Details for: TRIANAL
Company: LABORATOIRE RIVA INC.
DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
---|---|---|---|---|---|
01971409 | TRIANAL TABLET | BUTALBITAL; CAFFEINE; ACETYLSALICYLIC ACID | 50 MG; 40 MG; 330 MG | TABLET | ORAL |
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
TRIANAL TABLETS/TRIANAL CAPSULES are used for the relief of tension-type headaches.
What it does
TRIANAL TABLETS/TRIANAL CAPSULES consist 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 TRIANAL TABLETS/TRIANAL CAPSULES if you:
- have a history of allergic reactions to ASA, caffeine, butalbital or any other components of the TRIANAL TABLETS/TRIANAL CAPSULES (see “What the nonmedicinal ingredients are”)
- have a condition that predisposes to bleeding such as hemophilia, hypoprothrombinemia, 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
TRIANAL TABLETS contain following non-medicinal ingredients: Croscarmellose sodium, Microcrystalline cellulose, Sodium lauryl sulphate and Stearic acid.
TRIANAL CAPSULES contain following non-medicinal ingredients: Brilliant Blue FCF sodium salt (FD&C Blue No. 1), Croscarmellose sodium, Erythrosine (FD&C Red No. 3), Gelatin, Microcrystalline cellulose, Stearic acid and Titanium dioxide. The imprinting ink contains: Ammonium hydroxide, Butyl alcohol, Ethanol, Isopropyl alcohol, Propylene glycol, Shellac, Simethicone and Titanium dioxide.
What dosage form it comes in
TRIANAL TABLETS/TRIANAL CAPSULES contain 330 mg ASA, 40 mg caffeine, 50 mg butalbital.
Warnings and precautions
Keep TRIANAL TABLETS/TRIANAL CAPSULES out of the reach of children. You should not give TRIANAL TABLETS/TRIANAL CAPSULES to anyone as inappropriate use may have severe medical consequences.
BEFORE you use TRIANAL TABLETS/TRIANAL CAPSULES 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.
TRIANAL TABLETS/TRIANAL CAPSULES are controlled medications. Butalbital is habit forming (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 TRIANAL TABLETS/TRIANAL CAPSULES. Physical dependence may lead to withdrawal side effects when you stop taking this medicine. Continuous daily use of TRIANAL TABLETS/TRIANAL CAPSULES should be avoided as medication overuse (rebound) headaches may result in addition to the tolerance and dependence risks. Patients should take TRIANAL TABLETS/TRIANAL CAPSULES 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 ASA containing medications to young adults who have fever, flu or chicken pox. TRIANAL TABLETS/TRIANAL CAPSULES should not be administered to children. Before you have any medical tests done, tell the person in charge that you are taking TRIANAL TABLETS/TRIANAL CAPSULES. ASA may interfere with the results of certain tests done in blood and urine.
Driving and operating machinery
TRIANAL TABLETS/TRIANAL CAPSULES 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
TRIANAL TABLETS/TRIANAL CAPSULES are not recommended during pregnancy because they may cause withdrawal symptoms in the newborn baby. Taking TRIANAL TABLETS/TRIANAL CAPSULES close to delivery may make delivery longer or lead to bleeding in the mother or in the newborn baby. TRIANAL TABLETS/TRIANAL CAPSULES pass 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 TRIANAL TABLETS/TRIANAL CAPSULES.
Check with your doctor or pharmacist before taking any other medication with TRIANAL TABLETS/TRIANAL CAPSULES.
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 TRIANAL TABLETS/TRIANAL CAPSULES exactly as directed by your doctor.
Usual dose
TRIANAL TABLETS/TRIANAL CAPSULES comes as a tablet/capsule to take by mouth.
Dosage: Adult: 1 or 2 tablets/capsules followed by 1 tablet/capsule every 3 to 4 hours, if needed.
Maximum daily dose: 6 tablets/capsules daily, or as prescribed by the physician.
Overdose
Missed Dose
If you forget to take a dose of TRIANAL TABLETS/TRIANAL CAPSULES, 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, TRIANAL TABLETS/TRIANAL CAPSULES 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, light-headedness 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.
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 | ✔ | ||
Unkowon | |||
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 TRIANAL TABLETS/TRIANAL CAPSULES, contact your doctor or pharmacist.
How to store
- store your TRIANAL TABLETS/TRIANAL 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 side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. 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.labriva.com or by contacting the sponsor, Laboratoire Riva Inc., at:
1-800-363-7988
This leaflet was prepared by Laboratoire Riva Inc.
Last revised: June 30, 2017