Tramadol and acetaminophen (Oral)

Tramadol and acetaminophen combination is used to relieve severe acute pain that requires opioid treatment and when other pain medications did not work well enough or cannot be tolerated. Using both medicines together provides better pain relief than either one alone. In some cases, you might find relief with lower doses of each medicine.

Tramadol is part of a group of medicines known as opioid analgesics (narcotics). It works in the central nervous system (CNS) to relieve pain. When tramadol is taken for a long time, it can become habit-forming (leading to mental or physical dependence). It is unlikely to cause mental dependence (addiction) when used for this purpose. However, physical dependence can cause side effects if you suddenly stop taking the medicine. Since this medicine is meant for short-term pain relief, mental and physical dependence will likely not happen.

Acetaminophen is used to relieve pain and reduce fever in patients. It does not lead to habit formation when taken long-term. However, taking large doses of acetaminophen may cause unwanted effects, including liver damage. Although rare, taking acetaminophen has been linked to liver transplantation and death, usually at high doses or when using multiple acetaminophen-containing products.

This medicine is available only through a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.

It is very important for your doctor to check on you or your child's progress at regular visits, especially during the first 24 to 72 hours of treatment, to ensure the medicine is working properly. Blood and urine tests may be needed to look for any unwanted effects.

Do not use this medicine if you are currently taking or have taken an MAO inhibitor (MAOI) like isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®] in the past 14 days.

Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn baby. Contact your doctor immediately if your baby has unusual sleep patterns, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or does not gain weight. Inform your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Tramadol is processed in the body in a significant way. Some people convert tramadol to a stronger product (O-desmethyltramadol) faster than others. These individuals are referred to as "ultra-rapid metabolizers of tramadol." Contact your doctor immediately if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may mean you are an "ultra-rapid metabolizer of tramadol," leading to too much O-desmethyltramadol in the body and increased side effects. Children may be particularly sensitive to this, resulting in serious breathing problems or even death. Do not give this medicine to:

• Children younger than 12 years of age.
• Children younger than 18 years of age who have had surgery to remove tonsils or adenoids.
• Children 12 to 18 years of age who are at high risk for breathing problems (for example, obstructive sleep apnea, obesity, lung disease).

If a nursing mother is an ultra-rapid metabolizer of tramadol, it could lead to an overdose in the nursing baby, causing very serious side effects.

For nursing mothers using this medicine:

• Talk to your doctor if you have any questions about taking tramadol or how this medicine may affect your baby.
• Call your doctor if you become extremely tired and have difficulty caring for your baby.
• Your baby should generally nurse every 2 to 3 hours and should not sleep more than 4 hours at a time.
• Contact your doctor, hospital emergency room, or local emergency services (for example, "call 9-1-1") immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and require immediate medical attention.

Check with your doctor right away if you or your child experience pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellowing of the eyes or skin. These could be signs of a serious liver problem.

This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions (for example, Stevens-Johnson syndrome, toxic epidermal necrolysis). These reactions can be life-threatening and need immediate medical attention. Call your doctor right away if you or your child have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, cough, red irritated eyes, red skin lesions (often with a purple center), sore throat, sores, ulcers, or white spots in the mouth or on the lips, trouble breathing or swallowing, unusual tiredness or weakness, or any swelling of your hands, face, mouth, or throat while using this medicine.

Check the labels of all nonprescription (over-the-counter [OTC]) or prescription medicines you are currently taking. If any contain acetaminophen or tramadol, consult your doctor. Taking them together with this medicine may lead to an overdose.

Before undergoing any kind of surgery (including dental surgery) or emergency treatment, inform the doctor or dentist in charge that you or your child are taking this medicine. Serious side effects can occur if your doctor or dentist prescribes certain medicines without being aware that you have been taking this medicine.

If you suspect that you or someone else may have taken an overdose of this medicine, seek emergency help immediately. Your doctor may also provide naloxone and other medicines to treat an overdose. Signs of an overdose include: dark urine, difficulty breathing, irregular, fast or slow, or shallow breathing, nausea, vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or yellowing of the eyes or skin.

Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). Using alcohol or other CNS-affecting medicines with Ultracet® may worsen the side effects of this medicine, including dizziness, poor concentration, drowsiness, unusual dreams, and trouble sleeping. Some examples of medicines that affect the CNS include antihistamines or allergy/cold medicines, sedatives, tranquilizers, sleeping medicines, depression medications, anxiety medications, prescription pain medications or narcotics, attention deficit and hyperactivity disorder medications, seizure medications or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

This medicine may cause sleep-related breathing problems (for example, sleep apnea, sleep-related hypoxemia). Your doctor may reduce your dose if you have sleep apnea while using this medicine.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not exceed your prescribed dose. Contact your doctor for guidance.

Using narcotics for a long time can lead to severe constipation. To prevent this, your doctor may recommend taking laxatives, drinking plenty of fluids, or increasing your dietary fiber. Be sure to follow the instructions carefully, as ongoing constipation can lead to more serious issues.

Check with your doctor right away if you or your child have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or experience hallucinations. These may be signs of a serious condition called serotonin syndrome. Your risk may increase if you also take certain other medicines that affect serotonin levels in your body.

This medicine may cause some people to feel agitated, irritable, or show other abnormal behaviors. It may also lead some individuals to have suicidal thoughts or tendencies or to become more depressed. Make sure your doctor knows if you have trouble sleeping, get upset easily, experience a significant increase in energy, or start acting recklessly. Also, inform your doctor if you have any sudden or intense feelings, such as feeling nervous, angry, restless, violent, or scared. Let your doctor know if you or anyone in your family has attempted suicide.

This medicine may cause some individuals to become dizzy, drowsy, or have difficulty thinking or controlling movements, which could lead to falls, fractures, or other injuries. Do not drive or engage in any activity that could be dangerous until you know how this medicine affects you.

This medicine may cause problems with the adrenal gland. Contact your doctor immediately if you experience darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Dizziness, lightheadedness, or fainting may occur, especially when you suddenly get up from a lying or sitting position. Rising slowly may help. Additionally, lying down for a while may relieve dizziness or lightheadedness. If this issue continues or worsens, check with your doctor immediately.

This medicine may cause hyponatremia (low sodium levels in the blood). Contact your doctor right away if you have coma, confusion, decreased urine output, dizziness, fast or irregular heartbeat, headache, increased thirst, muscle pain or cramps, nausea or vomiting, swelling of the face, ankles, or hands, trouble breathing, or unusual tiredness or weakness.

Check with your doctor right away if you experience anxiety, blurred vision, chills, cold sweats, coma, confusion, cool, pale skin, depression, dizziness, fast heartbeat, headache, increased hunger, nausea, nervousness, nightmares, seizures, shakiness, slurred speech, or unusual tiredness or weakness. These may be symptoms of hypoglycemia (low blood sugar level).

Do not change the dose or stop taking this medicine suddenly without consulting your doctor first. Your doctor may advise you to gradually reduce the dosage before stopping completely. This may help prevent a worsening of your condition and reduce the risk of withdrawal symptoms, such as anxiety, diarrhea, headache, nausea, shivering, sweating, tremors, or trouble sleeping.

Analgesics may cause a dry mouth. For temporary relief, you can try sugarless candy or gum, melting bits of ice in your mouth, or a saliva substitute. If dry mouth lasts more than 2 weeks, consult your dentist. Ongoing dry mouth may raise the risk of dental problems, such as tooth decay, gum disease, and fungal infections.

Using too much of this medicine may lead to infertility (being unable to have children). Speak with your doctor before using this medicine if you are planning to have children.

Do not take any other medicines unless you have discussed them with your doctor. This includes both prescription and nonprescription (over-the-counter [OTC]) medicines, as well as herbal or vitamin supplements.

In deciding to use a medicine, the chances of taking the drug must be weighed against the beneficial it will do. This is a decision you and your clinician will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this drug or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of tramadol and acetaminophen combination in the pediatric population. It should not be used in children younger than 12 years of age. Safety and efficacy have not been established.

This medicine should not be used to ease pain following surgery removal of tonsils or adenoids in any children. Severe breathing problems and deaths have been reported in some children who received codeine following tonsil or adenoid surgery.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific issues that would limit the usefulness of tramadol and acetaminophen combination in the elderly. Nevertheless, elderly patients are more likely to have age-related liver, kidney, heart, or lung issues which may require caution and an adjustment in the dose for patients receiving tramadol and acetaminophen combination.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should discontinue breastfeeding while using this drug.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are using this drug, it is especially important that your healthcare professional know if you are taking any of the medications listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medications is not advised. Your doctor may decide not to treat you with this drug or change some of the other medications you take.

