• Tapentadol

    (ta pen' ta dol)

    WHY is this medicine prescribed?

    Tapentadol is used to treat moderate to severe pain that is expected to last for a short time. Tapentadol is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the body responds to pain.

    HOW should this medicine be used?

    Tapentadol comes as a tablet to take by mouth. It is usually taken with or without food every 4 to 6 hours as needed. 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. 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.
    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.
    Tapentadol should only be used to treat moderate to severe pain. You should not take tapentadol if your pain is mild and can be controlled with other pain medicines.
    Tapentadol may be habit forming. Do not take a larger dose, take it more often, or take it for a longer period of time or in a different way than prescribed by your doctor.
    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 anxiety; sweating; difficulty falling asleep or staying asleep; shivering; shaking of a part of your body that you cannot control; pain; nausea; diarrhea; runny nose, sneezing, or coughing; hair on your skin standing on end; or hallucinations (seeing things or hearing voices that do not exist).
    Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with tapentadol. 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 ( http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

    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. 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; medications for anxiety, mental illness, or seizures; medications for migraines such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex, in Treximet), and zolmitriptan (Zomig); narcotic medications for pain; 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); sedatives; sleeping pills; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with tapentadol, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
    • tell your doctor if you have or have ever had asthma, lung disease, chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways), slowed breathing, 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 or anyone in your family drinks or has ever drunk large amounts of alcohol, has used street drugs, or has overused prescription medications. Also tell your doctor if you are very overweight, and 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); kyphoscoliosis (curving of the spine that may cause breathing problems); seizures; sleep apnea (condition in which breathing stops or becomes shallow during sleep); 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.
    • ask your doctor about the safe use of alcoholic beverages while you are taking tapentadol. Alcohol can make the side effects from tapentadol worse.
    • 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?

    This medication is usually taken as needed. If your doctor has told you to take tapentadol regularly, 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:
    • nausea
    • vomiting
    • loss of appetite
    • constipation
    • dry mouth
    • dizziness
    • drowsiness
    • difficulty falling asleep or staying asleep
    • abnormal dreams
    • shaking of a part of the body that you cannot control
    • pain in the joints
    • itching
    • rash
    • increased sweating
    • difficulty urinating or pain when urinating
    Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:
    • slow, shallow, or difficult breathing
    • slow or fast heartbeat
    • severe sleepiness
    • cold, clammy skin
    • feeling faint, dizzy, or confused
    • difficulty thinking, walking, or talking normally
    • seizures
    • hallucinations
    • agitation
    • feeling overheated
    • loss of coordination
    • overactive reflexes
    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 http://www.fda.gov/Safety/MedWatch ] 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). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
    Store tapentadol in a safe place so that no one else can take it accidentally or on purpose. Keep track of how many tablets are left so you will know if any are missing.

    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:
    • decrease in pupil (dark circle in the eye) size
    • vomiting
    • seizures
    • slow or stopped heartbeat
    • difficulty breathing or slowed or stopped breathing
    • loss of consciousness or coma

    What OTHER INFORMATION should I know?

    Keep all appointments with your doctor.
    Do not let anyone else take your medication. Selling or giving away this medication may cause severe harm or death to others and is illegal.
    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.

    Brand Names

    • Nucynta®
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