VORTIOSON FILM-COATED TABLET 20MG

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Vortioxetine hydrobromide eqv Vortioxetine

Available from:

LUNDBECK SINGAPORE PTE. LTD.

ATC code:

N06AX26

Pharmaceutical form:

TABLET, FILM COATED

Composition:

Vortioxetine hydrobromide eqv Vortioxetine 20 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

H. Lundbeck A/S

Authorization status:

ACTIVE

Authorization date:

2022-07-20

Summary of Product characteristics

H. Lundbeck A/S
Vortioson
®
5mg, 10mg, 20mg film-coated tablets
1. NAME OF THE MEDICINAL PRODUCT
Vortioson 5 mg film-coated tablets
Vortioson 10 mg film-coated tablets
Vortioson 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
5 MG FILM-COATED TABLETS
Each film-coated tablet contains vortioxetine hydrobromide equivalent
to 5 mg vortioxetine.
10 MG FILM-COATED TABLETS
Each film-coated tablet contains vortioxetine hydrobromide equivalent
to 10 mg vortioxetine.
20 MG FILM-COATED TABLETS
Each film-coated tablet contains vortioxetine hydrobromide equivalent
to 20 mg vortioxetine-
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Film-coated tablet (tablet)
5 mg Film-coated Tablets
Pink, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with
“TL” on one side and “5” on the
other side.
10 mg Film-coated Tablets
Yellow, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with
“TL” on one side and “10” on
the other side.
20 mg Film-coated Tablets
Red, almond-shaped (5 x 8.4 mm) film-coated tablet engraved with
“TL” on one side and “20” on the
other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vortioson is indicated for the treatment of major depressive episodes
in adults.
H. Lundbeck A/S
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). However, there is insufficient data to
provide specific recommendations
for a tapering schedule for patients treated with Vortioson.
Speci