Nucynta ER extended-release tablets

Pronunciation

Generic Name: tapentadol (ta-PEN-ta-dol)
Brand Name: Nucynta ER

Nucynta ER extended-release tablets is a narcotic pain medicine that may become habit-forming. Misuse or abuse can lead to overdose and death. Do NOT take more than the recommended dose, take for longer than prescribed, or take more often than prescribed without checking with your doctor.

Nucynta ER extended-release tablets may cause severe and sometimes fatal breathing problems. The risk may be greater when you first start this drug or with any increase in dose. Contact your doctor right away if you experience slow, shallow, or difficult breathing.

Be sure to swallow Nucynta ER extended-release tablets whole. Do NOT break, crush, cut, dissolve, or chew Nucynta ER extended-release tablets before swallowing it. Do NOT inject or snort Nucynta ER extended-release tablets. Doing any of these things could result in very serious side effects, including severe trouble breathing and death from overdose.

Accidental swallowing of even one dose of Nucynta ER extended-release tablets may be fatal, especially in children. Keep Nucynta ER extended-release tablets out of the reach of children. Seek emergency medical care right away if another person swallows Nucynta ER extended-release tablets.

Do NOT drink alcohol or take medicines (prescription or nonprescription) that contain alcohol while you are taking Nucynta ER extended-release tablets. This could cause a fatal overdose. If you are unsure if any of your medicines contain alcohol, check with your doctor or pharmacist.

Long-term use of Nucynta ER extended-release tablets during pregnancy may cause dependence in the unborn baby. This can lead to withdrawal in the newborn, which can be life-threatening. Discuss any questions or concerns with your doctor.


Nucynta ER extended-release tablets is used for:

Managing severe pain. Nucynta ER extended-release tablets is only for use when continuous (around-the-clock) treatment is needed for a long time. It is also only for use when other pain treatments do not treat your pain well enough or you cannot take them. It is NOT for use right after surgery if you have not already been using narcotic pain medicines, if you need only occasional or as-needed pain relief, or if the pain is mild or is not expected to last for a long time.

Nucynta ER extended-release tablets is a narcotic (opioid) pain medicine. It works in the brain and nervous system to decrease pain.

Do NOT use Nucynta ER extended-release tablets if:

  • you are allergic to any ingredient in Nucynta ER extended-release tablets
  • you have slow, shallow, or difficult breathing; high levels of carbon dioxide in the blood (hypercapnia or hypercarbia), or severe lung problems (eg, severe asthma), or you are having an asthma attack
  • you have narrowing of the stomach or bowels or known or suspected stomach or bowel blockage (eg, paralytic ileus)
  • you have severe kidney or liver problems
  • you are taking buprenorphine, mixed agonist/antagonist pain medicines (eg, butorphanol, nalbuphine, pentazocine), sodium oxybate (GHB), tramadol, or another medicine that contains tapentadol
  • you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or have taken an MAOI within the past 14 days

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Nucynta ER extended-release tablets:

Some medical conditions may interact with Nucynta ER extended-release tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of liver or kidney problems, stomach or bowel problems (eg, blockage, inflammation), gallbladder problems, thyroid problems, a urinary blockage or trouble urinating, or pancreas problems (eg, pancreatitis)
  • if you have severe drowsiness, a recent head injury, growths in the brain (eg, lesions, tumors), increased pressure in the brain, or a history of seizures (eg, epilepsy)
  • if you have a history of chronic obstructive pulmonary disease (COPD) or other lung or breathing problems (eg, asthma, emphysema, bronchitis), sleep apnea, curvature of the spine (scoliosis), a certain heart problem (cor pulmonale), hypercapnia or hypercarbia, or low levels of oxygen in the blood (hypoxia)
  • if you have low blood pressure, dehydration, low blood volume, constipation, stomach pain, poor health, or trouble swallowing
  • if you are very overweight, or have recently had or will be having surgery (eg, stomach or bowel surgery)
  • if you drink alcohol, have symptoms of alcohol withdrawal, or have a history of suicidal thoughts or attempts
  • if you or a member of your family has a history of mental or mood problems (eg, depression), or alcohol or other substance abuse or dependence
  • if you have never taken a narcotic pain medicine before

Some MEDICINES MAY INTERACT with Nucynta ER extended-release tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anticholinergics (eg, scopolamine, oxybutynin) because the risk of constipation and difficulty urinating may be increased
  • Phenothiazines (eg, chlorpromazine) because the risk of low blood pressure may be increased
  • Sodium oxybate (GHB) because the risk of severe drowsiness, coma, confusion, or slowed or difficult breathing may be increased
  • MAOIs (eg, phenelzine), mirtazapine, selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine, paroxetine), serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, duloxetine), St. John's wort, tramadol, trazodone, tricyclic antidepressants (eg, amitriptyline), or triptans (eg, sumatriptan) because the risk of developing a severe side effect called serotonin syndrome may be increased
  • Other narcotic pain medicines (eg, codeine, hydrocodone) because they may increase the risk of Nucynta ER extended-release tablets's side effects
  • Buprenorphine, mixed agonist/antagonist pain medicines (eg, butorphanol, nalbuphine, pentazocine), or naltrexone because they may decrease Nucynta ER extended-release tablets's effectiveness and withdrawal may occur

This may not be a complete list of all interactions that may occur. Ask your health care provider if Nucynta ER extended-release tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Nucynta ER extended-release tablets:

