TRAMADOL (Systemic)?

Some commonly used brand names are:

In the U.S.?

• Ultram
• Ultram ER

? Not commercially available in Canada.

Category

• Analgesic

Description

Tramadol (TRA-ma-dole) is used to relieve pain, including pain aftersurgery. The long-acting tablets are used for chronic ongoing pain. The effectsof tramadol are similar to those of narcotic analgesics. Although tramadolis not classified as a narcotic, it may become habit-forming, causing mentalor physical dependence.

Tramadol is available only with your doctor's prescription, in the followingdosage form:

Oral
• Extended-release (long-acting) tablets (U.S.)
• 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, the followingshould be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to tramadol or narcotic analgesics. Also tell your healthcare professional if you are allergic to any other substances, such as foods,preservatives, or dyes.

Pregnancy?Although studies on birth defects have not been donein pregnant women, tramadol has not been reported to cause birth defects.In animal studies, there were drug-related birth defects observed. Studiesdone in animals given very high (toxic) doses resulted in lower than normalbirth weights and some deaths in the fetuses and birth defects in some ofthe newborns. Before taking this medicine, make sure your doctor knows ifyou are pregnant or if you may become pregnant.

Breast-feeding?Tramadol passes into breast milk and may causeunwanted effects in nursing babies. It may be necessary for you to take anothermedicine or to stop breast-feeding during treatment. Be sure you have discussedthe risks and benefits of the medicine with your doctor.

Children?There is no specific information on the relationshipof age to the effects of tramadol tablets in patients less than 16 years ofage and tramadol extended-release tablets in patients less than 18 years ofage.

Older adults?Studies in older adults show that tramadol staysin the body a little longer than it does in younger adults. Your doctor willconsider this when deciding on your doses.

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, it is especially important that your health care provider know ifyou are taking any of the following:

• Carbamazepine (e.g., Tegretol)?May decrease the effects oftramadol by decreasing the amount of medicine in the body

• Central nervous system (CNS) depressants (medicines that cause drowsiness)?Usingthese medicines with tramadol may increase the chance of serious side effectsor increase the risk of convulsions (seizures).

• 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])?The chance of convulsions(seizures) may be increased.

• Neuroleptic drugs (antipsychotic drugs) (chlorpromazine [e.g., Thorazine],clozapine [e.g., Clozaril], haloperidol [e.g., Haldol], loxapine [e.g., Loxitane])or
• Other drugs that lower seizure threshold (epilepsy drugs)?Mayincrease chances of seizures so caution is recommended

Other medical problems?The presence of other medicalproblems may affect the use of tramadol. Make sure you tell your doctor ifyou have any other medical problems, especially:

• Abdominal or stomach conditions (severe)?Tramadol may hidesigns of other medical conditions.

• Addiction problems or
• Suicidal?Tramadol should not be used.

• Alcohol or drug abuse, or history of?May increase the seriousside effects of tramadol

• Epilepsy or
• History of seizures
• Increased risk for seizures caused by alcohol and drug withdrawal,brain or spinal cord infections, or head trauma?Risk of seizures maybe increased.

• Head injury?Tramadol can hide signs of other medical conditions.

• Kidney disease or
• Liver disease?The chance of side effects may be increased.Your doctor will consider this when deciding on your doses.

Proper Use of This Medicine

If you thinkthat this medicine is not working as well after you have been taking it fora few weeks, do not increase the dose. Instead,check with your medical doctor or dentist.

Dosing?The dose of tramadol will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage doses of tramadol. 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 allowedbetween doses, and the length of time you take the medicine depend on themedical problem for which you are taking tramadol.

Take this medicine only as directed. Do not take more of it, do not takeit more often, and do not take it for a longer time than your doctor ordered.Using too much of this medicine increases the chance of unwanted effects.

• For chronic pain:
  • For oral dosage form (long-acting tablets):
    • Adults?100 mg once a day. Your doctor may increase your doseas needed. You should not take more than 300 mg per day.
    • Children up to 18 years of age?Use and dose must be determinedby your doctor.
• For pain:
  • For oral dosage form (tablets):
    • Adults?One-half to two 50-milligram (mg) tablets every fourto six hours as needed, no more than 8 tablets in a day
      Your healthcare professional may want you to break the tablets in halffor the first dose and increase your dose by half-tablets, up to a maximumof 2 full tablets per dose. By starting at a lower dose and slowly increasingthe amount of medicine you take, this will help you get used to the medicinegradually.
      Your healthcare professional may want you to take 2 tablets for the firstdose if you are having severe pain. This helps the medicine start workinga little faster.
    • Children up to 16 years of age?Use and dose must be determinedby your doctor.

