Consumer Information for: BELBUCA

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

BELBUCA is used for the long-term management of pain, when:

  • the pain is severe enough to require daily, around-the-clock pain medication
  • the doctor determines that other treatment options are not able to effectively treat your pain

BELBUCA is NOT used (“as needed”) to treat pain that you only have once in a while.

What it does

BELBUCA contains buprenorphine, a pain medication belonging to the class of medicines known as opioids. It relieves pain by acting on specific nerve cells of the spinal cord and brain.

What the medicinal ingredient is

Buprenorphine hydrochloride

What the non-medicinal ingredients are

Carboxymethylcellulose sodium, citric acid anhydrous, hydroxypropylcellulose, hydroxyethylcellulose, methylparaben, monobasic sodium phosphate, peppermint oil, polycarbophil, propylene glycol, propylparaben, saccharin sodium, sodium benzoate, sodium hydroxide, titanium dioxide, vitamin E acetate, yellow iron oxide, purified water and black ink (shellac, black iron oxide).

What dosage form it comes in

Buccal soluble films: 75 mcg, 150 mcg, 300 mcg, 450 mcg, 600 mcg, 750 mcg and 900 mcg.

When it should not be used
  • you are allergic to buprenorphine hydrochloride, other opioids, or any of the other ingredients in BELBUCA
  • your pain is mild
  • your pain comes and goes or only lasts for a short time, even if it is severe
  • you have acute pain, including after an out-patient or day surgery
  • you have severe asthma, trouble breathing, or any heart problems
  • you need pain relief after surgery or in cases where your pain varies a lot
  • you have appendicitis or a problem with your pancreas called pancreatitis
  • you are going to have a planned surgery
  • you have a blockage in your intestines or narrowing of the stomach or intestines (e.g., paralytic ileus)
  • you have a head injury or other risks for seizures
  • you have CNS depression (reduced functioning of your brain and spinal cord)
  • you suffer from alcoholism, including symptoms of alcohol withdrawal like confusion and seizures
  • you take a type of medication called monoamine oxidase inhibitors or if you took them within the last 14 days
  • you have a painful sore on the inside of the cheek
  • you are being treated for narcotic withdrawal or dependence
  • you are pregnant or plan to become pregnant, breast-feeding, or in labour
  • you have myasthenia gravis, a condition where you have abnormal weakness in certain muscles
  • you are under 18 years of age.
Warnings and precautions

Serious Warnings and Precautions

  • Even if you take BELBUCA as prescribed you are at risk for opioid addiction, abuse and misuse that can lead to overdose and death. To understand your risk of opioid addiction, abuse, and misuse, you should speak to your prescriber (e.g., doctor).

  • Life-threatening breathing problems can happen while taking BELBUCA, especially if not taken as directed. Babies are at risk of life-threatening breathing problems if their mothers take opioids while pregnant or nursing. You will be at significant risk for overdose and death if you misuse or abuse BELBUCA by snorting or injecting the active ingredient.

  • Never give anyone your BELBUCA. They could die from taking it. If a person has not been prescribed BELBUCA, taking even one dose can cause a fatal overdose. This is especially true for children. Selling or giving away this medicine is against the law.

  • If you took BELBUCA while you were pregnant, whether for short or long periods of time or in small or large doses, your baby can suffer life-threatening withdrawal symptoms after birth. This can occur in the days after birth and for up to 4 weeks after delivery. If your baby has any of the following symptoms:
    • has changes in their breathing (such as weak, difficult or fast breathing)
    • is unusually difficult to comfort
    • has tremors (shakiness)
    • has increased stools, sneezing, yawning, vomiting, or fever.
      • Seek immediate medical help for your baby

  • Taking BELBUCA with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

  • Keep BELBUCA in a safe place away from children. Accidental use by a child is a medical emergency and may result in death. Never take your medicine in front of children as they will want to copy you. If a child accidentally comes in contact with BELBUCA, get emergency help right away.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take BELBUCA. Talk about any health conditions or problems you may have, including if:

  • you have a history of illicit or prescription drug or alcohol abuse
  • you have severe kidney, liver, or lung disease
  • you have heart disease
  • you have problems with your thyroid, adrenal or prostate gland
  • you have low blood pressure or are at risk of having low blood pressure
  • you are going to have, or recently had, a planned surgery
  • you have past or current depression
  • you, or an immediate family member, have a heart rhythm problem (called Long QT syndrome)
  • you suffer from chronic or severe constipation
  • suffer from migraines

Other warnings you should know about:

Opioid dependence and addiction: There are important differences between physical dependence and addiction. It is important that you talk to your doctor if you have questions or concerns about abuse, addiction or physical dependence.

