Uses of Tapentadol Extended-Release Tablets:

• It is used to ease pain.

What do I need to tell my doctor BEFORE I take Tapentadol Extended-Release Tablets?

• If you are allergic to this medicine (tapentadol extended-release tablets); any part of this medicine (tapentadol extended-release tablets); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Lung or breathing problems like asthma, trouble breathing, or sleep apnea; high levels of carbon dioxide in the blood; or stomach or bowel block or narrowing.
• If you have any of these health problems: Kidney disease or liver disease.
• If you have taken certain drugs for depression or Parkinson's disease in the last 14 days. This includes isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline. Very high blood pressure may happen.
• If you are taking any of these drugs: Linezolid or methylene blue.
• If you are taking any of these drugs: Buprenorphine, butorphanol, nalbuphine, pentazocine, or tramadol.
• If you are taking another drug that has the same drug in it.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine (tapentadol extended-release tablets).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (tapentadol extended-release tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Tapentadol Extended-Release Tablets?

• Tell all of your health care providers that you take this medicine (tapentadol extended-release tablets). This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how this medicine (tapentadol extended-release tablets) affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Do not take this medicine (tapentadol extended-release tablets) with other strong pain drugs or if you are using a pain patch without talking to your doctor first.
• This medicine may raise the chance of seizures in some people, including people who have had seizures in the past. Talk to your doctor to see if you have a greater chance of seizures while taking this medicine (tapentadol extended-release tablets).
• Long-term or regular use of opioid drugs like this medicine (tapentadol extended-release tablets) may lead to dependence. Lowering the dose or stopping this medicine (tapentadol extended-release tablets) all of a sudden may cause a greater risk of withdrawal or other severe problems. Talk to your doctor before you lower the dose or stop this medicine (tapentadol extended-release tablets). You will need to follow your doctor’s instructions. Tell your doctor if you have more pain, mood changes, thoughts of suicide, or any other bad effects.
• If you have been taking this medicine (tapentadol extended-release tablets) for a long time or at high doses, it may not work as well and you may need higher doses to get the same effect. This is known as tolerance. Call your doctor if this medicine (tapentadol extended-release tablets) stops working well. Do not take more than ordered.
• Long-term use of an opioid drug may lead to lower sex hormone levels. Call your doctor if you have a lowered interest in sex, fertility problems, no menstrual period (women), or change in sex ability (men).
• If you are 65 or older, use this medicine (tapentadol extended-release tablets) with care. You could have more side effects.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine (tapentadol extended-release tablets), call your doctor right away.

How is this medicine (Tapentadol Extended-Release Tablets) best taken?

Use this medicine (tapentadol extended-release tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food. Take with food if it causes an upset stomach.
• Take by mouth only.
• Do not inject or snort this medicine (tapentadol extended-release tablets). Doing any of these things can cause very bad side effects like trouble breathing and death from overdose.
• Do not use for fast pain relief or on an as needed basis.
• Do not use for pain relief after surgery if you have not been taking drugs like this medicine (tapentadol extended-release tablets).
• Swallow whole. Do not chew, break, or crush.
• Take 1 tablet at a time if your dose is more than 1 tablet. Do not lick or wet the tablet before putting it in your mouth. Swallow the tablet with lots of water right after putting it in your mouth.
• If you have trouble swallowing, talk with your doctor.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• Some products are to be taken to ease pain as needed. If you are taking this medicine (tapentadol extended-release tablets) as needed, do not take more often than told by your doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• Seizures.
• Severe constipation or stomach pain. These may be signs of a severe bowel problem.
• Chest pain or pressure or a fast heartbeat.
• Feeling confused.
• Mood changes.
• Shortness of breath.
• Trouble walking.
• Feeling overheated.
• A severe and sometimes deadly problem called serotonin syndrome may happen if you take this medicine (tapentadol extended-release tablets) with certain other drugs. Call your doctor right away if you have agitation; change in balance; confusion; hallucinations; fever; fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; severe diarrhea, upset stomach, or throwing up; or severe headache.
• Taking an opioid drug like this medicine (tapentadol extended-release tablets) may lead to a rare but very bad adrenal gland problem. Call your doctor right away if you have very bad dizziness or passing out, very bad upset stomach or throwing up, or if you feel less hungry, very tired, or very weak.

What are some other side effects of Tapentadol Extended-Release Tablets?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Constipation.
• Feeling dizzy, sleepy, tired, or weak.
• Upset stomach or throwing up.
• Itching.
• Dry mouth.
• Headache.
• Stomach pain or diarrhea.
• Not hungry.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Tapentadol Extended-Release Tablets?

• Store at room temperature in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine (tapentadol extended-release tablets) is refilled. If you have any questions about this medicine (tapentadol extended-release tablets), please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.