Vortioxetine is an active pharmaceutical ingredient in the Other Antidepressants group (N06AX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised April 30, 2026[1]
Vortioxetine is indicated for the treatment of major depressive episodes in adults.
How to take
GBOfficial regulatory label
CACanada· Health Canada
8 products
Uses
CAOfficial regulatory label· revised March 22, 2025[2]
3 Pediatrics 05/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................
2 TABLE OF CONTENTS.................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................... 4 1 INDICATIONS ......................................................................................................
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Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]MHRA (UK) · PL140170327 · revised April 30, 2026
[2]Health Canada (DPD) · 02432919 · revised March 22, 2025
[3]European Medicines Agency · EMEA/H/C/002717 · revised January 19, 2026
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
Posology The starting and recommended dose is 10 mg vortioxetine once daily in adults less than 65 years of age. Depending on individual patient response, the dose may be increased to a maximum of 20 mg vortioxetine once daily or decreased to a minimum of 5 mg vortioxetine once daily.
After the depressive symptoms resolve, treatment for at least 6 months is recommended for consolidation of the antidepressive response. 8). However, there is insufficient data to provide specific recommendations for a tapering schedule for patients treated with vortioxetine.
Special populations Elderly patients The lowest effective dose of 5 mg vortioxetine once daily should always be used as the starting dose in patients ≥ 65 years of age. 4). g. 5). 5). 1). 1. 2). Method of administration Vortioxetine film-coated tablets are for oral use.
The film-coated tablets can be taken with or without food.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised April 30, 2026[1]
Summary of the safety profile The most common adverse reaction was nausea. (<1/10,000), not known (cannot be estimated from the available data). The list is based on information from clinical trials and post-marketing experience. 4) Uncommon FlushingVascular disorders Not known* Haemorrhage (including contusion, ecchymosis, epistaxis, gastrointestinal or vaginal bleeding) Very common NauseaGastrointestinal disorders Common Diarrhoea, Constipation, Vomiting, Dyspepsia Common Pruritus, including pruritus generalised Hyperhidrosis Uncommon Night sweats Skin and subcutaneous tissue disorders Not known* Angioedema, Urticaria Rash Reproductive system and breast disorders Not known* Sexual dysfunction General disorder and administration site conditions Not known* Discontinuation syndrome * Based on post-marketing cases Description of selected adverse reactions Nausea Nausea was usually mild or moderate and occurred within the first two weeks of treatment.
The reactions were usually transient and did not generally lead to cessation of therapy. Gastrointestinal adverse reactions, such as nausea, occurred more frequently in women than men. Elderly patients For doses ≥10 mg vortioxetine once daily, the withdrawal rate from the studies was higher in patients aged ≥65 years.
4). Sexual dysfunction In clinical studies, sexual dysfunction was assessed using the Arizona Sexual Experience Scale (ASEX). Doses of 5 to 15 mg showed no difference to placebo. 1). In the post-marketing setting cases of sexual dysfunction have also been reported with doses of vortioxetine below 20 mg.
Class effect Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving a medicinal product from related pharmacological classes of antidepressants (SSRIs or TCAs).
The mechanism behind this risk is unknown, and it is not known if this risk is also relevant for vortioxetine. Paediatric population A total of 304 children aged 7 to 11 years and 308 adolescents aged 12 to 17 years with major depressive disorder (MDD) were treated with vortioxetine in two double- blind, placebo-controlled studies, respectively.
1). Two long-term open-label extension studies were performed with vortioxetine doses of 5 to 20 mg/day, and with a treatment duration of 6 months (N=662) and 18 months (N=94), respectively. Overall, the safety and tolerability profile of vortioxetine in the paediatric population after long-term use was comparable to what has been observed after short-term use.
Symptoms upon discontinuation of vortioxetine treatment In the clinical studies, discontinuation symptoms were systematically evaluated following abrupt cessation of vortioxetine treatment. 1). Cases describing discontinuation symptoms have been reported in the post-marketing setting and have included symptoms such as dizziness, headache, sensory disturbances (including paraesthesia, electric shock sensations), sleep disturbances (including insomnia), nausea and/or vomiting, anxiety, irritability, agitation, fatigue and tremor.
