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FIORINAL-C is a brand name for Aspirin (also known as Acetylsalicylic Acid), supplied as a capsule. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
• Patients who are hypersensitive to the active substances acetylsalicylic acid (ASA), caffeine, codeine or other opioid analgesics, butalbital, or to any ingredient in the formulation. For a complete listing, see the DOSAGE FORMS, COMPOSITION AND PACKAGING section of the Product Monograph.
, acute appendicitis or pancreatitis) • Patients with mild pain that can be managed with other pain medications • Patients with acute or severe bronchial asthma, chronic obstructive airway, or status asthmaticus • Patients with acute respiratory depression, elevated carbon dioxide levels in the blood and cor pulmonale • Patients with acute alcoholism, delirium tremens, and convulsive disorders • Patients with severe CNS depression, increased cerebrospinal or intracranial pressure, and head injury • Patients taking monoamine oxidase (MAO) inhibitors (or within 14 days of such therapy) • Women who are breast-feeding, pregnant or during labour and delivery (see SERIOUS WARNINGS AND PRECAUTIONS, and WARNINGS AND PRECAUTIONS).
, hemophilia, hypoprothrombinemia, von Willebrand’s disease, thrombocytopenia, thrombasthenia and other ill-defined hereditary platelet dysfunctions, severe vitamin K deficiency and severe liver damage) • Patients with the syndrome of nasal polyps, angioedema and bronchospastic reactivity to ASA or other nonsteroidal anti-inflammatory drugs.
, non-opioid analgesics) are ineffective, not tolerated, or would be otherwise inadequate to provide appropriate management of pain (see DOSAGE AND ADMINISTRATION). Addiction, Abuse, and Misuse FIORINAL®-C poses risks of opioid addiction, abuse, and misuse, which can lead to overdose and death.
Each patient’s risk should be assessed prior to prescribing FIORINAL®-C and all patients should be monitored regularly for the development of these behaviours or conditions (see WARNINGS AND PRECAUTIONS). FIORINAL®-C should be stored securely to avoid theft or misuse.
Life-threatening Respiratory Depression:
OVERDOSE Serious, life-threatening, or fatal respiratory depression may occur with use of FIORINAL®-C. Infants exposed in-utero or through breast milk are at risk of life- threatening respiratory depression upon delivery or when nursed.
Patients should be monitored for respiratory depression, especially during initiation of FIORINAL®-C or following a dose increase. FIORINAL®-C must be swallowed whole. Cutting, breaking, crushing, chewing, or dissolving FIORINAL®-C can lead to dangerous adverse events including death (see WARNINGS AND PRECAUTIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Aspirin in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Further, instruct patients of the hazards related to taking opioids including fatal overdose. Accidental Exposure Accidental ingestion of even one dose of FIORINAL®-C especially by children, can result in a fatal overdose of codeine (see DOSAGE AND ADMINISTRATION, Disposal, for instructions on proper disposal).
Neonatal Opioid Withdrawal Syndrome Prolonged maternal use of FIORINAL®-C during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening (see WARNINGS AND PRECAUTIONS). Interaction with Alcohol Page 6 of 44 The co-ingestion of alcohol with FIORINAL®-C should be avoided as it may result in dangerous additive effects, causing serious injury or death (see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS).
Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death (see WARNINGS AND PRECAUTIONS, Neurologic and DRUG INTERACTIONS).
• Reserve concomitant prescribing of FIORINAL®-C and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. • Limit dosages and durations to the minimum required. • Follow patients for signs and symptoms of respiratory depression and sedation.
General Patients should be instructed not to give FIORINAL®-C (acetylsalicylic acid-caffeine- codeine-butalbital) capsules to anyone other than the patient for whom it was prescribed, as such inappropriate use may have severe medical consequences, including death.
FIORINAL®-C should be stored securely to avoid theft or misuse. FIORINAL®-C should only be prescribed by persons knowledgeable in the continuous administration of potent opioids, in the management of patients receiving potent opioids for the treatment of pain, and in the detection and management of respiratory depression, including the use of opioid antagonists.
Patients should be cautioned not to consume alcohol while taking FIORINAL®-C as it may increase the chance of […]