Pregnancy, nursing, labour and delivery: Do not use BELBUCA while pregnant, nursing, during labour or delivery. Opioids can be transferred to your baby through breast milk, or while still in the womb. BELBUCA can then cause life-threatening breathing problems in your unborn baby or nursing infant.

Heart rhythm disorder:
Buprenorphine, the active ingredient in BELBUCA, can cause a heart rhythm disorder. This disorder is called Long QT Syndrome. You may have no symptoms or you may:

  • feel dizzy
  • have chest pain or discomfort
  • have a rapid, fluttering or pounding heart
  • faint
  • have seizures.

Tell your doctor immediately if you have these symptoms. If you continue to have these symptoms, you could develop a more serious heart rhythm problem that could lead to death.

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

  • drowsiness
  • dizziness or
  • light headedness

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

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 BELBUCA.

Serotonin syndrome: BELBUCA can cause serotonin syndrome, a rare but potentially lifethreatening condition. It can cause serious changes in how your brain, muscles and digestive system work. You may develop Serotonin Syndrome if you take BELBUCA 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.

Monitoring:
Your doctor will monitor you while you are taking BELBUCA. The monitoring will occur:

  • to determine if you are abusing or misusing BELBUCA
  • to determine if you are at risk of overdose or serious breathing troubles
  • to determine if you are developing low blood pressure
  • if you already have seizures
  • if you are taking certain other drugs while taking BELBUCA
  • if you have problems with the ducts in your liver or pancreas

Your doctor will decide how often to monitor you and whether your dose needs to be adjusted.

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

Interactions with this medication
  • Alcohol, including prescription and non-prescription medications containing alcohol. Avoid alcohol while taking BELBUCA. It can lead to:
    • drowsiness
    • depressed breathing
    • serious side effects
    • a fatal overdose
  • other sedative drugs which may enhance the drowsiness caused by BELBUCA
  • other opioid analgesics (for pain)
  • certain drugs to treat seizures
  • certain heart drugs
  • certain cancer drugs
  • diuretic drugs (to help your kidneys)
  • laxative drugs and enemas
  • high-dose steroids
  • drugs used to help your muscles relax
  • general anesthetics (used during surgery)
  • drugs used to help you sleep or to reduce anxiety
  • antidepressants (for depression and mood disorders). Do not take BELBUCA with monoamine oxidase (MAO) inhibitors or if you have taken MAO inhibitors in the last 14 days before treatment with BELBUCA
  • drugs used to treat serious mental or emotional disorders, such as schizophrenia
  • antihistamines (for allergies)
  • anti-emetics (for prevention of vomiting)
  • drugs used to treat muscle spasms and back pain
  • warfarin and other coumarin anticoagulants (for prevention or treatment of blood clots)
  • anti-retroviral drugs (used to treat certain viral infections, such as HIV/AIDS)
  • anti-fungal drugs (used to treat fungal infections)
  • antibiotic drugs (used to treat bacterial infections)
  • grapefruit juice
  • St. John’s Wort

Taking BELBUCA with some of the drugs listed above can have serious side effects such as:

  • severe breathing problems
  • low blood pressure
  • coma
  • feeling very sedated
  • death

Only take drugs that your doctor knows about and that have been prescribed for you.

Proper use of this medication
  • BELBUCA is an oral adhesive film that you place on the inside of your cheek.
  • Use BELBUCA only for the condition for which it was prescribed.
  • Tell your doctor if your pain increases or if you have any new issues after starting BELBUCA.
  • Contact your doctor or pharmacist if you have any questions about how to apply BELBUCA.

Usual Adult Dose

  • Take BELBUCA as prescribed by your doctor. Your doctor will determine the best dose for you:
    • If you have not taken opioids before, you will start with the 75 mcg dose.
    • If you are already taking opioids, your doctor will adjust the dose of your other opioids before you start taking BELBUCA.
    • If you have severe liver disease, you may be given a lower starting dose.
  • The maximum daily dose of BELBUCA is 1800 mcg.
  • Do not increase or decrease your dose or stop taking BELBUCA without talking to your doctor.
  • Apply BELBUCA every twelve (12) hours (morning and evening) at the same times each day.
  • After the film has stuck to your cheek, don’t eat or drink until the film is dissolved. This may take 30 minutes.

