This medicine is an analgesic used to treat moderate to moderately severe chronic pain in certain patients.

DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it or if you are allergic to any ingredient in this product. DO NOT TAKE THIS MEDICINE if you have had a severe allergic reaction to codeine or another opioid (eg, morphine). DO NOT EXCEED THE RECOMMENDED DOSE or take this medicine for longer than prescribed without checking with your doctor. Exceeding the recommended dose or taking this medicine for longer than prescribed may be habit-forming or may increase the risk of seizures or breathing problems. If using this medicine for an extended period of time, DO NOT SUDDENLY STOP taking this medicine without your doctor's approval. Your dose may need to be slowly lowered to avoid side effects. When used for an extended period of time, this medicine may not work as well and may require different dosing. Talk with your doctor if this medicine stops working well. DO NOT TAKE MORE THAN PRESCRIBED. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are using this medicine. DO NOT DRINK ALCOHOL while you are using this medicine. CHECK WITH YOUR DOCTOR BEFORE you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers, narcotic pain medicines) while you are using this medicine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness. This medicine may cause drowsiness or dizziness. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. Alcohol, hot weather, exercise, or fever may increase dizziness. IF DIZZINESS OCCURS, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of this effect. THIS MEDICINE MAY INCREASE YOUR RISK OF SEIZURES. Your risk may be greater if you also have certain medical conditions, use certain medicines, or if you use a lot of alcohol. Talk to your doctor to see if you may have a greater risk of seizures while taking this medicine. SEROTONIN SYNDROME is a possibly fatal syndrome that can be caused by this medicine. Your risk may be greater if you take this medicine with certain other medicines (eg, "triptans," MAOIs, antidepressants). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms. BEFORE YOU BEGIN TAKING ANY NEW MEDICINES, either prescription or over-the-counter, check with your doctor or pharmacist. CAUTION IS ADVISED WHEN USING THIS MEDICINE IN THE ELDERLY because they may be more sensitive to the effects of this medicine. FOR WOMEN: This medicine may cause harm to the fetus. IF YOU THINK YOU MAY BE PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. THIS MEDICINE IS EXCRETED in breast milk. DO NOT BREAST-FEED while taking this medicine.

Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are taking sodium oxybate (GHB), or another product that contains tramadol. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking alpha-2 receptor blockers (eg, yohimbine), anorexiants (eg, phentermine), anticoagulants (eg, warfarin), azole antifungals (eg, ketoconazole), butyrophenones (eg, haloperidol), carbamazepine, cyclobenzaprine, digoxin, furazolidone, linezolid, lithium, loxapine, macrolide antibiotics (eg, erythromycin), certain medicines for mental or mood disorders (eg, olanzapine), molindone, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine, selegiline), nefazodone, opioid pain medicines (eg, codeine, hydrocodone), phenothiazines (eg, promethazine), quinidine, rifampin, serotonin-norepinephrine reuptake inhibitors (SNRIs) (eg, duloxetine), selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine, paroxetine), sleeping medicines (eg, zolpidem), St. John's wort, thioxanthenes (eg, thiothixene), tiagabine, tricyclic antidepressants (eg, amitriptyline), or "triptans" (eg, sumatriptan). DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including liver, kidney, or thyroid problems; blockage in the bladder; diabetes; heart problems (eg, cor pulmonale); high blood pressure; pancreas problems; prostate problems; metabolism problems; allergies; pregnancy; or breast-feeding. Tell your doctor if you have or recently have had any head injury, brain injury or tumor, increased pressure in the brain, or infection of the brain or nervous system. Tell your doctor if you have a history of lung or breathing problems (eg, asthma, chronic obstructive pulmonary disease / COPD); seizures (eg, epilepsy); recent stomach or bowel surgery; other stomach or bowel problems (eg, pain, inflammation, ulcers); alcohol or other substance abuse; mood or mental problems (eg, depression); or suicidal thoughts or actions. Tell your doctor if you drink alcohol or if you are going through withdrawal from alcohol or other substances. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have severe or persistent diarrhea caused by antibiotic use; severe liver or kidney problems; suicidal thoughts or actions; or a history of alcohol or other substance abuse or addiction. USE OF THIS MEDICINE IS NOT RECOMMENDED if you are intoxicated with alcohol, opioids or narcotics (eg, codeine, morphine), or sedatives or sleeping medicines (eg, temazepam, zolpidem). This medicine should not be used in CHILDREN younger than 16 years; safety and effectiveness in these children have not been confirmed. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.

Follow the directions for taking this medicine provided by your doctor. SWALLOW THIS MEDICINE WHOLE. Do not break, crush, or chew before swallowing. TAKE THIS MEDICINE with or without food. Try to take it the same way (either with food or without food) each time you take your dose. Check with your doctor or pharmacist if you have questions about taking this medicine with food. STORE THIS MEDICINE at 77 degrees F (25 degrees C) away from heat, moisture, and light. Do not store in the bathroom. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. KEEP THIS MEDICINE out of the reach of children and away from pets. IF YOU MISS A DOSE OF THIS MEDICINE and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. DO NOT take 2 doses at once.

SIDE EFFECTS that may occur while taking this medicine include constipation; diarrhea; dizziness; drowsiness; dry mouth; headache; indigestion; mildly increased sweating; mild itching; nausea; trouble sleeping; vomiting; weakness. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience agitation; chest pain; confusion; difficult or painful urination; excessive sweating; fainting; fast or irregular heartbeat; fever; hallucinations; loss of coordination; mood or mental changes (eg, depression); red, blistered, swollen, or peeling skin; seizures; severe dizziness or lightheadedness; severe nausea, vomiting, or diarrhea; severe or persistent headache; slow or shallow breathing; suicidal thoughts or behaviors; tremor; or vision problems. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately. Symptoms may include bluish skin; cold, clammy skin; difficult, shallow, or slow breathing; drowsiness leading to unresponsiveness or coma; excessive sweating; limp muscles; pinpoint pupils; seizures; slow or irregular heartbeat.

DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.