Patient Medication Information: uses, side effects, how to take - Teva-Buprenorphine/Naloxone
Serious Warnings and Precautions
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What is Teva-Buprenorphine/Naloxone used for?
- Teva-Buprenorphine/Naloxone is part of a medical, social and psychological treatment program for adults undergoing substitution treatment for problematic opioid drug dependence.
Treatment with Teva-Buprenorphine/Naloxone is intended for use in adults (18 years of age or older) and is voluntary.
Only a qualified doctor can prescribe Teva-Buprenorphine/Naloxone. The dose of Teva-Buprenorphine/Naloxone needs to be taken under the daily supervision of a healthcare professional until you are clinically stable and able to safely store Teva-Buprenorphine/Naloxone take-home doses.
How does Teva-Buprenorphine/Naloxone work?
Buprenorphine, a component of Teva-Buprenorphine/Naloxone, works in the brain as other opioid drugs (e.g. morphine, methadone). If you are in withdrawal from opioid drugs, Teva-
Buprenorphine/Naloxone will stop the feelings of withdrawal.
Teva-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 Teva-Buprenorphine/Naloxone to stop people from injecting (“shooting-up”) Teva-Buprenorphine/Naloxone. When you use Teva-Buprenorphine/Naloxone under your tongue as prescribed, the naloxone in Teva-Buprenorphine/Naloxone should not stop the medicine’s effects. However, if you inject Teva-Buprenorphine/Naloxone, the naloxone can give you withdrawal symptoms.
What are the ingredients in Teva-Buprenorphine/Naloxone?
Medicinal ingredients: buprenorphine / naloxone
Non-medicinal ingredients: citric acid, crospovidone, lactose monohydrate, magnesium stearate, mannitol, natural & artificial lemon flavor, povidone, pregelatinized starch, sodium citrate, and sucralose.
Teva-Buprenorphine/Naloxone comes in the following dosage forms:
Tablets:
- 2 mg / 0.5 mg
- 8 mg / 2 mg
Do not use Teva-Buprenorphine/Naloxone if:
- your doctor did not prescribe it for you
- you are allergic to buprenorphine, naloxone, or to any of the ingredients in Teva-Buprenorphine/Naloxone
- you have never taken opioids before
- you have severe asthma, trouble breathing, or other lung problems
- you have serious problems with your liver
you suffer from alcoholism or alcohol withdrawal
- you have bowel blockage or narrowing of the stomach or intestines
- you have severe pain in your abdomen
- you have increased pressure in your skull or a head injury
- you suffer from convulsive or seizure disorder
- 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 planned surgery
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Teva-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 a history or a family history of heart problems
- have low or decrease in blood pressure
- have past or current depression
- suffer from chronic or severe constipation
- have gallbladder or pancreas problems
- have adrenal gland problems, such as Addison’s disease
- have low thyroid hormone levels (hypothyroidism)
- are a man and have urinary disorders (especially linked to enlarged prostate)
- are pregnant/breastfeeding or are planning to become pregnant or to breastfeed
- have difficulty urinating
- have a curve in your spine that affects your breathing
- have severe mental problems or hallucinations (seeing or hearing things that are not there)
- suffer from migraines
Other warnings you should know about:
Driving and using machines: Teva-Buprenorphine/Naloxone can cause you to feel drowsy, dizzy, or light-headed. This usually occurs after you take your first dose, or when your dose is increased. Before you do tasks which require special attention, you should wait until you know how you react to Teva-Buprenorphine/Naloxone.
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”.
Dependence: Teva-Buprenorphine/Naloxone can cause opioid drug dependence and opioid withdrawal signs and symptoms may occur when the medication is discontinued. You should discuss with your doctor if you want to stop taking Teva-Buprenorphine/Naloxone.
Pregnancy, nursing, labour and delivery: Opioids can be transferred to your baby through breast milk, or while still in the womb. Teva-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 Teva-Buprenorphine/Naloxone, outweigh the risks to your unborn baby or nursing infant.