Missed dose?If your medical doctor or dentist has directedyou to take this medicine according to a regular schedule and you miss a doseof this medicine, take it as soon as possible. However, if it is almost timefor your next dose, skip the missed dose and go back to your regular dosingschedule. Do not double doses.

Storage?To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store tramadol tablets in the bathroom, near the kitchen sink,or in other damp places. Heat or moisture may cause the medicine to breakdown.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Thismedicine will add to the effects of alcohol and other CNS depressants (medicinethat causes drowsiness). Some examples of CNS depressants are antihistaminesor medicine for hay fever, other allergies, or colds; sedatives, tranquilizers,or sleeping medicine; prescription pain medicine or narcotics; barbiturates;medicine for seizures; muscle relaxants; or anesthetics, including some dentalanesthetics. Do not drink alcoholic beverages, and checkwith your medical doctor or dentist before taking any of the medicines listedabove while you are using this medicine.

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

Dizziness, lightheadedness, or fainting may occur,especially when you get up suddenly from a lying or sitting position. Gettingup 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 awhile. 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. Taking tramadol together with medicines that are used duringsurgery or dental or emergency treatments may cause increased side effects.

If you think you or someone else may have taken anoverdose of tramadol, get emergency help at once. Signs of an overdoseinclude convulsions (seizures) and pinpoint pupils of the eyes.

Side Effects of This Medicine

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 mayneed medical attention.

Get emergency help immediatelyif any of the following symptoms of overdose occur:

Change in consciousness; chest painor discomfort; convulsions (seizures); decreased awareness or responsiveness; difficulty in breathing; dizziness or fainting; lack of muscle tone; lightheadedness; loss of consciousness; pinpointed pupils of the eyes; severe sleepiness; shortness of breath; slow or irregular heartbeat; unusual tiredness

Also, check with your doctoras soon as possible if any of the following side effects occur:

Less common or rare

Abdominal fullness; abnormal or decreasedtouch sensation; blisters under the skin; bloating; blood in urine; blood pressure increased; blurred vision; chest pain or discomfort; change in walking and balance; chills; convulsions (seizures); darkened urine; difficult urination; dizziness or lightheadedness when getting up from a lying or sitting position; fainting; fast heartbeat; frequent urge to urinate; gaseous abdominal pain; heart rate increased; indigestion; irregular heartbeat; loss of memory; numbness and tinglingof face, fingers, or toes; numbness, tingling, pain,or weakness in hands or feet; pain in arms, legs,or lower back, especially pain in calves and/or heels upon exertion; pain or discomfort in arms, jaw, back or neck; pains in stomach, side, or abdomen, possibly radiating to the back; pale bluish-colored or cold hands or feet; recurrent fever; seeing, hearing, or feeling thingsthat are not there; severe cramping; severe nausea; severe redness, swelling,and itching of the skin; shortness of breath; sweats; trembling and shaking of handsor feet; trouble performing routine tasks; weak or absent pulses in legs; yelloweyes or skin

Other side effects may occur that usually donot need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor if anyof the following side effects continue or are bothersome:

More common

Abdominal or stomach pain; agitation; anxiety; constipation; cough; diarrhea; discouragement; dizziness; drowsiness; dry mouth; feeling of warmth; feeling sad or empty; feeling unusually cold; fever; general feeling of discomfort or illness; headache; heartburn; itching of the skin; irritability; joint pain; loss of appetite; loss of interest or pleasure; loss of strength orweakness; muscle aches and pains; nausea; nervousness; rednessof the face, neck, arms and occasionally, upper chest; restlessness; runny nose; shivering; skin rash; sleepinessor unusual drowsiness; sore throat; stuffy nose; sweating; tiredness; trouble concentrating; unusual feeling of excitement; unusualtiredness or weakness; vomiting; weakness

Less common or rare

After you stop using this medicine, your bodymay need time to adjust. The length of time this takes depends on the amountof medicine you were using and how long you used it. During this period oftime check with your doctor if you notice any of the following side effects:

Anxiety; body aches; diarrhea; fast heartbeat; fever, runny nose, or sneezing; gooseflesh; high blood pressure; increased sweating; increased yawning; lossof appetite; nausea or vomiting; nervousness, restlessness or irritability; shiveringor trembling; stomach cramps; trouble in sleeping; unusually large pupils; weakness

Other side effectsnot listed above may also occur in some patients. If you notice any othereffects, check with your doctor.