OXYCODONE HYDROCHLORIDE- oxycodone hydrochloride tablet, film coated, extended release 
Par Pharmaceutical, Inc.

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 This Medication Guide has been approved by the U.S. Food and Drug Administration.
 Revised: September 2014
 

Medication Guide
OXYCODONE HCL EXTENDED-RELEASE TABLETS ® (ox-e-KON-tin) (oxycodone hydrochloride extended-release tablets), CII

 

OXYCODONE HCL EXTENDED-RELEASE TABLETS are:

  • •A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid 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 for use to treat pain that is not around-the-clock.
 

Important information about OXYCODONE HCL EXTENDED-RELEASE TABLETS :

  • Get emergency help right away if you take too much OXYCODONE HCL EXTENDED-RELEASE TABLETS (overdose). When you first start taking OXYCODONE HCL EXTENDED-RELEASE TABLETS, 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.
  • •Never give anyone else your OXYCODONE HCL EXTENDED-RELEASE TABLETS. They could die from taking it. Store OXYCODONE HCL EXTENDED-RELEASE TABLETS away from children and in a safe place to prevent stealing or abuse. Selling or giving away OXYCODONE HCL EXTENDED-RELEASE TABLETS is against the law.
 

Do not take OXYCODONE HCL EXTENDED-RELEASE TABLETS if you have:

  • •severe asthma, trouble breathing, or other lung problems.
  • •a bowel blockage or have narrowing of the stomach or intestines.
 

Before taking OXYCODONE HCL EXTENDED-RELEASE TABLETS , tell your healthcare provider if you have a history of:

  • •head injury, seizures
  • •liver, kidney, thyroid problems
  • •problems urinating
  • •pancreas or gallbladder problems
  • •abuse of street or prescription drugs, alcohol addiction, or mental health problems.

Tell your healthcare provider if you are:

  • pregnant or planning to become pregnant. Prolonged use of OXYCODONE HCL EXTENDED-RELEASE TABLETS during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • breastfeeding. OXYCODONE HCL EXTENDED-RELEASE TABLETS passes into breast milk and may harm your baby.
  • •taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking OXYCODONE HCL EXTENDED-RELEASE TABLETS with certain other medicines can cause serious side effects that could lead to death.
 

When taking OXYCODONE HCL EXTENDED-RELEASE TABLETS :

  • •Do not change your dose. Take OXYCODONE HCL EXTENDED-RELEASE TABLETS exactly as prescribed by your healthcare provider.
  • •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 OXYCODONE HCL EXTENDED-RELEASE TABLETS whole. Do not cut, break, chew, crush, dissolve, snort, or inject OXYCODONE HCL EXTENDED-RELEASE TABLETS because this may cause you to overdose and die.
  • •OXYCODONE HCL EXTENDED-RELEASE TABLETS 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.
  • Call your healthcare provider if the dose you are taking does not control your pain.
  • Do not stop taking OXYCODONE HCL EXTENDED-RELEASE TABLETS without talking to your healthcare provider.
  • •After you stop taking OXYCODONE HCL EXTENDED-RELEASE TABLETS, flush any unused tablets down the toilet.
 

While taking OXYCODONE HCL EXTENDED-RELEASE TABLETS DO NOT:

  • •Drive or operate heavy machinery, until you know how OXYCODONE HCL EXTENDED-RELEASE TABLETS affects you. OXYCODONE HCL EXTENDED-RELEASE TABLETS 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 OXYCODONE HCL EXTENDED-RELEASE TABLETS may cause you to overdose and die.
 

The possible side effects of OXYCODONE HCL EXTENDED-RELEASE TABLETS 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.
 

Get emergency medical help if you have:

  • •trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue or throat, extreme drowsiness, light-headedness when changing positions, or you are feeling faint.
 

These are not all the possible side effects of OXYCODONE HCL EXTENDED-RELEASE TABLETS. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov


Distributed by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977, www.parpharm.com or call 1-800-828-9393

Revised: 3/2016
Par Pharmaceutical, Inc.