Nucynta ER

Nucynta ER is used to manage severe and persistent pain in adults that requires an extended treatment period with a daily opioid pain medicine, when other pain medicines do not treat your pain well enough, or you cannot tolerate them.

Nucynta ER is also used to manage severe and persistent pain in adults from damaged nerves (neuropathic pain) that happens with diabetes, and that requires an extended treatment period with a daily opioid pain medicine, when other pain medicines do not treat your pain well enough, or you cannot tolerate them.

Nucynta ER (tapentadol ER) is a strong, long-acting (extended-release), 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.

• Not to be taken on an "as needed" basis. For acute, short-term pain, Nucynta immediate-release tablets should be used instead.

Nucynta ER 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 ER (overdose). When you first start taking Nucynta ER, 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 ER 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.
• Never give anyone else your Nucynta ER. They could die from taking it. Selling or giving away Nucynta ER is against the law.
• Store Nucynta ER 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 ER 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 past 14 days.

Before taking Nucynta ER, 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 ER, do not take more of Nucynta ER without first talking to your healthcare provider. Talk to 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 ER
• pregnant or planning to become pregnant. Use of Nucynta ER for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated
• breastfeeding. Not recommended during treatment with Nucynta ER. It may harm your baby.
• 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 ER with certain other medicines can cause serious side effects.

The possible side effects of Nucynta ER 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.

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.
• agitation, hallucinations, coma, feeling overheated, or heavy sweating.

These are not all the possible side effects of Nucynta ER. 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 ER exactly as prescribed by your healthcare provider. Use the lowest effective dose for the shortest time needed. Do not change your dose.

• Take your prescribed dose every 12 hours, at the same time every day. Do not take more than your prescribed dose in 24 hours. If you miss a dose, take your next dose at your usual time.
• Swallow Nucynta ER whole, one tablet at a time, with enough water to ensure complete swallowing right away. Do not cut, break, chew, crush, dissolve, snort, or inject Nucynta ER because this may cause you to overdose and die.
• Call your healthcare provider if the dose you are taking does not control your pain.
• Do not stop taking Nucynta ER without talking to your healthcare provider.
• Dispose of expired, unwanted, or unused Nucynta ER 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 ER affects you. Nucynta ER 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 ER 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 person using opioid medicine without a prescription, especially children who accidentally take it. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you carry naloxone or nalmefene (medicines that reverse an opioid overdose) and keep it 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, blood pressure, 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; or
• drugs that affect serotonin, such as antidepressants, stimulants, or medicine for migraines or Parkinson's disease.

Taking Nucynta ER 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 ER. 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: alpha-tocopherol (vitamin E), hypromellose, polyethylene glycol, and polyethylene oxide.

Film coating: polyvinyl alcohol, polyethylene glycol, talc, and titanium dioxide. The colorant FD&C Blue #2 aluminum lake is used for 100, 150, 200, and 250 mg strengths, and additionally, yellow iron oxide is used in 150 mg tablets.

Printing inks: shellac glaze and propylene glycol for all strengths, and black iron oxide (50, 100, 150, and 200 mg tablets) or titanium dioxide (250 mg tablets).

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

• What does XR or ER mean after a drug name?