• Furazolidone
• Iproniazid
• Isocarboxazid
• Linezolid
• Methylene Blue
• Moclobemide
• Nalmefene
• Naltrexone
• Nialamide
• Phenelzine
• Procarbazine
• Rasagiline
• Safinamide
• Samidorphan
• Selegiline
• Tranylcypromine

Using this medication with any of the following drugs is normally not advised, but may be required in some cases. If both drugs are prescribed together, your physician may change the dose or how often you use one or both of the medicines.

• Abiraterone Acetate
• Acepromazine
• Alfentanil
• Almotriptan
• Alprazolam
• Amifampridine
• Amineptine
• Amiodarone
• Amitriptyline
• Amitriptylinoxide
• Amobarbital
• Amoxapine
• Amphetamine
• Amprenavir
• Anileridine
• Aprepitant
• Aripiprazole
• Armodafinil
• Asenapine
• Atazanavir
• Baclofen
• Benperidol
• Benzhydrocodone
• Benzphetamine
• Boceprevir
• Bosentan
• Bromazepam
• Bromopride
• Bromperidol
• Brompheniramine
• Buprenorphine
• Bupropion
• Buspirone
• Butabarbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbamazepine
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Ceritinib
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpheniramine
• Chlorpromazine
• Chlorzoxazone
• Cimetidine
• Cinacalcet
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clobazam
• Clomipramine
• Clonazepam
• Clopidogrel
• Clorazepate
• Clozapine
• Cobicistat
• Cocaine
• Codeine
• Conivaptan
• Crizotinib
• Cyclobenzaprine
• Cyclosporine
• Daridorexant
• Darunavir
• Delavirdine
• Desipramine
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Dexmedetomidine
• Dextroamphetamine
• Dextromethorphan
• Dezocine
• Diazepam
• Dibenzepin
• Dichloralphenazone
• Difenoxin
• Dihydrocodeine
• Diltiazem
• Diphenhydramine
• Diphenoxylate
• Dolasetron
• Donepezil
• Dothiepin
• Doxepin
• Doxylamine
• Dronedarone
• Droperidol
• Duloxetine
• Efavirenz
• Eletriptan
• Enflurane
• Enzalutamide
• Erythromycin
• Escitalopram
• Esketamine
• Eslicarbazepine Acetate
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Etravirine
• Fedratinib
• Fenfluramine
• Fentanyl
• Flibanserin
• Fluconazole
• Fluoxetine
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fluvoxamine
• Fosamprenavir
• Fosaprepitant
• Fosphenytoin
• Fospropofol
• Frovatriptan
• Gabapentin
• Gabapentin Enacarbil
• Gepirone
• Granisetron
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Hydrocodone
• Hydromorphone
• Hydroxyamphetamine
• Hydroxytryptophan
• Hydroxyzine
• Idelalisib
• Imatinib
• Imipramine
• Indinavir
• Isoflurane
• Isoniazid
• Itraconazole
• Ivacaftor
• Ketamine
• Ketazolam
• Ketobemidone
• Ketoconazole
• Lacosamide
• Lasmiditan
• Lemborexant
• Lenacapavir
• Levocetirizine
• Levoketoconazole
• Levomilnacipran
• Levorphanol
• Lisdexamfetamine
• Lithium
• Lofepramine
• Lofexidine
• Lomitapide
• Lopinavir
• Lorazepam
• Lorcaserin
• Loxapine
• Lumacaftor
• Magnesium Oxybate
• Meclizine
• Melitracen
• Melperone
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaxalone
• Methadone
• Methamphetamine
• Methocarbamol
• Methohexital
• Methotrexate
• Methotrimeprazine
• Metoclopramide
• Mibefradil
• Midazolam
• Mifepristone
• Milnacipran
• Mirabegron
• Mirtazapine
• Mitotane
• Modafinil
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nafcillin
• Nalbuphine
• Naratriptan
• Nefazodone
• Nelfinavir
• Nevirapine
• Nicomorphine
• Nilotinib
• Nitrazepam
• Nitrous Oxide
• Nortriptyline
• Olanzapine
• Ondansetron
• Opipramol
• Opium
• Opium Alkaloids
• Orphenadrine
• Oxazepam
• Oxcarbazepine
• Oxycodone
• Oxymorphone
• Ozanimod
• Palbociclib
• Palonosetron
• Papaveretum
• Paregoric
• Paroxetine
• Peginterferon Alfa-2b
• Pentazocine
• Pentobarbital
• Perampanel
• Periciazine
• Perphenazine
• Phenobarbital
• Phenytoin
• Pimozide
• Piperacetazine
• Pipotiazine
• Piritramide
• Pixantrone
• Pneumococcal 13-Valent Vaccine, Diphtheria Conjugate
• Posaconazole
• Potassium Oxybate
• Prazepam
• Prednisone
• Pregabalin
• Primidone
• Prochlorperazine
• Promethazine
• Propofol
• Protriptyline
• Quazepam
• Quetiapine
• Quinidine
• Quinine
• Ramelteon
• Ranitidine
• Ranolazine
• Remifentanil
• Remimazolam
• Remoxipride
• Rifabutin
• Rifampin
• Rifapentine
• Ritonavir
• Rizatriptan
• Rolapitant
• Ropeginterferon Alfa-2b-njft
• Saquinavir
• Scopolamine
• Secobarbital
• Sertindole
• Sertraline
• Sibutramine
• Sodium Oxybate
• St John's Wort
• Sufentanil
• Sulpiride
• Sumatriptan
• Suvorexant
• Tapentadol
• Telaprevir
• Telithromycin
• Temazepam
• Terbinafine
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Tianeptine
• Tilidine
• Tizanidine
• Tolonium Chloride
• Topiramate
• Trazodone
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Trimipramine
• Tryptophan
• Venlafaxine
• Verapamil
• Vilazodone
• Voriconazole
• Vortioxetine
• Zaleplon
• Ziprasidone
• Zolmitriptan
• Zolpidem
• Zopiclone
• Zotepine
• Zuranolone

