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The following information outlines essential safety considerations and warnings related to the use of this medication. It is crucial to understand these details to minimize potential risks. If you have any concerns, please consult your healthcare provider.

• Stomach Bleeding and Ulcers: The aspirin in Fiorinal can cause irritation leading to stomach issues like pain or heartburn, potentially resulting in serious complications such as bleeding or ulcers. Seek immediate medical attention if you experience persistent stomach pain, vomit blood, or have black, tarry stools. Risks include being over 65, having a history of stomach issues or conditions that cause bleeding, and consuming three or more alcoholic drinks daily.

• Kidney Problems: High doses of aspirin in Fiorinal can increase the risk of kidney damage, especially if used with certain medications like ACE inhibitors and diuretics. Stop using Fiorinal and contact your prescriber if you notice reduced urination, muscle weakness, numbness in limbs, or a rapid heartbeat. Risks are higher for those with a history of kidney or liver issues, heart failure, long-term use of Fiorinal, or taking certain blood pressure medications.

• Reye's Syndrome in Children: Fiorinal is not approved for children. Aspirin use in children recovering from viral infections can lead to Reye's syndrome, a rare but serious condition. Symptoms include vomiting, headache, confusion, and behavioral changes. Consult a healthcare professional for headache treatment in children. Risks are particularly high for children under 18 recovering from chickenpox or flu-like symptoms.

• Difficulty Concentrating and Extreme Sleepiness: The butalbital in Fiorinal may cause drowsiness and impaired concentration, especially when combined with alcohol or other sedative medications. Avoid driving or engaging in activities requiring focus until you know how Fiorinal affects you. Contact your healthcare provider if you experience excessive drowsiness. Risks are greater for individuals over 65, those taking higher doses, or consuming alcohol.

• Potential for Misuse, Dependence, and Withdrawal: Butalbital in Fiorinal has a misuse potential, which can lead to overdose. Seek emergency help if you experience extreme drowsiness, breathing difficulties, dizziness, confusion, or unconsciousness. Risks increase with prolonged use, higher doses, or more frequent use than prescribed.

• Severe Allergic Reactions and Skin Reactions: Severe allergic reactions, including anaphylaxis, can occur. Notify your prescriber of any aspirin or NSAID allergies before starting Fiorinal. Call emergency services if you experience hives, breathing trouble, or facial swelling.

Contraindications: Certain conditions contraindicate the use of this medication. Consult your healthcare provider if you have:

• Nasal polyps
• Stomach ulcers or sores
• Blood disorders
• Porphyria
• Severe allergy to aspirin or other NSAIDs

Consult your healthcare provider to ensure this medication is safe for you based on your health history and current medications.

Common side effects:

• Sleepiness
• Dizziness
• Lightheadedness
• Nausea
• Vomiting
• Passing gas

Serious side effects:

• Signs of a stomach bleed (feeling faint or dizzy, long-lasting stomach pain, blood in vomit or stools)
• Symptoms indicating an overdose (extreme sleepiness, slow breathing, confusion)
• Withdrawal symptoms (seizures, restlessness, trouble sleeping)
• Serious allergic reactions (difficulty breathing, hives, severe skin reactions)