Nucynta ER is an opioid medicine that is used to treat moderate to severe pain.

Nucynta ER extended-release form (Nucynta ER) is for around-the-clock treatment of pain that is not controlled by other medicines. This form of tapentadol is not for use on an as-needed basis for pain.

Nucynta ER may also be used for purposes not listed in this medication guide.

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine where others cannot get to it.

Using opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Follow the directions on your prescription label and read all medication guides. Never use Nucynta ER in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more of Nucynta ER.

Never share opioid medicine with another person, especially someone with a history of drug addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine where others cannot get to it. Selling or giving away this medicine is against the law.

Stop taking all other medications that contain Nucynta ER or tramadol when you start taking this medicine extended-release tablets.

Take this medicine with a full glass of water at the same times each day, with or without food.

Do not crush, break, or open an extended-release pill. Swallow it whole to avoid exposure to a potentially fatal dose.

Nucynta ER can cause constipation. Talk to your doctor before using a laxative or stool softener to treat or prevent this side effect.

Never crush a pill to inhale the powder or inject it into your vein. This could result in death.

You may have withdrawal symptoms if you stop using Nucynta ER suddenly. Ask your doctor before stopping the medicine.

Store at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

You should not use Nucynta ER if you are allergic to it, or if you have:

• severe asthma or breathing problems;

• a stomach or bowel obstruction (including paralytic ileus); or

• if you have taken an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine.

Tell your doctor if you have ever had:

• breathing problems, sleep apnea (breathing that stops during sleep);

• a head injury, brain tumor, or seizures;

• alcoholism or drug addiction, mental illness;

• urination problems,

• liver or kidney disease; or

• problems with your gallbladder, pancreas, thyroid, or adrenal gland.

If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks.

Ask a doctor before using opioid medicine if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

Do not give Nucynta ER to a child.

Since Nucynta ER is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Do not take extra medicine to make up a missed dose. Do not take more than your prescribed dose in a 24-hour period.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose can be fatal, especially in a child or 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 (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone 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 naloxone and how to use it.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how Nucynta ER will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Get emergency medical help if you have signs of an allergic reaction: hives; chest pain, fast heartbeats, difficult breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Nucynta ER may cause serious side effects. Call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing, breathing that stops;

• a light-headed feeling, like you might pass out;

• agitation, feeling hot;

• severe drowsiness or dizziness, confusion, problems with speech or balance;

• a seizure;

• serotonin syndrome--agitation, hallucinations, fever, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, diarrhea; or

• low cortisol levels-- nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.

Common side effects of Nucynta ER may include:

• constipation, nausea, vomiting, stomach pain;

• headache, feeling tired; or

• drowsiness, dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

• medicine for allergies, asthma, blood pressure, motion sickness, irritable bowel, or overactive bladder;

• other opioid medicines;

• a benzodiazepine sedative like Valium, Klonopin, or Xanax;

• 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.

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