Valdoxan Dosage/Direction for Use

Posology: The recommended dose is 25 mg once daily taken orally at bedtime.
After two weeks of treatment, if there is no improvement of symptoms, the dose may be increased to 50 mg once daily, i.e. two 25 mg tablets, taken together at bedtime.
Decision of dose increase has to be balanced with a higher risk of transaminases elevation. Any dose increase to 50 mg should be made on an individual patient benefit/risk basis and with strict respect of Liver Function Test monitoring.
Liver function tests should be performed in all patients before starting treatment. Treatment should not be initiated if transaminases exceed 3 X upper limit of normal (see Contraindications and Precautions). During treatment transaminases should be monitored periodically after around three weeks, six weeks (end of acute phase), twelve weeks and twenty four weeks (end of maintenance phase) and thereafter when clinically indicated (see Precautions). Treatment should be discontinued if transaminases exceed 3 X upper limit of normal (see Contraindications and Precautions).
When increasing the dosage, liver function tests should again be performed at the same frequency as when initiating treatment.
Treatment duration: Patients with depression should be treated for a sufficient period of at least 6 months to ensure that they are free of symptoms.
Switching therapy from SSRI/SNRI antidepressant to agomelatine: Patients may experience discontinuation symptoms after cessation from an SSRI/ SNRI antidepressant.
The SmPC of the actual SSRI/SNRI should be consulted on how to withdraw the treatment to avoid this. Agomelatine can be started immediately while tapering the dosage of a SSRI//SNRI (see Pharmacology: Pharmacodynamics under Actions).
Treatment discontinuation: No dosage tapering is needed on treatment discontinuation.
Special populations: Elderly: The efficacy and safety of agomelatine (25 to 50 mg/day) have been established in elderly depressed patients (<75 years). No effect is documented in patients ≥ 75 years. Therefore agomelatine should not be used by patients in this age group (see Precautions and Pharmacology: Pharmacodynamics under Actions). No dose adjustment is required in relation to age (see Pharmacology under Actions).
Renal impairment: No relevant modification in agomelatine pharmacokinetic parameters in patients with severe renal impairment has been observed. However, only limited clinical data on the use of agomelatine in depressed patients with severe or moderate renal impairment with major depressive episodes is available. Therefore, caution should be exercised when prescribing agomelatine to these patients.
Hepatic impairment: Agomelatine is contraindicated in patients with hepatic impairment (see Contraindications, Precautions, Pharmacology under Actions).
Paediatric population: The safety and efficacy of agomelatine in children from 2 years onwards for treatment of major depressive episodes have not yet been established. No data are available (see Precautions). There is no relevant use of agomelatine in children from birth to 2 years for treatment of major depressive episodes.
Method of administration: For oral use.
Valdoxan film-coated tablets may be taken with or without food.