When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to tapentadol, or if you have severe breathing problems or paralytic ileus.

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
• 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. Do not throw unused medicine in the trash. Ask your pharmacist about the best way to dispose of medicine you do not use. Keep the oral liquid bottle upright after you open it.

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

• Some foods and medicines can affect how tapentadol works. Tell your doctor if you are using any of the following:
  
  • Tramadol
  • A phenothiazine medicine
  • Medicine to treat depression (such as mirtazapine, trazodone)
  • Medicine to treat migraine headaches
  • An MAO inhibitor (MAOI) within the past 14 days
• 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.

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 (such as COPD or asthma), low blood pressure, 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)
• 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.
• 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
• Extreme dizziness or weakness, shallow breathing, slow or uneven heartbeat, sweating, seizures, and cold, clammy skin
• Severe confusion, lightheadedness, dizziness, fainting
• Severe constipation, stomach pain, or vomiting
• Trouble breathing or slow breathing

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

• Mild constipation, diarrhea, nausea, or vomiting
• Mild 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