In the U.S.—

• Analgesic

Combination medicines containing opioid analgesics (nar-KOT-ik an-al-JEE-zicks ) such as tramadol (TRA-ma-dole) and acetaminophen (a-seat-a-MIN-oh-fen ) are used to relieve pain. An opioid analgesic and acetaminophen used together may provide better pain relief than either medicine used alone. In some cases, you may get relief with lower doses of each medicine.

Opioid analgesics act in the central nervous system (CNS) to relieve pain. Many of their side effects are also caused by actions in the CNS. When opioids are used for a long time, your body may get used to them so that larger amounts are needed to relieve pain. This is called tolerance to the medicine. Also, when opioids are used for a long time or in large doses, they may become habit-forming (causing mental or physical dependence). Physical dependence may lead to withdrawal symptoms when you stop taking the medicine.

Acetaminophen does not become habit-forming when taken for a long time but it may cause other unwanted effects, when taken in large doses including liver damage, if too much is taken.

This medicine is available only with your doctor's prescription, in the following dosage form:

Oral
• Tablets (U.S.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For tramadol and acetaminophen, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to tramadol, other opioid analgesics or acetaminophen. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Tramadol and acetaminophen has not been studied in pregnant women. However, studies in animals have shown that tramadol and acetaminophen causes birth defects and other problems. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Too much use of an opioid during pregnancy may cause the fetus to become dependent on the medicine. This may lead to withdrawal side effects in the newborn baby. Newborn seizures, symptoms of withdrawal from opioids, death of the fetus and still birth have been reported.

Breast-feeding—Tramadol and acetaminophen pass into breast milk and may cause unwanted side effects in nursing babies. It may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of tramadol and acetaminophen in children up to 16 years of age with use in other age groups.

Older adults—This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Other 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 taking tramadol and acetaminophen, it is especially important that your health care professional know if you are taking any of the following:

Tramadol and acetaminophen
• Anticoagulants (e.g., Coumadin [blood thinners])—Tramadol and acetaminophen may increase the amount of blood thinners in your blood, which can cause problems with bleeding.
• Alcohol and products with alcohol in them—Taking these medicines with tramadol and acetaminophen may cause problems with your liver.

For acetaminophen:

• Acetaminophen-containing products (e.g., Tylenol, Nyquil, Chlor-Trimeton Sinus)—Taking additional acetaminophen may increase the risk of liver problems.

For tramadol:
• Analgesics, opioid (e.g., codeine, morphine) or
• Antidepressants such as tricyclic antidepressants (e.g., amitriptyline [Elavil], doxepin [Sinequan]), and selective serotonin reuptake inhibitors (e.g., citalopram [Celexa], fluvoxamine [Luvox], sertraline [Zoloft]), and medicines with Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate]) or
• Neuroleptics (e.g., Thorazine, Prolixin)—Taking these medicines with tramadol may increase the possibility of seizures or convulsions.
• Alcohol and products with alcohol in them or
• Anesthetic medicines or
• Central nervous system (CNS) depressants such as , narcotic pain relievers (e.g., Codeine, Darvon), phenothiazines (e.g., Thorazine, Prolixin), sedative hypnotics (e.g., Valium, Xanax), tranquilizers (e.g., Ativan, Haldol—Taking these medicines with tramadol may increase the chance of serious side effects.
• Carbamazepine (e.g., Tegretol)— May decrease the blood levels of Tramadol, which increases the chance of serious side effects
• Monoamine oxidase (MAO) inhibitor activity (isocarboxazid [e.g., Marplan], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegiline [e.g., Eldepryl], tranylcypromine [e.g., Parnate]) (taken currently or within the past 2 weeks)—Taking tramadol with these medicines may cause more of a chance for seizures. It may also cause high blood pressure, unusual heartbeats, or headache

• Selective serotonin reuptake inhibitors (SSRI) (citalopram [e.g., Celexa], fluvoxamine [e.g., Luvox], and sertraline [e.g., Zoloft] —Taking these medicines with tramadol and acetaminophen may increase the possibility of seizures or convulsions

• Alcohol and/or other drug abuse, or history of, or
• Convulsions (seizures), history of, or
• Head injury, or
• Hormonal problems or
• Infections of the central nervous system or
• Kidney disease or
• Liver disease, or
• Respiratory difficulty or troubled breathing, or
• Severe abdominal problems—The chance of serious side effects may be increased

Take this medicine only as directed by your medical doctor or dentist. Do not take more of it, do not take it more often, and do not take it for a longer time than your medical doctor or dentist ordered. This is especially important for young children and elderly patients, who may be more sensitive than other people to the effects of analgesics. If too much of a analgesic is taken, it may become habit-forming (causing mental or physical dependence) or lead to medical problems because of an overdose. Taking too much acetaminophen may cause liver damage.

