This medicine is a narcotic (opioid) analgesic used to treat pain in certain patients.
Follow the directions for using this medicine provided by your doctor. THIS MEDICINE MUST ONLY BE TAKEN BY MOUTH. This medicine may be taken on an empty stomach or with food. If stomach upset occurs, take with food to reduce stomach irritation. IF YOU HAVE BEEN TAKING THIS MEDICINE REGULARLY, do not suddenly stop taking it without checking with your doctor. If you have been taking this medicine for more than a few weeks and your doctor tells you to stop taking it, your dose may need to be gradually lowered as directed by your doctor to avoid side effects. STORE THIS MEDICINE at room temperature at 77 degrees F (25 degrees C), away from heat, moisture, and light. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not store in the bathroom. KEEP THIS MEDICINE out of the reach of children and away from pets. IF YOU ARE TAKING THIS MEDICINE FOR PERSISTENT PAIN, take it on a regular schedule to help control the pain more effectively. IF YOU MISS A DOSE OF THIS MEDICINE and you are taking it regularly, take it as soon as possible. If it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.
WARNING: This medicine is a narcotic pain reliever that may become habit-forming. Do NOT exceed the recommended dose, take for longer than prescribed, or take more often than prescribed without checking with your doctor. THIS MEDICINE MAY ALSO CAUSE SEVERE BREATHING PROBLEMS. This effect may be worse if you take it with alcohol, with other narcotic pain relievers, or with certain other medicines. Ask your doctor or pharmacist if you have questions about which medicines may add to this effect. Contact your doctor right away if you experience slow or shallow breathing. 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 also taking sodium oxybate (GHB). ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking anticholinergics (eg, oxybutynin, scopolamine), mixed agonist/antagonist pain medicines (eg, buprenorphine, butorphanol, pentazocine), naltrexone, other narcotic pain relievers (eg, codeine, morphine, oxycodone), phenothiazines (eg, chlorpromazine), or tricyclic antidepressants (eg, amitriptyline). Tell your doctor if you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or have taken one within the last 14 days. DO NOT START OR STOP any medicine without doctor or pharmacist approval. INFORM YOUR DOCTOR of any other medical conditions, including severe drowsiness, a recent head injury, growths in the brain (eg, lesions, tumors), increased pressure in the head, liver or kidney problems, gallbladder problems, pancreas problems, stomach or bowel problems (eg, inflammation, pseudomembranous colitis), stomach pain, allergies, pregnancy, or breast-feeding. Tell your doctor if you have a history of heart problems (eg, cor pulmonale), low blood pressure, dehydration, low blood volume, chronic obstructive pulmonary disease (COPD) or other lung or breathing problems (eg, asthma, emphysema, bronchitis, sleep apnea), adrenal gland problems (eg, Addison disease), enlarged prostate, urinary blockage or trouble urinating, thyroid problems, seizures (eg, epilepsy), curvature of the spine, low blood oxygen levels (hypoxia), high blood carbon dioxide levels (hypercapnia), or recent stomach or bowel surgery. Tell your doctor if you have a personal or family history of mental or mood problems (eg, depression), alcohol or other substance abuse or dependence, or suicidal thoughts or attempts. Tell your doctor if you drink alcohol; have symptoms of alcohol withdrawal; are in poor health; will be having surgery; or are in shock caused by heart problems, blood vessel problems, or severe bleeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you are having an asthma attack. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have difficult or slowed breathing, severe asthma, or known or suspected bowel blockage (paralytic ileus). Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.
SIDE EFFECTS that may occur while using this medicine include dizziness, drowsiness, dry mouth, flushing, lightheadedness, nausea, sweating, or vomiting. If they continue or are bothersome, check with your doctor. THIS MEDICINE MAY CAUSE CONSTIPATION. To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. Talk to your doctor about using laxatives or stool softeners to prevent or treat constipation while you use this medicine. CONTACT YOUR DOCTOR IMMEDIATELY if you experience confusion; fainting; fast, slow, or irregular heartbeat; hallucinations; mental or mood changes; seizures; severe or persistent dizziness or drowsiness; severe or persistent constipation, headache, vomiting, or stomach pain; shallow, slowed, or difficult breathing; tremor; trouble urinating; uncontrolled eye movements; uncoordinated muscle movements; or vision changes (eg, blurred vision). 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; or swelling of the mouth, face, lips, or tongue. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare 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 of overdose may include bluish skin; chest pain; cold and clammy skin; coma; excessive sweating; fainting; limp muscles; nausea and vomiting; pinpoint pupils; seizures; severe drowsiness or dizziness; slow or irregular heartbeat; or slow, shallow, or difficult breathing.
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.