BUTALBITAL/ASPIRIN/CAFFEINE - ORAL

BUTALBITAL/ASPIRIN/CAFFEINE - ORAL

PHONETIC PRONUNCIATION: (bue-TAL-bi-tal/AS-pir-in/KAF-een)

COMMON BRAND NAME(S): Fiorinal

GENERIC NAME(S): butalbital/aspirin/caffeine

Uses

USES: This combination medication is used to treat tension headaches. Aspirin helps to decrease the pain from the headache. Caffeine helps increase the effects of aspirin. Butalbital is a sedative that helps to decrease anxiety and cause sleepiness and relaxation.


How to use BUTALBITAL/ASPIRIN/CAFFEINE - ORAL

HOW TO USE: Take this medication by mouth, usually every 4 hours as needed or as directed by your doctor. Do not take more than 6 capsules/tablets in a 24-hour period. Take with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise. Do not lie down for at least 10 minutes after taking this medication. To help prevent stomach upset, take it with food or milk. The dosage is based on your medical condition and response to therapy. This medication works best if it is used as the first signs of a headache occur. If you wait until the headache has worsened, the medication may not work as well. This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as nausea/vomiting, mental/mood changes, seizures) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away. Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Do not increase your dose, take it more often, or use it for a longer time than prescribed. Use the smallest effective dose. Properly stop the medication when so directed. Inform your doctor if you notice increased use of this medication, a worsening of headaches, an increase in the number of headaches, the medication not working as well, or use of this medication for more than 2 headache episodes a week. Your doctor may need to change your medication and/or add a separate medication to prevent the headaches.

Side Effects

SIDE EFFECTS: Nausea, vomiting, stomach upset, gas, shaking (tremor), lightheadedness, dizziness, or drowsiness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. To lower your risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if any of these unlikely but serious side effects occur: mental/mood changes, fainting, fast/irregular heartbeat, increased thirst/urination, hearing changes (e.g., ringing in the ears), easy bruising/bleeding, signs of infection (e.g., fever, persistent sore throat), heartburn, discomfort when swallowing, dark urine, yellowing eyes/skin, signs of kidney problems (such as change in the amount of urine), unusual tiredness. Seek immediate medical attention if any of these rare but very serious side effects occur: black stools, severe stomach/abdominal pain, vomit that looks like coffee grounds, slurred speech, weakness on one side of the body. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

PRECAUTIONS: Before taking this medication, tell your doctor or pharmacist if you are allergic to aspirin, caffeine, or butalbital; or to other barbiturates (e.g., phenobarbital), salicylates (e.g., salsalate), nonsteroidal anti-inflammatory drugs (e.g., ibuprofen), or xanthine derivatives (e.g., theophylline); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe breathing problems (e.g., bronchopneumonia), a certain enzyme disorder (porphyria), aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), severe stomach/bowel problems (e.g., stomach/intestinal ulcers), bleeding/blood clotting disorders (e.g., hemophilia, von Willebrand's disease, thrombocytopenia). Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, asthma, heartburn, gout, growths in the nose (nasal polyps), personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), certain enzyme deficiencies (pyruvate kinase or G6-PD deficiency), mental/mood disorders, heart disease (e.g., irregular heartbeat, recent heart attack). Before having surgery or certain medical procedures (such as a heart stress test or a procedure to restore a normal heart rhythm if you have an unusually fast heartbeat), tell your doctor or dentist that you use this medication and about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). This drug may make you dizzy or drowsy. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana. This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information. This medication contains aspirin. Children and teenagers less than 18 years old should not take aspirin if they have chickenpox, flu, or any undiagnosed illness, or if they have just been given a live virus vaccine, without first consulting a doctor about Reye's syndrome, a rare but serious illness. Older adults may be more sensitive to the side effects of this drug, especially drowsiness, stomach/intestinal bleeding and ulcers, and trouble falling asleep. Drowsiness and trouble falling asleep can increase the risk of falling. This medication is not recommended for use during pregnancy. Consult your doctor for more details. This drug passes into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

