VORTIOSON FILM-COATED TABLET 10MG [SIN16556P]

Product Info

VORTIOSON FILM-COATED TABLET 10MG

[SIN16556P]

4.1 Therapeutic indications

Vortioson is indicated for the treatment of major depressive episodes in adults.

4.2 Posology and method of administration

Posology

The starting and recommended dose of Vortioson is 10 mg vortioxetine once daily in adults less than 65 years of age.

Depending on individual patient response, the dose may be increased to a maximum of 20 mg vortioxetine once daily or decreased to a minimum of 5 mg vortioxetine once daily.

After the depressive symptoms resolve, treatment for at least 6 months is recommended for consolidation of the antidepressive response.

Treatment discontinuation

A gradual reduction in dosage may be considered to avoid the occurrence of discontinuation symptoms (see section 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). However, there is insufficient data to provide specific recommendations for a tapering schedule for patients treated with Vortioson.

Special populations

Elderly patients
The lowest effective dose of 5 mg vortioxetine once daily should always be used as the starting dose in patients ≥ 65 years of age. Caution is advised when treating patients ≥ 65 years of age with doses higher than 10 mg vortioxetine once daily for which data are limited (see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Cytochrome P450 inhibitors
Depending on individual patient response, a lower dose of vortioxetine may be considered if a strong CYP2D6 inhibitor (e.g. bupropion, quinidine, fluoxetine, paroxetine) is added to vortioxetine treatment (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Cytochrome P450 inducers
Depending on individual patient response, a dose adjustment of vortioxetine may be considered if a broad cytochrome P450 inducer (e.g., rifampicin, carbamazepine, phenytoin) is added to vortioxetine treatment (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Paediatric population

Vortioson should not be used in paediatric patients (under 18 years of age) with major depressive disorder (MDD) because efficacy has not been demonstrated (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The safety of Vortioson in paediatric patients is described in section 4.4, 4.8 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Renal or hepatic impairment
No dose adjustment is needed based on renal or hepatic function (see section 4.4 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Method of administration

Vortioson is for oral use.
The film-coated tablets can 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.
Concomitant use with nonselective monoamine oxidase inhibitors (MAOIs) or selective MAO-A inhibitors (see section 4.5 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).