NUCYNTA - tapentadol hydrochloride tablet, film coated 
Stat Rx USA


NUCYNTA™ (new-SINN-tah)
immediate-release oral tablets   C-II

  • NUCYNTA™ is a federally controlled substance (C-II) because it can be abused. Keep NUCYNTA™ in a safe place to prevent theft. Selling or giving away NUCYNTA™ may harm others, and is against the law.
  • Tell your doctor if you (or a family member) have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

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™?

Who should not take NUCYNTA™?

Do not take NUCYNTA™ if you:

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:

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:

How should I take NUCYNTA™?

What should I avoid while taking NUCYNTA™?

What are the possible side effects of NUCYNTA™?

NUCYNTA™ can cause serious side effects including:

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™?

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.

Revised: 10/2009
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