In the U.S.—

• Analgesic

Combination medicines containing narcotic 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.

ULTRACET 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 ULTRACET, 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 ULTRACET 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—ULTRACET 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 ULTRACET 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 ULTRACET:

• 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.