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Details for: FIORINAL

Company: ARALEZ PHARMACEUTICALS CANADA INC

DIN DIN name Active Ingredient(s) Strength Dosage Form Route of Administration
00226327FIORINALBUTALBITAL; CAFFEINE; ACETYLSALICYLIC ACID50 MG; 40 MG; 330 MGCAPSULEORAL
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Consumer Information

This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.

What the medication is used for

FIORINAL® is used for the relief of tension-type headaches.

What it does

FIORINAL® consists of acetylsalicylic acid (ASA), caffeine and butalbital. ASA reduces pain, fever and inflammation. Caffeine is a mild stimulant which may enhance pain-relieving effects. Butalbital is a sedative that causes relaxation. This combination is used to relieve tension-type headaches.

When it should not be used

You should NOT take FIORINAL® if you:

  • have a history of allergic reactions to ASA, caffeine, butalbital or any other components of the FIORINAL® capsules (see “What the nonmedicinal ingredients are”)
  • have a condition that predisposes to bleeding such as hemophilia, hyproprothrombinemia, von Willebrand’s disease, thrombocytopenia, thrombasthenia and other ill-defined hereditary platelet dysfunctions, severe vitamin K deficiency and severe liver damage
  • have nasal polyps, allergic reaction or bronchospastic reactivity to ASA or other nonsteroidal anti-inflammatory drugs (NSAIDs)
  • have stomach ulcers or other serious stomach or bowel sores
  • have a disease called porphyria
  • have a history of drug abuse or drug overdose due to alcohol, sleeping pills, drugs to treat pain or any other prescription or illegal drugs
  • are pregnant, in labour or breast-feeding.
What the medicinal ingredient is

ASA (acetylsalicylic acid), caffeine and butalbital.

What the non-medicinal ingredients are

FIORINAL® capsules contain the following non-medicinal ingredients: cornstarch, microcrystalline cellulose, stearic acid and talc.

What dosage form it comes in

FIORINAL® capsules contain 330 mg ASA, 40 mg caffeine, 50 mg butalbital.

Warnings and precautions

Keep FIORINAL® out of the reach of children. You should not give FIORINAL® to anyone as inappropriate use may have severe medical consequences.

BEFORE you use FIORINAL® talk to your doctor or pharmacist if you:

  • are allergic to ASA as it can cause anaphylactic shock and other severe allergic reactions
  • have nasal polyps or asthma
  • have a history of stomach ulcers, sores in your stomach or bowel or any other serious stomach problems
  • have a history of bleeding
  • will be having surgery
  • have severe liver or kidney disease
  • have a blood clotting disorder or are taking blood thinners
  • have recently suffered a head injury or elevated pressure in your brain
  • have problems with your thyroid gland
  • have narrowing of the urethra caused by injury or disease
  • have Addison’s disease
  • have an enlarged prostate gland
  • have softening or weakening of bones or osteoporosis
  • have any allergies to any medicines, food, dyes or preservatives
  • have the flu or chickenpox
  • are pregnant, may become pregnant, in labour or breastfeeding

FIORINAL® is a controlled medication. Butalbital is habitforming (tolerance, mental and physical dependence) and potentially abusable. Some patients, particularly those who have abused drugs in the past, may have a higher risk of abusing or developing an addiction while taking a barbiturate-containing product such as FIORINAL®. Physical dependence may lead to withdrawal side effects when you stop taking this medicine. Continuous daily use of FIORINAL® should be avoided as medication overuse (rebound) headaches may result in addition to the tolerance and dependence risks. Patients should take FIORINAL® for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.

While there are important differences between physical dependence and addiction, each is a reason for close medical supervision and honest discussions with your doctor. If you have questions or concerns about abuse, addiction or physical dependence, please tell your doctor.

ASA may increase the risk of Reye's syndrome, a rare but often fatal condition. Caution should be used in administering ASAcontaining medications to young adults who have fever, flu or chicken pox. FIORINAL® should not be administered to children

Before you have any medical tests done, tell the person in charge that you are taking FIORINAL®. ASA may interfere with the results of certain tests done in blood and urine

Driving and operating machinery

FIORINAL® may impair the mental and/or physical abilities required for performance of potentially hazardous task such as driving a car or operating machinery. If you experience drowsiness or dizziness, such tasks should be avoided. Avoid alcohol as it can increase drowsiness and dizziness.

Pregnancy, labour and breastfeeding

FIORINAL® is not recommended during pregnancy because it may cause withdrawal symptoms in the newborn baby. Taking FIORINAL® close to delivery may make delivery longer or lead to bleeding in the mother or in the newborn baby

FIORINAL® passes into breast milk and may harm a nursing infant.

