Nucynta Extended-Release: Uses, Side Effects and Dosage

Serious warnings and precautions box

• Even if you take NUCYNTA EXTENDED-RELEASE as prescribed, you are at risk for opioid addiction, abuse and misuse. This can lead to overdose and death. Your healthcare professional will only prescribe NUCYNTA EXTENDED-RELEASE if other non-opioid treatment options are not effective to manage your pain. To understand your risk of opioid addiction, abuse, and misuse, you should speak to your healthcare professional.
• When you take NUCYNTA EXTENDED-RELEASE it must be swallowed whole. Do not cut, break, crush, chew or dissolve the tablet. This can be dangerous and can lead to death or seriously harm you.
• You may get life-threatening breathing problems while taking NUCYNTA EXTENDED-RELEASE, especially if not taken as directed. This is less likely to happen if you take it as prescribed by your healthcare professional. Babies are at risk of life-threatening breathing problems if their mothers take opioids while pregnant or nursing.
• You should never give anyone your NUCYNTA EXTENDED-RELEASE. They could die from taking it. If a person has not been prescribed NUCYNTA EXTENDED-RELEASE, taking even one dose can cause a fatal overdose. This is especially true for children.

• If you took NUCYNTA EXTENDED-RELEASE 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 alcohol with NUCYNTA EXTENDED-RELEASE can lead to dangerous unwanted effects, serious injury, or even death. You should avoid taking alcoholic beverages or medications containing alcohol while on NUCYNTA EXTENDED-RELEASE therapy.
• Taking NUCYNTA EXTENDED-RELEASE 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. You should avoid taking NUCYNTA

What NUCYNTA EXTENDED-RELEASE is used for:

NUCYNTA EXTENDED-RELEASE is used in adults to manage pain when:

• the pain is severe enough to require daily, continuous, long-term opioid treatment, and
• other treatment options are not able to effectively treat your pain.

NUCYNTA EXTENDED-RELEASE is NOT used “as needed” to treat pain that you only have once in a while.

How NUCYNTA EXTENDED-RELEASE works:

NUCYNTA EXTENDED-RELEASE is a painkiller belonging to the class of drugs known as opioids. It relieves pain by acting on specific nerve cells of the spinal cord and brain.

The ingredients in NUCYNTA EXTENDED-RELEASE are:

Medicinal ingredient: tapentadol hydrochloride

Non-medicinal ingredients: Ammonium hydroxide, black iron oxide (50 mg, 100 mg, 150 mg, 200 mg tablets), butyl alcohol, butylated hydroxytoluene, FD&C blue #2 aluminum lake (100 mg, 150 mg, 200 mg, and 250 mg tablets), hypromellose, isopropyl alcohol, polyethylene glycol, polyethylene oxide, polyvinyl alcohol, propylene glycol, shellac glaze, talc, titanium dioxide, vitamin E, yellow iron oxide (150 mg tablets).

NUCYNTA EXTENDED-RELEASE comes in the following dosage form:

Extended-Release Tablets: 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg of tapentadol (as tapentadol hydrochloride)

Do not use NUCYNTA EXTENDED-RELEASE if:

• your healthcare professional did not prescribe it for you
• you are allergic to tapentadol, to opioids, to any of the other ingredients of NUCYNTA EXTENDED-RELEASE, or to any component of the container
• you have mild or short term pain or you can control your pain by the occasional use of other pain medications. This includes those available without a prescription.
• you are going to have, or recently had, a planned surgery
• you have severe asthma, trouble breathing or any breathing problems
• you have bowel blockage, problems that affect bowel movement (e.g., ileus of any type) or narrowing of the stomach or intestines
• you have severe pain in your abdomen (e.g., acute appendicitis or pancreatitis)
• you have a head injury or problem (e.g., increased pressure in the brain or disturbed consciousness)
• you are at risk for seizures or have convulsive disorders
• you suffer from alcoholism or have delirium tremens
• you are pregnant or are in labour
• you are breastfeeding
• you are taking or have taken within the past 14 days a monoamine oxidase inhibitor (MAOI); certain medicines used for treatment of depression
• you have severe kidney or liver problems

• you have severe central nervous system (CNS) depression

  • EXTENDED-RELEASE if you are taking other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants.

