Leaflet ZILBEA 25mg film-coated tablets

Product code:
W65495001
Quantity:
28
Indicated for:
depression
Route of administration:
oral
Substance:
agomelatine (antidepressant)
ATC
N06AX22 — Nervous system | Antidepressants | Other antidepressants

Precautions:

Driving impairment

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

Dizziness / vertigo

This medicine may cause dizziness or vertigo.

Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning

Use during pregnancy only on medical advice.

Suicidal ideation / mental changes

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

Withdrawal / do not stop abruptly

Do not stop treatment abruptly without medical advice.

Drowsiness / sedation

This medicine may cause drowsiness or reduced alertness.

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 latest medicines list:
01-06-2019
Product code:
W65495001
Concentration:
25mg
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:
ZENTIVA, K.S. - REPUBLICA CEHA
Holder:
ZENTIVA, K.S. - REPUBLICA CEHA
Number:
11173/2018/01
Shelf life:
2 years