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Nucynta

side effects drug center nucynta (tapentadol immediate-release oral tablets) drug - patient side effects and images

 

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Nucynta Patient Information Including Side Effects

Brand Names: Nucynta, Nucynta ER

Generic Name: tapentadol

What is tapentadol (Nucynta, Nucynta ER)?

Tapentadol is an opioid medicine that is used to treat moderate to severe pain.

Tapentadol extended-release form (Nucynta ER) is for around-the-clock treatment of pain that is not controlled by other medicines. This form of tapentadol is not for use on an as-needed basis for pain.

Tapentadol may also be used for purposes not listed in this medication guide.

What are the possible side effects of tapentadol (Nucynta, Nucynta ER)?

Get emergency medical help if you have signs of an allergic reaction: hives; chest pain, fast heartbeats, difficult breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should give naloxone and/or seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.

Call your doctor at once if you have:

  • noisy breathing, sighing, shallow breathing, breathing that stops;
  • a light-headed feeling, like you might pass out;
  • agitation, feeling hot;
  • severe drowsiness or dizziness, confusion, problems with speech or balance;
  • a seizure;
  • serotonin syndrome--agitation, hallucinations, fever, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, diarrhea; or
  • low cortisol levels-- nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Serious breathing problems may be more likely in older adults and in those who are debilitated or have wasting syndrome or chronic breathing disorders.

Common side effects may include:

  • constipation, nausea, vomiting, stomach pain;
  • headache, feeling tired; or
  • drowsiness, dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about tapentadol (Nucynta, Nucynta ER)?

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine where others cannot get to it.

Using opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Nucynta Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking tapentadol (Nucynta, Nucynta ER)?

You should not use tapentadol if you are allergic to it, or if you have:

  • severe asthma or breathing problems;
  • a stomach or bowel obstruction (including paralytic ileus); or
  • if you have taken an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, or tranylcypromine.

Tell your doctor if you have ever had:

If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks.

Ask a doctor before using opioid medicine if you are breastfeeding. Tell your doctor if you notice severe drowsiness or slow breathing in the nursing baby.

Do not give tapentadol to a child.

How should I take tapentadol (Nucynta, Nucynta ER)?

Follow the directions on your prescription label and read all medication guides. Never use tapentadol in larger amounts, or for longer than prescribed. Tell your doctor if you feel an increased urge to take more of this medicine.

Never share opioid medicine with another person, especially someone with a history of drug addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine where others cannot get to it. Selling or giving away this medicine is against the law.

Stop taking all other medications that contain tapentadol or tramadol when you start taking tapentadol extended-release tablets.

Take this medicine with a full glass of water at the same times each day, with or without food.

Do not crush, break, or open an extended-release pill. Swallow it whole to avoid exposure to a potentially fatal dose.

Tapentadol can cause constipation. Talk to your doctor before using a laxative or stool softener to treat or prevent this side effect.

Never crush a pill to inhale the powder or inject it into your vein. This could result in death.

You may have withdrawal symptoms if you stop using tapentadol suddenly. Ask your doctor before stopping the medicine.

Store at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

Nucynta Patient Information including If I Miss a Dose

What happens if I miss a dose (Nucynta, Nucynta ER)?

Since tapentadol is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Do not take extra medicine to make up a missed dose. Do not take more than your prescribed dose in a 24-hour period.

What happens if I overdose (Nucynta, Nucynta ER)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose can be fatal, especially in a child or person using opioid medicine without a prescription. Overdose symptoms may include severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don't wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

What should I avoid while taking tapentadol (Nucynta, Nucynta ER)?

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

What other drugs will affect tapentadol (Nucynta, Nucynta ER)?

Many other drugs can be dangerous when used with opioid medicine. Tell your doctor if you also use:

This list is not complete. Many drugs may affect tapentadol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.

Where can I get more information (Nucynta, Nucynta ER)?

Your doctor or pharmacist can provide more information about tapentadol.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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