Using this medicine with any of the following medications may cause an increased chance of certain side effects, but using both drugs may be the best therapy for you. If both drugs are prescribed together, your clinician may change the dose or how frequently you use one or both of the medicines.

• Acenocoumarol
• Carbamazepine
• Digoxin
• Fosphenytoin
• Lixisenatide
• Phenytoin
• Warfarin
• Zidovudine

Interactions with Food/Tobacco/Alcohol

Certain drugs should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain drugs may as well cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not advised, but may be unavoidable in some cases. If used together, your clinician may change the dose or how frequently you use this medication, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol
• Grapefruit Juice
• Tobacco

Using this medication with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this drug, or give you special instructions about the use of food, alcohol, or tobacco.

• Cabbage

Other Medical Issues

The presence of other medical issues may affect the use of this drug. Make sure you inform your doctor if you have any other medical issues, especially:

• Adrenal issues or
• Alcohol abuse, or history of or
• Brain tumor or
• Depression, history of or
• Diabetes or
• Drug dependence, especially narcotic abuse or dependence, or history of or
• Gallstones or
• Head injuries or
• Increased pressure in the head or
• Lung or breathing issues (eg, COPD, hypercapnia, hypoxia, sleep apnea) or
• Mental illness (eg, suicidal ideation), history of or
• Obesity (overweight) or
• Seizures, history of or
• Stomach problems, serious—Use with caution. May increased risk for more adverse effects.

• Asthma, acute or serious or
• Lung or breathing problems, serious or
• Stomach or bowel blockage (eg, paralytic ileus) or
• Surgery (eg, nasopharyngeal tonsils, tonsils)—Should not be used in patients with these conditions.

• Kidney disease—Use with caution. The effects may be increased since of slower removal of the drug from the body.

• Liver disease—Use is not recommended in patients with this condition.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects will happen, but if they do, you may need medical help.

Check with your doctor right away if any of the following side effects occur:

Rare

• Burning, itching, and redness of the skin
• Chest pain or tightness
• Cough
• Difficulty swallowing
• Dizziness
• Fast heartbeat
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Seizures
• Skin rash, hives, or itching skin
• Trouble breathing
• Unusual tiredness or weakness
• Vomiting

