OXYCONTIN is:

• A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage severe and persistent pain, that requires an extended treatment period with a daily opioid pain medicine when other pain medicines do not treat your pain well enough or you cannot tolerate them.
• A long-acting (extended-release) opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
• Not to be taken on an “as-needed” basis.
• Not for use in children less than 11 years of age and who are not already using opioid pain medicines regularly to manage pain severe enough to require daily around-the-clock long-term treatment of pain with an opioid.

Important information about OXYCONTIN:

• Get emergency help or call 911 right away if you take too much OXYCONTIN (overdose). When you first start taking OXYCONTIN, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur. Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose.
• Taking OXYCONTIN with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
• Never give anyone else your OXYCONTIN. They could die from taking it. Selling or giving away OXYCONTIN is against the law.
• Store OXYCONTIN securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Tell your healthcare provider if you are:

• noticing your pain getting worse. If your pain gets worse after you take OXYCONTIN, do not take more OXYCONTIN without first talking to your healthcare provider. Talk to your healthcare provider if the pain that you have increases, if you feel more sensitive to pain, or if you have new pain after taking OXYCONTIN.
• pregnant or planning to become pregnant. Use of OXYCONTIN for an extended period of time during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
• breastfeeding. Not recommended during treatment with OXYCONTIN. It may harm your baby.
• living in a household where there are small children or someone who has abused street or prescription drugs taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking OXYCONTIN with certain other medicines can cause serious side effects that could lead to death.

When taking OXYCONTIN:

• Do not change your dose. Take OXYCONTIN exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
• Take your prescribed dose every 12 hours at the same time every day. Do not take more than your prescribed dose in 12 hours. If you miss a dose, take your next dose at your usual time.
• Swallow OXYCONTIN whole. Do not cut, break, chew, crush, dissolve, snort, or inject OXYCONTIN because this may cause you to overdose and die.
• OXYCONTIN should be taken 1 tablet at a time. Do not pre-soak, lick, or wet the tablet before placing in your mouth to avoid choking on the tablet.

• Do not stop taking OXYCONTIN without talking to your healthcare provider.
• Dispose of expired, unwanted, or unused OXYCONTIN by promptly flushing down the toilet, if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

While taking OXYCONTIN DO NOT:

• Drive or operate heavy machinery until you know how OXYCONTIN affects you. OXYCONTIN can make you sleepy, dizzy, or lightheaded.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with OXYCONTIN may cause you to overdose and die.

The possible side effects of OXYCONTIN are:

• constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.