These symptoms may occur within the first week of vortioxetine discontinuation. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
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GBOfficial regulatory label· Warnings and precautions· revised April 30, 2026[1]
1). 1). In clinical studies in children and adolescents treated with antidepressants, suicide-related behaviour (suicide attempt and suicidal thoughts) and hostility (predominantly aggression, oppositional behaviour, anger) were more frequently observed than in those treated with placebo.
Suicide/suicidal thoughts or clinical worsening Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suiciderelated events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
It is general clinical experience that the risk of suicide may increase in the early stages of recovery. Patients with a history of suicide-related events or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
A meta-analysis of placebocontrolled clinical studies of antidepressants in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo, in patients less than 25 years old.
Close supervision of patients and in particular those at high risk should accompany treatment especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted to the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Seizures Seizures are a potential risk with antidepressants. 5). Treatment should be discontinued in any patient who develops seizures or for whom there is an increase in seizure frequency. Serotonin Syndrome (SS) or Neuroleptic Malignant Syndrome (NMS) Serotonin Syndrome (SS) or Neuroleptic Malignant Syndrome (NMS), potentially life-threatening conditions, may occur with vortioxetine.
The risk of SS or NMS is increased with concomitant use of serotonergic-active substances (including opioids and triptans), medicinal products that impair the metabolism of serotonin (including MAOIs), antipsychotics, and other dopamine antagonists.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised April 30, 2026[1]
1. 5).
This is not medical advice. Consult a qualified healthcare professional.
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other TRINTELLIX® (vortioxetine) Product Monograph Page 3 of 46 Quantitative Data ................................................................................................
5 Post-Market Adverse Reactions ................................................................ 22 9 DRUG INTERACTIONS ..................................................................................... 1 Serious Drug Interactions ..........................................................................
28 10 ACTION AND CLINICAL PHARMACOLOGY ................................................... 1 Mechanism of Action .............................................................................. 2 Pharmacodynamics ................................................................................
3 Pharmacokinetics ................................................................................... 29 Special Populations and Conditions ................................................................... 30 11 STORAGE, STABILITY AND DISPOSAL .........................................................
32 12 SPECIAL HANDLING INSTRUCTIONS ............................................................ 32 PART II: SCIENTIFIC INFORMATION ......................................................................... 33 13 PHARMACEUTICAL INFORMATION ...............................................................
33 14 CLINICAL TRIALS ............................................................................................. 1 Clinical Trials by Indication ..................................................................... 33 Major Depressive Disorder .................................................................................
33 15 MICROBIOLOGY […]
How to take
CAOfficial regulatory label· revised March 22, 2025[2]
1 Dosing Considerations • TRINTELLIX is not indicated for use in patients below the age of 18 (see 7 WARNINGS AND PRECAUTIONS, Potential Association With Behavioural And Emotional Changes, Including Self-Harm). 2 Recommended Dose and Dosage Adjustment Adults The starting and recommended dose of TRINTELLIX is 10 mg vortioxetine once daily for adults less than 65 years of age.
Depending on individual patient response, the dose may be increased to a maximum of 20 mg vortioxetine once daily, as tolerated. A dose decrease to a minimum of 5 mg vortioxetine once daily may be considered for patients who do not tolerate higher doses.
In clinical trials conducted outside the United States, efficacy was demonstrated with 5 mg/day, 10 mg/day, 15 mg/day and 20 mg/day. 1 Clinical Trials by Indication, Study Results). The efficacy and safety of doses greater than 20 mg/day were not evaluated in controlled clinical trials.
1 Clinical Trials by Indication, Study Results). During long-term therapy, the dosage should be maintained at the lowest effective level and patients should be periodically reassessed to determine the need to continue treatment. • Pediatrics (<18 years of age) Health Canada has not authorized an indication for pediatric use.
• Geriatrics (>65 years of age) The lowest effective dose of 5 mg/day vortioxetine should always be used as the starting dose for patients of 65 years of age or older. 1 Clinical Trials by Indication, Study Results). Dosage Adjustment Patients with Renal Impairment No dose adjustment is recommended for patients with renal impairment or for patients with end- stage renal disease.
