VORTIOSON FILM-COATED TABLET 5MG

LUNDBECK SINGAPORE PTE. LTD.

LUNDBECK SINGAPORE PTE. LTD.

Therapeutic

Prescription Only

TABLET, FILM COATED

**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_ The safety and efficacy of Vortioson in children aged 7–11 years have not been established. The efficacy of Vortioson in adolescents aged 12 to 17 years have not been demonstrated. Some safety data is available for adolescents as described in section 4.8 – _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.