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

• have a history of using illicit or prescription drug or alcohol abuse
• are drinking or planning to drink alcoholic beverages or take medications that contain alcohol
• have or had severe lung problems
• have or had liver problems
• have heart problems
• have low blood volume or low blood pressure
• have past or current depression
• suffer from chronic or severe constipation
• have or had pancreas problems (e.g., pancreatitis)
• have or had breathing problems (e.g., slow, fast, or shallow breathing)
• have or had brain problems (e.g., brain tumours, stroke, transient ischemic attack, brain neoplasm or severe traumatic brain injury)
• have had an epileptic fits or seizures, or are at a higher risk of developing these
• have had serious allergic reactions to other medications (e.g., anaphylaxis)
• suffer from migraines
• have adrenal problems
• have sleep-related breathing disorders (e.g., central sleep apnea)
• are planning to undergo an anesthetic procedure
• have an underactive thyroid (hypothyroidism) or severe hypothyroidism (myxedema)
• are planning to become pregnant or to breastfeed

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 healthcare professional if you have questions or concerns about abuse, addiction or physical dependence.

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

Driving and using machines: Before you do tasks which may require special attention, you should wait until you know how you react to NUCYNTA EXTENDED-RELEASE. NUCYNTA EXTENDED-RELEASE 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 healthcare professional may do tests, give you another medication, and slowly take you off NUCYNTA EXTENDED-RELEASE.

Serotonin toxicity (also known as Serotonin Syndrome): NUCYNTA EXTENDED-RELEASE 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 NUCYNTA EXTENDED-RELEASE 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.

Opioid withdrawal symptoms: If you are converting from a previous opioid analgesic to NUCYNTA EXTENDED-RELEASE, or converting from NUCYNTA EXTENDED-RELEASE to another opioid, you may experience opioid withdrawal symptoms. The symptoms may include: nausea, vomiting, diarrhea, anxiety and shivering. Contact your healthcare professional if you experience these symptoms when switching to or from NUCYNTA EXTENDED-RELEASE.

Seizures: NUCYNTA EXTENDED-RELEASE can cause seizures, especially if you are at a higher risk for seizures or have epilepsy. Tell your healthcare professional if you have a seizure. They will stop your treatment accordingly.

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.

Sleep apnea: Opioids can cause sleep-related breathing disorders such as sleep apnea syndromes (including central sleep apnea [CSA]) and hypoxia (including sleep-related hypoxia). Tell your healthcare professional if you have a history of sleep apnea, or if anyone notices that you stop breathing from time to time while sleeping.

Worsening pain: Taking opioids for pain can sometimes have the unintended effect of making your pain feel worse (opioid-induced hyperalgesia) even though your opioid dose has been unchanged or increased. This can also include feeling pain in new places in your body, or feeling pain from something that would not normally hurt, for example, feeling pain from clothing touching your skin. Tell your healthcare professional if you notice a change like this in your pain while you are taking NUCYNTA EXTENDED-RELEASE.

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

Serious drug interactions:

Serious drug interactions with NUCYNTA EXTENDED-RELEASE include:

• monoamine oxidase inhibitors (MAOIs), which are used to treat depression. Do not take NUCYNTA EXTENDED-RELEASE with MAOIs, or if you have taken MAOIs in the last 14 days.
• benzodiazepines (drugs used to help you sleep or that help reduce anxiety)

• central nervous system (CNS) depressants used to slow down the nervous system. These can include:

  • other opioids used to relieve pain;
  • hypnotics used to help with sleeping;
  • antidepressants used for depression and mood disorders (including St. John’s Wort);
  • tranquilizers, and phenothiazines used to treat mental or emotional disorders;
  • muscle relaxants used to treat muscle spasms and back pain (e.g., baclofen);
  • antipsychotics and neuroleptics used to treat mental health disorders;
  • antihistamines used to treat allergies;
  • antiemetics used to prevent nausea or vomiting;
  • cough medicines containing opioids such as codeine;
  • sedatives which may enhance the drowsiness;
  • pregabalin, used to treat nerve pain;
  • gabapentin, used to prevent and control seizures in the treatment of epilepsy;
  • beta blockers used to lower blood pressure.
  • alcohol. This includes prescription and non-prescription medications that contain alcohol. Do not drink alcohol while you are taking NUCYNTA EXTENDED-RELEASE. It can lead to drowsiness, unusually slow or weak breathing, serious side effects, or a fatal overdose.

If you are unsure about any of the medications you take, talk to your healthcare professional.

The following may also interact with NUCYNTA EXTENDED-RELEASE:

• medications used to treat migraines (e.g., triptans)
• medications known as anticholinergic drugs (e.g., oxybutynin, ipratropium bromide, tiotropium, and carbamazepine)

How to take NUCYNTA EXTENDED-RELEASE:

• NUCYNTA EXTENDED-RELEASE is usually taken twice daily, approximately every 12 hours.
• Your healthcare professional may prescribe a different, more appropriate dose or interval of dosing, if this is necessary for you. If you feel that the effect of these tablets is too strong or too weak, talk to your healthcare professional or pharmacist.

• NUCYNTA EXTENDED-RELEASE is for oral use only. You may take the tablets with or without food.

