Trianal C½: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What are TRIANAL C¼ and TRIANAL C½ used for?

TRIANAL C¼ and TRIANAL C½, are used in adults for the relief of tension-type headache.

TRIANAL C¼ and TRIANAL C½ are recommended for adults 18 years and older.

How do TRIANAL C¼ and TRIANAL C½ work?

TRIANAL C¼ and TRIANAL C½ consist of acetylsalicylic acid, caffeine, codeine and butalbital. Acetylsalicylic acid reduces pain, fever and inflammation. Caffeine is a mild stimulant which may enhance pain-relieving effects. Codeine is an opioid that relieves pain by acting on specific nerve cells of the spinal cord and brain. Butalbital is a sedative that causes relaxation. This combination is used to relieve tension-type headaches.

What are the ingredients in TRIANAL C¼ and TRIANAL C½?

Medicinal ingredients: Butalbital, Acetylsalicylic Acid, Caffeine and Codeine Phosphate.

Non-medicinal ingredients:

TRIANAL C¼ capsules contain the following non-medicinal ingredients: Brilliant Blue FCF sodium salt (FD&C Blue No. 1), Corn starch, Croscarmellose sodium, Erythrosine (FD&C Red No. 3), Gelatin, Microcrystalline cellulose, Stearic acid and Titanium dioxide. The imprinting ink contains: Butyl alcohol, Concentrated ammonia solution, Ethanol, Iron oxide black, Isopropyl alcohol, Potassium hydroxide, Propylene glycol, Purified water and Shellac.

TRIANAL C½ capsules contain the following non-medicinal ingredients: Brilliant Blue FCF sodium salt (FD&C Blue No. 1), Corn starch, Croscarmellose sodium, Erythrosine (FD&C Red No. 3), Gelatin, Microcrystalline cellulose, Stearic acid and Titanium dioxide. The imprinting ink contains: Allura Red AC (FD&C Red No.40) Aluminum Lake, Brilliant Blue FCF (FD&C Blue No. 1) Aluminum Lake, Denatured alcohol, Ethanol, Indigo Carmine (FD&C Blue No.2) Aluminum Lake, Iron oxide black, Quinoline Yellow WS (FD&C Yellow No.10) Aluminum Lake and Shellac.

TRIANAL C¼ and TRIANAL C½ come in the following dosage forms:

TRIANAL C¼: Light blue opaque cap and white opaque body hard gelatin capsule, printed in black “TRIANAL C1/4” on cap and with 3 “T” ‘s in their own triangle on body capsules containing 50 mg butalbital, 330 mg acetylsalicylic acid, 40 mg caffeine and 15 mg codeine phosphate.

TRIANAL C½: Light blue opaque cap and powder blue opaque body hard gelatin capsule, printed in black “TRIANAL C1/2” on cap and with 3 “T” ‘s in their own triangle on body capsules containing 50 mg butalbital, 330 mg acetylsalicylic acid, 40 mg caffeine and 30 mg codeine phosphate.

Do not use TRIANAL C¼ and TRIANAL C½ if:

• your doctor did not prescribe it for you
• you are allergic to butalbital, acetylsalicylic acid, caffeine, codeine, or any of the other ingredients in TRIANAL C¼ and TRIANAL C½ capsules (see What are the ingredients in TRIANAL C¼ and TRIANAL C½?)
• you can control your pain by the occasional use of other pain medications. This includes those available without a prescription
• you have severe asthma, trouble breathing, or other breathing problems
• you have any heart problems
• you have bowel blockage or narrowing of the stomach or intestines
• you have severe pain in your abdomen
• you have a head injury
• you are at risk for seizures
• you suffer from alcoholism
• you are taking or have taken within the past 2 weeks a Monoamine Oxidase inhibitor (MAOi) (such as phenelzine sulphate, tranylcypromine sulphate, moclobemide or selegiline)
• you are going to have, or recently had, a planned surgery
• you are pregnant, planning to become pregnant or you are in labour
• you are breastfeeding. The use of codeine-containing products while breast-feeding may harm your baby. If you breastfeed and take TRIANAL C¼ and TRIANAL C½, seek immediate medical care for your baby if they are overly drowsy, sedated, have difficulty breast-feeding, have breathing difficulties, and are floppy (have decreased muscle tone). This is very serious for the baby and can lead to death. Tell the baby’s doctor that you are breastfeeding and took TRIANAL C¼ and TRIANAL C½.
• you are under 12 years old
• you are less than 18 years old and are having (or have recently had) your tonsils or adenoids removed because of frequent interruption of breathing during sleep
• 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 acetylsalicylic acid 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
• have pneumonia (a lung infection)
• have been told by your doctor that you break down codeine rapidly. This can lead to codeine overdose even at the usual adult dose.