Dosing—

The dose of tramadol and acetaminophen 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 tramadol and acetaminophen. If your dose is different, do not change it unless your doctor tells you to do so.

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 taking tramadol and acetaminophen

• For oral dosage form (tablets):
  • For pain:
    • Adults and adolescents 16 years and older—Take 2 tablets every 4–6 hours as needed for up to 5 days.
    • Children under 16 years of age–use and dose must be determined by your doctor.

Storage—

To store this medicine:

• Keep out of the reach of children. Overdose of tramadol and acetaminophen is very dangerous in young children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

The analgesic in this medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; other prescription pain medicine or narcotics; opioids; barbiturates; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages, and check with your medical doctor or dentist before taking any of the medicines listed above, while you are using this medicine.

This medicine may cause some people to become drowsy, dizzy, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem.

Nausea or vomiting may occur, especially after the first couple of doses. This effect may go away if you lie down for a while. However, if nausea or vomiting continues, check with your medical doctor or dentist. Lying down for a while may also help relieve some other side effects, such as dizziness or lightheadedness, that may occur.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

Analgesics may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

If you have been taking this medicine regularly , do not suddenly stop taking it without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely, to lessen the chance of withdrawal side effects. This will depend on which of these medicines you have been taking, and the amount you have been taking every day.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

• Rare
  • Burning, itching, and redness of skin; vomiting ;  chest pain;  cough; difficulty swallowing; dizziness; fast heartbeat; hives; itching; puffiness or swelling of the eyelids or around the eyes, face, lips or tongue; shortness of breath; skin rash; tightness in chest; unusual tiredness or weakness; wheezing;  seizures 
  
  

• Symptoms of Overdose

  If you think you, or someone else may have taken an overdose, get emergency help at once. Get emergency help immediately if any of the following symptoms of overdose occur

  • Chest pain or discomfort;  convulsions ;  difficulty breathing 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome.

• Less common
  • Abdominal pain;  aches, pains or weakness of muscles; numbness or tingling of hands, legs, and feet;  acid or sour stomach; belching; heartburn; indigestion; stomach discomfort ;  anxiety;  bloated full feeling; excess air or gas in stomach or intestines;  confusion;  constipation;  dizziness;  dry mouth;  false or unusual sense of well-being;  feeling of warmth; redness of the face, neck, arms, and occasionally the upper chest;  headache;  increased sweating;  increase in bowel movements; loose stools; soft stools;  itching skin;  loss of appetite; weight loss;  loss of strength or energy; muscle pain or weakness;  mood or mental changes;  nausea;  nervousness;  painful or difficult urination;  rash;  sleepiness or unusual drowsiness;  sleeplessness; trouble sleeping; unable to sleep;  unusual tiredness or weakness;  vomiting 
  
  

• Rare
  • Abnormal thinking;  bloody or black, tarry stools; vomiting of blood or material that looks like coffee grounds; sever stomach pain; constipation;  blurred vision; dizziness; severe or continuing, dull headache; pounding in the ears; slow or fast heartbeat;  change in vision;  chills; cold sweats; confusion; dizziness; faintness, or light-headedness when getting up from lying or sitting position;  continuing ringing or buzzing or other unexplained noise in ears;  crying; depersonalization; dysphoria; euphoria; mental depression; paranoia; quick to react or overreact emotionally; rapidly changing moods ;  decreased awareness or responsiveness;  decrease in amount of urine;  decrease in urine volume; decrease in frequency of urination; difficulty in passing urine [dribbling]; painful urination;  depression ;  difficulty swallowing;  dizziness or lightheadedness; feeling of constant movement of self or surroundings; sensation of spinning;  drug abuse and dependence ;  fainting; fast, pounding, or irregular heartbeat or pulse; palpitations;  feeling unusually cold; shivering ;  high or low blood pressure; dizziness; lightheadedness ;  increased muscle tone;  involuntary muscle contractions;  loss in sexual ability, desire, drive, or performance; decreased interest in sexual intercourse; inability to have or keep an erection;  loss of memory; problems with memory;  loss of sense of reality;  morbid dreaming;  migraine headache;  seeing, hearing, or feeling things that are not there;  shakiness and unsteady walk; clumsiness, unsteadiness, trembling, or other problems with muscle control or coordination;  shortness of breath; difficult or labored breathing; tightness in chest; wheezing ;  swelling of tongue;  trouble in holding or releasing urine; painful urination;  unusual tiredness or weakness;  weight loss;  yellow eyes or skin 
  
  

  After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on which of these medicines you were taking, the amount of medicine you were using, and how long you used it. During this time check with your doctor if you notice any of the following side effects:

• Anxiety;  diarrhea;  fever, runny nose, or sneezing ;  gooseflesh;  increased sweating;  nausea or vomiting;  nervousness, restlessness, or irritability;  pain ;  seeing, hearing, or feeling things that are not there;  shivering or trembling;  trouble in sleeping 

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