Common Uses: This medicine is a narcotic analgesic used to treat patients who have moderate to severe pain that requires continuous treatment and is expected to last for an extended period of time. This medicine is not for use as short-term pain treatment.

Before Using This Medicine: WARNING: OXYCODONE IS A NARCOTIC PAIN MEDICINE SIMILAR TO MORPHINE. NARCOTIC PAIN MEDICINES ARE SOMETIMES ABUSED. TELL YOUR DOCTOR IF YOU HAVE A HISTORY OF DRUG OR ALCOHOL ABUSE OR ADDICTION. DO NOT SHARE THIS MEDICINE WITH ANYONE ELSE. This medicine is only used for around-the-clock treatment of moderate or severe pain. It should not be used to treat occasional pain. Swallow this medicine whole. Do NOT break, crush, or chew this medicine. Doing so may cause the release of too much medicine into the bloodstream, which could be fatal. 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. If you have taken a monoamine oxidase inhibitor (MAOI) (such as phenelzine) within the past 14 days, TELL YOUR DOCTOR BEFORE YOU BEGIN to take this medicine. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you take barbiturates (such as phenobarbital), cimetidine, mixed agonist/antagonist pain medicines (such as pentazocine), naltrexone, phenothiazines (such as chlorpromazine), or rifampin. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions including liver or kidney problems; gallbladder, pancreas, stomach or bowel problems (such as inflammation); recent surgery; allergies; pregnancy; or breast-feeding. TELL YOUR DOCTOR IF YOU HAVE a history of lung or breathing problems (such as asthma, emphysema, bronchitis), adrenal gland problems (such as Addison disease), heart problems, low blood pressure, dehydration, low blood volume, certain blood problems (such as porphyria), prostate problems, bladder blockage, underactive thyroid, or seizures. Inform your doctor if you have a history of curvature of the spine, severe drowsiness, head injury, growths in the brain, or increased pressure in the brain. INFORM YOUR DOCTOR if you have a personal or family history of mental or mood problems, regular alcohol use, alcohol or other substance abuse, or suicidal thoughts or actions. Tell your doctor if you have symptoms of alcohol withdrawal, are in poor health, or will be having surgery. DO NOT TAKE THIS MEDICINE if you are having an asthma attack. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have severe asthma, severe lung or breathing problems (such as slow or difficult breathing, or chronic obstructive pulmonary disease), certain heart problems (such as cor pulmonale), alcohol intoxication, delirium caused by alcohol withdrawal, severe drowsiness, current brain injury, growths in the brain, increased pressure in the brain, or severe diarrhea or other bowel problems caused by antibiotic use or food poisoning. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.

How to Use This Medicine: Follow the directions for using this medicine provided by your doctor. An additional patient information leaflet is available with this medicine. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. This medicine may be taken on an empty stomach or with food. SWALLOW WHOLE. Do not break, crush, or chew before swallowing. Doing so may cause you to absorb too much of this medicine too quickly. This could cause serious side effects including severe trouble breathing, severe drowsiness, coma, or death. STORE THIS MEDICINE at room temperature, at 77 degrees F (25 degrees C), away from heat and light. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. TAKE THIS MEDICINE on a regular schedule to help control the pain more effectively. IF YOU MISS A DOSE OF THIS MEDICINE and you are using 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. If you miss more than 2 doses in a row, contact your doctor before taking this medicine again.

Cautions: DO NOT TAKE THIS MEDICINE IF YOU HAVE HAD A SEVERE ALLERGIC REACTION to oxycodone, or to any codeine or morphine related medicine (such as hydrocodone, hydromorphone) without first talking with your doctor. A severe allergic reaction includes a severe rash, hives, breathing difficulties, or dizziness. If you have a question about whether you are allergic to this medicine or if a certain product contains any morphine or codeine related medicine, contact your doctor or pharmacist. IF YOU EXPERIENCE difficulty breathing; tightness of chest; swelling of eyelids, face, or lips; or if you develop a rash or hives, tell your doctor immediately. Do not take any more of this medicine unless your doctor tells you to do so. 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 CHANGE YOUR DOSE OR SUDDENLY STOP taking this medicine without first checking with your doctor. Exceeding the recommended dose may be habit-forming. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are using this medicine. AVOID ALCOHOL while you are using this medicine. This medicine will add to the effects of alcohol and other depressants (such as sleep aids, tranquilizers, and certain antihistamines). Ask your pharmacist if you have questions about which medicines are depressants. 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. THIS MEDICINE MAY CAUSE DIZZINESS, lightheadedness, or fainting. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness. YOU MAY NOTICE THE TABLET SHELL in the stool. This is normal and not a cause for concern. Constipation is a common side effect of this medicine. TALK WITH YOUR DOCTOR ABOUT USING LAXATIVES or stool softeners while you take this medicine. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, 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 the medicine, especially drowsiness and breathing problems. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. THIS MEDICINE IS EXCRETED IN BREAST MILK. IF YOU ARE OR WILL BE BREAST-FEEDING while you are using this medicine, check with your doctor or pharmacist to discuss the risks to your baby.

Possible Side Effects: SIDE EFFECTS that may occur while using this medicine include drowsiness, dizziness, flushing, lightheadedness, sweating, weakness, dry mouth, nausea, vomiting, or constipation. If they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience blurred vision or other visual disturbances, difficulty urinating, or mental or mood changes. CONTACT YOUR DOCTOR IMMEDIATELY if you experience confusion; hallucinations; fainting; fast, slow, or irregular heartbeat; seizures; severe or persistent dizziness or drowsiness; severe or persistent headache or vomiting; or shallow, slowed, or difficult breathing. An allergic reaction to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, severe dizziness, or trouble breathing. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist.

Overdose: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include cold and clammy skin; coma; slow, shallow, or difficult breathing; severe dizziness, drowsiness, or lightheadedness; muscle weakness; pinpoint pupils; and slow heartbeat.

Additional Information: DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the reach of children. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.