Tapentadol is an opioid pain medication. An opioid is sometimes called a narcotic. Tapentadol is used to treat moderate to severe pain. The extended-release form of tapentadol (Nucynta ER) is for around-the-clock treatment of pain that is not controlled by other medicines. Nucynta ER is not for use on an as-needed basis for pain.

Before taking this medicine

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

• severe asthma or breathing problems; or
• a blockage in your digestive tract (stomach or intestines).

Do not use tapentadol if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, and tranylcypromine.

To make sure tapentadol is safe for you, tell your doctor if you have ever had:

• breathing problems, sleep apnea;
• a head injury, brain tumor, or seizures;
• drug or alcohol addiction, or mental illness;
• urination problems;
• liver or kidney disease; or
• problems with your gallbladder, pancreas, or thyroid.

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 opioids may need medical treatment for several weeks.

You should not breast-feed while using tapentadol.

Do not give tapentadol to a child.

How should I take tapentadol?

Take tapentadol exactly as prescribed. 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 abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it. Selling or giving away opioid medicine is against the law.

Take this medicine with a full glass of water. Tapentadol can be taken with or without food.

Stop taking all other around-the-clock narcotic pain medications when you start taking tapentadol extended-release tablets.

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.

Do not stop using tapentadol suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Never crush or break a tablet to inhale the powder or mix it into a liquid to inject the drug into your vein. This practice has resulted in death with the misuse of tapentadol and similar prescription drugs.

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.