Tapentadol extended-release tabletsPronunciation
Generic Name: tapentadol (ta-PEN-ta-dol)
Brand Name: Nucynta ER
Tapentadol extended-release tablets are 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.
Tapentadol 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 tapentadol extended-release tablets whole. Do NOT break, crush, cut, dissolve, or chew tapentadol extended-release tablets before swallowing it. Do NOT inject or snort tapentadol 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 tapentadol extended-release tablets may be fatal, especially in children. Keep tapentadol extended-release tablets out of the reach of children. Seek emergency medical care right away if another person swallows tapentadol extended-release tablets.
Do NOT drink alcohol or take medicines (prescription or nonprescription) that contain alcohol while you are taking tapentadol 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 tapentadol 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.
Tapentadol extended-release tablets are used for:
Managing severe pain. Tapentadol extended-release tablets are 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.
Tapentadol extended-release tablets are a narcotic (opioid) pain medicine. It works in the brain and nervous system to decrease pain.
Do NOT use tapentadol extended-release tablets if:
- you are allergic to any ingredient in tapentadol 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, butorphanol, nalbuphine, pentazocine, 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.
Before using tapentadol extended-release tablets:
Some medical conditions may interact with tapentadol 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 tapentadol 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
- 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 tapentadol extended-release tablets's side effects
- Buprenorphine, butorphanol, nalbuphine, pentazocine, or naltrexone because they may decrease tapentadol 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 tapentadol 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 tapentadol extended-release tablets:
Use tapentadol extended-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Tapentadol extended-release tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get tapentadol extended-release tablets refilled.
- Take tapentadol extended-release tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
- Tapentadol extended-release tablets must only be taken by mouth. Do not inject or snort tapentadol 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 tapentadol extended-release tablets whole. Do not break, cut, crush, chew, or dissolve the tablet before swallowing it. Contact your doctor if you cannot swallow tapentadol 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 tapentadol extended-release tablets. You may have an increased risk of withdrawal symptoms (eg, nausea, vomiting, diarrhea, anxiety, shivering). If you need to stop tapentadol extended-release tablets, your doctor will gradually lower your dose.
- Tapentadol 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 tapentadol 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 tapentadol extended-release tablets.
Important safety information:
- Tapentadol 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 tapentadol 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 tapentadol 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 tapentadol 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.
- Tapentadol 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.
- Tapentadol 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 tapentadol 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 tapentadol extended-release tablets before you receive any medical or dental care, emergency care, or surgery.
- Tapentadol 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 tapentadol extended-release tablets and seek immediate medical attention if you have a seizure.
- Serotonin syndrome is a possibly fatal syndrome that has happened when tapentadol extended-release tablets was taken with medicines for depression or 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 tapentadol extended-release tablets. Accidental swallowing of tapentadol extended-release tablets may be fatal, especially in children.
- Use tapentadol extended-release tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially breathing problems.
- 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 tapentadol extended-release tablets while you are pregnant. Long-term use of tapentadol 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 this medicine is found in breast milk. Do not breast-feed while taking tapentadol extended-release tablets.
When used for long periods of time or at high doses, tapentadol 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 tapentadol extended-release tablets stops working well. Do not take more than prescribed.
Some people who use tapentadol 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 tapentadol 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 tapentadol 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:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; dizziness; drowsiness; dry mouth; headache; mild itching; mild stomach pain; nausea; tiredness; vomiting.
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; fainting; fast, slow, or irregular heartbeat; feeling overheated; 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; unusual sweating; 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.Proper storage of tapentadol extended-release tablets:
Store tapentadol 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 tapentadol extended-release tablets out of the reach of children and away from pets.
- If you have any questions about tapentadol extended-release tablets, please talk with your doctor, pharmacist, or other health care provider.
- Tapentadol extended-release tablets are 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 tapentadol 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 tapentadol 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 tapentadol 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 health care provider for complete information about the risks and benefits of using tapentadol extended-release tablets.
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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