Leaflet IRSAMLA 5mg film-coated tablets


Indicated for: depression

Substance: vortioxetine (antidepressant)

ATC: N06AX26 (Nervous system | Antidepressants | Other antidepressants)

Vortioxetine is a medication used for the treatment of major depressive disorder (MDD) in adults. It belongs to the class of antidepressants and has a complex mechanism of action, combining serotonin reuptake inhibition (SSRI) with modulation of serotonin receptors. This mechanism helps increase serotonin levels in the brain and regulate the activity of other neurotransmitters involved in mood, anxiety, and cognitive function.

Vortioxetine is indicated for relieving depressive symptoms such as persistent sadness, loss of interest in activities, fatigue, difficulty concentrating, and sleep disturbances. It may also have beneficial effects on cognitive function, such as improving memory and attention, in patients with depression.

Common side effects include nausea, vomiting, constipation, dizziness, and headache. Rarely, more serious reactions such as serotonin syndrome (a potentially severe condition caused by excess serotonin) or severe allergic reactions may occur. Patients should be monitored for signs of worsening depression or the emergence of suicidal thoughts, especially at the beginning of treatment.

Vortioxetine should be taken as directed by a doctor, usually once daily, with or without food. The treatment should not be stopped abruptly, and dose adjustments should be made gradually under medical supervision.

General data about IRSAMLA 5mg

  • Substance: vortioxetine
  • Date of last drug list: 01-09-2024
  • Commercial code: W70462001
  • Concentration: 5mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 28
  • Product type: generic
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: PHARMADOX HEALTHCARE LTD. - MALTA
  • Holder: EGIS PHARMACEUTICALS PLC. - UNGARIA
  • Number: 15552/2024/01
  • Shelf life: 2 years

Concentrations available for vortioxetine

  • 10mg
  • 15mg
  • 20mg
  • 5mg