Tapentadol (ta-PEN-ta-dol)

Treats severe pain. This medicine is a narcotic pain reliever.

Brand Name(s):

Nucynta, Nucynta ER

When This Medicine Should Not Be Used:

How to Use This Medicine:

Liquid, Tablet, Long Acting Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. An overdose can be dangerous. Follow directions carefully so you do not get too much medicine at one time. Your doctor may also give naloxone to treat an overdose.
• Oral liquid: Measure the oral liquid medicine with a marked measuring spoon, oral syringe, or medicine cup.
• Swallow the extended-release tablet whole. Do not crush, break, or chew it. Take the tablet with enough water to swallow it completely. If you have been told to use more than one tablet, take them one at a time.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store the medicine in a safe and secure place. Keep the oral liquid bottle upright after you open it.
• Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are using or have used an MAO inhibitor within the past 14 days.
• Some medicines can affect how tapentadol works. Tell your doctor if you are using any of the following:
  • Buprenorphine, butorphanol, cyclobenzaprine, metaxalone, nalbuphine, pentazocine, tramadol
  • Benzodiazepine medicine
  • Diuretic medicine
  • Medicine to treat depression (including mirtazapine, trazodone, SNRIs, SSRIs, TCAs)
  • Phenothiazine medicine
  • Triptan medicine to treat migraine headaches
• Do not drink alcohol while you are using this medicine.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol. Tell your doctor if you are also using buprenorphine, butorphanol, nalbuphine, pentazocine, or a muscle relaxer (including cyclobenzaprine, metaxalone).

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, breathing or lung problems (including COPD, asthma, sleep apnea), adrenal problems, diabetes, gallbladder problems, pancreas problems, stomach or bowel problems, or trouble urinating. Tell your doctor if you have a history of head injury, brain tumor, seizures, depression, or alcohol or drug abuse.
• This medicine may cause the following problems:
  • High risk of overdose, which can lead to death
  • Respiratory depression (serious breathing problem that can be life-threatening)
  • Worsening of pain
  • Serotonin syndrome, when used with certain medicines
  • Adrenal gland problem
  • Low blood pressure
  • Increased risk of seizures
  • Sleep-related breathing problems (including sleep apnea, sleep-related hypoxemia)
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• This medicine may make you dizzy, drowsy, or faint. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Sit or lie down if you feel dizzy. Stand up carefully.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• This medicine may cause constipation, especially with long-term use. Ask your doctor if you should use a laxative to prevent and treat constipation.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, restlessness, muscle spasms, twitching, diarrhea, seeing or hearing things that are not there
• Blue lips, fingernails, or skin
• Changes in skin color, dark freckles, cold feeling, tiredness, weight loss
• Confusion, headache
• Extreme dizziness or weakness, shallow breathing, slow or uneven heartbeat, sweating, seizures, and cold, clammy skin
• Lightheadedness, dizziness, fainting
• Worsening of pain, increased sensitivity to pain

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea, stomach pain, nausea, vomiting
• Sleepiness or tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088