Patient Medication Information: uses, side effects, how to take - Nucynta CR
Serious Warnings and Precautions
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What is NUCYNTA® CR used for:
NUCYNTA® CR is used for the long-term management of pain, when:
- the pain is severe enough to require daily, around the clock painkillers
- the doctor determines that other treatment options are not able to effectively treat your pain
NUCYNTA® CR is NOT used (“as needed”) to treat pain that you only have once in a while.
How does NUCYNTA® CR work:
NUCYNTA® CR is a painkiller 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 are the ingredients in NUCYNTA® CR:
Medicinal ingredients: tapentadol hydrochloride
Non-medicinal ingredients: Hypromellose, magnesium stearate, polyethylene glycol, polyvinyl alcohol, talc, silicified microcrystalline cellulose, titanium dioxide, FD&C Blue #2 Aluminum Lake (100 mg, 150 mg, 200 mg, and 250 mg tablets), yellow iron oxide (150 mg tablets).
NUCYNTA® CR comes in the following dosage forms:
NUCYNTA® CR is available as controlled-release tablets containing 50 mg, 100 mg, 150 mg, 200 mg and 250 mg tapentadol, as tapentadol hydrochloride.
Do not use NUCYNTA® CR if:
- you are allergic (hypersensitive) to tapentadol or any of the other ingredients of NUCYNTA® CR
- you have acute pain
- your pain can be controlled by occasional use of painkillers including those available without a prescription
- you have severe asthma, trouble breathing or any heart problems
- you have bowel blockage or narrowing of the stomach or intestines
- you have a head injury or other risks for seizures
- you suffer from alcoholism
you are pregnant or plan to be pregnant, in labour or are breast-feeding
- you have paralysis of the gut
- you are also taking MAO inhibitors (certain medicines used for treatment of depression) or have taken them in the last 14 days before treatment with NUCYNTA® CR
- you have severe kidney or liver dysfunction
- you suffer from seizures
- you are under 18 years of age
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take NUCYNTA® CR. 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 severe liver, kidney or heart disease
- have low blood pressure
- have past or current depression
- suffer from chronic or severe constipation
- have problems with your pancreas
- have slow or shallow breathing
- suffer from increased pressure in the brain or disturbed consciousness
- have had a head injury or brain tumours
- have had an epileptic fit, or if you have an increased risk of having epileptic fits
- have had serious allergic reactions to other medications (anaphylaxis)
- are going to have, or recently had planned surgery
Other warnings you should know about:
Driving and using machines: Before you perform tasks which may require special attention, wait until you know how you respond to NUCYNTA® CR. Drowsiness, dizziness or lightheadedness, can especially occur after the first dose and when the dose is increased.
Tell your healthcare professional about all the medications you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with NUCYNTA® CR:
- alcohol, including prescription and non-prescription medication containing alcohol. Do not drink alcohol while taking NUCYNTA® CR. This can lead to drowsiness, depressed breathing, serious side effects or a fatal overdose
- other sedative drugs which may enhance the drowsiness caused by NUCYNTA® CR
- other opioid analgesics (for pain)
- cough medicines containing opioids such as codeine
- general anaesthetics (used during surgery)
- drugs used to help you sleep or to reduce anxiety
- antidepressants (for depression and mood disorders). Do not take NUCYNTA® CR with MAO inhibitors or if you have taken MAO inhibitors in the last 14 days before treatment with NUCYNTA® CR
- other serotonin and norepinephrine re-uptake inhibitors
- triptan medicines
- 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/treatment of blood clots)
- anti-retroviral, anti-fungal and antibiotic drugs
How to take NUCYNTA® CR:
Swallow whole. Do not break, chew, dissolve or crush as it would cause too much drug to be released into your blood at one time and expose yourself to a potentially toxic dose of tapentadol.
Usual Adult Starting dose:
Dosage is individualized. Be sure to follow your doctor’s dosing instructions exactly.
The usual dose is 1 tablet every 12 hours.
Your doctor 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 doctor or pharmacist.
Overdose:
Signs of overdose may include abnormally slow or weak breathing, dizziness, confusion, extreme drowsiness, pin-point pupils, vomiting, drop in blood pressure, fast heart beat, collapse, disturbed consciousness or coma (deep unconsciousness), epileptic fits.
| If you think you have taken too much NUCYNTA® CR, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no 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 succession, talk to your doctor before restarting your medication.
Refilling Prescriptions for NUCYNTA® CR:
A new written prescription is required from your doctor each time you need more NUCYNTA® CR. Therefore, it is important that you contact your doctor before your current supply runs out.
What are the possible side effects from using NUCYNTA® CR?
These are not all the possible side effects you may feel when taking NUCYNTA® CR. If you experience any side effects not listed here, contact your health care professional.
Side effects may include:
- Drowsiness, insomnia
- Dizziness, fainting
- Nausea, vomiting, poor appetite, dry mouth
- Headache
- Problems with vision
- Weakness, uncoordinated muscle movement
- Itching
- Sweating
- Constipation
Talk with your doctor or pharmacist about ways to prevent constipation when you start using NUCYNTA CR.
Seizures NUCYNTA® CR can cause seizures in people who are at risk for seizures or who have epilepsy. Tell your doctor right away if you have a seizure and stop taking NUCYNTA® CR.
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 | |
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 | ✓ | ||
Fast, Slow or Irregular Heartbeat: heart palpitations | ✓ | ||
| Low Blood Pressure: dizziness, fainting, light-headedness | ✓ | ||
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
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:
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect. 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. |
Storage:
Keep unused or expired NUCYNTA® CR in a secure place to prevent theft, misuse or accidental exposure.
Keep NUCYNTA® CR out of the sight and reach of children and pets.
Store NUCYNTA® CR at 15-30°C.
Do not use NUCYNTA® CR after the expiry date.
Disposal:
NUCYNTA® CR 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 NUCYNTA® CR:
- Talk to your healthcare professional
- Find the full Product Monograph that is prepared for health professionals and includes this patient medication information by visiting the Health Canada website, the manufacturer’s website http://www.janssen.ca, or by contacting the sponsor, Janssen Inc., at: 1-800-567-3331 or at: 1-800-387-8781.
Janssen Inc.
Markham, Ontario L3R 0T5