3 Pharmacokinetics, Special Populations and Conditions, Renal Insufficiency). Patients with Hepatic Impairment No dose adjustment is recommended for patients with hepatic impairment. 3 Pharmacokinetics, Special Populations and Conditions, Hepatic Insufficiency).
g. 4 Drug-Drug Interactions). g. 4 Drug-Drug Interactions). 2 Clinical Trial Adverse Reactions, Discontinuation Symptoms). Patients should be monitored for discontinuation symptoms when discontinuing treatment with TRINTELLIX. A gradual reduction in the dose, rather than an abrupt cessation, is recommended whenever possible.
3 Pharmacokinetics, Elimination). 3 Reconstitution Not Applicable. 4 Administration TRINTELLIX should be administered as a single daily dose, with or without food. 5 Missed Dose If a dose is missed, the next dose should be taken at the usual time.
Patients should not take a double dose to make up for a missed dose.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[2]
). Gastrointestinal and gynaecological bleeding have also been reported following treatment with TRINTELLIX. 1 Pregnant Women). g. thrombocytopenia or coagulation disorders). 2 Drug Interactions Overview). Hepatic/Biliary/Pancreatic Hepatic Impairment Based on studies conducted with TRINTELLIX in patients with mild, moderate or severe hepatic impairment, no dose adjustment is recommended on the basis of hepatic function (see 4.
3 Pharmacokinetics, Special Populations and Conditions, Hepatic Insufficiency). However, due to extensive hepatic metabolism of vortioxetine, caution is advised when TRINTELLIX is prescribed in patients with moderate or severe hepatic impairment.
Musculoskeletal Bone Fracture Risk Elderly patients, patients with osteoporosis and patients with important risk factors for bone fractures should be advised of possible adverse events which increase the risk of falls, such as dizziness and orthostatic hypotension, especially at the early stages of treatment but also soon after withdrawal.
Epidemiological studies show an increased risk of bone fractures following exposure to some antidepressants, including SSRIs and other newer antidepressants. The risks appear to be greater at the initial stages of treatment, but significant increased risks were also observed at later stages of treatment.
The possibility of fracture should be considered in the care of patients treated with TRINTELLIX. Preliminary data from observational studies show association of Selective Serotonin Reuptake Inhibitors (SSRIs)/Serotonin and Norepinephrine Reuptake Inhibitors (SNRIs) and low bone mineral density in older men and women.
Until further information becomes available, a possible effect on bone mineral density with long-term treatment with SSRIs and other newer antidepressants including TRINTELLIX, cannot be excluded. Neurologic Seizures Seizures are a potential risk with antidepressant drugs.
1% of patients that received TRINTELLIX compared to 0% that received placebo. As with other antidepressants, TRINTELLIX should be introduced cautiously in patients who have a history of seizures or in patients with unstable epilepsy.
Treatment should be discontinued in any patient who develops seizures or for whom there is an increase in seizure frequency. 2 Drug Interactions Overview, Serotonergic Medicinal Products). g. g. anxiety, agitation, hypomania). In accordance with the Hunter criteria, serotonin toxicity diagnosis is likely when, in the presence of at least one serotonergic agent, one of the following is observed: • Spontaneous clonus • Inducible clonus or ocular clonus with agitation or diaphoresis • Tremor and hyperreflexia • Hypertonia and body temperature > 38°C and ocular clonus or inducible clonus Neuroleptic malignant syndrome has also been rarely reported with TRINTELLIX, particularly during combined use with neuroleptic/antipsychotic drugs.
The clinical manifestations of neuroleptic malignant syndrome often overlap with those of serotonin toxicity, including hyperthermia, hypertonia, altered mental status, and autonomic instability. In contrast to serotonin toxicity, patients with neuroleptic malignant syndrome may present with “lead pipe” muscle rigidity as well as hyporeflexia.
The concomitant use of TRINTELLIX with monoamine oxidase inhibitors, including linezolid and methylthioninium chloride (methylene blue), is contraindicated (see 2 CONTRAINDICATIONS, Monoamine Oxidase Inhibitors (MAOIs)). TRINTELLIX should be used with caution in patients receiving other serotonergic drugs or antipsychotics/neuroleptics.
2 Drug Interactions Overview, Serotonergic Medicinal Products). Serotonin toxicity and neuroleptic malignant syndrome may result in potentially life-threatening conditions. If serotonin toxicity or neuroleptic malignant syndrome is suspected, discontinuation of TRINTELLIX should be considered.
