stop taking Mylan-Buprenorphine/Naloxone. This may help avoid serious harm to your unborn baby. If you stop Mylan-Buprenorphine/Naloxone during your pregnancy, it is important that you continue to see the healthcare professional that prescribed you Mylan-Buprenorphine/Naloxone in order to prevent relapse to opioid use and to reinstate Mylan-Buprenorphine/Naloxone at an adjusted dose if required. Mylan-Buprenorphine/Naloxone should not be restarted at the same dose if it has been stopped for some time. This could cause harm to you or your baby and you could overdose. Speak to your doctor first for help restarting Mylan-Buprenorphine/Naloxone at a safe dose.

Disorder of the adrenal gland: You may develop a disorder of the adrenal gland called adrenal insufficiency. This means that your adrenal gland is not making enough of certain hormones. You may experience symptoms such as:

• nausea, vomiting
• feeling tired, weak or dizzy
• decreased appetite

You may be more likely to have problems with your adrenal gland if you have been taking opioids for longer than one month. Your doctor may do tests, give you another medication, and slowly take you off Mylan-Buprenorphine/Naloxone.

Serotonin Syndrome: Mylan-Buprenorphine/Naloxone can cause Serotonin Syndrome, a rare but potentially life-threatening condition. It can cause serious changes in how your brain, muscles and digestive system work. You may develop Serotonin Syndrome if you take Mylan-Buprenorphine/Naloxone with certain antidepressants or migraine medications.

Serotonin Syndrome symptoms include:

• fever, sweating, shivering, diarrhea, nausea, vomiting;
• muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination;
• fast heartbeat, changes in blood pressure;
• confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma.

Sexual Function/Reproduction: Long term use of opioids may lead to a decrease in sex hormone levels. It may also lead to low libido (desire to have sex), erectile dysfunction or being infertile.

The following may interact with Mylan-Buprenorphine/Naloxone:

• alcohol or other sedative drugs which may enhance the drowsiness caused by Mylan-Buprenorphine/Naloxone. This includes prescription and non-prescription medications that contain alcohol. Avoid alcohol while you are taking Mylan-Buprenorphine/Naloxone. It can lead to:

  • drowsiness
  • unusually slow or weak breathing
  • serious side effects or a fatal overdose
• opioid analgesics (drugs used to treat pain)
• general anesthetics (drugs used during surgery)
• benzodiazepines (drugs used to help you sleep or that help reduce anxiety)
• antidepressants (for depression and mood disorders). Do not take Mylan-Buprenorphine/Naloxone with MAO inhibitors (MAOi) or if you have taken MAOis in the last 14 days.
• drugs used to treat serious mental or emotional disorders (such as schizophrenia)
• antihistamines (drugs used to treat allergies)
• anti-emetics (drugs used for the prevention or treatment of vomiting)
• drugs used to treat muscle spasms and back pain
• warfarin (such as coumadin) and other anticoagulants (used for prevention or treatment of blood clots)
• anti-retroviral drugs (used to treat certain viral infections)
• anti-fungal drugs (used to treat fungal infections)
• antibiotic drugs (used to treat bacterial infections)
• drugs used to treat high blood pressure
• some heart medication (such as beta blockers)
• grapefruit juice
• drugs used to treat migraines (e.g. triptans)
• St. John’s Wort

To avoid the possibility of drug interactions (one drug affecting another drug), be sure to advise your doctor or pharmacist of any other medications that you are taking.

Taking Mylan-Buprenorphine/Naloxone may make it difficult to get full pain relief from other opioid drugs. Make sure you tell your doctor that you are taking Mylan-Buprenorphine/Naloxone if they are treating you for pain.

Take exactly as directed. As with other narcotics, serious harm or death can result from misusing Mylan-Buprenorphine/Naloxone.

Mylan-Buprenorphine/Naloxone sublingual tablets must be placed under the tongue until dissolved. Do not cut, break, crush, or chew the tablets or take it any other way than under the tongue as this can seriously harm you, can lead to death or can result in very unpleasant opioid withdrawal effects.

You should tell your family members that you are using Mylan-Buprenorphine/Naloxone to treat your opioid dependence.

Usual Adult Starting Dose:

Your doctor will determine the best dose for you. During your treatment, the doctor may adjust the dose, depending upon your response. The effectiveness of this treatment depends on the dose taken, and on medical, psychological and social treatment provided.

Your dose is tailored/personalized just for you. Be sure to follow your doctor’s dosing instructions exactly. Do not increase or decrease your dose without consulting your doctor.

After the first dose of Mylan-Buprenorphine/Naloxone, you may have some opioid withdrawal symptoms such as shaking, sweating, headache, pain, stomach pain, back pain, muscle aches, diarrhea, nausea, insomnia, runny nose, and watery eyes.

