MEDICATION GUIDE

NUCYNTA®
(new-SINN-tah)
(tapentadol) Immediate-Release Oral Tablets

Read the Medication Guide that comes with NUCYNTA® before you start taking it and each time you get a new prescription. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or your treatment. Talk to your doctor if you have any questions.

What is the most important information I should know about NUCYNTA®?

NUCYNTA® is a tablet that contains tapentadol, a strong medicine that is a pain medicine.

Use NUCYNTA® exactly how your doctor tells you to. Do not use NUCYNTA® if it has not been prescribed for you.

You should not take NUCYNTA® if your pain is mild and can be controlled with other pain medicines such as non-steroidal anti-inflammatory medicines (NSAIDS) or acetaminophen.

What is NUCYNTA®?

• NUCYNTA® is a prescription medicine that is used in adults 18 years of age or older to treat moderate to severe pain that is expected to last a short time.
  NUCYNTA® is for short-term use only because the risks for withdrawal symptoms, abuse and addiction are higher when NUCYNTA® is used longer.

Who should not take NUCYNTA®?

Do not take NUCYNTA® if you:

• have severe lung problems
• have a gastrointestinal problem called paralytic ileus in which the intestines are not working normally.
• take a monoamine oxidase inhibitor (MAOI) medicine or have taken an MAOI within the last 14 days. Ask your doctor or pharmacist if any of your medicines is an MAOI.

What should I tell my doctor before taking NUCYNTA®?

NUCYNTA® 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®.
• are pregnant or plan to become pregnant
• are breast-feeding. You should not breast-feed while taking NUCYNTA®.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Using NUCYNTA® 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®. Especially tell your doctor if you take:

• Monoamine Oxidase Inhibitors (MAOIs). See “Who should not take NUCYNTA®.”
• any medicine that makes you sleepy. NUCYNTA® can make you sleepy and affect your breathing. Taking these medicines together can be dangerous.

How should I take NUCYNTA®?

• Do not take NUCYNTA® unless it has been prescribed for you by your doctor.
• Take NUCYNTA® exactly as prescribed by your doctor.
• Do not change the dose of NUCYNTA® unless your doctor tells you to. Your doctor may change your dose after seeing how the medicine affects you. Do not use NUCYNTA® more often than prescribed. Call your doctor if your pain is not well controlled while taking NUCYNTA®.
• Follow your doctor's instructions about how to slowly stop taking NUCYNTA® to help lessen withdrawal symptoms.
• NUCYNTA® can be taken with or without food.

What should I avoid while taking NUCYNTA®?

• Do not drive, operate machinery, or participate in any other possibly dangerous activities until you know how you react to this medicine. NUCYNTA® can make you sleepy.
• You should not drink alcohol while using NUCYNTA®. Alcohol increases your chance of having dangerous side effects.

What are the possible side effects of NUCYNTA®?

NUCYNTA® 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® can cause physical dependence. Talk to your doctor about slowly stopping NUCYNTA® 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, lifethreatening problem that could happen if you take NUCYNTA® 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® 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®.
• Low blood pressure. This can make you feel dizzy if you get up too fast from sitting or lying down.

The common side effects with NUCYNTA® 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®.

Tell your doctor about any side effect that bothers you or that does not go away. These are not all the possible side effects of

NUCYNTA®. For a complete list, ask your doctor or pharmacist.

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

How should I store NUCYNTA®?

• Store NUCYNTA® at 59°F to 86°F (15°C to 30°C). Keep NUCYNTA® tablets dry.
• Dispose of NUCYNTA® tablets you no longer need.

Keep NUCYNTA® in a safe place out of the reach of children.

General information about NUCYNTA®

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NUCYNTA® for a condition for which it was not prescribed. Do not give NUCYNTA® to other people, even if they have the same symptoms you have. Sharing NUCYNTA® could be harmful and is against the law.

This Medication Guide summarizes the most important information about NUCYNTA®. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about NUCYNTA® that is written for doctors. For more information about NUCYNTA® call 1-800-526-7736.

What are the ingredients in NUCYNTA®?

Active Ingredient: tapentadol

Inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, povidone, magnesium stearate, and Opadry® II, a proprietary film-coating mixture containing polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and aluminum lake coloring.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Medication Guide

NUCYNTA®
(new-SINN-tah)
(tapentadol) oral solution

What is the most important information I should know about NUCYNTA® oral solution?

• Get emergency help right away if you take too much NUCYNTA® oral solution (overdose). NUCYNTA® oral solution can cause life threatening breathing problems that can lead to death.
• Never give anyone else your NUCYNTA® oral solution. They could die from taking it. Store NUCYNTA® oral solution away from children and in a safe place to prevent stealing or abuse. Selling or giving away NUCYNTA® oral solution is against the law.
• Do not change your dose. Take NUCYNTA® oral solution exactly as prescribed by your healthcare provider.
• Always use the oral syringe provided with NUCYNTA® oral solution, 20 mg/mL to help make sure you measure the right amount.

What is NUCYNTA® oral solution?

NUCYNTA® oral solution is a strong prescription pain medicine that contains an opioid (narcotic) that is used to treat moderate to severe pain that is expected to last a short time.

Who should not take NUCYNTA® oral solution?

