"Young children have died or become seriously ill from accidental exposure to a skin patch containing fentanyl, a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a Drug Safety Communication to warn pa"...
(tapentadol) Extended-Release Oral Tablets
NUCYNTA® ER is:
- A strong prescription pain medicine that contains an opioid (narcotic) that is used to treat moderate to severe aroundthe-clock pain and pain from damaged nerves (neuropathic pain) that happens with diabetes.
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.
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.
Before taking NUCYNTA® ER, tell your healthcare provider if you have a history of:
- head injury, seizures
- problems urinating
- liver, kidney, thyroid problems
- pancreas or gallbladder problems
- abuse of street or prescription drugs, alcohol addiction, or mental health problems.
Tell your healthcare provider if you are:
- pregnant or planning to become pregnant. NUCYNTA® ER may harm your unborn baby.
- breastfeeding. NUCYNTA® ER passes into breast milk and may harm your baby.
- taking prescription or over-the-counter medicines, vitamins, or herbal supplements.
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.
- Call your healthcare provider if the dose you are taking does not control your pain.
- 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.
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.
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.
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.
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
Last reviewed on RxList: 10/5/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Nucynta ER Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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