• TRIANAL C¼ and TRIANAL C½ are not recommended in children less than 18 years old.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TRIANAL C¼ and TRIANAL C½. Talk about any health conditions or problems you may have, including if you:

• have a history of illicit or prescription drug or alcohol abuse
• have severe kidney, liver or lung disease
• have heart disease
• have low blood pressure
• have past or current depression
• suffer from chronic or severe constipation
• are allergic to acetylsalicylic acid as it can cause anaphylactic shock and other severe allergic reactions
• have nasal polyps or asthma
• have a history of blocked bowels, stomach ulcers, sores in your stomach or bowel or any other serious stomach problems
• have a history of bleeding
• will be having surgery
• 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
• suffer from migraines
• are pregnant, planning on becoming or become pregnant while taking TRIANAL C¼ and TRIANAL C½
• have reacted strongly to other codeine-containing drugs in the past (i.e. got sleepy, confused and/or had trouble breathing) even when taking the dose recommended by your doctor.

Other warnings you should know about:

TRIANAL C¼ and TRIANAL C½ are not recommended for anyone who has or is at risk for breathing problems such as:

• lung infections, or respiratory conditions
• neuromuscular disorders
• severe heart problems
• recent multiple traumas or extensive surgical procedures

Sleep Apnea: the codeine in TRIANAL C¼ and TRIANAL C½can cause a problem called sleep apnea (stopping breathing from time to time while sleeping). Tell your healthcare professional if you have a history of sleep apnea or if anyone notices that you stop breathing from time to time while sleeping.

Serious Skin Reactions: In rare cases, serious or life-threatening skin reactions listed below have been reported with some NSAIDs, such as TRIANAL C¼ and TRIANAL C½.

• Drug reaction with eosinophilia and systemic symptoms (DRESS)
• Stevens-Johnson syndrome (SJS),
• toxic epidermal necrolysis (TEN),
• exfoliative dermatitis and
• erythema multiforme

You may be at a greater risk of experiencing a serious skin reaction usually during the first month of treatment. See the Serious side effects and what to do about them table, below, for more information on these and other serious side effects.

Some people metabolize codeine at a much faster rate than the general population, which may lead to accidental overdose, if this should happen to you, seek help immediately (see Overdose, for symptoms of overdose and what to do if it happens). If you know that you metabolize codeine rapidly, tell your doctor BEFORE starting this medication.

Opioid dependence and addiction: There are important differences between physical dependence and addiction. It is important that you talk to your doctor if you have questions or concerns about abuse, addiction or physical dependence.

TRIANAL C¼ and TRIANAL C½ are controlled medication. Butalbital and codeine are both 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 barbiturate- or opioid-containing products, such as TRIANAL C¼ and TRIANAL C½. Physical dependence may lead to withdrawal side effects when you stop taking this medicine. Continuous daily use of TRIANAL C¼ and TRIANAL C½ should be avoided as medication overuse (rebound) headaches may result in addition to the tolerance and dependence risks. Patients should take TRIANAL C¼ and TRIANAL C½ only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.

Reye's syndrome: Acetylsalicylic acid may increase the risk of Reye's syndrome, a rare but often fatal condition. Caution should be used in administering acetylsalicylic acid -containing medications to young adults who have fever, flu or chicken pox. TRIANAL C¼ and TRIANAL C½ should not be administered to children.

Medical tests: Before you have any medical tests done, tell the person in charge that you are taking TRIANAL C¼ and TRIANAL C½. Acetylsalicylic acid and codeine may interfere with the results of certain tests done in blood and urine.

Testing and check-ups: Your healthcare professional will regularly monitor your health. This includes monitoring for signs of:

• misuse and abuse;
• sleep apnea (a sleep disorder which causes pauses in breathing or shallow breathing while sleeping);
• respiratory depression and sedation (e.g., slow, shallow, or weak breathing).

Pregnancy, nursing, labour and delivery: Do not use TRIANAL C¼ and TRIANAL C½ while pregnant, nursing, during labour or delivery. Opioids can be transferred to your baby through breast milk, or while still in the womb. TRIANAL C¼ and TRIANAL C½ can then cause life-threatening breathing problems in your unborn baby or nursing infant.