Do not take NUCYNTA® oral solution if you:

• have severe asthma, trouble breathing, or other lung problems
• have a bowel blockage or narrowing of the stomach or intestines
• take a monoamine oxidase inhibitor (MAOI) medicine or have taken an MAOI medicine within the last 14 days
• are allergic to tapentadol or any of its ingredients.

What should I tell my healthcare provider before taking NUCYNTA® oral solution?

Before taking NUCYNTA® oral solution, 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:

• pregnant or planning to become pregnant. NUCYNTA® oral solution may harm your unborn baby.
• breastfeeding. NUCYNTA® oral solution may pass into your breast milk and harm your baby.
• planning to have surgery
• taking prescription or over-the-counter medicines, vitamins, or herbal supplements.

How should I take NUCYNTA® oral solution?

• Do not change your dose. Take NUCYNTA® oral solution exactly as prescribed by your healthcare provider.
• If you miss a dose of NUCYNTA® oral solution you can take the dose when you remember if you have pain, or you can wait for the next dose.
• You can take NUCYNTA® oral solution with or without food.
• Make sure you understand exactly how to measure your dose. Always use the oral syringe provided with your NUCYNTA® oral solution to help make sure you measure the right amount. Call your pharmacist if you have difficulties with measuring your medicine.
• Call your healthcare provider if the dose you are taking does not control your pain.
• Do not stop taking NUCYNTA® oral solution without talking to your healthcare provider.
• After you stop taking NUCYNTA® oral solution, flush any unused oral solution down the toilet.

What should I avoid while taking NUCYNTA® oral solution?

While taking NUCYNTA® oral solution do not:

• Drive or operate heavy machinery, until you know how NUCYNTA® oral solution affects you. NUCYNTA® oral solution can make you sleepy, dizzy, or lightheaded.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol.

What are the possible side effects of NUCYNTA® oral solution?

The possible side effects of NUCYNTA® oral solution are:

• constipation, nausea, dizziness, vomiting, and sleepiness. 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.
• are feeling agitated or restless, have hallucinations, pass out (become unconscious), feel overheated, have heavy sweating that is not due to activity, or loss of coordination.

These are not all the possible side effects of NUCYNTA® oral solution.

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

Instructions for Use

NUCYNTA®
(tapentadol), oral solution 20 mg/mL

Read the Instructions for Use before you start taking NUCYNTA® oral solution and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Important information about measuring NUCYNTA® oral solution

• Always use the oral syringe provided with your NUCYNTA® oral solution to make sure you measure the right amount.
• You will be provided (See Figure A.):
  • 1 bottle of NUCYNTA® oral solution
  • 1 oral syringe
  • 1 adapter

If you do not receive an oral syringe with your NUCYNTA® oral solution, ask your pharmacist to give you one.

Figure A

Before you use NUCYNTA® oral solution for the first time:

1. Remove the child-resistant cap and completely remove the foil seal (See Figure B).

Figure B

2. Push the ribbed end of the adapter into the neck of the bottle until it is firmly in place. The bottom edge of the adapter should fully contact the top rim of the bottle (See Figure C). Do not remove the adapter from the bottle after it is inserted.

Figure C

To prepare a dose of NUCYNTA® oral solution:

3. Hold the oral syringe in one hand. With your other hand, fully push down (depress) the plunger (See Figure D).

Figure D

4. Insert the tip of the oral syringe into the adapter (See Figure E).

Figure E

5. Turn the bottle upside down. Pull back slowly on the oral syringe plunger to withdraw the dose prescribed by your healthcare provider (2.5 mL, 3.75 mL, or 5 mL). If you see air bubbles in the oral syringe, fully push in the plunger so that the oral solution flows back into the bottle. Then, withdraw your prescribed dose of oral solution (See Figure F).

Figure F

6. Leave the oral syringe in the bottle adapter and turn the bottle right-side up. Place the bottle onto a flat surface. Remove the oral syringe from the bottle (See Figure G).

Figure G

7. Place the tip of the oral syringe in your mouth. Squirt the oral solution into your mouth by pushing on the plunger until the oral syringe is empty (See Figure H).

Figure H

8. Leave the adapter in the bottle. Put the childresistant cap back on the bottle. (See Figure I).

Figure I

9. Remove the plunger from the oral syringe barrel. Rinse the oral syringe with water after each use and let it air dry. When the oral syringe is dry, put the plunger back into the oral syringe barrel for the next use. Do not throw away the oral syringe.

• Talk to your pharmacist if you have questions about how to use the oral syringe, or if you lose or misplace the oral syringe.

What are the ingredients in NUCYNTA® oral solution?

Active ingredient: tapentadol

Inactive ingredients: citric acid monohydrate, sucralose, raspberry flavor, sodium hydroxide, and purified water.

How should I store NUCYNTA® oral solution?

• Store NUCYNTA® oral solution at room temperature between 68°F to 77°F (20°C to 25°C).
• Store the NUCYNTA® oral solution bottle upright after opening. Keep the oral syringe with your medicine.
• After you stop taking NUCYNTA® oral solution, flush the unused oral solution down the toilet.

Keep NUCYNTA® oral solution out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 11/20/2012
This monograph has been modified to include the generic and brand name in many instances.