OxyContin Sustained-Release Tablets

OxyContin Sustained-Release Tablets is used for:

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Treating moderate to severe pain. It may also be used for other conditions as determined by your doctor.

OxyContin Sustained-Release Tablets is a narcotic pain reliever. It works by dulling the pain perception center in the brain. It may also affect other body systems (eg, respiratory and circulatory systems) at higher doses.

Do NOT use OxyContin Sustained-Release Tablets if:

• you are allergic to any ingredient in OxyContin Sustained-Release Tablets or any other oxycodone- or morphine-related medicine (eg, codeine)
• you are taking sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days
• you have severe bowel motility problems (eg, paralytic ileus) or severe diarrhea associated with antibiotic use (pseudomembranous colitis)
• you have severely slow or difficult breathing or severe asthma, or you are having an asthma attack

Contact your doctor or health care provider right away if any of these apply to you.

Before using OxyContin Sustained-Release Tablets:

Some medical conditions may interact with OxyContin Sustained-Release Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of asthma, chronic obstructive pulmonary disease (COPD), or other lung or breathing problems
• if you have a history of recent head injury, increased pressure in the brain, growths in the brain (eg, tumors), or seizures
• if you have a history of heart problems, low blood pressure, liver or kidney problems, underactive thyroid, adrenal gland problems (eg, Addison disease), stomach or bowel problems, gallbladder problems, inflammation of the pancreas, a blockage of the bladder or bowel, an enlarged prostate, or the blood disease porphyria
• if you have a history of drug or alcohol abuse, mood or mental problems, or suicidal thoughts or behavior

Some MEDICINES MAY INTERACT with OxyContin Sustained-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Cimetidine, furazolidone, MAOIs (eg, phenelzine), phenothiazines (eg, chlorpromazine), or sodium oxybate (GHB) because the risk of side effects such as severe drowsiness, slow or difficult breathing, confusion, and seizures may be increased
• Buprenorphine, butorphanol, nalbuphine, naltrexone, or pentazocine because the effectiveness of OxyContin Sustained-Release Tablets may be decreased

This may not be a complete list of all interactions that may occur. Ask your health care provider if OxyContin Sustained-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use OxyContin Sustained-Release Tablets:

Use OxyContin Sustained-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with OxyContin Sustained-Release Tablets. Talk to your pharmacist if you have questions about this information.
• Take OxyContin Sustained-Release Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Swallow OxyContin Sustained-Release Tablets whole. Do not break, crush, or chew before swallowing.
• If you miss a dose of OxyContin Sustained-Release Tablets, use 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 use 2 doses at once.

Ask your health care provider any questions you may have about how to use OxyContin Sustained-Release Tablets.

Important safety information:

• OxyContin Sustained-Release Tablets may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use OxyContin Sustained-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using OxyContin Sustained-Release Tablets; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• OxyContin Sustained-Release Tablets may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Tell your doctor or dentist that you take OxyContin Sustained-Release Tablets before you receive any medical or dental care, emergency care, or surgery.
• Use OxyContin Sustained-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects.
• OxyContin Sustained-Release Tablets should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY AND BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using OxyContin Sustained-Release Tablets while you are pregnant. OxyContin Sustained-Release Tablets is found in breast milk. Do not breast-feed while taking OxyContin Sustained-Release Tablets.

When used for long periods of time or at high doses, OxyContin Sustained-Release Tablets may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if OxyContin Sustained-Release Tablets stops working well. Do not take more than prescribed.

Some people who use OxyContin Sustained-Release Tablets for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you suddenly stop taking OxyContin Sustained-Release Tablets, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goose bumps and abnormal skin sensations; nausea; vomiting; pain; rigid muscles; rapid heartbeat; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; and trouble sleeping.

Possible side effects of OxyContin Sustained-Release Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; headache; nausea; sleeplessness; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; difficulty urinating; fast or slow heartbeat; seizures; severe dizziness, lightheadedness, or fainting; slowed or difficult breathing; tremor; vision changes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include cold and clammy skin; confusion; loss of consciousness; seizures; severe drowsiness, dizziness, or lightheadedness; slow breathing; slow heartbeat.

Store OxyContin Sustained-Release Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from light, heat, and moisture. Do not store in the bathroom. Keep OxyContin Sustained-Release Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about OxyContin Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
• OxyContin Sustained-Release Tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about OxyContin Sustained-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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