Ibuprofen; Oxycodone Oral Tablets

What is this medication?

IBUPROFEN; OXYCODONE (eye BYOO proe fen; ox i KOE done) is a combination of 2 drugs to treat pain. Ibuprofen is a non-steroidal anti-inflammatory drug, also known as an NSAID. It treats pain, inflammation, and swelling. Oxycodone is a pain reliever. It treats 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): Combunox

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
• coronary artery bypass graft (CABG) within the past 2 weeks
• dehydration
• depression
• diarrhea
• drug abuse or addiction
• head injury
• heart attack
• heart disease
• heart failure
• high blood pressure
• if you often drink alcohol
• kidney disease
• liver disease
• low adrenal gland function
• lung disease, asthma, or breathing problem
• receiving steroids like dexamethasone or prednisone
• seizures
• smoke tobacco cigarettes
• stomach bleeding
• stomach ulcers, other stomach or intestine problems
• stroke
• take drugs that treat or prevent blood clots
• taken an MAOI like Marplan, Nardil, or Parnate in the last 14 days
• vomiting
• an unusual or allergic reaction to ibuprofen, oxycodone, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this drug by mouth. Take it as directed on the prescription label at the same time every day. Do not cut, crush or chew this drug. Swallow the tablets whole. You can take it with or without food. If it upsets your stomach, take it with food.

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 drug in children. While it may be prescribed for children as young as 14 for selected conditions, precautions do apply.

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 take this drug on a regular basis, 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 medicines:

• cidofovir
• ketorolac

This medicine may interact with the following medications:

• alcohol
• antihistamines for allergy, cough and cold
• antiviral medicines for HIV or AIDS
• aspirin and aspirin-like drugs
• 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 blood pressure, heart disease, irregular heart beat
• certain medicines for depression like amitriptyline, fluoxetine, lithium, 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, primidone
• certain medicines for stomach problems like dicyclomine, hyoscyamine
• certain medicines for travel sickness like scopolamine
• certain medicines to treat or prevent blood clots like warfarin
• 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
• methotrexate
• methylene blue
• NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen
• nilotinib
• other narcotic medicines for pain or cough
• pemetrexed
• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine
• steroid medicines like prednisone or cortisone

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

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

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

Talk to your health care provider about naloxone and how to get it. Naloxone is an emergency medicine 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 medicines 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.

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

Check with your health care provider 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 medicine.

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

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

This medicine may cause serious skin reactions. They can happen weeks to months after starting the medicine. Contact your health care provider 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 health care provider if you are pregnant before taking this medicine. Taking this medicine between weeks 20 and 30 of pregnancy may harm your unborn baby. Your health care provider will monitor you closely if you need to take it. After 30 weeks of pregnancy, do not take this medicine.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine 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 effects of this medicine. Avoid alcoholic drinks.

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)
• aseptic meningitis (stiff neck; sensitivity to light; headache; drowsiness; fever; nausea, vomiting; rash)
• bleeding (bloody or black, tarry stools; red or dark brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eyes, gums, or nose)
• blurred vision OR changes in vision
• confusion
• heart attack (trouble breathing; pain or tightness in the chest, neck, back or arms; unusually weak or tired)
• heart failure (trouble breathing; fast, irregular heartbeat; sudden weight gain; swelling of the ankles, feet, hands; unusually weak or tired)
• high potassium levels (chest pain; fast, irregular heartbeat; muscle weakness)
• increase in blood pressure
• infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• kidney injury (trouble passing urine or change in the amount of urine)
• 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)
• low red blood cell counts (trouble breathing; feeling faint; lightheaded, falls; unusually weak or tired)
• rash, fever, and swollen lymph nodes
• redness, blistering, peeling, or loosening of the skin, including inside the mouth
• seizures
• serotonin syndrome (irritable; confusion; diarrhea; fast or irregular heartbeat; muscle twitching; stiff muscles; trouble walking; sweating; high fever; seizures; chills; vomiting)
• stroke (changes in vision; confusion; trouble speaking or understanding; severe headaches; sudden numbness or weakness of the face, arm or leg; trouble walking; dizziness; loss of balance or coordination)
• trouble breathing

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

• constipation
• diarrhea
• dry mouth
• headache
• nausea, vomiting
• tiredness
• upset stomach

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 drug 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 drug is dangerous and against the law.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Talk to your health care provider about how to dispose of unused drug. Special directions may apply.

This drug may cause harm and death if it is taken by other adults, children, or pets. Return drug 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 drug, flush it down the toilet. Do not use the drug 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.