Trintellix: Uses, Side Effects and Dosage

Serious warnings and precautions box

What TRINTELLIX is used for:

TRINTELLIX is used for the treatment of depression in adults (18 years of age or older). It is used to relieve the symptoms of depression, which may include:

• feeling sad, restless, irritable, tired
• a change in weight or appetite
• difficulty concentrating or sleeping
• headaches
• unexplained aches and pains.

Self-harm or suicide:

• Antidepressants, such as TRINTELLIX, may increase the risk of suicidal thoughts and actions in some children, teenagers, or young adults at the beginning of treatment, or when the dose is changed. TRINTELLIX is not approved for use in children and teenagers.
• If you have thought of harming or killing yourself at any time, tell your healthcare professional or go to a hospital right away. Close observation by a healthcare professional is necessary in this situation.

New or worsened emotional or behaviour problems:

• When you first start taking TRINTELLIX or when your dose is adjusted, you may feel worse instead of better. You may feel new or worsened feelings of agitation, hostility, anxiety, or impulsivity.
• During your treatment with TRINTELLIX, it is important that you and your healthcare professional talk regularly about how you are feeling. They will closely monitor you for signs of new or worsened emotions or behaviours while you are taking TRINTELLIX.

• You may find it helpful to tell a relative or close friend that you are depressed. Ask them to read this leaflet. You might ask them to tell you if they:

  • think your depression is getting worse, or
  • are worried about changes in your behaviour.
• If your depression worsens or you experience changes in your behaviour, tell your healthcare professional right away. Do not stop taking TRINTELLIX on your own.

How TRINTELLIX works:

TRINTELLIX belongs to a group of medicines called antidepressants. It is thought to work by correcting the imbalance of a chemical in the brain called serotonin. This may help to relieve your symptoms of depression.

The ingredients in TRINTELLIX are:

Medicinal ingredient: Vortioxetine hydrobromide

Non-medicinal ingredients: Hydroxypropyl cellulose, hypromellose, iron oxide red (5 mg, 15 mg and 20 mg) and/or iron oxide yellow (10 mg and 15 mg), Macrogol 400, magnesium stearate, mannitol, microcrystalline cellulose, sodium starch glycolate (type A), and titanium dioxide (E 171).

TRINTELLIX comes in the following dosage form:

Tablets: 5 mg (pink), 10 mg (yellow), 15 mg (orange), and 20 mg (red) vortioxetine (as vortioxetine hydrobromide).

Do not use TRINTELLIX if:

• you are allergic to vortioxetine hydrobromide or to any of the other ingredients in TRINTELLIX.
• you are taking or have recently taken in the last 14 days Monoamine Oxidase Inhibitors (MAOIs) such as phenelzine sulfate, tranylcypromine, moclobemide, linezolid, methylene blue, rasagiline, and selegiline. Ask your healthcare professional if you are not sure.

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

• have ever had any allergic reaction to medications, food, etc.;
• have or have had a seizure disorder;
• have liver or kidney problems;
• have or have had glaucoma or increased pressure in your eyes;
• have or have had manic episodes or have been diagnosed with bipolar disorder;
• are pregnant, think you might be pregnant or are planning to become pregnant;
• are breast-feeding or are planning to breast-feed;
• have a bleeding disorder or have been told that you have low blood platelets;
• have been told you have or take medications known to cause low sodium levels in your blood;
• take certain medicines that can affect blood clotting and increase bleeding, such as oral anticoagulants (e.g., warfarin), acetylsalicylic acid (ASA) and other non-steroidal anti-inflammatory drugs (NSAIDs);
• had a recent bone fracture or were told you have osteoporosis (weak or brittle bones) or risk factors for osteoporosis;
• have a history of illicit or prescription drug abuse;
• are receiving Electroconvulsive Therapy (ECT).

Other warnings you should know about:

TRINTELLIX should not be used in children and adolescents under 18 years of age.

Discontinuation symptoms: Abruptly stopping your treatment with TRINTELLIX or missing a dose may cause you to experience discontinuation symptoms. This may occur within the first or second week. Contact your healthcare professional before stopping or reducing your dose of TRINTELLIX. If your healthcare professional recommends that you stop taking TRINTELLIX, they will gradually lower your dose. This may help manage any symptoms of discontinuation, such as:

• dizziness
• headaches
• sensory disturbances (like pins and needles or electric shock sensations)
• nausea, vomiting
• sweating
• agitation, irritability, anxiety, confusion, mood swings, emotional indifference
• lack of energy, reduced mental alertness
• sleep disturbances (like trouble falling or staying asleep, abnormal dreams)
• tremor (shakiness)
• tinnitus (ringing in the ears)
• seizures (fits)

Tell your healthcare professional immediately if you have these or any other symptoms during this time. Your healthcare professional may adjust your dose of TRINTELLIX to reduce the symptoms.

