| IMPORTANT WARNING
| WHY is this medicine prescribed?
| HOW should this medicine be used?
| Are there OTHER USES for this medicine?
| What SPECIAL DIETARY instructions should I follow?
| What should I do IF I FORGET to take a dose?
| What SIDE EFFECTS can this medicine cause?
| What should I know about STORAGE and DISPOSAL of this medication?
| What should I do in case of OVERDOSE?
| What OTHER INFORMATION should I know?
Tapentadol may be habit-forming. Do not take more of it, take it more often, or take it in a different way than directed by your doctor. Tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used street drugs, or has overused prescription medications, or if you have or have ever had depression or another mental illness. There is a greater risk that you will overuse tapentadol if you have or have ever had any of these conditions.
Do not allow anyone else to take your medication. Tapentadol may harm or cause death to other people who take your medication, especially children. Keep tapentadol in a safe place so that no one else can take it accidentally or on purpose. Be especially careful to keep tapentadol out of the reach of children. Keep track of how many tablets or extended-release tablets are left so you will know if any medication is missing. Flush any tablets or extended-release tablets that are outdated or no longer needed down the toilet so that others will not take them.
Tapentadol may cause slowed or stopped breathing, especially when you begin your treatment and any time your dose is increased. Your doctor will monitor you carefully during your treatment, especially during the first 72 hours after you start taking tapentadol or after your dose is increased. Your doctor will adjust your dose to control your pain and decrease the risk that you will experience serious breathing problems. Tell your doctor if you have or have ever had slowed breathing or asthma. Your doctor will probably tell you not to take tapentadol. Also tell your doctor if you have or have ever had lung disease such as chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways). The risk that you will develop breathing problems may be higher if you are an older adult or are weakened or malnourished due to disease. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: slowed breathing, long pauses between breaths, or shortness of breath.
Drinking alcohol, taking prescription or non-prescription medications that contain alcohol, or using street drugs during your treatment with tapentadol increases the risk that you will experience serious, life-threatening side effects. Do not drink alcohol, take prescription or non-prescription medications that contain alcohol, or use street drugs during your treatment with tapentadol.
Taking certain other medications during your treatment with tapentadol may increase the risk that you will experience breathing problems or other serious, life-threatening side effects. Tell your doctor if you are taking or plan to take any of the following medications: other narcotic pain medications; medications for anxiety, seizures, mental illness, or nausea; muscle relaxants; sedatives; sleeping pills; or tranquilizers.
Swallow tapentadol extended-release tablets whole; do not chew, break, divide, crush, or dissolve them. If you swallow broken, chewed, crushed, or dissolved extended-release tablets, you may receive too much tapentadol at once instead of slowly over 12 hours. This may cause serious problems, including overdose and death.
Talk to your doctor about the risks of taking tapentadol.
If you are taking tapentadol extendedrelease tablets, your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin your treatment and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website ( Web Site) or the manufacturer's website to obtain the Medication Guide.
WHY is this medicine prescribed?
Tapentadol tablets are used to treat moderate to severe acute pain (pain that begins suddenly, has a specific cause, and is expected to go away when the cause of the pain is healed). Tapentadol extended-release tablets are used to treat moderate to severe chronic pain (pain that is expected to last a long time that may not have a known cause or that may be due to an ongoing condition) and to treat neuropathic pain (pain caused by nerve damage) in people who have diabetes. Tapentadol extended-release tablets are only used to treat people who are expected to need medication to relieve pain around the clock. Tapentadol is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.
HOW should this medicine be used?
Tapentadol comes as a tablet and an extended-release (long acting) tablet to take by mouth. The tablets are usually taken with or without food every 4 to 6 hours as needed. If you are taking tapentadol tablets, your doctor may tell you that you may take a second dose as soon as 1 hour after the first dose on your first day of treatment if needed to treat your pain. Do not take extra doses at any other time during your treatment. The extended-release tablets are taken once every 12 hours. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take tapentadol exactly as directed.
If you are taking the extended-release tablets, swallow them one at a time with plenty of water. Swallow each tablet right after you put it in your mouth.
Your doctor will probably start you on a low dose of tapentadol and gradually increase your dose until your pain is controlled. Your doctor may adjust your dose at any time during your treatment if your pain is not controlled. If you feel that your pain is not controlled, call your doctor. Do not change the dose of your medication without talking to your doctor.
