Tapentadol, Oral ta-PEN-ta-dohl

What are other names for this medicine?

Type of medicine: analgesic (painkiller)

Generic and brand names: tapentadol, oral; Nucynta

What is this medicine used for?

This medicine is taken by mouth for a short time to relieve moderate to severe pain caused by surgery or other conditions.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• an allergic reaction to any medicine
• a head injury or brain tumor
• liver or kidney disease
• lung disease or breathing problems
• pancreas or gallbladder problems
• paralytic ileus (digestive problem)
• problems with drug or alcohol abuse
• seizures

Do not take this medicine if you have taken an MAO inhibitor antidepressant or thioridazine in the last 2 weeks. Serious side effects can occur. Talk with your healthcare provider about this.

Females of childbearing age: Tell your healthcare provider if you are pregnant or if you plan to become pregnant while taking this medicine. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Check the label on the medicine for directions about your specific dose. Take this medicine exactly as your healthcare provider prescribes. Do not take more or less or take it longer than prescribed. Taking too much of this medicine may be habit-forming and may increase your risk serious side effects, such as seizures and breathing problems, or death. Do not stop taking this medicine without your healthcare provider's approval. You may have to reduce your dosage gradually.

You may take this medicine with or without food, but take it the same way each time.

What if I miss a dose?

If you are taking this medicine on a regular schedule and you miss a dose or forget to take your medicine, take it as soon as you can. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: drowsiness, vomiting, slow breathing, extreme weakness, cold clammy skin, pinpoint pupils, confusion, seizures, coma.

What should I watch out for?

This medicine may cause serotonin syndrome, which can be life-threatening. It may be caused by taking this medicine in combination with other medicines. These medicines include antidepressants, medicines to treat migraines, pain medicines, some cough medicines, St. John’s wort, and others. Make sure that your providers know ALL of the medicines that you take.

Contact your healthcare provider right away if you have:

• restlessness
• hallucinations
• loss of coordination
• fast heart beat
• rapid changes in blood pressure
• increased body temperature
• nausea
• vomiting
• diarrhea

This medicine may be habit-forming or you may become dependent on the medicine. Contact your healthcare provider if your condition does not improve in a few days or if it gets worse. Contact your healthcare provider if the medicine does not seem to be working as well. Do not use more than your prescribed dose. Also, do not stop taking this medicine without your healthcare provider's approval. Stopping suddenly may cause serious side effects. You may have to gradually reduce your dosage. Talk with your healthcare provider about this.

This medicine may make you drowsy or dizzy. Do not drive or operate machinery until you are fully alert. You may feel dizzy or faint when you get up quickly after sitting or lying down. Getting up slowly may help.

This medicine may make you constipated. You may need to take a laxative or stool softener while taking this medicine. Talk with healthcare provider or pharmacist about this.

This medicine increases the effects of alcohol and other drugs that slow down your nervous system. Do not drink alcohol or take other medicines unless your healthcare provider approves.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

This medicine is a controlled substance. It is illegal for you to give it to anyone else. Do not take the medicine for any other conditions without your healthcare provider's approval.

If you need emergency care, surgery, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you are unable to reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reactions (hives, itching, rash, tightness in your chest, trouble breathing, swelling of your lips, tongue or throat); seizures.

Serious (report these to your healthcare provider right away): Severe dizziness; severe confusion; hallucinations; chest pain; fast, slow, or irregular heartbeat; unusual or severe drowsiness; trouble breathing; severe restlessness; severe nausea or vomiting; severe diarrhea; trouble walking or talking.

Other: Constipation, headache, dizziness, drowsiness, weakness, sweating, diarrhea, nausea, vomiting, heartburn, flushing, dry mouth, loss of appetite, trouble sleeping, nervousness, itching.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• alcohol
• anesthetic or numbing medicines such as lidocaine
• antianxiety medicines such as alprazolam (Xanax), clonazepam (Klonopin), clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan), and oxazepam
• antidepressants such as nefazodone, amitriptyline, amoxapine, citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), desvenlafaxine (Pristiq), doxepin, duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor), paroxetine (Paxil), protriptyline (Vivactil), sertraline (Zoloft), trazodone, trimipramine (Surmontil), and venlafaxine (Effexor)
• antipsychotic medicines such as chlorpromazine, clozapine (Clozaril), fluphenazine, haloperidol (Haldol), olanzapine (Zyprexa), perphenazine, prochlorperazine (Compro), risperidone (Risperdal), thioridazine, trifluoperazine, and ziprasidone (Geodon)
• antiseizure medicines such as carbamazepine (Tegretol), felbamate (Felbatol), gabapentin (Neurontin), lamotrigine (Lamictal), levetiracetam (Keppra), phenytoin (Dilantin), primidone (Mysoline), tiagabine (Gabitril), and topiramate (Topamax)
• barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), and secobarbital (Seconal)
• bupropion (Wellbutrin, Wellbutrin SR, Zyban)
• dextromethorphan, an ingredient in many cough and cold medicines such as Robitussin-DM
• lithium (Lithobid)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• migraine medicines such as almotriptan (Axert), dihydroergotamine (Migranal Nasal Spray, DHE 45), ergotamine (Cafergot), frovatriptan (Frova), isometheptene (Midrin), rizatriptan (Maxalt), sumatriptan (Imitrex), and zolmitriptan (Zomig)
• muscle relaxants such as baclofen (Lioresal), carisoprodol (Soma), cyclobenzaprine (Flexeril), dantrolene (Dantrium), methocarbamol (Robaxin), and tizanidine (Zanaflex)
• natural remedies such as gotu kola, kava, St. John's wort, and valerian
• narcotic cough medicines such as guaifenesin/codeine (Tussi-Organidin, Robitussin AC), hydrocodone/chlorpheniramine (Tussionex), hydrocodone/homatropine, promethazine (Phenergan), and promethazine with codeine (Phenergan with codeine)
• narcotic pain medicines such as codeine, fentanyl (Duragesic, Actiq), hydrocodone/acetaminophen (Vicodin, Lortab), hydromorphone (Dilaudid), meperidine (Demerol), methadone (Dolophine), morphine (Kadian, MS Contin), oxycodone (OxyContin, Roxicodone), oxycodone/acetaminophen (Percocet, Tylox), and pentazocine (Talwin)
• phenothiazines such as chlorpromazine, prochlorperazine (Compro), perphenazine, thioridazine, and trifluoperazine
• sleeping pills such as amobarbital (Amytal), butabarbital (Butisol), flurazepam, phenobarbital, temazepam (Restoril), triazolam (Halcion), zaleplon (Sonata), and zolpidem (Ambien
• tramadol (Ultram)

Do not drink alcohol while you are taking this medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.