Leaflet ZILBEA 25mg film-coated tablets


Indicated for: depression

Substance: agomelatine (antidepressant)

ATC: N06AX22 (Nervous system | Antidepressants | Other antidepressants)

Agomelatine is a medication used to treat major depressive disorder in adults. It works by regulating the circadian rhythm and serotonin levels, providing benefits for sleep and mood. It is an agonist of melatonin receptors (MT1 and MT2) and an antagonist of serotonin 5-HT2C receptors, which helps improve depressive symptoms.

One advantage of agomelatine is that it does not affect sexual function and has a low risk of causing weight gain compared to other antidepressants. It also helps restore normal sleep patterns without having a sedative effect.

Side effects may include nausea, dizziness, headache, or fatigue. In rare cases, it can affect liver function, so regular monitoring of liver enzymes is required during treatment. It is contraindicated in patients with severe liver conditions. The medication should be taken as prescribed by a doctor, usually once daily in the evening.

General data about ZILBEA 25mg

  • Substance: agomelatine
  • Date of last drug list: 01-06-2019
  • Commercial code: W65495001
  • Concentration: 25mg
  • 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: ZENTIVA, K.S. - REPUBLICA CEHA
  • Holder: ZENTIVA, K.S. - REPUBLICA CEHA
  • Number: 11173/2018/01
  • Shelf life: 2 years