Driving and using machines: Before you do tasks which may require special attention, you should wait until you know how you react to TRIANAL C¼ and TRIANAL C½. TRIANAL C¼ and TRIANAL C½ can cause:

• drowsiness
• dizziness or
• lightheadedness

This can usually occur after you take your first dose and when your dose is increased.

Disorder of the adrenal gland: You may develop a disorder of the adrenal gland called adrenal insufficiency. This means that your adrenal gland is not making enough of certain hormones.

You may experience symptoms such as:

• nausea, vomiting
• feeling tired, weak or dizzy
• decreased appetite

You may be more likely to have problems with your adrenal gland if you have been taking opioids for longer than one month. Your doctor may do tests, give you another medication, and slowly take you off TRIANAL C¼ and TRIANAL C½.

Serotonin Toxicity or Serotonin Syndrome: TRIANAL C¼ and TRIANAL C½ can cause serotonin toxicity, also known as Serotonin Syndrome, a rare but potentially life-threatening condition. It can cause serious changes in how your brain, muscles and digestive system work.

You may develop Serotonin Syndrome if you take TRIANAL C¼ and TRIANAL C½ with certain anti-depressants or migraine medications.

Serotonin Syndrome symptoms include:

• fever, sweating, shivering, diarrhea, nausea, vomiting;
• muscle shakes, jerks, twitches or stiffness, overactive reflexes, loss of coordination;
• fast heartbeat, changes in blood pressure;
• confusion, agitation, restlessness, hallucinations, mood changes, unconsciousness, and coma.

Sexual Function/Reproduction: Long term use of opioids may lead to a decrease in sex hormone levels. It may also lead to low libido (desire to have sex), erectile dysfunction or being infertile.

Worsened Pain: Taking opioids for pain can sometimes have the unintended effect of making your pain feel worse (opioid-induced hyperalgesia), even though your opioid dose has been unchanged or increased. This can also include feeling pain in new places in your body, or feeling pain from something that would not normally hurt, for example, feeling pain from clothing touching your skin. Tell your doctor if you notice a change like this in your pain while you are taking TRIANAL C¼ and TRIANAL C½.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with TRIANAL C¼ and TRIANAL C½:

• Alcohol. This includes prescription and non-prescription medications that contain alcohol. Do not drink alcohol while you are taking TRIANAL C¼ and TRIANAL C½. It can lead to:

  • drowsiness
  • unusually slow or weak breathing
  • serious side effects or
  • a fatal overdose
  • other sedative drugs which may enhance the drowsiness caused by TRIANAL C¼ and TRIANAL C½
  • other opioid analgesics (drugs used to treat pain)
  • general anesthetics (drugs used during surgery)
  • benzodiazepines (drugs used to help you sleep or that help reduce anxiety)
  • antidepressants (for depression and mood disorders). Do not take TRIANAL C¼ and TRIANAL C½ with MAO inhibitors (MAOi) or if you have taken MAOi’s in the last 14 days.
  • triptans used to treat migraines (e.g. oxitriptan)
  • drugs used to treat serious mental or emotional disorders (such as schizophrenia)
  • antihistamines (drugs used to treat allergies)
  • anti-emetics (drugs used for the prevention of vomiting)
  • drugs used to treat muscle spasms and back pain
  • some heart medications (such as beta blockers)
  • St. John’s Wort
  • warfarin (such as Coumadin^®) and other anticoagulants (used for prevention or treatment of blood clots)
  • drugs used to treat panic attacks and seizures
  • corticosteroids
  • oral drugs to treat diabetes and/or insulin
  • 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
  • drugs used to treat gout such as probenecid and sulfinpyrazone
  • birth control pills

How to take TRIANAL C¼ and TRIANAL C½:

Swallow whole. Do not cut, break, crush, chew or dissolve the capsules. This can be dangerous and can lead to death or seriously harm you.

Usual Adult Starting Dose:

Your dose is tailored/personalized just for you. Be sure to follow your doctor’s dosing instructions exactly. Do not increase or decrease your dose without consulting your doctor.

Your doctor will prescribe the lowest effective dose for the shortest period of time that works to control your pain. It is recommended that you only take TRIANAL C¼ and TRIANAL C½ for up to 3 days. If you need to take TRIANAL C¼ and TRIANAL C½ for longer, your doctor will determine the best dose for you to lower the risk of side effects and overdose. Higher doses can lead to more side effects and a greater chance of overdose.

