Benzhydrocodone; Acetaminophen Tablets

What is this medication?

BENZHYDROCODONE; ACETAMINOPHEN (benz hye droe KOE done; a set a MEE noe fen) treats severe pain. It is prescribed when other pain medications have not worked or cannot be tolerated. It works by blocking pain signals in the brain. This medication is a combination of acetaminophen 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): APADAZ

What should I tell my care team before I take this medication?

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

• Brain tumor
• Frequently drink alcohol
• Head injury
• Heart disease
• Kidney disease
• Liver disease
• Lung or breathing disease, like asthma
• Seizures
• Stomach or intestine problems
• Substance use disorder
• An unusual or allergic reaction to benzhydrocodone, acetaminophen, 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 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 medication at regular intervals. Do not take it more often than directed. Do not stop taking except on your care team's advice.

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. 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 medication?

This medication may interact with the following:

• Alcohol or any product that contains alcohol
• Antihistamines for allergy, cough, and cold
• Antiviral medications for HIV or AIDS
• Atropine
• Certain antibiotics, such as clarithromycin, erythromycin, linezolid, rifampin
• Certain medications for anxiety or sleep
• Certain medications for bladder problems, such as oxybutynin or tolterodine
• Certain medications for depression, such as amitriptyline, fluoxetine, sertraline
• Certain medications for fungal infections, such as ketoconazole or itraconazole
• Certain medications for migraine headache, such as almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
• Certain medications for Parkinson's disease, such as benztropine or trihexyphenidyl
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin, primidone
• Certain medications for stomach problems, such as dicyclomine or hyoscyamine
• Certain medications for travel sickness, such as scopolamine
• Diuretics
• General anesthetics, such as halothane, isoflurane, methoxyflurane, propofol
• Ipratropium
• Local anesthetics, such as lidocaine, pramoxine, tetracaine
• MAOIs, such as Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Medications that relax muscles for surgery
• Methylene blue
• Other opioid medications for pain
• Phenothiazines, such as chlorpromazine, mesoridazine, prochlorperazine, thioridazine

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 the 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 the 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 non-medical 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.

There are different types of opioids medications for pain. If you take more than one type at the same time or if you are taking another medication that also causes drowsiness, you may have more side effects. Give your care team a list of all medications you use. Your care team will tell you how much medication to take. Do not take more medication than directed. Call emergency for help if you have problems breathing or unusual sleepiness.

Do not take other medications that contain acetaminophen with this medication. Always read labels carefully. If you have questions, ask your care team or pharmacist.

If you take too much acetaminophen get medical help right away. Too much acetaminophen can be very dangerous and cause liver damage. Even if you do not have symptoms, it is important to get help right away.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.

This medication 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 care team.

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
• CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake
• 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
• Redness, blistering, peeling, or loosening of the skin, including inside the mouth

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
• Nausea
• Trouble sleeping
• 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 your medication in a safe place to protect it from theft. Do not share this medication with anyone. Selling or giving away this medication is dangerous and against the law.

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.

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

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.