Interactions with this medication

Tell your doctor or pharmacist if you are taking or have recently taken any other prescription or over-the-counter medicines, vitamins or natural health products during your treatment with FIORINAL®.

Check with your doctor or pharmacist before taking any other medication with FIORINAL®.

Tell your doctor if you are taking any of the following medications:

  • alcohol and other CNS depressants (such as sleeping pills, muscle relaxants, pain killers, allergy medication (antihistamines), drugs used to treat anxiety, panic attacks and seizures)
  • monoamine oxidase (MAO) inhibitors e.g., phenelzine sulphate, tranylcypromine sulphate, moclobemide or selegiline)
  • corticosteroids
  • oral drugs to treat diabetes and/or insulin
  • blood thinners such as warfarin
  • drugs used to suppress the immune system such as 6- mercaptopurine and methotrexate
  • NSAIDs (non-steroidal anti-inflammatory drugs) to treat pain such as ibuprofen and naproxen
  • tranquilizers such as chlordiazepoxide
  • drugs used to treat gout such as probenecid and sulfinpyrazone
  • birth control pills
Proper use of this medication

Take FIORINAL® exactly as directed by your doctor.

Usual dose

FIORINAL® comes as a capsule to take by mouth.

Adults: Take 2 capsules at once, followed if necessary, by 1 capsule every 3 to 4 hours. Do not take more than 6 capsules daily or as prescribed.

Overdose

The most important sign of overdose is decreased breathing (abnormally slow or weak breathing), dizziness, confusion or extreme drowsiness. If you accidentally take too much FIORINAL®, call your doctor and/or your local emergency number and/or a Regional Poison Control Centre immediately, or go to a hospital emergency and take any remaining tablets and the container with you, even though you may not feel sick.

Missed Dose

If you forget to take a dose of FIORINAL®, do not worry. Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for the missed one.

Side effects and what to do about them

Like all medicines, FIORINAL® may cause unwanted reactions called side effects. Not all of these side effects may occur. Check with your doctor if the unwanted effects do not go away during treatment or become bothersome

The following side effects may occur during treatment:

  • drowsiness, lightheadedness and/or dizziness
  • constipation
  • skin rash
  • small pupils
  • nausea, vomiting indigestion and/or gas
  • increased risk of infection
  • fast or irregular heart beat
  • irritability
  • tremor
  • lack of coordination
  • difficulty thinking
  • poor memory and judgement
  • decreased attention
  • mood swings
  • exaggeration of personality traits

If any of these side effects affects you severely, tell your doctor

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor or pharmacist right away Only if severe Talk with your doctor or pharmacist right away In all cases Stop taking drug and seek immediate emergency medical attention
Uncommon
Reye's syndrome: rash on the palms of hands and feet, severe vomiting, high fever, weakness, confusions, headache, fast breathing leading to unresponsiveness and death     ✔
Allergic reactions: itching, rash, hives, difficulty breathing or swallowing not present before using this medicine     ✔
Unknown
Serious skin reactions including toxic epidermal necrolysis, Stevens-Johnson syndrome erythema multiforme and exfoliative dermatitis: fever, itching, skin sores     ✔
Anemia: fatigue, breathing difficulties, irregular heart beat or pale skin ✔    
Stomach ulcer: heartburn, long lasting stomach pain, loss of appetite and weight loss   ✔  
Prolonged bleeding time ✔    
Hepatitis: loss of appetite, dark urine, yellowing of eyes and skin   ✔  
Blood in the stool   ✔  

This is not a complete list of side effects. For any unexpected effects while taking FIORINAL® , contact your doctor or pharmacist.

How to store
  • store your FIORINAL® capsules at room temperature (between 15-30°C)
  • keep out of reach and sight of children
  • discard any expired medicine or medicine no longer needed
Reporting side effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  1. Report online at www.healthcanada.gc.ca/medeffect
  2. Call toll-free at 1-866-234-2345
  3. Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa, Ontario
      K1A 0K9

    Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More information

This document plus the full product monograph, prepared for health professionals can be found at: http://www.aralez.com

or by contacting the sponsor, Aralez Pharmaceuticals Canada Inc., at: 1-866-391-4503 (toll-free)

This leaflet was prepared by Aralez Pharmaceuticals Canada Inc.

Last revised: May 17, 2018

Fiorinal® is a registered trademark of Aralez Pharmaceuticals Canada Inc.

Date modified: