Nucynta

Nucynta is used to manage short-term (acute) pain in adults and children 6 years of age and older who weigh at least 88 pounds (40 kg), when other pain treatments such as non-opioid pain medicines do not treat the pain well enough, or cannot be tolerated.

Nucynta (tapentadol) is a strong, prescription, opioid (narcotic) pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed, you are at risk for opioid addiction, abuse, and misuse that can lead to death.

• Used for short-term pain only. For severe and persistent pain that needs daily opioid treatment over an extended period, Nucynta ER extended-release tablets may be considered by your healthcare provider.

Nucynta is a Schedule II (CII) controlled substance. These are substances with a high potential for abuse but also a currently accepted medical use in treatment in the United States, sometimes with strict limitations. Misuse of these drugs may lead to severe psychological or physical dependence.

• Get emergency help or call 911 right away if you take too much Nucynta (overdose). When you first start taking Nucynta, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose.
• Taking Nucynta with other opioid medicines, benzodiazepines, gabapentinoids (gabapentin or pregabalin), alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
• Accidental ingestion of even one dose of Nucynta, especially by children, can result in a fatal overdose.
• Never give anyone else your Nucynta. They could die from taking it. Selling or giving away Nucynta is against the law.
• Store Nucynta securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Do not take Nucynta if you have:

• severe asthma, trouble breathing, or other lung problems
• a bowel blockage or have a narrowing of your stomach or intestines
• taken a monoamine oxidase inhibitor (MAOI) in the last 14 days.

Before taking Nucynta, tell your healthcare provider if you have a history of:

• head injury, seizures
• problems urinating
• abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems
• liver, kidney, thyroid problems
• pancreas or gallbladder problems.

Tell your healthcare provider if you are:

• noticing your pain getting worse. If your pain gets worse after you take Nucynta, do not take more Nucynta without first talking to your healthcare provider. Tell your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking Nucynta
• pregnant or planning to become pregnant. Prolonged use of Nucynta during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated
• breastfeeding. Nucynta passes into breast milk and may harm your baby. Carefully observe infants for increased sleepiness (more than usual), breathing difficulties, or limpness. Seek immediate medical care if you notice these signs.
• living in a household where there are small children or someone who has abused street or prescription drugs
• taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking Nucynta with certain other medicines can cause serious side effects that could lead to death.

The possible side effects of Nucynta are constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, and abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.

In children 6 years of age and older, the most common side effects are vomiting, constipation, nausea, itching, and fever.

Get emergency medical help or call 911 right away if you have trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

These are not all the possible side effects of Nucynta. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Take Nucynta exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed. Do not change your dose.

• Take your prescribed dose every 4 to 6 hours as needed for pain, at the same time every day. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
• Nucynta can be taken with or without food.
• For acute (short-term) pain, you may only need to take Nucynta for a few days. You may have some tablets left over that you did not use. See the disposal instructions below.
• Call your healthcare provider if the dose you are taking does not control your pain.
• If you have been taking Nucynta regularly, do not stop taking it without talking to your healthcare provider.
• Dispose of expired, unwanted, or unused Nucynta by promptly flushing down the toilet, if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

Avoid driving or operating heavy machinery until you know how Nucynta affects you. Nucynta can make you sleepy, dizzy, or lightheaded.

Do not drink alcohol or use prescription or over-the-counter medicines containing alcohol. Using products containing alcohol during treatment with Nucynta may cause you to overdose and die.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose can be fatal, especially in a child who takes it by accident, or in a person using opioid medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you get naloxone or nalmefene (medicines that reverse an opioid overdose) and keep one with you at all times. A person caring for you can give the medicine if you stop breathing or don't wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep it and how to use it.

Many other drugs can be dangerous when used with opioid medicine. Tell your doctor if you also use:

• medicine for allergies, cough, asthma, motion sickness, irritable bowel, or overactive bladder;
• other opioid medicine;
• a benzodiazepine sedative like Valium, Klonopin, or Xanax;
• gabapentin or pregabalin;
• sleep medicine, muscle relaxers, or other drugs that make you drowsy;
• water pills (diuretics); or
• drugs that affect serotonin, such as antidepressants, stimulants, or medicine for migraines or Parkinson's disease.

Do not take Nucynta if you are taking a monoamine oxidase inhibitor (MAOI), or if you have taken one in the past 14 days. MAOIs include phenelzine, tranylcypromine, and linezolid.

Some opioids, including butorphanol, nalbuphine, pentazocine, and buprenorphine, can reduce the pain relief you get from Nucynta or bring on withdrawal symptoms, and should be avoided.

Taking Nucynta with other opioid medicines, benzodiazepines, gabapentinoids, alcohol, or other medicines that slow the central nervous system can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

This list is not complete, and many other drugs may affect Nucynta. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Active ingredient: tapentadol HCl

Inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone.

Film coating: hypromellose, lactose monohydrate, titanium dioxide, polyethylene glycol, talc, and the colorant FD&C Yellow #6 aluminum lake. The film coating for the 50 mg and 75 mg tablets also contains the colorant D&C Yellow #10 aluminum lake.

Nucynta is distributed by Collegium Pharmaceutical, Inc., 100 Technology Center Drive Suite 300, Stoughton, MA, 02072, www.collegiumpharma.com, or call 1-855-331-5615.