TRAMADOL AND ACETAMINOPHEN (Systemic)?

Some commonly used brand names are:

In the U.S.?

• Ultracet

? Not commercially available in Canada.

Category

• Analgesic

Description

Combinationmedicines containing narcotic analgesics (nar-KOT-ikan-al-JEE-zicks) such as tramadol (TRA-ma-dole) and acetaminophen (a-seat-a-MIN-oh-fen) are used to relieve pain. An opioidanalgesic and acetaminophen used together may provide better pain relief thaneither medicine used alone. In some cases, you may get relief with lower dosesof 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 opioidsare used for a long time, your body may get used to them so that larger amountsare 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 withdrawalsymptoms when you stop taking the medicine.

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

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

Oral
• Tablets (U.S.)

Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. 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 unusualor 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 studiedin pregnant women. However, studies in animals have shown that tramadol andacetaminophen causes birth defects and other problems. Before taking thismedicine, make sure your doctor knows if you are pregnant or if you may becomepregnant.

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

Breast-feeding?Tramadol and acetaminophen pass into breast milkand may cause unwanted side effects in nursing babies. It may be necessaryfor 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 yourdoctor.

Children?Studies on this medicine have been done only inadult patients, and there is no specific information comparing use of tramadoland acetaminophen in children up to 16 years of age with use in other agegroups.

Older adults?This medicine has been tested and has not beenshown to cause different side effects or problems in older people than itdoes in younger adults.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingtramadol and acetaminophen, it is especially important that your health careprofessional know if you are taking any of the following:

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

For acetaminophen:

• Acetaminophen-containing products (e.g., Tylenol, Nyquil, Chlor-TrimetonSinus)?Taking additional acetaminophen may increase the risk of liverproblems.

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]), andmedicines 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 medicineswith 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 painrelievers (e.g., Codeine, Darvon), phenothiazines (e.g., Thorazine, Prolixin),sedative hypnotics (e.g., Valium, Xanax), tranquilizers (e.g., Ativan, Haldol?Takingthese medicines with tramadol may increase the chance of serious side effects.
• Carbamazepine (e.g., Tegretol)? May decrease the blood levelsof 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 withinthe past 2 weeks)?Taking tramadol with these medicines may cause moreof 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 increasethe possibility of seizures or convulsions

Other medical problems?The presence of other medicalproblems may affect the use of tramadol and acetaminophen. Make sure you tellyour doctor if you have any other medical problems, especially:

• 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 effectsmay be increased

Proper Use of This Medicine

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 fora longer time than your medical doctor or dentist ordered. This is especiallyimportant for young children and elderly patients, who may be more sensitivethan other people to the effects of analgesics. If too much of a analgesicis taken, it may become habit-forming (causing mental or physical dependence)or lead to medical problems because of an overdose. Taking too much acetaminophenmay cause liver damage.

Dosing?The dose of tramadol and acetaminophen willbe different for different patients. Follow your doctor'sorders or the directions on the label. The following information includesonly the average doses of tramadol and acetaminophen. If your dose is different, do not change it unless your doctor tellsyou to do so.

The number of doses you take each day, the time allowedbetween doses, and the length of time you take the medicine depend on themedical 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 every4-6 hours as needed for up to 5 days.
    • Children under 16 years of age-use and dose must be determinedby your doctor.

Storage?To store this medicine:

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

Precautions While Using This Medicine

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

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

Dizziness, lightheadedness, or fainting may occur, especially when youget up suddenly from a lying or sitting position. Getting up slowly may helplessen 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 orvomiting continues, check with your medical doctor or dentist. Lying downfor a while may also help relieve some other side effects, such as dizzinessor lightheadedness, that may occur.

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

Analgesics may cause dryness of the mouth. For temporary relief, use sugarlesscandy 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 beforestopping completely, to lessen the chance of withdrawal side effects. Thiswill depend on which of these medicines you have been taking, and the amountyou have been taking every day.

Side Effects of This Medicine

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

Check with your doctorimmediately 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 eyelidsor 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 anoverdose, get emergency help at once. Get emergency help immediately if anyof the following symptoms of overdose occur

Chest pain or discomfort; convulsions; difficulty breathing

Other side effects mayoccur that usually do not need medical attention. These side effects may goaway during treatment as your body adjusts to the medicine. However, checkwith your doctor if any of the following side effects continue or are bothersome.

Less common

Abdominal pain; aches, pains or weaknessof muscles; numbness or tingling of hands, legs, and feet; acid or sour stomach; belching; heartburn; indigestion; stomach discomfort; anxiety; bloated fullfeeling; excess air or gas in stomach or intestines; confusion; constipation; dizziness; dry mouth; falseor 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; weightloss; loss of strength or energy; muscle pain orweakness; mood or mental changes; nausea; nervousness; painfulor difficult urination; rash; sleepiness or unusual drowsiness; sleeplessness;trouble sleeping; unable to sleep; unusual tirednessor 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; slowor fast heartbeat; change in vision; chills; cold sweats; confusion; dizziness; faintness, or light-headednesswhen 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; decreasein urine volume; decrease in frequency of urination; difficulty in passingurine [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 heartbeator 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; inabilityto have or keep an erection; loss of memory; problemswith 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; troublein holding or releasing urine; painful urination; unusual tiredness or weakness; weight loss; yellow eyes or skin

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

Anxiety; diarrhea; fever, runny nose, or sneezing; gooseflesh; increasedsweating; nausea or vomiting; nervousness, restlessness, or irritability; pain; seeing, hearing, or feeling things that are notthere; shivering or trembling; trouble in sleeping

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