Use Nucynta ER extended-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Nucynta ER extended-release tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Nucynta ER extended-release tablets refilled.
  • Take Nucynta ER extended-release tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
  • Nucynta ER extended-release tablets must only be taken by mouth. Do not inject or snort Nucynta ER extended-release tablets.
  • Do not swallow more than 1 tablet at a time. If your dose requires more than 1 tablet, take only 1 tablet at a time.
  • Swallow Nucynta ER extended-release tablets whole. Do not break, cut, crush, chew, or dissolve the tablet before swallowing it. Contact your doctor if you cannot swallow Nucynta ER extended-release tablets whole.
  • Do not presoak, lick, or wet the tablet before you place it in your mouth. Take each tablet with enough water to be sure that it can be completely swallowed immediately after you place it in your mouth.
  • Do not suddenly stop taking Nucynta ER extended-release tablets. You may have an increased risk of withdrawal symptoms (eg, nausea, vomiting, diarrhea, anxiety, shivering). If you need to stop Nucynta ER extended-release tablets, your doctor will gradually lower your dose.
  • Nucynta ER extended-release tablets works best if it is taken at the same time(s) each day. Do not miss any doses.
  • If you miss a dose of Nucynta ER extended-release tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Do not take more than your prescribed dose in 24 hours.

Ask your health care provider any questions you may have about how to use Nucynta ER extended-release tablets.

Important safety information:

  • Nucynta ER extended-release tablets may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Take Nucynta ER extended-release tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol or take medicines (prescription or nonprescription) that contain alcohol while you are taking Nucynta ER extended-release tablets. Check with your pharmacist if you have questions about whether any of your medicines contain alcohol.
  • Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Nucynta ER extended-release tablets; the risk of severe drowsiness or breathing problems may be increased. Ask your pharmacist if you have questions about which medicines may increase the risk of these effects.
  • Nucynta ER extended-release tablets may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase this effect. To prevent it, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of this effect.
  • Do NOT take more than the recommended dose, take for longer than prescribed, or take more often than prescribed without checking with your doctor.
  • Nucynta ER extended-release tablets may cause constipation. Talk with your doctor or pharmacist about using a stool softener or laxative to prevent constipation. It is also important to maintain a diet adequate in fiber, to drink plenty of water, and to exercise to prevent constipation. If you become constipated while taking Nucynta ER extended-release tablets, talk with your doctor or pharmacist.
  • If your pain continues or becomes worse, or if you have side effects that concern you, contact your doctor.
  • Tell your doctor or dentist that you take Nucynta ER extended-release tablets before you receive any medical or dental care, emergency care, or surgery.
  • Nucynta ER extended-release tablets may increase the risk of seizures in certain patients, including patients who have a history of seizures. Talk to your doctor to see if you may have a greater risk of seizures while taking Nucynta ER extended-release tablets and seek immediate medical attention if you have a seizure.
  • Serotonin syndrome is a possibly fatal syndrome that can be caused by Nucynta ER extended-release tablets. Your risk may be greater if you take Nucynta ER extended-release tablets with certain other medicines (eg, "triptans," MAOIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.
  • Seek emergency medical care right away if another person swallows Nucynta ER extended-release tablets. Accidental swallowing of Nucynta ER extended-release tablets may be fatal, especially in children.
  • Use Nucynta ER extended-release tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially breathing problems.
  • Nucynta ER extended-release tablets is not approved for use in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Nucynta ER extended-release tablets while you are pregnant. Long-term use of Nucynta ER extended-release tablets during pregnancy may cause dependence in the fetus or newborn. Discuss any questions or concerns with your doctor. It is not known if Nucynta ER extended-release tablets is found in breast milk. Do not breast-feed while taking Nucynta ER extended-release tablets.

When used for long periods of time or at high doses, Nucynta ER extended-release tablets may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Nucynta ER extended-release tablets stops working well. Do not take more than prescribed.

Some people who use Nucynta ER extended-release tablets for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you suddenly stop taking Nucynta ER extended-release tablets, you may experience WITHDRAWAL symptoms, including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of Nucynta ER extended-release tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; dry mouth; headache; mild itching; mild stomach pain; nausea; sweating; tiredness; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); abnormal sighing; burning, numbness, or tingling; chest pain; confusion; difficult or increased urination; difficult, slow, or shallow breathing; fainting; fast, slow, or irregular heartbeat; fever; hallucinations; loss of coordination; memory problems; mood or mental changes (eg, agitation, depression); seizures; severe or persistent constipation or stomach pain; severe or persistent dizziness, drowsiness, headache, or light-headedness; shortness of breath; suicidal thoughts or actions; tremor; trouble talking, thinking, or walking; vision changes (eg, blurred vision).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bluish skin or nails; cold and clammy skin; coma; difficult, slow, or shallow breathing; excessive sweating; fainting; limp muscles; pinpoint or enlarged pupils; seizures; severe drowsiness, dizziness, or light-headedness; shortness of breath; slow or irregular heartbeat.

Proper storage of Nucynta ER extended-release tablets:

Store Nucynta ER extended-release tablets at room temperature between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Nucynta ER extended-release tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about Nucynta ER extended-release tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Nucynta ER extended-release tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Nucynta ER extended-release tablets or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Nucynta ER extended-release tablets. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Nucynta ER extended-release tablets. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Nucynta ER extended-release tablets.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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