Pregnancy: You should not take TRINTELLIX if you are pregnant unless you and your healthcare professional have discussed the risks and decided that you should take it. If you take TRINTELLIX near the end of your pregnancy, you may be at a higher risk of vaginal bleeding after childbirth that exceeds normal postpartum levels. If you become pregnant while taking TRINTELLIX, do NOT stop taking TRINTELLIX without first talking to your healthcare professional.

Effects on newborns: Some newborn babies whose mothers took medications such as TRINTELLIX during pregnancy have developed problems at birth. These problems include prolonged hospitalisation, breathing support and tube feeding. Symptoms can include:

• feeding and/or breathing difficulties
• bluish skin
• seizures (fits)
• body temperature changes
• vomiting
• low blood sugar
• tense or overly relaxed muscles
• vivid reflexes
• tremor (shaking)
• jitteriness
• irritability
• sleeping difficulties and constant crying.

In most cases, these medications were taken during the third trimester of pregnancy. These symptoms are caused by the medication itself or from the effects of suddenly stopping the medication. These symptoms normally go away over time. However, if your baby experiences any of these symptoms, contact your healthcare professional as soon as you can.

Persistent Pulmonary Hypertension of the Newborn (PPHN): If you take TRINTELLIX towards the end of your pregnancy, your newborn may be at risk of having a serious lung condition called Persistent Pulmonary Hypertension of the Newborn (PPHN). This causes breathing problems in newborns soon after birth. Newborn babies may breathe faster and appear bluish. These symptoms usually begin during the first 24 hours after the baby is born. If this happens to your newborn baby, get immediate medical help for them.

Breast-feeding: TRINTELLIX can pass into breast milk in small amounts. TRINTELLIX is not recommended during breast-feeding. You should not breastfeed a baby if you are taking TRINTELLIX unless you and your healthcare professional have discussed the risks and decided that you should.

Effects on sexual function: Taking medicines like TRINTELLIX may increase your risk of having sexual problems. This may continue after TRINTELLIX has been discontinued, including for months or years afterwards in some cases. Tell your healthcare professional if you experience symptoms such as a decrease in sexual desire, performance or satisfaction.

Bleeding problems: Medications from the class that TRINTELLIX belongs to may increase the chance of a bleeding event such as nose bleeds, bruising and even life-threatening bleeding. This is more likely if you have a history of a bleeding disorder or are taking other medications that are known to affect blood clotting. Talk to your healthcare professional about medications that might increase bleeding.

Falls and fractures: Taking TRINTELLIX may increase your risk of breaking a bone if you are elderly or have osteoporosis or have other major risk factors for breaking a bone. You should take extra care to avoid falls, especially if you get dizzy or have low blood pressure.

Serotonin Toxicity (also known as Serotonin Syndrome) or Neuroleptic Malignant Syndrome: TRINTELLIX can cause Serotonin toxicity or Neuroleptic Malignant Syndrome, rare but potentially life-threatening conditions. They can cause serious changes in how your brain, muscles and digestive system work. You may develop Serotonin toxicity or Neuroleptic Malignant Syndrome if you take TRINTELLIX with certain medications used to treat depression, migraine or other mental health problems such as schizophrenia.

Serotonin toxicity or Neuroleptic Malignant 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.

Angle-closure glaucoma (eye pain caused by increased pressure in the eyes): TRINTELLIX can cause dilation of the pupil. This can cause an acute attack of glaucoma. Having your eyes examined before you take TRINTELLIX could help identify if you are at risk of having angle-closure glaucoma. Get immediate medical help if you experience:

• eye pain;
• changes in vision;
• swelling or redness in or around the eye.

Activation of mania: Antidepressants, such as TRINTELLIX, may trigger manic episodes in patients with a history of manic episodes or bipolar disorder during the depressed state of their illness.

Misuse: If you have a history of illicit or prescription drug abuse, your healthcare professional may regularly monitor you for signs of misuse and abuse during your treatment with TRINTELLIX.

Driving and using machines: TRINTELLIX may impair your ability to drive or use machinery, especially when you first start taking TRINTELLIX or when you are prescribed a higher dose. Do not drive or use machinery until you know how TRINTELLIX affects you.

Laboratory drug testing: If you take a urine drug screening test, TRINTELLIX may give a positive test result for methadone. Tell the laboratory technician that you are taking TRINTELLIX. They can do a more specific drug screening test for you.

