Medication Guide

IBUDONE ® (eye " bue done)
(hydrocodone bitartrate and ibuprofen tablets), CII

IBUDONE ® is:

• A strong prescription pain medicine that contains an opioid (narcotic) and a non-steroidal anti- inflammatory drug (NSAID), that is used to manage short-term (acute) pain, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
• An opioid pain medicine can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
• NSAIDs are used to treat pain, redness, swelling, and inflammation.

Important information about IBUDONE ®:

•  Get emergency help right away if you take too much IBUDONE ® (overdose). When you first start taking IBUDONE ®, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.
• Taking IBUDONE ® with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
• Never give anyone else your IBUDONE ®. They could die from taking it. Store IBUDONE ® away from children and in a safe place to prevent stealing or abuse. Selling or giving away IBUDONE ® is against the law.

IBUDONE ® contains an NSAID. NSAIDs can cause serious side effects, including:

•  Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:
    ◦  with increasing doses of medicine containing NSAIDs
    ◦  with longer use of medicine containing NSAIDs
  Do not take NSAIDS right before or after a heart surgery called a “coronary artery bypass graft (CABG)."
  Avoid taking NSAIDS after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.
•  Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines:
    ◦  any time during use
    ◦  without warning symptoms
    ◦  that may cause death
  The risk of getting an ulcer or bleeding increases with:
    ◦  past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
    ◦  taking medicines called “corticosteroids,” “anticoagulants,” “SSRIs,” or “SNRIs”
    ◦  increasing doses of NSAIDS
    ◦  older age
    ◦  longer use of NSAIDS
    ◦  poor health
    ◦  smoking
    ◦  advanced liver disease
    ◦  drinking alcohol
    ◦  bleeding problems

Do not take IBUDONE ®:

• if you have severe asthma, trouble breathing, or other lung problems.
• if you have a bowel blockage or have narrowing of the stomach or intestines.
• if you have had an asthma attack, hives, or other allergic reaction with aspirin, other NSAIDs, or opioid medicine.
• right before or after heart bypass surgery.

Before taking IBUDONE ®, tell your healthcare provider if you have a history of:

• head injury or seizures
• liver, kidney, or thyroid problems
• problems urinating
• pancreas or gallbladder problems
• high blood pressure
• asthma
• abuse of street or prescription drugs, alcohol addiction, or mental health problems.

Tell your healthcare provider if you are:

•  pregnant or planning to become pregnant. Talk to your healthcare provider if you are considering taking IBUDONE ® during pregnancy. Prolonged use of IBUDONE ® during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated. You should not take NSAIDs after 29 weeks of pregnancy.
•  breastfeeding or planning to breastfeed. IBUDONE ® passes into breast milk and may harm your baby.
• taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking IBUDONE ® with certain other medicines can cause serious side effects that could lead to death.

When taking IBUDONE ®:

• Do not change your dose. Take IBUDONE ® exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
• Take your prescribed dose every 4 to 6 hours, as needed. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
• Call your healthcare provider if the dose you are taking does not control your pain.
• If you have been taking IBUDONE ® regularly, do not stop taking it without talking to your healthcare provider.
• After you stop taking IBUDONE ®, flush any unused tablets down the toilet or contact the Drug Enforcement Agency (DEA) to find the location of an authorized collector (1-800-882­-9539) after you stop taking IBUDONE ®.

While taking IBUDONE ® DO NOT:

• drive or operate heavy machinery, until you know how it affects you. IBUDONE ® can make you sleepy, dizzy, or lightheaded.
• drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with IBUDONE ® may cause you to overdose and die.

The possible side effects of IBUDONE ®:

•  constipation, diarrhea, gas, heartburn, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain, heart attack, stroke, new or worse high blood pressure, heart failure, liver problems including liver failure, kidney problems including kidney failure, bleeding and ulcers in the stomach and intestine, low red blood cells (anemia), life-threatening skin reactions, life- threatening allergic reactions, asthma attacks in people who have asthma. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help if you have:

• trouble breathing or shortness of breath
• agitation
• fast heartbeat
• high body temperature
• chest pain
• trouble walking
• swelling of your face, tongue, or throat
• stiff muscles
• extreme drowsiness
• mental changes such as confusion
• lightheadedness when changing positions
• weakness in one part or side of your body
• a fainting spell
• slurred speech

Stop IBUDONE ® and call your healthcare provider right away if you have any of the following symptoms:

• nausea
• flu-like symptoms
• more tired or weaker than usual
• vomit blood
• diarrhea
• there is blood in your bowel movement or it is black and sticky like tar
• itching
• unusual weight gain
• your skin or eyes look yellow
• skin rash or blisters with fever
• indigestion or stomach pain
• swelling of the arms and legs, hands and feet

These are not all the possible side effects of IBUDONE ®. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov.

Other information:

• Aspirin is an NSAID medicine, but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.
• Do not take other NSAID medicines, even those sold in lower doses without a prescription (over-the-counter) while taking IBUDONE ®. NSAIDs may be present in over-the-counter medications for treatment of colds, fever, or insomnia.

Manufactured for: Poly Pharmaceuticals, Inc. Huntsville, AL 35741

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Rev 5/17           8183126 R2