Patient Medication Information: uses, side effects, how to take - Nucynta Ir

Serious warnings and precautions box

Even if you take NUCYNTA IR as prescribed, you are at a risk for opioid addiction, abuse and misuse. This can lead to overdose and death. Your healthcare professional will only prescribe NUCYNTA IR 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 IR 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 IR, 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 IR. They could die from taking it. If a person has not been prescribed NUCYNTA IR, taking even one dose can cause a fatal overdose. This is especially true for children.
If you took NUCYNTA IR 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 IR can lead to dangerous unwanted effects, serious injury, or even death. You should avoid taking alcoholic beverages or medications containing alcohol while on NUCYNTA IR therapy.
Taking NUCYNTA IR 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 IR if you are taking other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants.

What NUCYNTA IR is used for:

NUCYNTA IR is used in adults to manage moderate to severe acute pain.

How NUCYNTA IR works:

NUCYNTA IR 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 IR are:

Medicinal ingredient: tapentadol hydrochloride

Non-medicinal ingredients: croscarmellose sodium, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, polyvinyl alcohol, talc, titanium dioxide

NUCYNTA IR comes in the following dosage form:

Immediate-Release Tablets: 50 mg, 75 mg and 100 mg of tapentadol (as tapentadol hydrochloride)

Do not use NUCYNTA IR if:

your healthcare professional did not prescribe it for you
you are allergic to tapentadol, to opioids, to any of the other ingredients in NUCYNTA IR, or to any component of the container
you can control your pain by the occasional use of other pain medications. This includes those available without a prescription
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 have severe central nervous system (CNS) depression
you suffer from alcoholism or have delirium tremens
you are taking or have taken within the past 14 days a Monoamine Oxidase inhibitor (MAOi; such as phenelzine sulphate, tranylcypromine sulphate, moclobemide or selegiline)
you have severe kidney or liver problems
you are pregnant or are in labour
you are breastfeeding

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take NUCYNTA IR. 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 low blood volume or low blood pressure
have heart problems
have past or current depression
suffer from chronic or severe constipation
have or had breathing problems (e.g., slow, fast, or shallow breathing)
have or had brain problems (e.g., tumour, 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
suffer from migraines
have or had lung problems
have or had pancreas problems (e.g., pancreatitis)
have or had liver problems
have urinary problems or problems with your adrenal or prostate gland
have had serious allergic reactions to other medications (e.g., anaphylaxis)
have, or had in the past, hallucinations or other severe mental problems
have had an operation within the last 24 hours, are planning to undergo an operation within the next 24 hours or are planning to undergo an anesthetic procedure
have sleep-related breathing disorders (e.g., central sleep apnea)
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 IR while pregnant, nursing, during labour, or delivery. Opioids can be transferred to your baby through breast milk, or while still in the womb. NUCYNTA IR 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 IR. NUCYNTA IR can cause:

drowsiness
dizziness or
lightheadedness

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 IR.

Serotonin toxicity (also known as Serotonin Syndrome): NUCYNTA IR 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 IR 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 IR, or converting from NUCYNTA IR 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 IR.

Seizures: NUCYNTA IR 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 IR.

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 IR include:

monoamine oxidase inhibitors (MAOIs), which are used to treat depression. Do not take NUCYNTA IR 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; o

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 IR. 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 IR:

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 IR:

NUCYNTA IR is usually taken every 4-6 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 IR is for oral use only. You may take the tablets with or without food.
Always swallow NUCYNTA IR 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 tailored/personalized just for you. Be sure to follow your healthcare professional’s dosing instructions exactly. Do not increase, decrease your dose, or stop without consulting your healthcare professional.

Your healthcare professional will prescribe the lowest dose that works to control your pain. It is recommended that you only take NUCYNTA IR for up to 7 days. If you need to take NUCYNTA IR for longer, your healthcare professional will determine the best dose for you to lower the risk of side effects and overdose. Higher doses can lead to more side effects and a greater chance of overdose or death.

Review your pain regularly with your healthcare professional to determine if you still need NUCYNTA IR. Be sure to use NUCYNTA IR 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 IR, tell your healthcare professional immediately.

Stopping your Medication:

If you have been taking NUCYNTA IR 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 IR.

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
a rapid heart rate (tachycardia)
trouble 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 IR.

Refilling your prescription for NUCYNTA IR:

A new written prescription is required from your healthcare professional each time you need more NUCYNTA IR. 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 healthcare professionals 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
floppy muscles/low muscle tone
pin-point pupils
pneumonia aspiration
slow heart beat
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 IR. 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 IR, 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 IR:

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

Like all medicines, NUCYNTA IR may cause unwanted effects, although not everybody gets them. Some of these effects are on the nervous system and some are outside of the nervous system. NUCYNTA IR can cause serious side effects including life-threatening breathing problems.

Side effects may include:

drowsiness
insomnia (difficult to fall asleep and/or stay asleep)
dizziness
nausea, vomiting, or a 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 IR.

Serious side effects and what to do about them

Frequency/Side Effect/Symptom	Talk to your healthcare professional
Only if severe	In all cases
Rare
Overdose: hallucinations, confusion, inability to walk normally, slow or weak breathing, extreme sleepiness, sedation, dizziness, floppy muscles/low muscle tone, cold and clammy skin, slow heartbeat, disturbed consciousness, convulsion		√
Respiratory Depression (hypoventilation): slow, shallow or weak breathing, blue lips		√
Allergic Reaction: rash, hives, swelling of the face, lips, tongue or throat, difficulty swallowing or breathing, wheezing, drop in blood pressure, feeling sick to your stomach and throwing up		√

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.

Frequency/Side Effect/Symptom	Talk to your healthcare professional	Get immediate medical help
Only if severe	In all cases
Bowel Blockage (impaction): abdominal pain, severe constipation, nausea, vomiting, liquid stool, urge to move bowels, poor appetite, weight loss, malaise			√
Withdrawal: nausea, vomiting, diarrhea, anxiety, shivering, cold and clammy skin, body aches, loss of appetite, sweating		√
Cardiac arrhythmias: fast, slow or irregular heartbeat, heart palpitations, shortness of breath		√
Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, fatigue (may occur when you go from lying or sitting to standing up)	√
Serotonin toxicity (also known as serotonin syndrome): a reaction which may cause feelings of agitation or restlessness, flushing, muscle twitching, involuntary eye movements, heavy sweating, high body temperature (>38 °C), or rigid muscles, coordination problems, uncontrolled muscle spasms, shaking, shivering, racing or fast heartbeat, high or low blood pressure, fever, nausea, vomiting, diarrhea, tremor, coma, loss of muscle control			√

Storage:

Store NUCYNTA IR at room temperature (15^oC to 30^oC).
Keep unused or expired NUCYNTA IR in a secure place to prevent theft, misuse, or accidental exposure.
Keep NUCYNTA IR 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 IR, get emergency help right away.

Do not use NUCYNTA IR after the expiry date.

Disposal:

Never throw NUCYNTA IR 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 IR:

Talk to your healthcare professional
Find the full Product Monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); manufacturer’s website (https://knighttx.com), by emailing medinfo@knighttx.com, or by calling 1-844-483-5636.

Nucynta Ir: Uses, Side Effects and Dosage