• Always swallow NUCYNTA EXTENDED-RELEASE tablets whole with sufficient liquid.
• Swallow whole. Do not cut, break, crush, chew or dissolve the tablet. This can be dangerous and can lead to death or seriously harm you.

Usual dose:

Your dose is personalized just for you. Be sure to follow your healthcare professional’s dosing instructions exactly. Do not increase, decrease, or stop your dose without consulting your healthcare professional.

Your healthcare professional will prescribe the lowest dose that works to control your pain. The usual dose is one tablet every 12 hours. Taking higher doses can lead to more side effects and a greater chance of overdose or death.

Your healthcare professional may prescribe a different, more appropriate dose or interval of dosing, if this is necessary for you. If you feel that the effect of these tablets is too strong or too weak, talk to your healthcare professional or pharmacist.

Review your pain regularly with your healthcare professional to determine if you still need NUCYNTA EXTENDED-RELEASE. Be sure to use NUCYNTA EXTENDED-RELEASE only for the condition for which it was prescribed.

If your pain increases or you develop any side effects as a result of taking NUCYNTA EXTENDED-RELEASE, tell your healthcare professional immediately.

Stopping your Medication:

If you have been taking NUCYNTA EXTENDED-RELEASE for more than a few days you should not stop taking it all of a sudden. Your healthcare professional will monitor and guide you on how to slowly stop taking NUCYNTA EXTENDED-RELEASE.

You should do it slowly to avoid uncomfortable symptoms such as having:

• body aches
• diarrhea
• goosebump
• a loss of appetite
• nausea
• a feeling of nervousness or restlessness
• a runny nose or sneezing

• tremors or shivering

  • stomach cramps
  • rapid heart rate (tachycardia)
  • 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 more sensitive 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 NUCYNTA EXTENDED-RELEASE.

Refilling your prescription for NUCYNTA EXTENDED-RELEASE:

A new written prescription is required from your healthcare professional each time you need more NUCYNTA EXTENDED-RELEASE. Therefore, it is important that you contact your healthcare professional before your current supply runs out.

Only obtain prescriptions for this medicine from the healthcare professional in charge of your treatment. Do not seek prescriptions from other doctors unless you switch to another healthcare professional for your pain management.

Overdose:

Signs of overdose may include:

• brain damage
• cold and clammy skin
• confusion
• convulsions
• death
• disturbed consciousness or coma (deep unconsciousness)
• dizziness
• drop in blood pressure and loss of consciousness
• extreme drowsiness
• pin-point pupils
• pneumonia aspiration
• respiratory depression up to respiratory arrest
• slow heart beat
• skeletal muscle flaccidity
• toxic leukoencephalopathy (a brain disorder affecting the brain’s white matter)
• unusually slow or weak breathing
• vomiting

It is recommended to have naloxone available if you are taking NUCYNTA EXTENDED-RELEASE. If an overdose occurs, another person will need to give it to you. They should call 911 as soon as possible and follow the instructions provided with the naloxone product.

If you think you, or a person you are caring for, have taken too much NUCYNTA EXTENDED-RELEASE, contact a healthcare professional, hospital emergency department, or regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

Missed dose:

If you miss one dose, 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. If you miss several doses in a row, talk to your healthcare professional before restarting your medication.

Possible side effects from using NUCYNTA EXTENDED-RELEASE:

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

Side effects may include:

• drowsiness
• insomnia (difficult to fall asleep and/or stay asleep)
• dizziness
• nausea, vomiting, poor appetite, dry mouth
• headache
• problems with vision
• weakness, fatigue
• uncoordinated muscle movement
• itching
• constipation
• low sex drive (libido)
• impotence (erectile dysfunction)
• infertility

Talk with your healthcare professional or pharmacist about ways to prevent constipation when you start using NUCYNTA EXTENDED-RELEASE.

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

You can report any suspected side effects associated with the use of health products to Health Canada by:

• Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

• Store at room temperature (15°C to 30°C). Keep in a dry place.
• Keep unused or expired NUCYNTA EXTENDED-RELEASE in a secure place to prevent theft, misuse, or accidental exposure.
• Keep NUCYNTA EXTENDED-RELEASE 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 NUCYNTA EXTENDED-RELEASE, get emergency help right away.
• Do not use NUCYNTA EXTENDED-RELEASE after the expiry date.

Disposal:

Never throw NUCYNTA EXTENDED-RELEASE into household trash, where children and pets may find it. Return any unused or expired medication to a pharmacy for proper disposal.

If you want more information about NUCYNTA EXTENDED-RELEASE:

• 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 (https://knighttx.com), by emailing medinfo@knighttx.com, or by calling 1-844-483-5636.