NUCYNTA- tapentadol hydrochloride tablet, film coated 
Janssen Pharmaceuticals, Inc.

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This Medication Guide has been approved by the U.S. Food and Drug AdministrationNUC-022-C.1 Issued: 12/2016

Medication Guide

NUCYNTA (new-SINN-tah)
(tapentadol) tablets , CII

NUCYNTA tablets are:

  • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage short term (acute) pain in adults, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
  • An opioid 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.

Important information about NUCYNTA tablets:

  • Get emergency help right away if you take too much NUCYNTA (overdose) tablets. When you first start taking NUCYNTA tablets, 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.
  • Taking NUCYNTA tablets with other opioid medicines, benzodiazepines, 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 tablets. They could die from taking it. Store NUCYNTA tablets away from children and in a safe place to prevent stealing or abuse. Selling or giving away NUCYNTA tablets is against the law.

Do not take NUCYNTA tablets if you have:

  • severe asthma, trouble breathing, or other lung problems.
  • a bowel blockage or have narrowing of the stomach or intestines.

Before taking NUCYNTA tablets, tell your healthcare provider if you have a history of:

  • head injury, seizures
  • problems urinating
  • abuse of street or prescription drugs, alcohol addiction, or mental health problems.
  • liver, kidney, thyroid problems
  • pancreas or gallbladder problems

Tell your healthcare provider if you are:

  • pregnant or planning to become pregnant. Prolonged use of NUCYNTA tablets during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • breastfeeding. NUCYNTA tablets pass into breast milk and may harm your baby.
  • taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking NUCYNTA tablets with certain other medicines can cause serious side effects that could lead to death.

When taking NUCYNTA tablets:

  • Do not change your dose. Take NUCYNTA tablets exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
  • Take your prescribed dose every 4-6 hours, at the same time every day. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
  • Call your healthcare provider if the dose you are taking does not control your pain.
  • If you have been taking NUCYNTA tablets regularly, do not stop taking NUCYNTA tablets without talking to your healthcare provider.
  • After you stop taking NUCYNTA tablets, flush any unused tablets down the toilet.

While taking NUCYNTA tablets DO NOT:

  • Drive or operate heavy machinery, until you know how NUCYNTA tablets affect you. NUCYNTA tablets can make you sleepy, dizzy, or lightheaded.
  • Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with NUCYNTA tablets may cause you to overdose and die.

The possible side effects of NUCYNTA tablets:

  • constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help 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.

These are not all the possible side effects of NUCYNTA tablets. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov
Manufactured by: Janssen Ortho, LLC, Gurabo, PR 00778, www.NUCYNTA.com or call 1-866-458-6389

Revised: 10/2018
Document Id: 926544cc-122c-4f9f-9434-a886827b0871
Set id: 00a8921e-46a6-4df1-a744-9e532b6fb06f
Version: 11
Effective Time: 20181030
Janssen Pharmaceuticals, Inc.