Tramadol/Acetaminophen, Oral

________________________________________________________________________

KEY POINTS

• This medicine is taken by mouth to relieve pain caused by surgery or other conditions. Take it exactly as directed. Taking too much may cause liver damage. Narcotic pain medicine may be habit-forming and can put you at risk for addiction, abuse, and misuse that may lead to overdose and death.
• This medicine may cause serious or life-threatening breathing problems, liver damage, or other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Taking this medicine with alcohol or other medicines that make you sleepy or slow your breathing can cause coma or death. Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

________________________________________________________________________

What are other names for this medicine?

Type of medicine: narcotic (opioid) pain reliever/analgesic

Generic and brand names: tramadol/acetaminophen, oral; Ultracet

What is this medicine used for?

This medicine is a combination of a narcotic (tramadol) and a non-narcotic analgesic (acetaminophen). It is taken by mouth for a short time (usually 5 days or less) to relieve pain caused by surgery or other conditions.

This medicine may be used to treat other conditions as determined by your healthcare provider.

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 blockage in the intestines, Crohn's disease, ulcerative colitis, or severe constipation
• A blood disorder such as G6PD deficiency
• A head injury, stroke, or brain tumor
• A stroke, head injury, or brain tumor
• Addison's disease
• Depression or thoughts of suicide
• Heart disease or irregular heartbeat
• Liver or kidney disease
• Low blood pressure
• Lung or breathing problems such as asthma, COPD, or sleep apnea
• Mental health problems such as depression or bipolar disorder
• Pancreas or gallbladder problems
• Problems with alcohol or drug abuse
• Seizures
• Thyroid problems
• Trouble swallowing
• Trouble urinating or an enlarged prostate gland

Females of childbearing age: Tell your healthcare provider if you are pregnant or if you plan to become pregnant while taking this medicine. Long-term use of this medicine during pregnancy can cause withdrawal symptoms in your newborn 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.

Check with your healthcare provider before using this medicine in children under age 18.

You should not take more than 4000 mg of acetaminophen per day or as directed by your healthcare provider. You may need a lower amount of acetaminophen, especially if you drink alcohol or take certain other medicines. If you do not know how much acetaminophen is in your medicine, ask your pharmacist. Many nonprescription products such as those for pain, cold and flu, allergy, and trouble sleeping contain acetaminophen. Check the label or ask your pharmacist to avoid taking too much acetaminophen.

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 take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

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: extreme drowsiness, pinpoint pupils, confusion, trouble breathing or breathing that stops, cold or clammy skin, irregular or slow heartbeat, nausea, vomiting, diarrhea, stomach pain, sweating, seizures, coma.

What should I watch out for?

Do not take other medicines unless you check with your healthcare provider first. Taking this medicine with alcohol or medicines that make you sleepy or slow your breathing can cause life-threatening side effects. Tell your healthcare if you take any kind of sleeping pill, pain medicine, muscle relaxant, nausea medicine, or medicine to treat anxiety, depression, or seizures. This medicine may cause a life-threatening problem called serotonin syndrome if you take it with certain other medicines, such as migraine medicines, some cough medicines, St. John’s wort, and others. Make sure that your healthcare providers know ALL of the medicines that you take.

This medicine may cause life-threatening or fatal breathing problems. Taking this medicine for a long time may also cause a rare but very serious adrenal gland problem or decreased sex hormone levels. Talk with your healthcare provider about this.

Narcotic pain medicine may be habit-forming and can put you at risk for addiction, abuse, and misuse that may lead to overdose and death. Take it exactly as directed by your healthcare provider. Do not take more of it or take it more often than directed. Taking too much of this medicine increases your chance of side effects. If you use this medicine regularly for a long time or in high doses, ask your healthcare provider how to reduce your dose gradually. Follow your healthcare provider’s instructions about how to stop taking the medicine.

This medicine is a controlled substance. It is illegal for you to give it to anyone else. Keep this medicine away from children. Accidental use by a child can cause death.

This medicine may cause severe liver damage if:

• An adult takes more than 4000 mg in 24 hours
• You take this medicine with other drugs that contain acetaminophen
• An adult has 3 or more alcoholic drinks every day while using this product

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.

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

If you need emergency care, surgery, lab tests, 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 cannot 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.): Trouble breathing; slow or shallow breathing; extreme sleepiness; confusion; seizures; hallucinations (seeing or hearing things that are not there); chest pain; fast, slow, or irregular heartbeat; black tarry or bloody bowel movements; bloody vomit; unusual bruising or bleeding; swelling of your feet, ankles, legs, or hands or any unexplained swelling; neck pain or stiffness; unusual muscle pain; unusual tiredness or weakness; skin rash, peeling or blisters; dark urine; light-colored bowel movements; yellowing of your skin or eyes; decreased or trouble urinating; severe nausea or vomiting; severe or continued stomach pain; severe constipation; severe dizziness or fainting; unusual mood changes; unexplained fever or flushing; trembling; pinpoint pupils; blurred vision.

Other: Constipation, headache, drowsiness, dizziness, weakness, sweating, diarrhea, nausea, vomiting, heartburn, flushing, dry mouth, change in sexual desire or ability, decreased appetite, trouble sleeping, nervousness, mild itching.

What products might interact with this medicine?