Incidence not known

• Agitation
• Anxiety
• Bigger, dilated, or enlarged pupils
• Blistering, peeling, or loosening of the skin
• Blurred vision
• Chills
• Cold sweats
• Coma
• Confusion
• Confusion about time, place, or person
• Constricted, pinpoint, or small pupils
• Cool, pale skin
• Darkening of the skin
• Decreased urine output
• Depression
• Diarrhea
• Fainting
• Fever
• Hallucinations
• Headache
• Holding false beliefs that cannot be changed by facts
• Increased hunger
• Increased sensitivity of the eyes to light
• Increased thirst
• Irregular or slow heart rate
• Joint or muscle pain
• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• Loss of appetite
• Muscle cramps
• Nausea
• Nervousness
• Nightmares
• Noisy breathing
• Overactive reflexes
• Poor coordination
• Red skin lesions, often with a purple center
• Red, irritated eyes
• Shakiness
• Shivering
• Slurred speech
• Sore throat
• Sores, ulcers, or white spots in the mouth or on the lips
• Sweating
• Swelling of the face, ankles, or hands
• Talking or acting with excitement you cannot control
• Trembling or shaking
• Twitching
• Unusual excitement, nervousness, or restlessness

Get emergency help right away if any of the following symptoms of overdose occur:

Symptoms of overdose

• Black, tarry stools
• Dark urine
• Depression
• Disorientation
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Drowsiness to profound coma
• Fever
• Headache
• Irregular, fast or slow, or shallow breathing
• Lightheadedness
• Loss of appetite
• Mood or other mental changes
• Nausea
• Pale or blue lips, fingernails, or skin
• Seeing, hearing, or feeling things that are not there
• Stomach pain
• Trouble sleeping
• Unpleasant breath odor
• Unusual drowsiness, dullness, tiredness, weakness, or feeling sluggish
• Vomiting blood
• Yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Anxiety
• Belching
• Bloated or feeling of fullness
• Constipation
• Dry mouth
• Excess air or gas in the stomach or bowels
• False or unusual sense of well-being
• Feeling of warmth
• Heartburn
• Increase in bowel movements
• Increased sweating
• Indigestion
• Loose stools
• Loss of strength or energy
• Muscle weakness
• Numbness or tingling of the hands, legs, and feet
• Painful or difficult urination
• Redness of the face, neck, arms, and occasionally the upper chest
• Sleepiness or unusual drowsiness
• Soft stools
• Stomach discomfort
• Weight loss

Rare

• Abnormal thinking
• Blurred vision
• Change in vision
• Clumsiness, unsteadiness, trembling, or problems with muscle control or coordination
• Cold sweats
• Continuing ringing, buzzing, or unexplained noise in the ears
• Crying
• Decrease in the frequency or amount of urination
• Decreased awareness or responsiveness
• Decreased interest in sexual intercourse
• Delusions of persecution, mistrust, suspiciousness, or combativeness
• Difficulty in passing urine (dribbling)
• False or unusual sense of well-being
• Feeling of constant movement of self or surroundings
• Feeling unusually cold
• Severe or continuing headache
• Increased muscle tone
• Involuntary muscle contractions
• Loss of memory
• Loss of sense of reality
• Loss of sexual ability, desire, drive, or performance
• Migraine headache
• Morbid dreaming
• Pounding in the ears
• Problems with memory
• Quick to react or overreact emotionally
• Rapidly changing moods
• Sensation of spinning
• Severe stomach pain
• Shakiness and unsteady walk
• Shivering
• Vomiting blood or material that looks like coffee grounds

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Ultracet

In Canada

• ACT-traMADol/ACET
• AG-ACET-traMADol
• APO-traMADol/ACET
• Auro-traMADol/Acetaminophen
• IPG-traMADol/ACET
• JAMP-ACET-traMADol
• Lupin-traMADol/ACET
• MAR-traMADol/ACET
• MINT-traMADol/ACET
• MYLAN-traMADol/ACET
• NRA-traMADol/ACET
• PAT-traMADol/ACET

Available Dosage Forms:

• Tablet

Therapeutic Class: Analgesic Combination

Chemical Class: Tramadol

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence) or cause an overdose. Also, large amounts of acetaminophen may cause liver damage if taken for a long time.

It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of tramadol and acetaminophen combination. This medicine should come with a Medication Guide. Read and follow the instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.

Swallow the tablet whole. Do not crush, break, or chew it.

This combination medicine contains acetaminophen (Tylenol®). Carefully check the labels of all other medicines you are using, because they may also contain acetaminophen. It is not safe to use more than 4 grams (4,000 milligrams) of acetaminophen in one day (24 hours), as this may increase the risk for serious liver problems.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For acute pain: Adults—2 tablets every 4 to 6 hours as needed for up to 5 days. Do not take more than 8 tablets per day. Children 12 years of age and older—Use and dose must be determined by your doctor. Children younger than 12 years of age—Should not be used in these patients.

Missed Dose

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm