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, such as 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, tinzaparin
• Medications for pain
• Muscle relaxants
• NSAIDs, medications for pain and inflammation, such as ibuprofen or naproxen
• 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 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.

Do not suddenly stop taking this medication. You may develop a severe reaction. Your care team will tell you how much medication to take. If your care team wants you to stop the medication, the dose may 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 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.

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.

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
• 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):

• Dizziness
• Drowsiness
• Headache
• Loss of appetite
• Nausea
• Stomach pain
• Upset stomach

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 it in a safe place to protect it from theft. Do not share it with anyone. It is only for you. Selling or giving away 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. You can do this in two ways:

• 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.