This medication is a strong narcotic pain reliever similar to morphine.

This medication is used to treat moderate to severe pain that is expected to last for a long period of time. It should be used on a regular schedule as prescribed by your doctor, not on an as-needed basis.

You should use the 60 milligram, 80 milligram, or 160 milligram tablets only if you have been taking moderate to large amounts of a potent narcotic medication (such as morphine). Use of these high-strength tablets by someone who is not regularly taking narcotic medications can cause serious (possibly fatal) breathing problems (such as very slow and shallow breathing).

Swallow the tablets whole. Broken, chewed or crushed tablets may release large (possibly life-threatening) amounts of medication into your body.

This drug is used to treat moderate to severe chronic pain (such as cancer pain). This medication acts on certain parts of the brain to relieve pain. This medication is a long-acting narcotic pain reliever (opiate-type).

This medication should not be used for mild pain which will go away in a few days, or for prevention of pain after surgery. If you have not been on this medication before surgery, you should not use it for short-term pain in the first 12 to 24 hours after surgery.

See also Warning section.

Read the Patient Information Leaflet provided by your pharmacist before you start taking this drug and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth only, usually twice daily (every 12 hours) or as directed by your doctor. Swallow this medication whole. Do not crush, chew, or break the tablets. Take this drug either always with food, or always on an empty stomach (one hour before or two hours after a meal). If you have nausea, you may take this drug with food. Consult your doctor or pharmacist about other ways to decrease nausea (such as taking antihistamines, lying down for 1 to 2 hours with as little head movement as possible).

The dosage is based on your medical condition, use of other pain medications, and response to treatment. Do not increase your dose without consulting your doctor or pharmacist.

You may take immediate-release narcotic pain medications for short-term pain if so directed by your doctor. Also follow your doctor's or pharmacist's instruction for the safe use of non-narcotic pain relievers (such as acetaminophen, ibuprofen, naproxen).

If you have been using other long-acting narcotic pain medications or narcotic patches regularly, check with your doctor or pharmacist because they may need to be discontinued before starting this medication. If you are currently using a narcotic patch (such as fentanyl), its effects may continue after removal. Ask your doctor or pharmacist when it is safe to start taking this medication (usually 18 hours after removing the patch).

If this medication has been taken regularly for a long time or in high doses, withdrawal symptoms (such as runny nose, irritability, trouble sleeping, sweating, stomach cramps, diarrhea) may occur if you suddenly stop taking this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

When this medication is taken for a long time, it may not work as well. Your doctor may need to increase your dose or change your medication. Talk with your doctor if this medication stops working well.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.

Tell your doctor if your pain persists or worsens.

Nausea, vomiting, constipation, dizziness, drowsiness, headache, increased sweating, dry mouth, lightheadedness, loss of appetite, or weakness may occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: slow/shallow breathing, fainting, slow/fast/irregular heartbeat, mental/mood changes (such as agitation, hallucinations, confusion), difficulty urinating, vision changes.

Tell your doctor immediately if any of these rare but very serious side effects occur: severe stomach/abdominal pain, change in the amount of urine, seizures.

An empty tablet shell may appear in your stool (or colostomy bag). This is harmless, because your body has already absorbed the medication.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking this medication, tell your doctor or pharmacist if you are allergic to it; or to other narcotic pain relievers (such as codeine, hydrocodone); or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: intestinal/bowel disorders (such as paralytic ileus, infectious diarrhea, colitis, blockage), kidney disease, liver disease, lung diseases (such as asthma, chronic obstructive pulmonary disease-COPD), breathing problems (such as slow/shallow breathing, sleep apnea), a certain spinal problem (kyphoscoliosis), certain heart problems (such as low blood pressure, irregular heartbeat), personal or family history of regular use/abuse of drugs/alcohol/other substances, brain disorders (such as seizures, head injury, tumor, increased intracranial pressure), underactive thyroid (hypothyroidism), difficulty urinating (for example, due to enlarged prostate or narrowed urethra), disease of the pancreas (such as pancreatitis), mental/mood disorders (such as toxic psychosis), gallbladder disease, adrenal gland problem (such as Addison's disease).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are using this medication.

Older adults may be more sensitive to the side effects of this drug, especially slow/shallow breathing and drowsiness.

During pregnancy, this medication should be used only when clearly needed. Using it for long periods or in high doses near the expected delivery date is not recommended because of possible harm to the unborn baby. Discuss the risks and benefits with your doctor. Infants born to mothers who have used this medication for a long time may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. Tell your doctor immediately if you notice any of these symptoms in your newborn.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor or pharmacist give you the best care, be sure to tell your doctor or pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some of the products that may interact with this drug include: cimetidine, certain medications for pain (opiate partial agonists such as butorphanol, nalbuphine, pentazocine), naltrexone.

The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that also affect breathing or cause drowsiness. Therefore, tell your doctor or pharmacist if you are taking other products such as alcohol, anti-seizure drugs (such as phenobarbital), medicine for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, other narcotic pain relievers (such as codeine), and psychiatric medicines (such as thioridazine, risperidone, amitriptyline, trazodone). Your medications or doses of your medications may need to be changed.

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

This medication may interfere with certain laboratory tests (including amylase and lipase levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents should call their local poison control center directly. Symptoms of overdose may include slow/shallow breathing, severe drowsiness, slow heartbeat, severe dizziness, pinpoint pupils, cold/clammy skin, limp/weak muscles, or loss of consciousness.

Do not share this medication with others. It is against the law and the medication may cause serious harm to others. (See also Warning section.)

This medication has been prescribed for your current condition only. Do not use it later for another condition unless your doctor directs you to do so. A different medication may be necessary in that case.

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Store at room temperature, 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59 and 86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Flush this medication down the toilet when it is expired or no longer needed.

Information last revised July 2009 Copyright(c) 2009 First DataBank, Inc.