This medicine may interact with MANY other medicines and cause life-threatening side effects. This list does not include all possible medicines that may interact. Do not start or stop ANY medicine unless you check with your healthcare provider or pharmacist first. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Tell your healthcare provider all the products you take, for example:

• Abiraterone (Zytiga)
• Acetaminophen and medicines that contain acetaminophen
• Antianxiety medicines such as alprazolam (Xanax), buspirone, diazepam (Valium), lorazepam (Ativan), and others
• Antibiotics such as erythromycin (E.E.S., Ery-Tab, Erythrocin), levofloxacin (Levaquin), linezolid (Zyvox), rifampin (Rifadin), telithromycin (Ketek), and others
• Anticholinergic medicines such as atropine/diphenoxylate (Lomotil), benztropine (Cogentin), dicyclomine (Bentyl), hyoscyamine (HyoMax, Levbid, Levsin), and others
• Antidepressants such as amitriptyline, duloxetine (Cymbalta), fluoxetine (Prozac), mirtazapine (Remeron), nefazodone, trazodone, and others
• Antifungal medicines such as itraconazole (Sporanox), ketoconazole (Nizoral), terbinafine (Lamisil), voriconazole (Vfend), and others
• Antihistamines such as azelastine (Astelin, Astepro), chlorpheniramine (Chlor-Trimeton), diphenhydramine (Benadryl), meclizine (Dramamine), and others
• Antipsychotic medicines such as chlorpromazine, haloperidol (Haldol), olanzapine (Zyprexa), risperidone (Risperdal), ziprasidone (Geodon), and others
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), gabapentin (Neurontin), levetiracetam (Keppra), phenytoin (Dilantin, Phenytek), and others
• Barbiturates such as butabarbital (Butisol), pentobarbital (Nembutal), phenobarbital, secobarbital (Seconal), and others
• Bladder control medicines such as darifenacin (Enablex), oxybutynin (Ditropan XL, Oxytrol), solifenacin (VESIcare), and tolterodine (Detrol)
• Bosentan (Tracleer)
• Bromocriptine (Cycloset, Parlodel)
• Bupropion (Aplenzin, Forfivo, Wellbutrin, Buproban, Zyban)
• Cancer medicines such as ceritinib (Zykadia), enzalutamide (Xtandi), idelalisib (Zydelig), nilotinib (Tasigna), and others
• Cimetidine (Tagamet)
• Cinacalcet (Sensipar)
• Dexamethasone
• Dextromethorphan, an ingredient in many allergy, cold, or cough medicines such as Robitussin-DM or dextromethorphan/quinidine (Nuedexta)
• Diflunisal
• Diuretics (water pills) such as bumetanide, furosemide (Lasix), hydrochlorothiazide (Microzide), torsemide (Demadex), and others
• Doxepin (Silenor)
• Enzalutamide (Xtandi)
• Heart medicines such as digoxin (Lanoxin), dronedarone (Multaq), and quinidine
• HIV medicines such as atazanavir (Reyataz), efavirenz (Sustiva), elvitegravir/cobicistat/emtricitabine/tenofovir (Stribild), saquinavir (Invirase), and others
• Lithium (Lithobid)
• Lorcaserin (Belviq)
• MAO inhibitors such as isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate) (Do not take this medicine and an MAO inhibitor within 14 days of each other.)
• Medicines that block or may partially block the effect of narcotic pain medicines such as buprenorphine/naloxone (Bunavil, Suboxone, Zubsolv), bupropion/naltrexone (Contrave), naltrexone (ReVia, Vivitrol), and others
• Medicines to treat breathing or lung problems such as aclidinium (Tudorza), ipratropium (Atrovent), tiotropium (Spiriva), and umeclidinium (Incruse Ellipta), and others
• Medicines to treat low sodium levels such as conivaptan (Vaprisol) and tolvaptan (Samsca)
• Migraine medicines such as dihydroergotamine (D.H.E. 45, Migranal), eletriptan (Relpax), ergotamine (Ergomar), sumatriptan (Alsuma, Imitrex, Sumavel), zolmitriptan (Zomig), and others
• Milnacipran (Savella)
• Muscle relaxants such as baclofen (Gablofen, Lioresal), carisoprodol (Soma), dantrolene (Dantrium), tizanidine (Zanaflex), and others
• Narcotic allergy, cold, or cough medicines such as guaifenesin/codeine (Robitussin AC, Tussi-Organidin), hydrocodone/chlorpheniramine (Tussionex), hydrocodone/homatropine, promethazine/codeine (Phenergan with codeine), and others
• Natural remedies such as gotu kola, kava, St. John's wort, valerian, and others
• Nausea medicines such as aprepitant (Emend), dolasetron (Anzemet), promethazine, prochlorperazine (Compro), and others
• Other pain medicines such as codeine, fentanyl (Abstral, Actiq, Duragesic, Fentora, Sublimaze), hydrocodone/acetaminophen (Norco, Vicodin), morphine (Kadian, MS Contin), and others
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Procarbazine (Matulane)
• Prochlorperazine (Compro)
• Products that contain methylene blue (Hyophen, Prosed DS, Urophen, Uta)
• Propranolol (Hemangeol, Inderal, InnoPran)
• Quinine
• Rasagiline (Azilect)
• Ropinirole (Requip)
• Sleeping pills such as eszopiclone (Lunesta), phenobarbital, triazolam (Halcion), zolpidem (Ambien, Edluar, Intermezzo), and others
• Tedizolid (Sivextro)
• Warfarin (Coumadin)

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.