Drug Information For: OXYCONTIN 40MG TABLETS

Ingredient Name: OXYCODONE (ox-i-KOE-done)

Drug Manufacturer: PURDUE

Common Uses: This medicine is a narcotic (opioid) 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: THIS MEDICINE IS A NARCOTIC PAIN MEDICINE SIMILAR TO MORPHINE. This medicine is only used for around-the-clock treatment of moderate or severe pain. It should not be used to treat occasional pain; mild, short-term pain after surgery; or pain that occurs immediately after surgery or injury. SWALLOW THIS MEDICINE WHOLE. Do NOT break, crush, chew, dissolve, or split this medicine. Doing so may cause the release of too much medicine into the bloodstream, which could be fatal. THIS MEDICINE MAY CAUSE SEVERE BREATHING PROBLEMS. These effects may be worse if you take it 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), or if you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the past 14 days. DO NOT TAKE THIS MEDICINE if you are taking another around-the-clock opioid pain medicine. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking azole antifungals (eg, ketoconazole), carbamazepine, certain medicines for nausea and vomiting (eg, ondansetron), cimetidine, macrolide antibiotics (eg, erythromycin), mixed narcotic agonist/antagonists (eg, buprenorphine, butorphanol, pentazocine), naltrexone, nefazodone, phenothiazines (eg, chlorpromazine), phenytoin, protease inhibitors (eg, boceprevir, ritonavir), rifamycins (eg, rifampin), or telithromycin. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including constipation, low blood volume, inflammation of the pancreas, severe drowsiness, stomach pain, difficulty swallowing, low blood oxygen levels, high blood carbon dioxide levels, a certain type of severe or persistent diarrhea (pseudomembranous colitis), allergies, pregnancy, or breast-feeding. Tell your doctor if you have a history of asthma, chronic obstructive pulmonary disease (COPD), or other lung or breathing problems (eg, emphysema, bronchitis); adrenal gland problems (eg, Addison disease); heart problems; stomach or bowel problems (eg, inflammation, blockage, esophagus or colon cancer) or surgery; kidney or liver problems; low blood pressure; the blood disease porphyria; curvature of the spine; gallbladder problems; prostate problems; thyroid problems; trouble urinating; recent head injury; increased pressure in the brain; growths in the brain (eg, tumors, lesions); or seizures. Tell your doctor if you or a family member has a history of mental or

How to Use This Medicine: Follow the directions for using this medicine provided by your doctor. This medicine has a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that your may have about this medicine. This medicine may be taken on an empty stomach or with food. If stomach upset occurs, take with food to reduce stomach irritation. SWALLOW WHOLE. Do not break, crush, chew, dissolve, or split 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. SOME PATIENTS HAVE REPORTED trouble swallowing this medicine. These reports have included choking, gagging, spitting tablets back up, and getting tablets stuck in the throat. To decrease these risks, take this medicine 1 tablet at a time if your dose calls for more than 1 tablet. Do not pre-soak, lick, or wet the tablet before you place it in your mouth. Take each tablet with enough water to be sure that you swallow it completely. Swallow this medicine immediately after you place it in your mouth. TELL YOUR DOCTOR if your pain gets worse or if you have breakthrough pain while taking this medicine. DO NOT SUDDENLY STOP TAKING THIS MEDICINE. You may experience withdrawal symptoms. If you need to stop this medicine, your doctor will gradually lower your dose. STORE THIS MEDICINE at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), away from heat, moisture, and light. KEEP THIS MEDICINE out of the reach of children and away from pets. IF THIS MEDICINE IS NO LONGER NEEDED, dispose of it as soon as possible by flushing it down the toilet. TAKE THIS MEDICINE on a regular schedule to help control the pain more effectively. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. Take your next dose 12 hours later. DO NOT take 2 doses at once. Call your doctor if you miss a dose and you are not sure what to do.

Cautions: DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it or if you are allergic to any ingredient in this medicine. CHECK WITH YOUR DOCTOR BEFORE TAKING THIS MEDICINE if you have had a severe allergic reaction to any morphine or codeine related medicine (eg, hydrocodone, hydromorphone). If you have questions about whether you are allergic to this medicine or if a certain medicine is morphine or codeine related, contact your doctor or pharmacist. 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, use for longer than prescribed, or suddenly stop taking this medicine without first checking with your doctor. DO NOT EXCEED THE RECOMMENDED DOSE or take this medicine for longer than prescribed. 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. This medicine may cause drowsiness, 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. 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. 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) while you are taking this medicine; they may add to this medicine’s effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness. Constipation is a common side effect of this medicine. TALK WITH YOUR DOCTOR ABOUT USING LAXATIVES or stool softeners while you take this medicine. It is also important to maintain a diet adequate in fiber, drink plenty of water, and exercise to prevent constipation. If you become constipated while taking this medicine, talk with your doctor or pharmacist. 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 severe breathing problems. FOR WOMEN: IF YOU BECOME 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.

Possible Side Effects: SIDE EFFECTS that may occur while using this medicine include drowsiness, dizziness, headache, sweating, weakness, dry mouth, nausea, vomiting, or constipation. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience abnormal snoring or sighing; confusion; difficulty urinating; hallucinations; fainting; fast, slow, or irregular heartbeat; mental or mood changes; seizures; severe dizziness, drowsiness, or lightheadedness; severe or persistent stomach pain, nausea, or constipation; shallow, slowed, or difficult breathing; shortness of breath; tremor; or vision changes. 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.