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ULTRAM^® ER is used to manage moderate to moderately severe chronic pain in adults who need to be treated around the clock for their pain for an extended period of time.

IMPORTANT SAFETY INFORMATION

Do not take ULTRAM^® ER if you have had an allergic reaction to tramadol, codeine, or other opioids in the past. Do not take ULTRAM^® ER in any situation where opioids should not be used, including acute intoxication with alcohol, hypnotics, narcotics, centrally acting analgesics, opioids, or psychotropic drugs. ULTRAM^® ER may worsen central nervous system and respiratory depression.

Seizures have been reported in people taking tramadol, the active ingredient in ULTRAM^® ER, at recommended doses. The risk of seizures is increased with doses of tramadol above the recommended range. Use of tramadol increases the risk of seizures in people taking antidepressants, other opioids, or other drugs that can cause seizures.

Risk of convulsions may also increase in people with epilepsy, a history of seizures, or a recognized risk for seizure (such as head trauma, metabolic disorders, alcohol and drug withdrawal, and central nervous system infections).

People who are suicidal or have a history of addiction should not take ULTRAM^® ER. Use of alcohol should be avoided when taking ULTRAM^® ER. Do not take more than the recommended dose of ULTRAM^® ER.

ULTRAM^® ER may be associated with a potentially life-threatening condition when taken together with selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants (TCAs) (classes of drugs for depression or other disorders), triptans, lithium, or St. John's wort. Some common SSRIs are Paxil (paroxetine), Prozac/Sarafem (fluoxetine), and Zoloft (sertraline). Some common SNRIs are Cymbalta (duloxetine) and Effexor (venlafaxine). Some common triptans are Axert (almotriptan), Imitrex (sumatriptan), and Relpax (eletriptan). Symptoms of Serotonin Syndrome can include mental-state changes such as agitation, hallucinations, and coma. Symptoms can also include autonomic instability (e.g. fast heartbeat, fluctuating blood pressure, increased body temperature), neuromuscular aberrations (e.g. overactive reflexes, incoordination), and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhea).

Serious and rarely fatal anaphylactic (allergic) reactions can occur, even if you have never taken tramadol.

Taking ULTRAM^® ER, alone or in combination with alcohol, or medications such as tranquilizers, hypnotics, or other opioids, can cause respiratory depression, seizures, overdose and possibly death. Taking certain medications together can increase the risk of respiratory and central nervous system depression. These medications may include alcohol, opioids, anesthetic agents, narcotics, phenothiazines, tranquilizers, or sedative hypnotics.

Before taking ULTRAM^® ER, you should inform your doctor if you have been diagnosed with increased intracranial pressure or have had a head injury.

ULTRAM^® ER may impair your ability to perform potentially hazardous tasks, such as driving a car or operating machinery.

Talk with your doctor about all medications you are taking. These may include antidepressants, tranquilizers, hypnotics, or other opioid pain medicines. If you experience symptoms such as restlessness, hallucinations, loss of coordination, fast heartbeat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting, or diarrhea, contact your doctor immediately.

Do not change your dose or stop taking ULTRAM^® ER without talking with your doctor first as you may experience withdrawal symptoms.

ULTRAM^® ER can be abused or cause dependence. ULTRAM^® ER tablets must be swallowed whole. Do not chew, crush, or split the tablet before swallowing. This can lead to overdose and possible serious injury including death. You should not use ULTRAM^® ER if you have severe renal impairment.

The most common side effects reported with ULTRAM^® ER were dizziness, nausea, constipation, headache, and drowsiness.

Tell your doctor about all your medical conditions and if you are pregnant, think you might be pregnant, or are trying to become pregnant.

Please talk to your healthcare professional for more information or if you have further questions about ULTRAM^® ER. You can also call the Janssen Scientific Affairs, LLC, Customer Communications Center at 1-800-526-7736 for more information. In addition, please visit www.ultram-er.com for full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full US Prescribing Information.

Paxil and Imitrex are registered trademarks of GlaxoSmithKline. Prozac/Sarafem and Cymbalta are registered trademarks of Eli Lilly. Zoloft/Relpax are registered trademarks of Pfizer, Inc. Effexor is a registered trademark of Wyeth. Axert is a registered trademark of Almirall Prodesfarma.

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This site is published by Janssen Pharmaceuticals, Inc., which is solely responsible for its contents. This information is intended for the use of our customers, patients, and healthcare professionals in the United States only.

Janssen Pharmaceuticals, Inc. recognizes that the Internet is a global communications medium; however, laws, regulatory requirements, and medical practices for pharmaceutical products vary from country to country. The prescribing information included here may not be appropriate for use outside of the United States. Capitalized product names are trademarks of Janssen Pharmaceuticals, Inc.

This page was last modified on Mar 24 2011 at 13:43:35 EDT.