If you are pregnant and are taking Teva-Buprenorphine/Naloxone, it is important that you don’t stop taking your medication suddenly. If you do, it can cause a miscarriage or a still-birth. If you choose to stop Teva-Buprenorphine/Naloxone treatment while pregnant, talk to your doctor for guidance. Your doctor will monitor and guide you on how to slowly stop taking Teva-
Buprenorphine/Naloxone. This may help avoid serious harm to your unborn baby. It is important that you continue to see the healthcare professional that prescribed you Teva-Buprenorphine/Naloxone in order to prevent relapse to opioid use and to reinstate Teva-Buprenorphine/Naloxone at an adjusted dose if required. Teva-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 Teva-Buprenorphine/Naloxone at a safe dose.
Disorder of the adrenal gland: You may develop 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 Teva-Buprenorphine/Naloxone.
Serotonin Toxicity (also known as Serotonin Syndrome): Teva-Buprenorphine/Naloxone 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. You may develop serotonin toxicity if you take Teva-Buprenorphine/Naloxone with certain anti-depressants or migraine medications.
Serotonin toxicity 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 and 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 and laboratory tests: Your healthcare professional should do liver function tests before you start treatment and during your treatment with Teva-Buprenorphine/Naloxone.
Heart problems: Teva-Buprenorphine/Naloxone can cause problems with your heart rhythm called QTc prolongation. You may have no symptoms, or you may have dizziness, feeling like your heart has skipped or added a beat, fainting or seizures. If these symptoms continue, they can lead to sudden death. You may be more at risk if you have had or have:
- a heart attack
- congestive heart failure
- an irregular heartbeat or heart rhythm
- a blockage in one or more of your arteries that affects blood flow to your heart
- an abnormally rapid heart rate
- heart palpitations (feeling like your heart has skipped a beat or added an extra beat)
- a family history of sudden cardiac death at less than 50 years of age
- problems of electrocardiogram (ECG) abnormality called “Long QT syndrome”
- diabetes
- imbalances in the electrolytes in your body (potassium, magnesium and calcium)
Dental Problems: Some people taking Teva-Buprenorphine/Naloxone have experienced dental problems such as cavities, tooth decay, dental infection, fillings falling out and/or tooth loss. You should have regular dental check-ups. If you have any problems with your teeth tell your healthcare professional and schedule an appointment with a dentist right away. Tell your dentist that you are taking Teva-Buprenorphine/Naloxone.
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 Teva-Buprenorphine/Naloxone:
- opioid analgesics (drugs used to treat pain)
- general anesthetics (drugs used during surgery)
- antidepressants (for depression and mood disorders). Do not take Teva-Buprenorphine/Naloxone with (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 (e.g., baclofen)
- pregabalin, used to treat nerve pain
- gabapentin, used to prevent and control seizures in the treatment of epilepsy
- anti-retroviral drugs (used to treat certain viral infections)
Serious Drug Interactions Taking:
while you are on Teva-Buprenorphine/Naloxone treatment can cause severe drowsiness, breathing problems, coma, and death. |
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- 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
Taking Teva-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 Teva-Buprenorphine/Naloxone if they are treating you for pain.
How to take Teva-Buprenorphine/Naloxone:
Take exactly as directed and follow the instructions below. As with other narcotics, serious harm or death can result from misusing Teva-Buprenorphine/Naloxone.
Teva-Buprenorphine/Naloxone must be placed under the tongue until dissolved. Do not cut, break, crush, chew or swallow Teva-Buprenorphine/Naloxone or take it any other way than directed by your doctor 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 Teva-Buprenorphine/Naloxone to treat your opioid dependence.
Place the appropriate number of Teva-Buprenorphine/Naloxone tablets under your tongue and allow them to dissolve. Do not swallow the tablets. The sublingual route (under your tongue) is the only effective way to take Teva-Buprenorphine/Naloxone tablet.