Cognitive and Motor Disturbances In a study of 21 healthy subjects who were administered single and multiple doses of 10 mg/day TRINTELLIX in the evening, there was no significant impairment, relative to placebo, in mean parameters of driving performance, cognitive function or other psychomotor skills using a battery of neuropsychological tests on the following morning.
However, some individuals may show impairment after taking TRINTELLIX (see 7 WARNINGS AND PRECAUTIONS, Driving and Operating Machinery). Ophthalmologic Angle-Closure Glaucoma As with other antidepressants, TRINTELLIX can cause mydriasis, which may trigger an angle- closure attack in a patient with anatomically narrow ocular angles.
Healthcare providers should inform patients to seek immediate medical assistance if they experience eye pain, changes in vision or swelling or redness in or around the eye. Psychiatric Potential Association with […]
CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[2]
3 Pediatrics 05/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES ............................................................................
2 TABLE OF CONTENTS.................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION .................................................... 4 1 INDICATIONS ......................................................................................................
7 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............. 7 7 WARNINGS AND PRECAUTIONS ...................................................................... 1 Special Populations ...................................................................................
1 Pregnant Women ................................................................................... 2 Breast-feeding ........................................................................................ 3 Pediatrics ...............................................................................................
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised March 22, 2025[2]
TRINTELLIX is contraindicated in: • patients who are hypersensitive to vortioxetine or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. Angioedema has been reported in patients treated with TRINTELLIX.
For a complete listing of excipients, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 2 Drug Interactions Overview; 7 WARNINGS AND PRECAUTIONS, Neurologic, Serotonin Toxicity/Neuroleptic Malignant Syndrome). TRINTELLIX® (vortioxetine) Product Monograph Page 5 of 46 Monoamine Oxidase Inhibitors (MAOIs) Vortioxetine increases serotonergic neurotransmission and must not be used concomitantly in patients taking MAOIs, including linezolid, an antibiotic, methylene blue, a dye used in certain surgeries, or in patients who have taken MAOIs within the preceding 14 days due to the risk of serious, sometimes fatal, drug interactions.
These interactions have been associated with symptoms that include tremor, myoclonus, diaphoresis, nausea, vomiting, flushing, dizziness, hyperthermia with features resembling neuroleptic malignant syndrome or serotonin toxicity, seizures, rigidity, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma.
Therefore, at least 14 days should be allowed after discontinuing treatment with a MAOI before starting treatment with vortioxetine. 2 Drug Interactions Overview).
This is not medical advice. Consult a qualified healthcare professional.
Posology The starting and recommended dose of Brintellix is 10 mg vortioxetine once daily in adults less than 65 years of age. Depending on individual patient response, the dose may be increased to a maximum of 20 mg vortioxetine once daily or decreased to a minimum of 5 mg vortioxetine once daily.
After the depressive symptoms resolve, treatment for at least 6 months is recommended for consolidation of the antidepressive response. 8). However, there is insufficient data to provide specific recommendations for a tapering schedule for patients treated with Brintellix.
Special populations Elderly patients The lowest effective dose of 5 mg vortioxetine once daily should always be used as the starting dose in patients ≥ 65 years of age. 4). g. 5). 5). 1). 1. 2). Method of administration Brintellix is for oral use.
The film-coated tablets can be taken with or without food. 4
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised January 19, 2026[3]
Summary of the safety profile The most common adverse reaction was nausea. Tabulated list of adverse reactions Adverse reactions are listed below using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
The list is based on information from clinical trials and post-marketing experience. 4) Vascular disorders Uncommon Flushing Not known* Haemorrhage (including contusion, ecchymosis, epistaxis, gastrointestinal or vaginal bleeding) Gastrointestinal disorders Very common Nausea Common Diarrhoea, Constipation, Vomiting, Dyspepsia Skin and subcutaneous tissue disorders Common Pruritus, including pruritus generalised Hyperhidrosis Uncommon Night sweats Not known* Angioedema, Urticaria Rash General disorder and administration site conditions Not known* Discontinuation syndrome * Based on post-marketing cases Description of selected adverse reactions Nausea Nausea was usually mild or moderate and occurred within the first two weeks of treatment.
