Pharmaceutical Form
Film-coated tablet

Agomelatine 25mg
•    Agomelatine is a melatonergic agonist (MT1 and MT2 receptors) and 5-HT2C antagonist
•    Agomelatine resynchronizes circadian rhythms in animal models of circadian rhythm disruption
•    Agomelatine increases nor adrenaline and dopamine release specifically in the frontal cortex
•    agomelatine has no effect on monoamine uptake and no affinity for
•    adrenergic, histaminergic, cholinergic, dopaminergic and benzodiazepine receptors
Absorption and bioavailability:
•    Agomelatine is rapidly and well (80%) absorbed after oral administration
•    The bioavailability is increased in women compared to men.
•    The bioavailability is increased by intake of oral contraceptives and
•    reduced by smoking.
•    Food intake (standard meal or high fat meal) does not modify the bioavailability or the absorption rate
•    Elimination
•    Elimination is rapid, the mean plasma half-life is between 1 and 2 hours and the clearance is high (about 1,100 ml/min) and essentially metabolic. Excretion is mainly (80%) urinary and in the form of metabolites

 Treatment of major depression

Dose and Method of Administration:

The recommended dose  is one tablet (25 mg) at bedtime. In some cases, your doctor may prescribe a higher dose (50 mg), i.e. two tablets to be taken together at bedtime.
Doxanero® is for oral use

- Contraindications:

•    Hypersensitivity to the active substance or to
•    any of the excipients.
•    Hepatic impairment (i.e. cirrhosis or active liver
•    disease)
•    Concomitant use of potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin)