BUTALBITAL COMPOUND-CODEINE

BUTALBITAL; ASPIRIN; CAFFEINE; CODEINE (byoo TAL bi tal; AS pir in; KAF een; KOE deen) treats tension headaches. It is prescribed when other pain medications have not worked or cannot be tolerated. It works by reducing pain. It also helps you relax. It is not used to prevent headaches or migraines. It is a combination of a barbiturate, an NSAID, caffeine, 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. Swallow it with a full glass of water. Follow the directions on the prescription label. If the medication upsets your stomach, take the medication with food or milk. Do not take more than you are told to take.
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. This medication is not for use in children less than 12 years of age. Do not give this medication to a child younger than 18 years of age after surgery to remove the tonsils and/or adenoids.

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:
-Abrocitinib
-Cidofovir
-Defibrotide
-Elbasvir; grazoprevir
-Ketorolac
-Linezolid
-Lonafarnib
-Lurasidone
-MAOIs, such as Marplan, Nardil, and Parnate
-Mavacamten
-Methylene blue
-Naltrexone
-Nirmatrelvir; ritonavir
-Olanzapine; samidorphan
-Pacritinib
-Praziquantel
-Probenecid
-Ranolazine
-Sodium oxybate
-Voriconazole
This medication may interact with the following:
-Alcohol
-Antihistamines for allergy, cough, and cold
-Atropine
-Benzodiazepines, such as alprazolam, diazepam, lorazepam
-Cyclosporine
-Diuretics
-Medications that cause drowsiness before a procedure, such as propofol
-Medications that help you fall asleep
-Medications that relax muscles
-Methotrexate
-NSAIDs, medications for pain and inflammation, such as ibuprofen or naproxen
-Other opioids
-Phenothiazines, such as chlorpromazine, prochlorperazine, thioridazine
-Some medications for bladder problems, such as oxybutynin or tolterodine
-Some medications for depression, anxiety, or other mental health conditions
-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
-Some medications that treat or prevent blood clots, such as warfarin, enoxaparin, dalteparin, apixaban, dabigatran, rivaroxaban
-Steroid medications, such as prednisone or cortisone
-Stimulant medications for ADHD, weight loss, or staying awake
-Supplements, such as St. John's wort
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 aspirin or other NSAIDs, such as ibuprofen or naproxen, while you are taking this medication. Side effects, such as upset stomach, nausea, and ulcers, may be more likely to occur. Many over-the-counter medications contain aspirin, ibuprofen, or naproxen. It is important to read labels carefully. Talk to your care team about all the medications you take. They can tell you what is safe to take together.
This medication can cause serious bleeding, ulcers, or tears in the stomach. These problems can occur at any time and with no warning signs. They are more common with long-term use. Talk to your care team right away if you have stomach pain, bloody or black, tar-like stools, or vomit blood that is red or looks like coffee grounds.
This medication may cause serious skin reactions. They can happen weeks to months after starting the medication. Talk to your care team right away if you have 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.
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. Taking this medication after 20 weeks of pregnancy may cause serious fetal side effects. Use of this medication after 30 weeks of pregnancy is not recommended.
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
-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
-Hearing loss, ringing in ears
-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
-Pain or trouble swallowing, heartburn, chest pain
-Rash, fever, and swollen lymph nodes
-Redness, blistering, peeling, or loosening of the skin, including inside the mouth
-Round red or dark patches on the skin that may itch, burn, and blister
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
-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.

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, check the package insert or medication guide to see if it should be flushed down the toilet or put in your trash at home. If you are not sure, ask your care team. If it is safe to put it in your trash, empty the medication out of the container. Mix it with cat litter, dirt, used coffee grounds, or another unwanted substance. Seal the mixture in a container, such as a plastic bag. Put it in the trash.

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.