Take 1 or 2 capsules at once with a glass of water, followed if necessary, by 1 capsule every 4 to 6 hours. Do not take more than 6 capsules daily or as prescribed.

TRIANAL C¼ and TRIANAL C½ come as a capsule to take by mouth.

Review your pain regularly with your doctor to determine if you still need TRIANAL C¼ and TRIANAL C½. Be sure to use TRIANAL C¼ and TRIANAL C½ only for the condition for which it was prescribed.

Let your doctor know rapidly if no effective pain relief is achieved after 3 days of treatment.

If your pain increases or you develop any side effect as a result of taking TRIANAL C¼ and TRIANAL C½, tell your doctor immediately.

Stopping your Medication

If you have been taking TRIANAL C¼ and TRIANAL C½ for more than a few days you should not stop taking it all of a sudden. Your doctor will monitor and guide you on how to slowly stop taking TRIANAL C¼ and TRIANAL C½. You should do it slowly to avoid uncomfortable symptoms such as having:

• body aches
• diarrhea
• goosebumps
• loss of appetite
• nausea
• feeling nervous or restless
• runny nose
• sneezing
• tremors or shivering
• stomach cramps
• rapid heart rate (tachycardia)
• having trouble sleeping
• an unusual increase in sweating
• heart palpitations
• an unexplained fever
• weakness
• yawning

By reducing or stopping your opioid treatment, your body will become less used to opioids. If you start treatment again, you will need to start at the lowest dose. You may overdose if you restart at the last dose you took before you slowly stopped taking TRIANAL C¼ and TRIANAL C½.

Refilling your Prescription for TRIANAL C¼ and TRIANAL C½:

A new written prescription is required from your doctor each time you need more TRIANAL C¼ and TRIANAL C½. Therefore, it is important that you contact your doctor before your current supply runs out.

Only obtain prescriptions for this medicine from the doctor in charge of your treatment. Do not seek prescriptions from other doctors unless you switch to another doctor for your tension headaches.

Overdose:

Signs of overdose may include:

• unusually slow or weak breathing
• dizziness
• confusion
• extreme drowsiness

Missed Dose:

If you miss one dose, take it as soon as possible. However, if it is almost time for your next dose, then skip the missed dose. Do not take two doses at once. If you miss several doses in a row , talk to your doctor before restarting your medication.

What are possible side effects from using TRIANAL C¼ and TRIANAL C½?

These are not all the possible side effects you may feel when taking TRIANAL C¼ and TRIANAL C½. If you experience any side effects not listed here, contact your healthcare professional.

Side effects may include:

• Drowsiness
• Lightheadedness
• Insomnia
• Dizziness
• Fainting
• Nausea, vomiting, or a poor appetite
• Indigestion and/or stomach pain
• Dry mouth
• Headache
• Difficulty thinking
• Poor memory and judgement
• Decreased attention
• Problems with vision
• Small pupils
• Fast or irregular heart beat
• Irritability
• Mood swings, exaggeration of personality traits
• Weakness, uncoordinated muscle movement
• Tremor
• Skin rash and itching
• Sweating
• Constipation and gas
• Low sex drive, impotence (erectile dysfunction), infertility

Talk with your doctor or pharmacist about ways to prevent constipation when you start using TRIANAL C¼ and TRIANAL C½.

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.

Reporting Side Effects

Storage:

• Keep unused or expired TRIANAL C¼ and TRIANAL C½ in a secure place to prevent theft, misuse or accidental exposure.
• Store your TRIANAL C¼ and TRIANAL C½ capsules at room temperature (between 15-30°C).
• Keep TRIANAL C¼ and TRIANAL C½ under lock, out of sight and reach of children and pets.
• Never take medicine in front of small children as they will want to copy you. Accidental ingestion by a child is dangerous and may result in death. If a child accidentally takes TRIANAL C¼ and TRIANAL C½, get emergency help right away.

Disposal:

TRIANAL C¼ and TRIANAL C½ should never be thrown into household trash, where children and pets may find it. It should be returned to a pharmacy for proper disposal.

If you want more information about TRIANAL C¼ and TRIANAL C½:

• Talk to your healthcare professional.
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (www.labriva.com), or by calling 1-800-363-7988.

Laboratoire Riva Inc.

660 Boul. Industriel

Blainville, Quebec

J7C 3V4

www.labriva.com

Last revised: APR 25, 2024