Leaflet IRSAMLA 20mg film-coated tablets

Indicated for: depression

Route of administration: oral

Substance: vortioxetine (antidepressant)

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

Precautions:
Driving impairment
Driving impairment

This medicine may affect your ability to drive or use machines.

Dizziness / vertigo
Dizziness / vertigo

This medicine may cause dizziness or vertigo.

Major drug interactions
Major drug interactions

This medicine may have important interactions with other medicines.

Breastfeeding warning
Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning
Pregnancy warning

Use during pregnancy only on medical advice.

Suicidal ideation / mental changes
Suicidal ideation / mental changes

Seek medical help if suicidal thoughts or major behavior changes occur.

Withdrawal / do not stop abruptly
Withdrawal / do not stop abruptly

Do not stop treatment abruptly without medical advice.

Drowsiness / sedation
Drowsiness / sedation

This medicine may cause drowsiness or reduced alertness.

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 20mg

  • Substance: vortioxetine
  • Date of latest medicines list: 01-09-2024
  • Product code: W70465001
  • Concentration: 20mg
  • Pharmaceutical form: film-coated tablets
  • Quantity: 28
  • Product type: Generic medicine
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: PHARMADOX HEALTHCARE LTD. - MALTA
  • Holder: EGIS PHARMACEUTICALS PLC. - UNGARIA
  • Number: 15555/2024/01
  • Shelf life: 2 years

Concentrations available for vortioxetine

  • 10mg
  • 15mg
  • 20mg
  • 5mg