XARTEMIS XR- oxycodone hydrochloride and acetaminophen tablet, coated 
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Medication Guide

XARTEMIS® XR (ZAR-tem-iss) (oxycodone hydrochloride and acetaminophen) Extended-Release Tablets, CII

XARTEMIS XR is:

  • A strong prescription pain medicine that contains an opioid (narcotic) and the medicine acetaminophen. XARTEMIS XR is used to treat certain types of short term (acute) pain when other pain treatments such as non-opioid 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.
Important information about XARTEMIS XR: 

  • Get emergency help right away if you take too much XARTEMIS XR (overdose). When you first start taking XARTEMIS XR, 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.

  • Taking XARTEMIS XR 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 XARTEMIS XR. They could die from taking it. Store XARTEMIS XR away from children and in a safe place to prevent stealing or abuse. Selling or giving away XARTEMIS XR is against the law.

  • Get emergency help right away if you take more than 4,000 mg of acetaminophen in 1 day. Taking XARTEMIS XR with other products that contain acetaminophen can lead to serious liver problems and death.

Do not take XARTEMIS XR if you have:

  • severe asthma, trouble breathing, or other lung problems.
  • allergy to acetaminophen or oxycodone.
  • a bowel blockage or have narrowing of the stomach or intestines.
 Before taking XARTEMIS XR, tell your healthcare provider if you have a history of:
  • head injury, seizures
  • problems urinating
  • abuse of street or prescription drugs, alcohol addiction, or mental health problems.
  • liver, kidney, thyroid problems
  • pancreas or gallbladder problems

Tell your healthcare provider if you are:

  • pregnant or planning to become pregnant. Prolonged use 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 XARTEMIS XR. It may harm your baby.
  • taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking XARTEMIS XR with certain other medicines can cause serious side effects that could lead to death.

When taking XARTEMIS XR:

  • Do not change your dose. Take XARTEMIS XR 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. If you miss a dose, take XARTEMIS XR as soon as possible, then take your next dose 12 hours later. If it is almost time for your next dose, skip the missed dose. Take your next dose at the regular time. Do not take more than your prescribed daily dose in 24 hours.

  • Swallow XARTEMIS XR whole. Do not cut, break, chew, crush, dissolve, snort or inject XARTEMIS XR because this may cause you to overdose and die. You should not receive XARTEMIS XR through a nasogastric tube or gastric tube (stomach tube).

  • Take XARTEMIS XR 1 tablet at a time. Do not pre-soak, lick, or wet the tablet before placing in your mouth. Take each XARTEMIS XR tablet with enough water to be sure that you swallow it completely as soon as you place it in your mouth. Do not take more than your prescribed dose. If you miss a dose, take our next dose at your usual time.

  • Call your healthcare provider if XARTEMIS XR does not control your pain.

  • If you have been taking XARTEMIS XR for more than a few days, do not stop taking it without talking to your healthcare provider.

  • After you stop taking XARTEMIS XR, flush any unused tablets down the toilet.

While taking XARTEMIS XR:

  • Do not drive or operate heavy machinery, until you know how XARTEMIS XR affects you. XARTEMIS XR can make you sleepy, dizzy, or lightheaded.

  • Do not drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with XARTEMIS XR may cause you to overdose and die.

  • Do not take other products that contain acetaminophen while taking XARTEMIS XR.

The possible side effects of XARTEMIS XR 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, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

  • rash with hives, sores in your mouth or eyes, or your skin blisters and peels.

    These are not all the possible side effects of XARTEMIS XR. 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: Mallinckrodt Brand Pharmaceuticals, Inc., Hazelwood, MO 63042 USA, www.Mallinckrodt.com or call 1-800-778-7898

This Medication Guide has been approved by the U.S. Food and Drug Administration.    Issue: December 2016

Revised: 8/2018
Document Id: 07db75be-c9b9-425c-9024-f908a104ecfe
Set id: efcb1e8b-c0be-47ee-b09e-7a6b41e64bdd
Version: 19
Effective Time: 20180822
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