Hydrocodone; Ibuprofen Tablets

What is this medication?

HYDROCODONE; IBUPROFEN (hye droe KOE done; eye BYOO proe fen) treats severe pain. It is prescribed when other pain medications have not worked or cannot be tolerated. It works by decreasing inflammation. It also blocks pain signals in the brain. It is a combination of an NSAID and an opioid.

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

COMMON BRAND NAME(S): Ibudone, Reprexain, Vicoprofen, Xylon, Xylon 10

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
• 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
• Medication abuse or addiction
• Receiving steroids like dexamethasone or prednisone
• Seizures
• Smoke tobacco cigarettes
• Stomach bleeding
• Stomach ulcers, other stomach or intestine problems
• Stroke
• Take medications 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, hydrocodone, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. Do not cut, crush or chew this medication. 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 care team about the use of this medication in children. While it may be prescribed for children as young as 16 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 medication 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:

• Cidofovir
• Ketorolac

This medication may interact with the following:

• Alcohol
• Antihistamines for allergy, cough and cold
• Antiviral medications for HIV or AIDS
• Aspirin and aspirin-like medications
• Atropine
• Certain antibiotics like clarithromycin, erythromycin
• Certain medications for anxiety or sleep
• Certain medications for depression like amitriptyline, fluoxetine, lithium, sertraline
• Certain medications for fungal infection like ketoconazole and itraconazole
• Certain medications for seizures like carbamazepine, phenobarbital, phenytoin, primidone
• Certain medications for stomach problems like dicyclomine, hyoscyamine
• Certain medications for travel sickness like scopolamine
• Certain medications that treat or prevent blood clots like warfarin, enoxaparin, dalteparin, apixaban, dabigatran, and rivaroxaban
• Diuretics
• General anesthetics like halothane, isoflurane, methoxyflurane, propofol
• Ipratropium
• Local anesthetics like lidocaine, pramoxine, tetracaine
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Medications that relax muscles for surgery
• Methotrexate
• Other narcotic medications for pain or cough
• Other NSAIDS, medications for pain and inflammation, like naproxen
• Pemetrexed
• Phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine
• Rifampin
• Steroid medications 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 care team 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 medication. Tolerance means that you will need a higher dose of the medication for pain relief. Tolerance is normal and is expected if you take this medication for a long time.

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

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

Talk to your care team about naloxone and how to get it. Naloxone is an emergency medication 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 medications 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 medication will cause constipation. If you do not have a bowel movement for 3 days, call your care team.

Check with your care team 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 medication.

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

This medication 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 care team right away if you have stomach pain or blood in your vomit or stool.

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

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

Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your care team 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 care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Bleeding—bloody or black, tar-like stools, vomiting blood or brown material that looks like coffee grounds, red or dark brown urine, small red or purple spots on skin, unusual bruising or bleeding
• CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake
• Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
• Heart failure—shortness of breath, swelling of the ankles, feet, or hands, sudden weight gain, unusual weakness or fatigue
• Increase in blood pressure
• Kidney injury—decrease in the amount of urine, swelling of the ankles, hands, or feet
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
• Rash, fever, and swollen lymph nodes
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision

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

• Constipation
• Dizziness
• Drowsiness
• Dry mouth
• Headache
• Loss of appetite
• Nausea
• Upset stomach
• Vomiting

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 medication 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 medication is dangerous and against the law.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Protect from light. Talk to your care team about how to dispose of unused medication. Special directions may apply.

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