After you take tapentadol for a period of time, your body may become used to the medication. If this happens, your doctor may need to increase your dose of medication to control your pain. Talk to your doctor about how you are feeling during your treatment with tapentadol.
Do not stop taking tapentadol without talking to your doctor. Your doctor will probably decrease your dose gradually. If you suddenly stop taking tapentadol, you may experience withdrawal symptoms such as restlessness; anxiety; irritability; sweating; difficulty falling asleep or staying asleep; shivering; uncontrollable shaking of a part of your body; muscle, back, or joint pain; weakness; nausea; vomiting; diarrhea; stomach cramps; loss of appetite; runny nose, sneezing, or coughing; hair on your skin standing on end; fast breathing; fast heartbeat; widening of the pupils (black circles in the middle of the eyes); or hallucinations (seeing things or hearing voices that do not exist).
Are there OTHER USES for this medicine?
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What SPECIAL PRECAUTIONS should I follow?
Before taking tapentadol,
- tell your doctor and pharmacist if you are allergic to tapentadol, or any other medications, or any of the ingredients in tapentadol tablets or extended-release tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- tell your doctor if you are taking the following medications or have stopped taking them within the past two weeks: monoamine oxidase (MAO) inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Emsam, Eldepryl, Zelapar), and tranylcypromine (Parnate). Also tell your doctor if any of these medications are prescribed for you during your treatment with tapentadol. Your doctor will probably tell you not to take tapentadol if you are taking one or more of these medications.
- tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antidepressants such as amitriptyline, amoxapine, clomipramine (Anafranil), desipramine (Norpramin), doxepin, imipramine (Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); antihistamines; buprenorphine (Buprenex, Subutex, in Suboxone); butorphanol (Stadol); medications for migraines such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex, in Treximet), and zolmitriptan (Zomig);mirtazapine (Remeron); nalbuphine (Nubain); pentazocine (Talwin); selective serotonin reuptake inhibitors (SSRIs) such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, in Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), and sertraline (Zoloft); selective serotonin/norepinephrine reuptake inhibitors (SNRIs) such as desvenlafaxine (Pristiq), duloxetine (Cymbalta), sibutramine (Meridia), and venlafaxine (Effexor); tramadol (Conzip, Ultram); and trazodone (Oleptro). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section, a blockage in your stomach or intestines, or paralytic ileus (condition in which digested food does not move through the intestines). Your doctor may tell you not to take tapentadol.
- tell your doctor if you have or have ever had a head injury; a tumor in your brain or nervous system; any condition causing increased pressure in your brain; hypothyroidism (condition in which the thyroid gland produces less hormone than normal); seizures;any condition that causes difficulty urinating; or pancreas, gallbladder, kidney, or liver disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking tapentadol, call your doctor.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking tapentadol.
- you should know that tapentadol may make you drowsy. Do not drive a car, operate machinery, or participate in any other possibly dangerous activities until you know how this medication affects you.
- you should know that tapentadol may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
What SPECIAL DIETARY instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What should I do IF I FORGET to take a dose?
Tapentadol tablets are usually taken as needed. If your doctor has told you to take the tablets regularly or if you are taking the extended-release tablets, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
What SIDE EFFECTS can this medicine cause?
Tapentadol may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- loss of appetite
- dry mouth
- difficulty falling asleep or staying asleep
- abnormal dreams
- blurred vision
- sudden feeling of warmth
- increased sweating
Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:
- swelling of the eyes, face, lips, tongue, or throat
- difficulty breathing or swallowing
Tapentadol may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at
] or by phone [1-800-332-1088].
What should I know about STORAGE and DISPOSAL of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Flush any medication that is outdated or no longer needed down the toilet. Talk to your pharmacist about the proper disposal of your medication.
What should I do in case of OVERDOSE?
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
- narrowing or widening of the pupils (dark circles in the eyes)
- loss of consciousness or coma
- muscle weakness
- cold, clammy skin
- slowed or stopped breathing
- slowed heartbeat
What OTHER INFORMATION should I know?
Keep all appointments with your doctor.
This prescription is not refillable. If you continue to have pain after you finish the medication, call your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
Selected Revisions: December 15, 2013.