Medication Guide
NUCYNTA® ER (new-SINN-tah E-R)
(tapentadol) extended-release oral tablets, CII |
| NUCYNTA® ER is: |
- A strong prescription pain medicine that contains an opioid (narcotic) that is used to treat moderate to severe around-the-clock pain and pain from damaged nerves (neuropathic pain) that happens with diabetes.
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| Important information about NUCYNTA® ER: |
- Get emergency help right away if you take too much NUCYNTA® ER (overdose). NUCYNTA® ER overdose can cause life threatening breathing problems that can lead to death.
- Never give anyone else your NUCYNTA® ER. They could die from taking it. Store NUCYNTA® ER away from children and in a safe place to prevent stealing or abuse. Selling or giving away NUCYNTA® ER is against the law.
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| Do not take NUCYNTA® ER if you have: |
- severe asthma, trouble breathing, or other lung problems.
- a bowel blockage or have narrowing of the stomach or intestines.
- taken a monoamine oxidase inhibitor (MAOI) medicine or have taken a MAOI medicine within the last 14 days.
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| Before taking NUCYNTA® ER, tell your healthcare provider if you have a history of: |
| • head injury, seizures | • liver, kidney, thyroid problems |
| • problems urinating | • pancreas or gallbladder problems |
| • abuse of street or prescription drugs, alcohol addiction, or mental health problems. |
| Tell your healthcare provider if you are: |
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pregnant or planning to become pregnant. NUCYNTA® ER may harm your unborn baby.
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breastfeeding. NUCYNTA® ER passes into breast milk and may harm your baby.
- taking prescription or over-the-counter medicines, vitamins, or herbal supplements.
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| When taking NUCYNTA® ER: |
- Do not change your dose. Take NUCYNTA® ER exactly as prescribed by your healthcare provider.
- Take your prescribed dose every 12 hours at the same time every day. Do not take more than your prescribed dose in 24 hours. If you miss a dose take the missed dose 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.
- Swallow NUCYNTA® ER whole with enough water to make sure that you completely swallow the tablet right away. Do not cut, break, chew, crush, dissolve, or inject NUCYNTA® ER.
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Call your healthcare provider if the dose you are taking does not control your pain.
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Do not stop taking NUCYNTA® ER without talking to your healthcare provider.
- After you stop taking NUCYNTA® ER flush any unused tablets down the toilet.
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| While taking NUCYNTA® ER Do Not: |
- Drive or operate heavy machinery, until you know how NUCYNTA® ER affects you. NUCYNTA® ER can make you sleepy, dizzy, or lightheaded.
- Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.
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| The possible side effects of NUCYNTA® ER are: |
- constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.
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| 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, a seizure, or you are feeling faint.
- agitation, hallucinations, coma, feeling overheated, or heavy sweating.
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These are not all the possible side effects of NUCYNTA® ER. 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; Manufactured for: Janssen Pharmaceuticals, Inc. Titusville, NJ 08560, www.Nucynta.com or call 1-800-526-7736 |