Oxycodone; Aspirin Tablets

What is this medication?

OXYCODONE; ASPIRIN (ox i KOE done; AS pir in) treats severe pain. It is prescribed when other pain medications have not worked or cannot be tolerated. It works by blocking pain signals in the brain. It also decreases inflammation. It is a combination of an opioid and an NSAID.

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

COMMON BRAND NAME(S): Endodan, Percodan, Percodan-Demi

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

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

• Bleeding disorder
• Brain tumor
• Constipation
• Frequently drink alcohol
• Head injury
• Heart disease
• Low adrenal gland function
• Lung disease, asthma, or breathing problem
• Seizures
• Stomach or intestine problems
• Substance use disorder
• Taken an MAOI like Marplan, Nardil, or Parnate in the last 14 days
• An unusual or allergic reaction to aspirin, oxycodone, other medications, foods, dyes, or preservative
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a full glass of water. Take it as directed on the prescription label at the same time every day. You can take this medication with or without food. If it upsets your stomach, take it with food. Keep taking it unless your care team tells you to stop.

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 care team about the use of this medication in children. This medication is not approved for use in children.

People over the age of 65 years 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 can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Cidofovir
• Defibrotide
• Ketorolac
• Methotrexate
• Probenecid

This medication may interact with the following:

• Alcohol
• Antihistamines for allergy, cough and cold
• Antiviral medications for HIV or AIDS
• Atropine
• Certain antibiotics like clarithromycin, erythromycin, linezolid, rifampin
• Certain medications for anxiety or sleep
• Certain medications for bladder problems like oxybutynin, tolterodine
• Certain medications for blood pressure, heart disease, irregular heart beat
• Certain medications for depression like amitriptyline, fluoxetine, sertraline
• Certain medications for fungal infections like ketoconazole, itraconazole, voriconazole
• Certain medications for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
• Certain medications for nausea or vomiting like dolasetron, ondansetron, palonosetron
• Certain medications for Parkinson's disease like benztropine, trihexyphenidyl
• Certain medications for seizures like phenobarbital, primidone
• Certain medications for stomach problems like dicyclomine, hyoscyamine
• Certain medications for travel sickness like scopolamine
• Certain medications that treat or prevent blood clots like warfarin, enoxaparin, dalteparin, apixaban, dabigatran, and rivaroxaban
• Diuretics
• General anesthetics like halothane, isoflurane, methoxyflurane, propofol
• Ipratropium
• Local anesthetics like lidocaine, pramoxine, tetracaine
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Medications that relax muscles for surgery
• Methylene blue
• Nilotinib
• NSAIDs, medications for pain and inflammation, like ibuprofen or naproxen
• Other opioid medications for pain or cough
• Phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine
• Sulfinpyrazone

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 care team 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 medication. Tolerance means that you will need a higher dose of the medication for pain relief. Tolerance is normal and is expected if you take this medication for a long time.

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

If you take other medications that also cause drowsiness like other opioid pain medications, benzodiazepines, or other medications for sleep, you may have more side effects. Give your care team a list of all medications you use. They will tell you how much medication to take. Do not take more medication than directed. Get emergency help right away if you have trouble breathing or are unusually tired or sleepy.

Naloxone is an emergency medication 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 medications or substances such as 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 your naloxone stored. Make sure they know how to use it. After naloxone is given, the person giving it must call emergency services. Naloxone is a temporary treatment. Repeat doses may be needed.

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

Check with your care team if you have severe diarrhea, nausea, and vomiting, or if you sweat a lot. The loss of too much body fluid may make it dangerous for you to take this medication.

Do not take other medications that contain aspirin, ibuprofen, or naproxen with this medication. Side effects such as stomach upset, nausea, or ulcers may be more likely to occur. Many non-prescription medications contain aspirin, ibuprofen, or naproxen. Always read labels carefully.

This medication can cause serious ulcers and bleeding in the stomach. It can happen with no warning. Tobacco, alcohol, older age, and poor health can also increase risks. Call your care team right away if you have stomach pain or blood in your vomit or stool.

This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Contact your care team right away if you notice fevers or flu-like symptoms with a rash. The rash may be red or purple and then turn into blisters or peeling of the skin. Or, you might notice a red rash with swelling of the face, lips or lymph nodes in your neck or under your arms.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your care team 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 care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake
• Hearing loss, ringing in ears
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
• Rash, fever, and swollen lymph nodes

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

• Constipation
• Dizziness
• Drowsiness
• Dry mouth
• Headache
• Loss of appetite
• Nausea
• Upset stomach
• Vomiting

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 medication 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 medication 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 medication may cause harm and death if it is taken by other adults, children, or pets. Return medication that has not been used to an official disposal site. Contact the DEA at 1-800-882-9539 or your city/county government to find a site. If you cannot return the medication, flush it down the toilet. Do not use the medication after the expiration date.

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.