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

Serious drug interactions

Serious drug interactions with TRINTELLIX include:

• Monoamine Oxidase Inhibitors (MAOIs) such as phenelzine sulfate, tranylcypromine, moclobemide, rasagiline, selegiline, linezolid, or methylene blue. Do not use TRINTELLIX if you are taking a MAOI, or have recently taken one in the last 14 days. You will need to wait at least 21 days after you stop taking TRINTELLIX before you can start taking a MAOI. Taking MAOIs can increase your chances of having serious side effects.

The following may also interact with TRINTELLIX:

• other antidepressants, such as Selective Serotonin Reuptake Inhibitors (SSRIs) (e.g., fluoxetine, paroxetine), Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) (e.g., venlafaxine), certain tricyclics (e.g., amitriptyline, desipramine).
• other medicines that affect serotonin such as medicines used to treat schizophrenia, lithium used to treat manic episodes in bipolar disorder, dextromethorphan used to relieve cough, triptans used to treat migraines, opioids used to relieve pain (e.g., tramadol, fentanyl, tapentadol, meperidine, methadone, pentazocine), medicines containing tryptophan, St. John’s Wort (a herbal remedy).
• medicines that can affect blood clotting and increase bleeding, such as oral anticoagulants (e.g., warfarin), acetylsalicylic acid (ASA) and other non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., ibuprofen).
• medicines that can increase the risk of seizures by lowering your seizure threshold such as antidepressants (e.g., tricyclics, SSRIs, SNRIs), medicines used to treat mental disorders (belonging to the groups called phenothiazines, thioxanthenes, butyrophenones), mefloquin used to prevent and treat malaria, bupropion used to treat depression and wean from smoking, tramadol used to relieve pain.
• medicines used to treat heart rhythm disorders such as quinidine, amiodarone.
• medicines used to treat fungal or bacterial infections such as itraconazole, ketoconazole, voriconazole, fluconazole, clarithromycin, telithromycin, rifampicin.
• medicines used to treat HIV infection.
• medicines used to treat seizures such as carbamazepine, phenytoin.
• diuretics, used to get rid of extra fluid from the body (also known as “water pills”).
• cinacalcet, used to treat high parathyroid hormone levels.
• alcohol. It is recommended to avoid drinking alcohol while taking TRINTELLIX.

How to take TRINTELLIX:

• Take TRINTELLIX exactly as your healthcare professional has told you.

• Take TRINTELLIX once a day with a glass of water, with or without food.

• Keep taking TRINTELLIX for as long as your healthcare professional recommends. Do not suddenly stop taking or change your dose without talking to your healthcare professional first. Suddenly stopping treatment or changing your dose may cause unpleasant side effects.

Usual dose:

• 18 to 64 years of age: the usual dose is 10 mg once a day. Based on how you respond and your tolerability, your healthcare professional may increase or decrease your dose.
• 65 years of age and over: The usual starting dose is 5 mg once a day.

Overdose:

Signs of an overdose with TRINTELLIX may include:

• Dizziness
• Nausea or vomiting
• Diarrhea and stomach discomfort
• Itching all over your body
• Sleepiness
• Reddening of the skin
• Seizures (fits)
• Serotonin toxicity, which is a serious condition that can be life-threatening. See the Serious side effects and what to do about them table for more details.

Missed dose:

If you missed a dose of this medication, you do not need to make up the missed dose. Skip the missed dose and continue with your next scheduled dose. Do not take two doses at the same time.

Possible side effects from using TRINTELLIX:

These are not all the possible side effects you may feel when taking TRINTELLIX. If you experience any side effects not listed here, tell your healthcare professional.

Side effects with TRINTELLIX may include:

• Abdominal pain, bloating
• Common cold, influenza (flu) symptoms
• Nausea, vomiting
• Decreased appetite
• Abnormal dreams, difficulty sleeping
• Dizziness
• Dry Mouth
• Diarrhea, constipation
• Fatigue, sleepiness
• Sedation (feeling calm)

If you think you, or a person you are caring for, have taken too much TRINTELLIX, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

• Itching all over your body
• Joint and muscle pain
• Increased sweating, abnormal excessive sweating
• Cough
• Dry eye
• Teeth grinding
• Headache
• Reddening of the skin
• Night sweats
• Weight gain
• Muscle twitching
• Yawning
• Dehydration
• Late menstrual cycle (period), sensitive breasts
• sexual problems (decreases in sexual desire, performance and satisfaction, which may continue after the medicine is stopped)

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, tell your healthcare professional.

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 (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
• Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

• Store at room temperature (15^o to 30^oC), protected from moisture.
• Do not use TRINTELLIX after the expiry date which is stated on the packaging after EXP. The expiry date refers to the last day of that month.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
• Keep out of reach and sight of children.

If you want more information about TRINTELLIX:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.lundbeck.ca; or by calling 1-800-586-2325.

Date of Authorization: 2026-07-10