Driving impairment
This medicine may affect your ability to drive or use machines.
Medicine information 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
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.
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
- Strength:
- 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.
Official documents
Professional information (SmPC) - Romanian
Patient leaflet - Romanian
Packaging and labelling information - Romanian
The correspondence between the document and the displayed text is unconfirmed.
- Source institution
- ANMDMR
- Document language
- Romanian
Warnings:
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.