Oxycodone Hydrochloride, Ibuprofen Oral tablet

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.

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

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

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

• brain tumor

• cigarette smoker

• constipation or other intestinal problems

• drink more than 3 alcohol containing drinks per day

• drug abuse or addiction

• kidney disease

• lung or breathing disease, like asthma

• recent head injury

• stomach ulcers

• 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

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.

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 medicine?

Do not take this medicine with any of the following medications:

• cidofovir

• methotrexate

• pemetrexed

This medicine may also interact with the following medications:

• alcohol

• antihistamines for allergy, cough and cold

• aspirin and aspirin-like drugs

• atropine

• barbiturates, like phenobarbital

• certain medicines for bladder problems like oxybutynin, tolterodine

• certain medicines for stomach problems like dicyclomine, hyoscamine

• diuretics

• ipratropium

• lithium

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

• medicines for depression, anxiety, or psychotic disturbances

• medicines for sleep

• medicines for travel sickness like scopolamine

• medicines that treat or prevent blood clots like warfarin

• muscle relaxants

• naltrexone, naloxone

• narcotic medicines (opiates) for pain

• other NSAIDs, medicines for pain and inflammation, like ibuprofen or naproxen

• phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine

• some medicines for high blood pressure like enalapril

• some medicines for Parkinson's disease like benztropine, trihexyphenidyl

• steroid medicines like prednisone or cortisone

• tramadol

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 medicine?

Tell your doctor or health care professional 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 the 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 the 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 drug for a non-medical reason. If you have pain, you have a medical reason to take pain medicine. Your doctor will tell you how much medicine to take. If your doctor wants you to stop the medicine, the dose will be slowly lowered over time to avoid any side effects.

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 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 medicine. Avoid alcoholic drinks.

There are different types of narcotic medicines (opiates) 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 medicines you use. Your doctor will tell you how much medicine to take. Do not take more medicine than directed. Call emergency for help if you have problems breathing.

Do not take naproxen with this medicine. Side effects such as stomach upset, nausea, or ulcers may be more likely to occur. Many medicines available without a prescription should not be taken with this medicine.

The medicine will cause constipation. Try to have a bowel movement at least every 2 to 3 days. If you do not have a bowel movement for 3 days, call your doctor or health care professional.

Do not smoke cigarettes or drink alcohol; these may increase the irritation to your stomach when taking this medicine. If you get black, tarry stools or vomit up what looks like coffee grounds, call your doctor or health care professional at once.

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

• difficulty passing urine

• feeling faint or lightheaded

• severe stomach pain

• 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 changes in vision; chest pain; severe, sudden headache; trouble speaking; sudden numbness of the face, arm, or leg

• unexplained weight gain or swelling

• unusually weak or tired

• yellowing of skin or eyes

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

• bruising

• constipation

• dizziness, drowsiness

• dry mouth

• headache

• nausea, vomiting

• trouble sleeping

• unusual sweating

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 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.

Throw away any unused medicine after the expiration date. Discard unused medicine and used packaging carefully. Pets and children can be harmed if they find used or lost packages.

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.