Keep the following points in mind when you are using BELBUCA:

  • Only open the pouch when you are ready to use it.
  • Open the pouch very carefully to avoid damaging the film.
  • Avoid cutting, tearing, chewing or swallowing the film.
  • Only use the film if the pouch seal is unbroken and if the film is undamaged or unchanged in any way.
  • Refer to the Questions and Answers section further down in this leaflet if you have difficulty:
    • opening the pouch or
    • applying BELBUCA to the inside of your cheek

Step 1: How to open the BELBUCA pouch

Each film is sealed in its own protective pouch.

  1. Hold the pouch as illustrated below (Figure 1)
  2. Fold along the dotted line at the top of the pouch. This will reveal the notch on the upper right hand corner to make the next step easier.
  3. Keep the top folded. Tear down at the notch in the direction of the scissors on the dotted line, either toward you or away from you. Tear all the way to the bottom (Figure 2). Use scissors to cut open the pouch if you have trouble tearing it. Be careful when tearing or cutting the pouch to avoid cutting and damaging the film.

Step 2: Applying the BELBUCA film

  1. Have a glass of water ready before you remove the film from the pouch. This will help you with step 2e) below)
  2. Hold the pouch open with one hand. Ensure the white side of the film is facing up. Insert your dry and clean forefinger into the pouch and place it on the white side of the film; then slowly pull it out. Try not to touch the yellow side of the film.
  3. When the film is half way out of the pouch, keep your forefinger on the film. Turn the pouch over with the other hand so the yellow side is facing up. The yellow side of the film will now be facing you.
  4. Do not use any objects to try to remove the film from the pouch. Do not cut or tear the film.
  5. Before applying the film:
    1. Rinse your mouth with water to moisten the area, especially if you have recently eaten or drank something other than water OR
    2. Use your tongue to wet the inside of your cheek.
  6. Hold the film with a clean, dry finger with the yellow side facing up (Figure 3).
  7. Using your finger, place the yellow side of the film against the inside of the moistened cheek. Avoid placing the film under your tongue. Press and hold the film in place for 5 seconds (Figure 4) and then take your finger away.
  8. The film will stick to the inside of your cheek (Figure 5).
  9. Leave the film in place until it has completely dissolved – usually within 30 minutes after you apply it.
    • Avoid eating or drinking until it has dissolved.
    • Avoid touching or moving the film with your tongue or finger.
    • Do not chew or swallow the film.

Questions and Answers about using the BELBUCA film:

  1. Is it safe to touch the yellow side of the BELBUCA film?

    When using BELBUCA, your finger should not come in contact with the yellow side of film. If this happens, immediately turn the film over to make sure you only touch the white side

  2. What if I can’t get the BELBUCA film out of the pouch?

    Cut along the top or bottom of the pouch. Try not to cut or damage the film. You can then peel back the pouch to access the film.

  3. What should I do if I cut or damage the BELBUCA film?

    Do not apply BELBUCA if the film is cut or damaged. If you cut or damage the film, place the damaged film back in its pouch and keep it in a safe place until it can be returned to the pharmacy for disposal.

  4. Can I wet my finger to pick up the BELBUCA film?

    Do not wet your finger to pick up the film. It will affect the way it works to relieve your pain. Always hold the film with clean, dry fingers with the yellow side facing up.

  5. Is there a specific place I should put the BELBUCA film in my mouth – deep, low, high or in the middle of my cheek?

    You can choose where to place the film on the inside of your cheek: deep, high, low or in the middle. Just make sure that the inside of your cheek is moistened.

  6. What should I do if I swallow the BELBUCA film?

    If you swallow your film, wait for 12 hours before applying another film. You may use acetaminophen to help with your pain, if necessary. Call your doctor or pharmacist with any further questions or concerns.

  7. What should I do if the BELBUCA film folds over while it is stuck to my cheek?

    Remove the film if it folds and does not stick to your cheek. Wait for 12 hours before applying another film. You may use acetaminophen to help with your pain, if necessary. Call your doctor or pharmacist with any further questions or concerns.

