Butalbital; Aspirin; Caffeine Capsules or Tablets

What is this medication?

BUTALBITAL; ASPIRIN; CAFFEINE (byoo TAL bi tal; AS pir in; KAF een) treats tension headaches. 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, and caffeine.

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

COMMON BRAND NAME(S): Fiorinal, Fortabs

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
• Frequently drink alcohol
• Heart disease
• Kidney disease
• Liver disease
• Lung or breathing disease (asthma, COPD)
• Porphyria
• Stomach ulcers, other stomach or intestine problems
• Substance use disorder
• An unusual or allergic reaction to aspirin, butalbital, caffeine, 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. If the medication upsets your stomach, take the medication with food or milk. Do not take more than you are told to take.

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?

Do not take this medication with any of the following:

• Alcohol or medications that contain alcohol
• Cidofovir
• Furazolidone
• Methotrexate
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Probenecid
• Procarbazine
• Voriconazole
• Warfarin

This medication may also interact with the following:

• Antidepressants
• Antihistamines
• Benzodiazepines
• Heparin and heparin-like medications including enoxaparin, dalteparin, and tinzaparin
• Medications for pain
• Muscle relaxants
• NSAIDs, medications for pain and inflammation, like ibuprofen or naproxen
• Phenothiazines like 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.

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 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 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 wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects.

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 does not prevent a heart attack or stroke. This medication may increase the chance of a heart attack or stroke. The chance may increase the longer you use this medication or if you have heart disease. If you take aspirin to prevent a heart attack or stroke, talk to your care team about using this medication.

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
• 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
• Rash, fever, and swollen lymph nodes

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

• Dizziness
• Drowsiness
• Loss of appetite
• 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 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 accidental overdose and death if it is taken by other adults, children, or pets.

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.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. 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.