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About ULTRAM(R) ER (tramadol HCl)

ULTRAM(R) 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. For more information, please visit http://www.ultram-er.com.

IMPORTANT SAFETY INFORMATION

Do not take ULTRAM(R) ER if you have had an allergic reaction to tramadol, codeine, or other opioids in the past.

ULTRAM(R) 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. Use of alcohol should be avoided when taking ULTRAM(R) ER.

The maximum daily dose of ULTRAM(R) ER is 300 mg. Do not change your dose or stop taking ULTRAM(R) ER without talking with your doctor first.

Talk with your doctor about all the medications you are taking. These may include antidepressants, tranquilizers, hypnotics or other opioid pain medicines. ULTRAM(R) ER may impair your ability to perform potentially hazardous tasks, such as driving a car or operating machinery.

Seizures have been reported in people taking tramadol, the medicine in ULTRAM(R) ER. 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 or a history of seizures.

ULTRAM(R) 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
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