Nucynta ER

Nucynta ER is a prescription medication used to treat moderate to severe around-the-clock pain and pain from damaged nerves (neuropathic pain) that happens with diabetes. Nucynta ER belongs to a group of drugs called opioids which work by stopping pain signals made in the brain.

This medication comes as an extended-release tablet that is taken usually twice daily with a full glass of water.

Common side effects of Nucynta ER are nausea, dizziness, and vomiting. Do not drive a car or operate machinery if you have these symptoms.

Nucynta ER is a prescription medication used to treat moderate to severe around-the-clock pain and pain from damaged nerves (neuropathic pain) that happens with diabetes. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Janssen Pharmaceuticals, Inc.

The common side effects with Nucynta ER are nausea, dizziness, vomiting, sleepiness, and itching.

Constipation is a common side effect of all opioid medicines. Talk to your doctor about the use of laxatives and stool softeners to prevent or treat constipation while taking Nucynta ER.

These are not all the possible side effects of Nucynta ER. For a complete list, ask your doctor or pharmacist.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Using Nucynta ER with other medicines can cause serious side effects. The doses of some other medicines may need to be changed. Your doctor can tell you what medicines can be safely taken with Nucynta ER. 

Especially tell your doctor if you take:

• Monoamine Oxidase Inhibitors (MAOIs)
• Any medicine that makes you sleepy. Nucynta ER can make you sleepy and affect your breathing. Taking these medicines together can be dangerous.

Nucynta ER can cause serious side effects including:

• Life-threatening breathing problems. Call your doctor right away or get emergency medical help if you:
  • have trouble breathing, or have slow or shallow breathing
  • have a slow heartbeat 
  • have severe sleepiness 
  • have cold, clammy skin 
  • feel faint, dizzy, confused, or can not think, walk or talk normally 
  • have a seizure 
  • have hallucinations
• Physical Dependence. Nucynta ER can cause physical dependence. Talk to your doctor about slowly stopping Nucynta ER to avoid getting sick with withdrawal symptoms. You could become sick with uncomfortable symptoms because your body has become used to the medicine. Tell your doctor if you have any of these symptoms of withdrawal: feeling anxious, sweating, sleep problems, shivering, pain, nausea, tremors, diarrhea, upper respiratory symptoms, hallucinations, hair "standing on end." Physical dependence is not the same as drug addiction. Your doctor can tell you more about the differences between physical dependence and drug addiction. 
• Serotonin syndrome. Serotonin syndrome is a rare, life-threatening problem that could happen if you take Nucynta ER with Selective Serotonin Reuptake Inhibitors (SSRIs), Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs), Monoamine Oxidase Inhibitors (MAOIs), triptans or certain other medicines. Call your doctor or get medical help right away if you have any one or more of the these symptoms: you feel agitated, have hallucinations, coma, rapid heart beat, feel overheated, loss of coordination, over active reflexes, nausea, vomiting, or diarrhea. 
• Seizures. Nucynta ER can cause seizures in people who are at risk for seizures or who have epilepsy. Tell your doctor right away if you have a seizure and stop taking Nucynta ER. 
• Low blood pressure. This can make you feel dizzy if you get up too fast from sitting or lying down.

Do not drive, operate machinery, or participate in any other possibly dangerous activities until you know how you react to this medicine. Nucynta ER can make you sleepy. 

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.

You should not drink alcohol while using Nucynta ER. Alcohol increases your chance of having dangerous side effects.

There are no known food interactions with Nucynta ER.

Nucynta ER may not be right for you. Tell your doctor about all your medical conditions, including if you have:

• trouble breathing or lung problems 
• or had a head injury 
• liver or kidney problems 
• convulsions or seizures 
• dependency problems with alcohol 
• pancreas or gall bladder problems 
• past or present substance abuse or drug addiction. There is a risk of abuse or addiction with narcotic pain medicines. If you have abused drugs in the past, you may have a higher chance of developing abuse or addiction again while using Nucynta ER. 
• are pregnant or plan to become pregnant 
• are breast-feeding. You should not breast-feed while taking Nucynta ER.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Using Nucynta ER with other medicines can cause serious side effects. The doses of some other medicines may need to be changed. Your doctor can tell you what medicines can be safely taken with Nucynta ER. 

Especially tell your doctor if you take:

• Monoamine Oxidase Inhibitors (MAOIs). 
• any medicine that makes you sleepy. Nucynta ER can make you sleepy and affect your breathing. Taking these medicines together can be dangerous.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Because of the potential for adverse reactions in nursing infants from Nucynta ER, a decision should be made whether to stop nursing or stop the drug.

• 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.

Nucynta ER is not for use in the following situations:

• as an as-needed pain medication
• for pain that is mild or not expected to persist for an extended period of time
• for pain due to surgery unless you are already taking an opioid for long-term use or if the pain due to surgery is expected to be moderate to severe and persist for an extended period of time

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Never give anyone else your Nucynta ER. This can cause them harm and can even cause death. 
• 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.