  8. The BELBUCA film is moving around in my mouth – what should I do?

    If the film moves, hold it in place for 5 seconds on your cheek by using your tongue or a dry, clean forefinger. If the film does not stick to your cheek, remove it and wait for 12 hours before applying another film. You may use acetaminophen to help with your pain, if necessary. Call your doctor or pharmacist with any further questions or concerns.

Stopping your Medication:

You should not stop taking BELBUCA all at once if you have been taking it for more than a few days.

Your doctor will monitor and guide you on how to slowly stop taking BELBUCA. You should do it slowly to avoid uncomfortable symptoms such as having:

  • 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 with sleeping
  • an unusual increase in sweating
  • heart palpitations
  • an unexplained fever
  • weakness
  • yawning.

By reducing or stopping your opioid treatment, your body will become less used to opioids. If you start treatment again, you will need to start at the lowest dose. You may overdose if you restart at the last dose you took before you slowly stopped taking BELBUCA.

Refilling Prescriptions for BELBUCA

A new written prescription is required from your doctor each time you need more BELBUCA. 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 your pain management.

Overdose

If you think you have taken too much BELBUCA, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Signs of overdose may include:

  • abnormally slow or weak breathing
  • dizziness
  • confusion
  • extreme drowsiness
  • tiredness
  • nausea
  • vomiting
  • narrowed pupils

Missed Dose

It is important that you do not miss any doses. If you miss a dose, take your next dose at your usual time. Do not take two doses at once. If you miss several doses in a row, talk to your doctor before restarting your medication.

Discontinuation:
If you have been taking BELBUCA for more than a few days, don’t stop taking it all at once. That may cause withdrawal symptoms or other side effects. Your doctor will tell you the best way for you to stop taking it.

Refilling Prescriptions for BELBUCA:
You will need a new written prescription from your doctor each time you need more BELBUCA. It is important that you contact your doctor before your current supply runs out.

Side effects and what to do about them

These are not all the possible side effects you may feel when taking BELBUCA. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

  • Nausea
  • Constipation
  • Headache
  • Dizziness
  • Diarrhea
  • Vomiting
  • Sleepiness
  • Tiredness
  • Less appetite
  • Muscle cramps
  • Itching
  • Sweating
  • Dry mouth
  • Low sex drive, impotence (erectile dysfunction), infertility

Serious side effects and what to do about them
Symptom / effect Talk to your healthcare professional Only if severe Talk to your healthcare professional In all cases Stop taking drug and get immediate medical help
COMMON
Fast, Slow or Irregular Heartbeat: heart palpitations, dizziness, chest pain or discomfort, rapid, fluttering or pounding heart, fainting, seizures.   ✔  
RARE
Overdose: hallucinations, confusion, inability to walk normally, slow or weak breathing, extreme sleepiness, sedation, or dizziness, floppy muscles/low muscle tone, cold and clammy skin     ✔
Respiratory Depression: slow, shallow or weak breathing     ✔
Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing     ✔
Bowel Blockage (impaction): abdominal pain, severe constipation, nausea     ✔
Withdrawal nausea, vomiting, diarrhea, anxiety, shivering, cold and clammy skin, body aches, loss of appetite, sweating   ✔  
Low Blood Pressure: dizziness, fainting, light-headedness ✔    
Jaundice: your skin or the white part of your eyes look yellow   ✔  
Serotonin Syndrome: agitation or restlessness, loss of muscle control or muscle twitching, tremor diarrhea     ✔

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.

How to store
  • Keep unused or expired BELBUCA in a secure place to prevent theft, misuse or accidental exposure.
  • Store between 15° and 30 °C.
  • Keep BELBUCA in its protective pouch until you are ready to use it.
  • Keep BELBUCA under lock and out of sight and reach of children and pets. If a child accidentally takes BELBUCA, get emergency help right away.
  • Expired or unused BELBUCA should never be thrown into the household trash, where children and pets may find it. It should be returned to a pharmacy for proper disposal.
Reporting side effects

We encourage you to report serious or unexpected side effects to Health Canada. The information is used to check for new safety concerns about health products. As a consumer, your report contributes to the safe use of health products for everyone.
3 ways to report:

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

This leaflet was prepared by Purdue Pharma.

Last Revised: February 15, 2018

BELBUCA® is a registered trademark of BioDelivery Sciences International, Inc., used with permission by Purdue Pharma.

Date modified: