Butalbital; Acetaminophen; Caffeine; Codeine Capsules

What is this medication?

BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE (byoo TAL bi tal; a set a MEE noe fen; 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, acetaminophen, caffeine, 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): Fioricet with Codeine, Phrenilin with Caffeine and Codeine

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
• Liver disease
• Lung disease, asthma, or breathing problems
• Seizures
• Stomach or intestinal problems
• Substance use disorder
• Taken an MAOI like Marplan, Nardil, or Parnate in the last 14 days
• An unusual or allergic reaction to acetaminophen, butalbital, caffeine, codeine, 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. Do not take your medication more often than directed.

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.

People over the age of 65 years 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 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?

Do not take this medication with any of the following:

• Elbasvir; grazoprevir
• Linezolid
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Methylene blue
• Nifedipine
• Praziquantel
• Ranolazine
• Sodium oxybate
• Voriconazole

This medication may also 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 like erythromycin and clarithromycin
• Certain medications for anxiety or sleep
• Certain medications for bladder problems like oxybutynin, tolterodine
• Certain medications for depression like amitriptyline, fluoxetine, sertraline
• Certain medications for fungal infections like ketoconazole and itraconazole
• Certain medications for irregular heart beat like amiodarone, quinidine
• Certain medications for migraine headache like almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
• Certain medications for Parkinson's disease like benztropine, trihexyphenidyl
• Certain medications for seizures like carbamazepine, phenobarbital, phenytoin, primidone
• Certain medications for stomach problems like dicyclomine, hyoscyamine
• Certain medications for travel sickness like scopolamine
• Diuretics
• General anesthetics like halothane, isoflurane, methoxyflurane, propofol
• Grapefruit juice
• Ipratropium
• Local anesthetics like lidocaine, pramoxine, tetracaine
• Medications that relax muscles for surgery
• Other medications with acetaminophen
• Other opioid medications for pain or cough
• Phenothiazines like chlorpromazine, mesoridazine, prochlorperazine, thioridazine
• Rifampin

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.

There are different types of medications for pain. If you take more than one type at the same time, you may have more side effects. Give your care team a list of all medications you use. They will tell you how much medication to take. Do not take more medication than directed. Call emergency services if you have problems breathing.

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.

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 such as 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 your naloxone stored. Make sure they know how to use it. After naloxone is given, the person giving it must call emergency services. Naloxone is a temporary treatment. Repeat doses may be needed.

Children may be at higher risk for side effects. Stop giving this medication and call emergency services right away if your child has slow or noisy breathing, confusion, or unusual sleepiness.

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 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. 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.

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 to not require medical attention (report to your care team if they continue or are bothersome):

• Constipation
• Dizziness
• Drowsiness
• Dry mouth
• Nausea
• Stomach pain
• 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. 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 accidental overdose and death if it is taken by other adults, children, or pets. Mix any unused medication with a substance like cat litter or coffee grounds. Then throw the medication away in a sealed container like a sealed bag or a coffee can with a lid. 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.