Ibuprofen (eye-bue-PROE-fen), Oxycodone Hydrochloride (ox-i-KOE-done hye-droe-KLOR-ide)

Treats moderate to severe pain. This medicine contains an opioid pain reliever and an NSAID.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• An overdose can be dangerous. Follow directions carefully so you do not get too much medicine at one time. Your doctor may also give naloxone to treat an overdose. Naloxone is a medicine that temporarily reverses the effects of an overdose. If you have been prescribed naloxone, make sure household members know how to use this on you in the event of an overdose or suspected overdose. Emergency medical attention is still needed after naloxone is used because the reversal effects are only temporary.
• Drink plenty of liquids to help avoid constipation.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose:Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Drop off any unused opioid medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused opioid medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how oxycodone or ibuprofen works. Tell your doctor if you are using any of the following:
  • Aspirin, carbamazepine, cyclosporine, diclofenac, diflunisal, digoxin, erythromycin, indomethacin, ketoconazole, lithium, meloxicam, methotrexate, mirtazapine, nabumetone, pemetrexed, phenytoin, rifampin, ritonavir, salsalate, tramadol, or trazodone
  • Blood pressure medicine
  • Blood thinner (including warfarin)
  • Diuretic (water pill)
  • MAO inhibitor
  • Medicine to treat depression, anxiety, or mental health problem
  • Phenothiazine medicine
  • Steroid medicine
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol. Tell your doctor if you are using buprenorphine, butorphanol, nalbuphine, pentazocine, or a muscle relaxer.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding. Do not use this medicine during the later part of your pregnancy.
• Tell your doctor if have kidney disease, liver disease, anemia, bleeding problems, heart failure or other heart problems, high blood pressure, lung or breathing problems, gallbladder problems, pancreas problems, Addison disease, other thyroid problems, enlarged prostate, trouble urinating, lupus, or a history of head injury, brain tumor, or seizures. Tell your doctor if you have or had alcohol or drug use disorder.
• This medicine may cause the following problems:
  • High risk of overdose, which can lead to death
  • Respiratory depression (serious breathing problem that can be life-threatening)
  • Higher risk of heart attack or stroke
  • Stomach ulcers and bleeding
  • Liver damage
  • High blood pressure
  • Kidney damage
  • Aseptic meningitis
  • Serotonin syndrome (when used with certain medicines)
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Sit or lie down if you feel dizzy. Stand up carefully.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• This medicine may cause constipation, especially with long-term use. Ask your doctor if you should use a laxative to prevent and treat constipation.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, restlessness, fast heartbeat, fever, sweating, muscle spasms, twitching, diarrhea, seeing or hearing things that are not there
• Blistering, peeling, red skin rash
• Blue lips, fingernails, or skin
• Change in how much or how often you urinate
• Chest pain that may spread, trouble breathing, unusual sweating, fainting
• Dark urine or pale stools, nausea, vomiting, loss of appetite, yellow skin or eyes
• Extreme weakness, shallow breathing, slow heartbeat, sweating, cold or clammy skin
• Fever, neck pain or stiff neck
• Lightheadedness, dizziness, fainting
• Numbness or weakness in one side of your body, sudden or severe headache, problems with vision, speech, or walking
• Rapid weight gain, swelling in your hands, ankles, or feet
• Severe stomach pain, constipation, vomiting blood, bloody or black, tarry stools
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Mild constipation, diarrhea, heartburn
• Sleepiness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088