Ibuprofen; Oxycodone tablets

What is this medicine?

IBUPROFEN; OXYCODONE (eye BYOO proe fen; ox i KOE done) is a pain reliever. It is used to treat moderate to severe pain for 7 days or less.

How should I use this medicine?

Take this medicine by mouth with a full glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Take your medicine at regular intervals. Do not take your medicine more often than directed.

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 pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

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

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• breathing problems

• confusion

• redness, blistering, peeling, or loosening of the skin, including inside the mouth

• signs and symptoms of bleeding such as 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 eye, gums, or nose

• signs and symptoms of a blood clot such as breathing problems; changes in vision; chest pain; severe, sudden headache; pain, swelling, warmth in the leg; trouble speaking; sudden numbness of the face, arm, or leg

• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

• signs and symptoms of low blood pressure like dizziness; feeling faint or lightheaded, falls; unusually weak or tired

• trouble passing urine or change in the amount of urine

• unexplained weight gain or swelling

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

• stomach pain

• tiredness

What may interact with this medicine?

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

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.

Where should I keep my medicine?

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

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep container tightly closed.

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

What should I tell my health care provider before I take this medicine?

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

• cigarette smoker

• coronary artery bypass graft (CABG) surgery within the past 2 weeks

• drink more than 3 alcohol-containing drinks per day

• head injury

• heart disease

• high blood pressue

• history of a drug or alcohol abuse problem

• history of stomach bleeding

• kidney disease

• liver disease

• lung or breathing disease, like asthma

• stomach or intestine problems

• an unusual or allergic reaction to oxycodone, codeine, ibuprofen, aspirin, other NSAIDs, other medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

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.

This drug may cause serious skin reactions. They can happen weeks to months after starting the drug. 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.

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

This drug 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 drug does not prevent a heart attack or stroke. This drug may increase the chance of a heart attack or stroke. The chance may increase the longer you use this drug or if you have heart disease. If you take aspirin to prevent a heart attack or stroke, talk to your health care provider about using this drug.

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.