Tapentadol Extended-Release Tablets

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Pronunciation: ta-PEN-ta-dol
Generic Name: Tapentadol
Brand Name: Nucynta ER

Tapentadol Extended-Release Tablets are a narcotic pain reliever used for around-the-clock treatment of moderate or severe pain. It should not be used to treat occasional pain or pain after injury or surgery.

Swallow Tapentadol Extended-Release Tablets whole. Do NOT break, crush, chew, dissolve, or split Tapentadol Extended-Release Tablets. Doing so may cause the release of too much medicine into the bloodstream, which could be fatal.

Do not drink alcohol or use medicines (prescription or nonprescription) that contain alcohol while you are taking Tapentadol Extended-Release Tablets. Using alcohol with Tapentadol Extended-Release Tablets may cause the release of too much medicine into the bloodstream, which could be fatal.

Tapentadol Extended-Release Tablets are used for:

Treating moderate to severe long-term pain when around-the-clock pain medicine is needed for more than a few days.

Tapentadol Extended-Release Tablets are a narcotic pain reliever. It works in certain areas of 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 very slow, shallow, or difficult breathing; severe lung problems (eg, severe asthma, wheezing, shortness of breath); severe hypercapnia (high blood carbon dioxide levels); or you are having an asthma attack you have or may have paralytic ileus (bowel paralysis) you have severe kidney or liver problems you are taking tramadol or another medicine that contains tapentadol you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) 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 (especially depression medicines) 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, blockage, or surgery; gallbladder problems; thyroid problems; metabolism problems; adrenal problems (eg, Addison disease); enlarged prostate; trouble urinating; curvature of the spine (scoliosis); or pancreas problems (eg, pancreatitis) if you have or recently have had any head injury, brain injury or tumor, increased pressure in the brain, or infection of the brain or nervous system if you have a history of lung or breathing problems (eg, asthma, chronic obstructive pulmonary disease [COPD], sleep apnea), a heart problem called cor pulmonale, low blood pressure, or a seizure disorder (eg, epilepsy) if you have severe drowsiness, constipation, hypercapnia, hypoxia (low blood oxygen levels), dehydration or low blood volume, poor health, or are severely overweight if you have a history of mental or mood problems (eg, depression, anxiety, hallucinations), if you are going through withdrawal from alcohol or other substances, or if you or a family member have a history of alcohol or other substance abuse if you have recently had or will be having surgery

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 or difficulty urinating may be increased MAOIs (eg, phenelzine), selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine, paroxetine), serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, duloxetine), St. John's wort, tricyclic antidepressants (eg, amitriptyline), or triptans (eg, sumatriptan) because a severe side effect called serotonin syndrome may occur. Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea Buprenorphine, butorphanol, nalbuphine, naltrexone, or pentazocine because they may decrease Tapentadol Extended-Release Tablets's effectiveness Other opioid pain medicines (eg, codeine, hydrocodone), muscle relaxers (eg, cyclobenzaprine), phenothiazines (eg, chlorpromazine), or medicines used for allergies, mental or mood disorders, nausea, or sleep disorders because the risk of side effects, including severe drowsiness, trouble breathing, or low blood pressure, may be increased

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 your dose requires more than 1 tablet, take only 1 tablet at a time. Swallow Tapentadol Extended-Release Tablets whole. Do not break, crush, chew, dissolve, or split before swallowing. Do not soak, lick, or wet the tablet before you put it in your mouth. Do not inject Tapentadol Extended-Release Tablets. Contact your doctor if you cannot swallow Tapentadol Extended-Release Tablets whole. 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. If you need to stop Tapentadol Extended-Release Tablets, your doctor will gradually lower your dose. Keep Tapentadol Extended-Release Tablets out of the reach of children and away from pets. If Tapentadol Extended-Release Tablets are no longer needed, discard it immediately by flushing down the toilet. 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.

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 or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use 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 use 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; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness. 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, change your dose, or use for longer than prescribed without checking with your doctor. Tapentadol Extended-Release Tablets may cause constipation. To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. Talk to your doctor about using fiber laxatives or stool softeners to prevent or treat constipation while you use Tapentadol Extended-Release Tablets. 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 can be caused by Tapentadol Extended-Release Tablets. Your risk may be greater if you take Tapentadol 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. Accidental ingestion or overdose of Tapentadol Extended-Release Tablets may be fatal in children or adults. Keep Tapentadol Extended-Release Tablets out of the reach of children. In case of accidental ingestion or an overdose, call a doctor or poison control center right away. Use Tapentadol Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially breathing problems, constipation, weakness or tiredness, and severe light-headedness. Tapentadol Extended-Release Tablets should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed. PREGNANCY and BREAST-FEEDING: Tapentadol Extended-Release Tablets may cause harm to the fetus. 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. It is not known if Tapentadol Extended-Release Tablets are 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 without a break may develop a physical need to continue taking it. This is known as physical DEPENDENCE. 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:

Constipation; dizziness; drowsiness; dry mouth; headache; nausea; 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, or tongue; unusual hoarseness); agitation; burning, numbness, or tingling; chest pain; cold, clammy skin; confusion; difficult or increased urination; difficult, slow, or shallow breathing; disorientation; fainting; fast, slow, or irregular heartbeat; hallucinations; loss of coordination; memory problems; mood or mental changes; seizures; severe or persistent dizziness, drowsiness, or light-headedness; trouble talking, thinking, or walking.

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.

See also: Tapentadol side effects (in more detail)

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; cold, clammy skin; difficult, slow, or shallow breathing; drowsiness leading to unresponsiveness or coma; excessive sweating; limp muscles; pinpoint pupils; seizures; slow or irregular heartbeat; vomiting.

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.

General information: 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 is a summary only. It does not contain all information about Tapentadol Extended-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012 Database Edition 12.1.1.002 Copyright © 2012 Wolters Kluwer Health, Inc. More Tapentadol resources Tapentadol Side Effects (in more detail)Tapentadol DosageTapentadol Use in Pregnancy & BreastfeedingTapentadol Drug InteractionsTapentadol Support Group105 Reviews for Tapentadol - Add your own review/rating Compare Tapentadol with other medications Diabetic Nerve DamagePain

Tapentadol Extended Release Tablets

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