The reactions were usually transient and did not generally lead to cessation of therapy. Gastrointestinal adverse reactions, such as nausea, occurred more frequently in women than men. Elderly patients For doses ≥10 mg vortioxetine once daily, the withdrawal rate from the studies was higher in patients aged ≥65 years.
4). Sexual dysfunction In clinical studies, sexual dysfunction was assessed using the Arizona Sexual Experience Scale (ASEX). Doses of 5 to 15 mg showed no difference to placebo. 1). In the post-marketing setting cases of sexual dysfunction have also been reported with doses of vortioxetine below 20 mg.
Class effect Epidemiological studies, mainly conducted in patients 50 years of age and older, show an increased risk of bone fractures in patients receiving a medicinal product from related pharmacological classes of antidepressants (SSRIs or TCAs).
The mechanism behind this risk is unknown, and it is not known if this risk is also relevant for vortioxetine. Paediatric population A total of 304 children aged 7 to 11 years and 308 adolescents aged 12 to 17 years with major depressive disorder (MDD) were treated with vortioxetine in two double-blind, placebo-controlled studies, respectively.
1). Two long-term open-label extension studies were performed with vortioxetine doses of 5 to 20 mg/day, and with a treatment duration of 6 months (N=662) and 18 months (N=94), respectively. Overall, the safety and tolerability profile of vortioxetine in the paediatric population after long-term use was comparable to what has been observed after short-term use.
Symptoms upon discontinuation of vortioxetine treatment In the clinical studies, discontinuation symptoms were systematically evaluated following abrupt cessation of vortioxetine treatment. 1). Cases describing discontinuation symptoms have been reported in the post-marketing setting and have included symptoms such as dizziness, headache, sensory disturbances (including paraesthesia, electric shock sensations), sleep disturbances (including insomnia), nausea and/or vomiting, anxiety, irritability, agitation, fatigue and tremor.
These symptoms may occur within the first week of vortioxetine discontinuation. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V
EUOfficial regulatory label· Warnings and precautions· revised January 19, 2026[3]
1). 1). In clinical studies in children and adolescents treated with antidepressants, suicide-related behaviour (suicide attempt and suicidal thoughts) and hostility (predominantly aggression, oppositional behaviour, anger) were more frequently observed than in those treated with placebo.
Suicide/suicidal thoughts or clinical worsening Depression is associated with an increased risk of suicidal thoughts, self harm and suicide (suicide-related events). This risk persists until significant remission occurs. As improvement may not occur during the first few weeks or more of treatment, patients should be closely monitored until such improvement occurs.
It is general clinical experience that the risk of suicide may increase in the early stages of recovery. Patients with a history of suicide-related events or those exhibiting a significant degree of suicidal ideation prior to commencement of treatment are known to be at greater risk of suicidal thoughts or suicide attempts, and should receive careful monitoring during treatment.
A meta-analysis of placebo-controlled clinical studies of antidepressants in adult patients with psychiatric disorders showed an increased risk of suicidal behaviour with antidepressants compared to placebo, in patients less than 25 years old.
Close supervision of patients and in particular those at high risk should accompany treatment especially in early treatment and following dose changes. Patients (and caregivers of patients) should be alerted to the need to monitor for any clinical worsening, suicidal behaviour or thoughts and unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Seizures Seizures are a potential risk with antidepressants. 5). Treatment should be discontinued in any patient who develops seizures or for whom there is an increase in seizure frequency. Serotonin Syndrome (SS) or Neuroleptic Malignant Syndrome (NMS) Serotonin Syndrome (SS) or Neuroleptic Malignant Syndrome (NMS), potentially life-threatening conditions, may occur with vortioxetine.
The risk of SS or NMS is increased with concomitant use of serotonergic-active substances (including opioids and triptans), medicinal products that impair the metabolism of serotonin (including MAOIs), antipsychotics, and other dopamine antagonists.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised January 19, 2026[3]
1. 5).
This is not medical advice. Consult a qualified healthcare professional.
5). , nausea, vomiting, diarrhoea). If this occurs, treatment with vortioxetine should be discontinued immediately and symptomatic treatment should be initiated. Mania/hypomania Vortioxetine should be used with caution in patients with a history of mania/hypomania and should be discontinued in any patient entering a manic phase.