How to take Mylan-Buprenorphine/Naloxone:

Place the Mylan-Buprenorphine/Naloxone tablet dose under your tongue and allow it to dissolve. This usually takes within 2 to 10 minutes. Do not swallow the tablets. The sublingual route (under the tongue) is the only effective way to take this product.

How often should you take it?

Take the dose once a day.

If you need to take more than one tablet to achieve the dose your doctor has prescribed, you can either place all the tablets under your tongue at the same time and allow them to dissolve or place them one after the other.

How long should you take it?

The length of treatment will be determined by you and your doctor.

After a time of successful treatment, the doctor may reduce the dose gradually to a lower maintenance dose. Depending on your condition, your Mylan-Buprenorphine/Naloxone dose may be reduced gradually until eventually stopped.

Do not change the treatment in any way or stop treatment without the agreement of the doctor who is treating you. Suddenly stopping treatment may cause withdrawal symptoms.

Stopping your Medication

If you have been taking Mylan-Buprenorphine/Naloxone for more than a few days, you should not stop taking it all of a sudden. Your doctor will monitor and guide you on how to slowly stop taking Mylan-Buprenorphine/Naloxone. You should do it slowly to reduce the occurrence of withdrawal symptoms such as:

• body aches
• diarrhea
• goosebumps
• loss of appetite
• nausea
• feeling nervous or restless
• runny nose
• sneezing
• tremors or shivering
• stomach cramps
• rapid heart rate (tachycardia)
• having trouble sleeping
• an unusual increase in sweating
• heart palpitations
• an unexplained fever
• weakness
• yawning

By reducing or stopping your Mylan-Buprenorphine/Naloxone treatment, your body will become less used to opioids. If you start treatment or using opioids again, your doctor will determine the best dose to restart treatment. You may overdose if you restart at the last dose you took before you slowly stopped taking Mylan-Buprenorphine/Naloxone.

Overdose:

Signs of overdose may include:

• unusually slow or weak breathing
• dizziness
• confusion
• extreme drowsiness

Missed Dose:

What do I do if I forget to take a dose?

If a single dose of this medication has been missed, take it as soon as possible. However, if it is almost time for your next dose, then skip the missed dose. Do not take two doses at once.

In the case you have missed more than one dose of Mylan-Buprenorphine/Naloxone, contact your pharmacist or prescribing doctor as soon as possible.

Refilling Prescriptions for Mylan-Buprenorphine/Naloxone:

A new written prescription is required from your doctor each time you need more Mylan-Buprenorphine/Naloxone. Therefore, it is important that you contact your doctor before your current supply runs out.

Only obtain prescriptions for this medicine from the doctor in charge of your treatment. Do not seek prescriptions from other doctors unless you switch to another doctor for opioid dependence treatment.

What are possible side effects from using Mylan-Buprenorphine/Naloxone?

These are not all the possible side effects you may feel when taking Mylan-Buprenorphine/Naloxone. If you experience any side effects not listed here, contact your healthcare professional. Please also see Warnings and Precautions.

Side effects may include:

• Drowsiness
• Insomnia
• Dizziness
• Fainting
• Nausea, vomiting, or a poor appetite
• Dry mouth
• Headache
• Problems with vision
• Weakness, uncoordinated muscle movement
• Itching
• Sweating
• Constipation
• Low sex drive, impotence (erectile dysfunction), infertility

Talk with your doctor or pharmacist about ways to prevent constipation when you start using Mylan-Buprenorphine/Naloxone.

Your doctor may do blood tests while you are taking Mylan-Buprenorphine/Naloxone to make sure your liver is okay.

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

Storage:

• Keep unused or expired Mylan-Buprenorphine/Naloxone in a secure place to prevent theft, misuse or accidental exposure.
• Keep at controlled room temperature (15°C to 30°C) in a dry place. Protect from light and moisture.
• Keep Mylan-Buprenorphine/Naloxone under lock, out of sight and reach of children and pets.
• Never take medicine in front of small children as they will want to copy you. Accidental ingestion by a child is dangerous and may result in death. If a child accidentally takes Mylan-Buprenorphine/Naloxone, get emergency help right away.

Do not use this product after the expiration date on the package. Check for signs of visible deterioration.

Disposal:

Mylan-Buprenorphine/Naloxone should never be thrown into household trash, where children and pets may find it. It should be returned to a pharmacy for proper disposal.

If you want more information about Mylan-Buprenorphine/Naloxone:

• 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://health-products.canada.ca/dpd-bdpp/index-eng.jsp); or by calling 1-844-596-9526

Etobicoke, Ontario M8Z 2S6.

Last revised: March 29, 2019

Mylan Pharmaceuticals ULC

Etobicoke, ON M8Z 2S6

1-844-596-9526

www.mylan.ca