VALDOXAN TABLET 25MG [SIN13770P]

Product Info

VALDOXAN TABLET 25MG

[SIN13770P]

4.1. Therapeutic indications

Valdoxan is indicated for the treatment of:

• major depressive episodes (MDE);

• generalised anxiety disorder (GAD).

4.2. Posology and method of administration

Posology
The recommended dose is 25 mg once daily taken orally at bedtime.
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

• 2 weeks after treatment initiation in major depressive episode;

• 4 weeks after treatment initiation in generalized anxiety disorder.

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 sections 4.3 and 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
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 also section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Treatment should be discontinued if transaminases exceed 3 X upper limit of normal (see sections 4.3 and 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
When increasing the dosage, liver function tests should again be performed at the same frequency as when initiating treatment.

Treatment duration
Patients should be treated for a sufficient period of at least 6 months following response 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 package insert 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 section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Treatment discontinuation
No dosage tapering is needed on treatment discontinuation.

Special populations
Elderly
The efficacy and safety of agomelatine (25 to 50mg/day) have been established in elderly patients with MDE (< 75years). No dose adjustment in the usual dose is recommended for elderly patients with MDE (aged < 75 years) solely because of their age. As efficacy has not been established in elderly patients aged ≥ 75 years with MDE, agomelatine should not be used in this patient group (see sections 4.4 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Data on the use of agomelatine in elderly patients with GAD are limited. Therefore, agomelatine is not recommended to treat GAD in the elderly aged ≥65 years (see sections 4.2 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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 sections 4.3, 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population
The safety and efficacy of agomelatine in children from 2 years onwards have not been established. No data are available (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
There is no relevant use of agomelatine in children from birth to 2 years.

Method of administration:
For oral use.
Valdoxan film-coated tablets may be taken with or without food.

4.3. Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Hepatic impairment (i.e. cirrhosis or active liver disease) or transaminases exceeding 3 X upper limit of normal (see sections 4.2 and 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Concomitant use of potent CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin) (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).