Interactions

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: darunavir, ketorolac, mifepristone, sodium oxybate, acetazolamide, certain drugs used to treat gout (e.g., uricosuric drugs such as probenecid, sulfinpyrazone), certain antibiotics (e.g., penicillin, sulfonamides such as sulfamethoxazole), drugs affecting liver enzymes that remove this medication from your body (such as macrolide antibiotics including erythromycin, cimetidine, disulfiram, valproic acid, MAO inhibitors including isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, safinamide, selegiline, tranylcypromine), lithium, 6-mercaptopurine, methotrexate, methoxyflurane, phenytoin. This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others. This drug can speed up the removal of other drugs from your body by affecting certain liver enzymes. These affected drugs include corticosteroids such as prednisone, estrogen, felodipine, quinidine, certain beta blockers such as metoprolol, theophylline, doxycycline. Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana, other drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine). Check the labels on all your medicines (allergy or cough-and-cold products, other headache medications) because they may contain aspirin, caffeine, or ingredients that cause drowsiness. Also keep in mind that certain beverages (e.g., coffee, colas, tea) contain caffeine. Ask your pharmacist about using those products safely. Also, check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (NSAIDs such as ibuprofen, naproxen, aspirin) that may increase your risk for side effects if taken together with this medication. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details. This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well. This medication may interfere with certain medical/laboratory tests (including fasting blood glucose, cholesterol levels, prothrombin time, urine 5-HIAA levels, urine VMA levels, certain urine glucose tests, dipyridamole-thallium imaging tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Overdose

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, slow breathing, severe dizziness, persistent nausea/vomiting, ringing in the ears.

Images

BUTALBITAL-ASA-CAFFEINE CAP

color
light green
shape
oblong
imprint
LOGO LANNETT, 1552
BUTALBITAL-ASA-CAFFEINE CAP

color
green
shape
oblong
imprint
WATSON, 3219

color
white
shape
round
imprint
P201
FIORINAL 50-325-40 MG CAPSULE

color
kelly green
shape
oblong
imprint
FIORINAL 955, FIORINAL 955

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Faq for BUTALBITAL/ASPIRIN/CAFFEINE - ORAL

Butalbital/Aspirin/Caffeine is a combination medication that contains three active ingredients: butalbital, aspirin, and caffeine. It is used to treat tension headaches and migraines.

The combination of butalbital, aspirin, and caffeine works by relaxing muscle contractions and constricting blood vessels in the brain, which helps to relieve tension headaches and migraines.

Before taking this medication, inform your doctor if you have any allergies, liver disease, bleeding disorders, stomach ulcers, a history of alcohol or drug addiction, or if you are pregnant or breastfeeding. It is important to discuss potential risks and side effects with your healthcare provider.

Follow the instructions provided by your doctor or pharmacist. Typically, this medication is taken as directed by your doctor, usually every 4 to 6 hours as needed for pain relief. Do not exceed the recommended dose or use it for a prolonged period without medical advice.

Common side effects may include dizziness, drowsiness, upset stomach, heartburn, nausea, vomiting, or rash. Seek immediate medical attention if you experience severe allergic reactions, signs of bleeding, liver problems, or unusual tiredness.

It is best to avoid consuming alcohol when taking this medication, as it may increase the risk of certain side effects and worsen drowsiness or dizziness.

Certain medications may interact with Butalbital/Aspirin/Caffeine, including blood thinners, antidepressants, anticonvulsants, sedatives, and certain herbal products. Inform your healthcare provider about all the medications and supplements you are taking to avoid potential interactions.

Butalbital, one of the active ingredients, can be habit-forming if used for a prolonged period. It is important to take this medication as prescribed and not to exceed the recommended dosage.

The onset of action varies from person to person, but it typically starts working within 30 to 60 minutes of ingestion.



Disclaimer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.