What is this medication?

ACETAMINOPHEN; OXYCODONE (a set a MEE noe fen; ox i KOE done) is a pain reliever. It is used to treat moderate to severe pain.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): XARTEMIS XR

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• brain tumor
• drug abuse or addiction
• head injury
• heart disease
• if you often drink alcohol
• kidney disease
• liver disease
• low adrenal gland function
• lung disease, asthma, or breathing problem
• seizures
• stomach or intestine problems
• taken an MAOI like Marplan, Nardil, or Parnate in the last 14 days
• an unusual or allergic reaction to acetaminophen, oxycodone, other medicines, foods, dyes, or preservative
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with water. Take it as directed on the label. Do not cut, crush or chew this medicine. Swallow the tablets whole. You can take it with or without food. If it upsets your stomach, take it with food. Do not use it more often than directed. There may be unused or extra doses in the bottle after you finish your treatment. Talk to your health care provider if you have questions about your dose.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your health care provider about the use of this medicine in children. Special care may be needed.

Patients over 65 years of age may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you remember. Then, take your next dose 12 hours later. Do not take double or extra doses.

What may interact with this medication?

This medicine may interact with the following medications:

• alcohol
• antihistamines for allergy, cough and cold
• antiviral medicines for HIV or AIDS
• atropine
• certain antibiotics like clarithromycin, erythromycin, linezolid, rifampin
• certain medicines for anxiety or sleep
• certain medicines for bladder problems like oxybutynin, tolterodine
• certain medicines for depression like amitriptyline, fluoxetine, sertraline
• certain medicines for fungal infections like ketoconazole, itraconazole, voriconazole
• certain medicines for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
• certain medicines for nausea or vomiting like dolasetron, ondansetron, palonosetron
• certain medicines for Parkinson’s disease like benztropine, trihexyphenidyl
• certain medicines for seizures like phenobarbital, phenytoin, primidone
• certain medicines for stomach problems like dicyclomine, hyoscyamine
• certain medicines for travel sickness like scopolamine
• diuretics
• general anesthetics like halothane, isoflurane, methoxyflurane, propofol
• ipratropium
• local anesthetics like lidocaine, pramoxine, tetracaine
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• medicines that relax muscles for surgery
• methylene blue
• nilotinib
• other medicines with acetaminophen
• other narcotic medicines for pain or cough
• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Tell your health care provider if your pain does not go away, if it gets worse, or if you have new or a different type of pain. You may develop tolerance to this drug. Tolerance means that you will need a higher dose of the drug for pain relief. Tolerance is normal and is expected if you take this drug for a long time.

There are different types of narcotic drugs (opioids) for pain. If you take more than one type at the same time, you may have more side effects. Give your health care provider a list of all drugs you use. He or she will tell you how much drug to take. Do not take more drug than directed. Get emergency help right away if you have problems breathing.

Do not suddenly stop taking your drug because you may develop a severe reaction. Your body becomes used to the drug. This does NOT mean you are addicted. Addiction is a behavior related to getting and using a drug for a nonmedical reason. If you have pain, you have a medical reason to take pain drug. Your health care provider will tell you how much drug to take. If your health care provider wants you to stop the drug, the dose will be slowly lowered over time to avoid any side effects.

Talk to your health care provider about naloxone and how to get it. Naloxone is an emergency drug used for an opioid overdose. An overdose can happen if you take too much opioid. It can also happen if an opioid is taken with some other drugs or substances, like alcohol. Know the symptoms of an overdose, like trouble breathing, unusually tired or sleepy, or not being able to respond or wake up. Make sure to tell caregivers and close contacts where it is stored. Make sure they know how to use it. After naloxone is given, you must get emergency help right away. Naloxone is a temporary treatment. Repeat doses may be needed.

Do not take other drugs that contain acetaminophen with this drug. Many non-prescription drugs contain acetaminophen. Always read labels carefully. If you have questions, ask your health care provider.

If you take too much acetaminophen, get medical help right away. Too much acetaminophen can be very dangerous and cause liver damage. Even if you do not have symptoms, it is important to get help right away.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this drug affects you. Do not stand up or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this drug. Avoid alcoholic drinks.

This drug will cause constipation. If you do not have a bowel movement for 3 days, call your health care provider.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your health care provider if the problem does not go away or is severe.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care provider as soon as possible:

• allergic reactions (skin rash, itching or hives; swelling of the face, lips, or tongue)
• confusion
• kidney injury (trouble passing urine or change in the amount of urine)
• light-colored stool
• liver injury (dark yellow or brown urine; general ill feeling or flu-like symptoms; loss of appetite, right upper belly pain; unusually weak or tired, yellowing of the eyes or skin)
• low adrenal gland function (nausea; vomiting; loss of appetite; unusually weak or tired; dizziness; low blood pressure)
• low blood pressure (dizziness; feeling faint or lightheaded, falls; unusually weak or tired)
• redness, blistering, peeling, or loosening of the skin, including inside the mouth
• serotonin syndrome (irritable; confusion; diarrhea; fast or irregular heartbeat; muscle twitching; stiff muscles; trouble walking; sweating; high fever; seizures; chills; vomiting)
• trouble breathing

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• constipation
• dry mouth
• nausea, vomiting
• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets. This medicine can be abused. Keep it in a safe place to protect it from theft. Do not share it with anyone. It is only for you. Selling or giving away this medicine is dangerous and against the law.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light and moisture. Keep the container tightly closed.

This medicine may cause harm and death if it is taken by other adults, children, or pets. It is important to get rid of the medicine as soon as you no longer need it or it is expired. You can do this in two ways:

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, flush it down the toilet.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.