BENZHYDROCODONE-ACETAMINOPHEN (Generic for APADAZ)

BENZHYDROCODONE; ACETAMINOPHEN (benz hye droe KOE done; a set a MEE noe fen) treats severe pain. It is often prescribed when other medications have not worked well enough or cannot be tolerated. It works by blocking pain signals in the brain. It 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.

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.

Do not take this medication with any of the following:
-Naltrexone
-Olanzapine; samidorphan
-Safinamide
This medication may also interact with the following:
-Alcohol
-Antihistamines for allergy, cough, and cold
-Atropine
-Benzodiazepines, such as alprazolam, diazepam, lorazepam
-Diuretics
-MAOIs, such as Marplan, Nardil, and Parnate
-Medications that cause drowsiness before a procedure, such as propofol
-Medications that help you fall asleep
-Medications that relax muscles
-Methylene blue
-Other opioids
-Phenothiazines, such as chlorpromazine, prochlorperazine, thioridazine
-Some antibiotics, such as erythromycin or linezolid
-Some antivirals for HIV or hepatitis
-Some medications for bladder problems, such as oxybutynin or tolterodine
-Some medications for depression, anxiety, or other mental health conditions
-Some medications for fungal infections, such as ketoconazole or itraconazole
-Some medications for migraines, such as sumatriptan
-Some medications for nerve pain, such as gabapentin or pregabalin
-Some medications for Parkinson disease, such as benztropine or trihexyphenidyl
-Some medications for seizures, such as phenobarbital or primidone
-Some medications for stomach problems, such as dicyclomine or hyoscyamine
-Some medications for travel sickness, such as scopolamine
-Supplements, such as St. John's wort or tryptophan
Other medications may affect the way this medication works. Talk with your care team about all the medications you take. They may suggest changes to your treatment plan to lower the risk of side effects and to make sure your medications work as intended.

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.

Tell your care team if your pain does not go away, gets worse, or if you have a new or different type of pain. If you take this medication for a long time, your body may get used to it. This means you may need a higher dose to help with pain. This is normal. Do not increase your dose without talking to your care team first.
This medication can make you very drowsy because it slows down your brain and nervous system. Taking it with alcohol or other medications that also work this way can be dangerous. It can make it hard to breathe or stay awake. In serious cases, it can cause coma and death. Talk to your care team about all the medications, vitamins, and supplements you take. They can tell you what is safe to take together. Call emergency services right away if you have slow or shallow breathing, feel dizzy or confused, or have trouble staying awake.
If you have taken this medication for a long time or at high doses, do not stop it suddenly. Stopping too fast can make you very sick. Your care team will slowly lower the dose when it is time to stop.
It may be important to have access to an opioid reversal agent, such as naloxone or nalmefene, while you are taking this medication. Talk to your care team about how to get one. An overdose can happen if you take too much of an opioid. It can also happen if you take an opioid with alcohol or other medications that make you drowsy. Know the symptoms of an overdose, such as slow or shallow breathing, feeling faint, dizzy, or confused, or having trouble staying awake. Tell caregivers and close contacts where your reversal agent is kept. Make sure they know how to use it. After it is given, they should call emergency services right away. Reversal agents are a temporary treatment. Repeat doses may be needed.
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.
Do not take other medications that contain acetaminophen with this medication. Many non-prescription medications contain acetaminophen. Always read labels carefully. If you have questions, ask your care team.
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 will cause constipation. If you do not have a bowel movement for 3 days, call your care team.
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.
Talk to your care team if you may be pregnant. Prolonged use of this medication during pregnancy can cause temporary withdrawal in a newborn.
Talk to your care team before breastfeeding. Changes to your treatment plan may be needed. If you breastfeed while taking this medication, seek medical care right away if you notice the child has slow or noisy breathing, is unusually sleepy or not able to wake up, or is limp.
Long-term use of this medication may cause infertility. Talk to your care team if you are concerned about your fertility.

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.

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
-Pain or trouble swallowing, heartburn, chest pain
-Redness, blistering, peeling, or loosening of the skin, including inside the mouth
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
-Constipation
-Dizziness
-Drowsiness
-Dry mouth
-Headache
-Nausea
-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.

Keep this medication out of reach of children and pets. Store it out of sight in a safe place. Do not share it with others. Misuse of this medication is dangerous and against the law.
Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.
This medication may cause harm and death if it is taken by other adults, children, or pets. It is important to get rid of the medication as soon as you no longer need it or it is expired. To get rid of this medication:
-Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
-Follow the steps given to you by your pharmacy. You may be given a pre-paid mail-back envelope or disposal product to safely get rid of your medication.
-If other options are not available, flush the medication down the toilet.

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.