Aggression/agitation Patients treated with antidepressants, including vortioxetine, may also experience feelings of aggression, anger, agitation and irritability. Patient’s condition and disease status should be closely monitored. Patients (and caregivers of patients) should be alerted to seek medical advice, if aggressive/agitated behaviour emerges or aggravates.
Haemorrhage Bleeding abnormalities, such as ecchymoses, purpura and other haemorrhagic events, such as gastrointestinal or gynaecological bleeding, have been reported rarely with the use of antidepressants with serotonergic effect, including vortioxetine.
6). 5) and in patients with known bleeding tendencies/disorders. Hyponatraemia Hyponatraemia, probably due to inappropriate antidiuretic hormone secretion (SIADH), has been reported rarely with the use of antidepressants with serotonergic effect (SSRIs, SNRIs).
Caution should be exercised in patients at risk, such as the elderly, patients with cirrhosis of the liver or patients concomitantly treated with medicinal products known to cause hyponatraemia. Discontinuation of vortioxetine should be considered in patients with symptomatic hyponatraemia and appropriate medical intervention should be instituted.
Glaucoma Mydriasis has been reported in association with use of antidepressants, including vortioxetine. This mydriatic effect has the potential to narrow the eye angle resulting in increased intraocular pressure and angle-closure glaucoma.
Caution is advised when prescribing vortioxetine to patients with increased intraocular pressure, or those at risk of acute narrow-angle glaucoma. Elderly Data on the use of vortioxetine in elderly patients with major depressive episodes are limited.
4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other TRINTELLIX® (vortioxetine) Product Monograph Page 3 of 46 Quantitative Data ................................................................................................
5 Post-Market Adverse Reactions ................................................................ 22 9 DRUG INTERACTIONS ..................................................................................... 1 Serious Drug Interactions ..........................................................................
28 10 ACTION AND CLINICAL PHARMACOLOGY ................................................... 1 Mechanism of Action .............................................................................. 2 Pharmacodynamics ................................................................................
3 Pharmacokinetics ................................................................................... 29 Special Populations and Conditions ................................................................... 30 11 STORAGE, STABILITY AND DISPOSAL .........................................................
32 12 SPECIAL HANDLING INSTRUCTIONS ............................................................ 32 PART II: SCIENTIFIC INFORMATION ......................................................................... 33 13 PHARMACEUTICAL INFORMATION ...............................................................
33 14 CLINICAL TRIALS ............................................................................................. 1 Clinical Trials by Indication ..................................................................... 33 Major Depressive Disorder .................................................................................
5). , nausea, vomiting, diarrhoea). If this occurs, treatment with vortioxetine should be discontinued immediately and symptomatic treatment should be initiated. Mania/hypomania Vortioxetine should be used with caution in patients with a history of mania/hypomania and should be discontinued in any patient entering a manic phase.
Aggression/agitation Patients treated with antidepressants, including vortioxetine, may also experience feelings of aggression, anger, agitation and irritability. Patient’s condition and disease status should be closely monitored. Patients (and caregivers of patients) should be alerted to seek medical advice, if aggressive/agitated behaviour emerges or aggravates.
Haemorrhage Bleeding abnormalities, such as ecchymoses, purpura and other haemorrhagic events, such as gastrointestinal or gynaecological bleeding, have been reported rarely with the use of antidepressants with serotonergic effect, including vortioxetine.
6). 5) and in patients with known bleeding tendencies/disorders. Hyponatraemia Hyponatraemia, probably due to inappropriate antidiuretic hormone secretion (SIADH), has been reported rarely with the use of antidepressants with serotonergic effect (SSRIs, SNRIs).
Caution should be exercised in patients at risk, such as the elderly, patients with cirrhosis of the liver or patients concomitantly treated with medicinal products known to cause hyponatraemia. Discontinuation of vortioxetine should be considered in patients with symptomatic hyponatraemia and appropriate medical intervention should be instituted.
Glaucoma Mydriasis has been reported in association with use of antidepressants, including vortioxetine. This mydriatic effect has the potential to narrow the eye angle resulting in increased intraocular pressure and angle-closure glaucoma.
Caution is advised when prescribing vortioxetine to patients with increased intraocular pressure, or those at risk of acute narrow-angle glaucoma. Elderly Data on the use of Brintellix in elderly patients with major depressive episodes are limited.