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 separate them into two portions and place them one after the other.
After Teva-Buprenorphine/Naloxone is completely dissolved, rinse your mouth with water and swallow. Wait for at least one hour before brushing your teeth.
Usual 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 Teva-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 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 until you eventually stop the treatment, if your condition allows it.
Do not change the treatment in any way or stop treatment without the agreement of the doctor who is treating you. Stopping treatment suddenly may cause withdrawal symptoms.
Stopping your Medication
If you have been taking Teva-Buprenorphine/Naloxone for more than a few days, you should not stop taking it suddenly. Your doctor will monitor and guide you on how to slowly stop taking Teva-Buprenorphine/Naloxone.
You should do it slowly to reduce the occurrence of withdrawal symptoms such as:
- body aches
- diarrhea
- goosebumps
- loss of appetite or nausea
- feeling nervous or restless
- runny nose
- sneezing
- tremors or shivering
- stomach cramps
- heart palpitations or rapid heart rate
- having trouble sleeping
- an unusual increase in sweating
- an unexplained fever
- weakness
- yawning
By reducing or stopping your Teva-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 Teva-Buprenorphine/Naloxone.
Overdose:
Signs of overdose may include:
- unusually slow or weak breathing
- dizziness
- confusion
- extreme drowsiness
If you think you, or a person you are caring for, have taken too much Teva-Buprenorphine/Naloxone, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
Missed 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 Teva-Buprenorphine/Naloxone, contact your pharmacist or prescribing doctor as soon as possible.
Refilling Prescriptions for Teva-Buprenorphine/Naloxone:
A new written prescription is required from your doctor each time you need more Teva-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 Teva-Buprenorphine/Naloxone?
These are not all the possible side effects you may have when taking Teva-Buprenorphine/Naloxone. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- Headache, drowsiness, or dizziness
- Insomnia
- Nausea, vomiting, or poor appetite
- Dry mouth
- Problems with vision
- Weakness
- Sweating
- Constipation, or stomach pain
- Pain, or itching
- Low sex drive, impotence (erectile dysfunction), infertility
Talk with your doctor or pharmacist about ways to prevent constipation when you start using Teva-Buprenorphine/Naloxone.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||||
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| Only if severe | In all cases | |||||
| COMMON | ||||||
| Chest pain | ✓ | |||||
| Feeling depressed | ✓ | |||||
| Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing | ✓ | |||||
| Wheezing | ✓ | |||||
| UNCOMMON | ||||||
| Convulsion or seizure | ✓ | |||||
| Dark urine | ✓ | |||||
| Hypotension (Low blood pressure): dizziness, fainting, light-headedness | ✓ | |||||
| Hallucination: seeing or hearing things that are not really there | ✓ | |||||
| High blood sugar symptoms such as dry mouth, increased hunger, thirst, frequent urination | ✓ | |||||
| Jaundice (your skin or the white part of your eyes look yellow) | ✓ | |||||
| Light coloured stools | ✓ | |||||
| Low blood sugar symptoms such as feeling faint, dizzy, confused | ✓ | |||||
| RARE | ||||||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | ||||
|---|---|---|---|---|---|---|
| Only if severe | In all cases | |||||
| 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. | ✓ | |||||
| Bowel Blockage (impaction): abdominal pain, severe constipation, nausea | ✓ | |||||
| Withdrawal: nausea, vomiting, diarrhea, anxiety, shivering, cold and clammy skin, body aches, loss of appetite, sweating. | ✓ | |||||
| Fast, Slow or Irregular Heartbeat: heart palpitations. | ✓ | |||||
| 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, 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 health 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:
- Keep unused or expired Teva-Buprenorphine/Naloxone in a secure place to prevent theft, misuse or accidental exposure.
- Store between 15oC to 30oC.
- Keep Teva-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 Teva-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:
Teva-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 Teva-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://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.