BRINTELLIX FILM-COATED TABLETS 5MG

Χώρα: Σιγκαπούρη

Γλώσσα: Αγγλικά

Πηγή: HSA (Health Sciences Authority)

Δραστική ουσία:

Vortioxetine (as hydrobromide 6.355 mg)

Διαθέσιμο από:

LUNDBECK SINGAPORE PTE. LTD.

Φαρμακολογική κατηγορία (ATC):

N06AX26

Δοσολογία:

5.00mg

Φαρμακοτεχνική μορφή:

TABLET, FILM COATED

Σύνθεση:

Vortioxetine (as hydrobromide 6.355 mg) 5.00mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

Prescription Only

Κατασκευάζεται από:

H.Lundbeck A/S

Καθεστώς αδειοδότησης:

ACTIVE

Ημερομηνία της άδειας:

2014-11-17

Φύλλο οδηγιών χρήσης

H. Lundbeck A/S 
Confidential 
_Product Information Tabular Template v. 1.0 _

NATIONAL PRODUCT INFORMATION (
English translation)

NAME OF THE MEDICINAL PRODUCT 
Brintellix 5 mg film-coated tablets 
Brintellix 10 mg film-coated tablets 
Brintellix 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. 

For the full list of excipients, see section 6.1. 

10 MG FILM-COATED TABLETS 
Each film-coated tablet contains vortioxetine hydrobromide
equivalent to 10 mg vortioxetine. 

For the full list of excipients, see section 6.1. 

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 

5 mg Film-coated Tablets 
Film-coated tablet. 

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 
Film-coated tablet. 

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 
Film-coated tablet. 

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 

Brintellix is indicated for the treatment of major
depressive episodes in adults. 
H. Lundbeck A/S 
Confidential 
_Product Information Tabular Template v. 1.0 _

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

Posology 

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

Depending on individual patient r

Αρχείο Π.Χ.Π.

H. Lundbeck A/S
Brintellix
®
5mg, 10mg, 20mg film-coated tablets
1. NAME OF THE MEDICINAL PRODUCT
Brintellix 5 mg film-coated tablets
Brintellix 10 mg film-coated tablets
Brintellix 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
Brintellix 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 Brintellix 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 symp-
toms (see section 4.8). However, there is insufficient data to provide
specific recommendations for a
tapering schedule for patients treated with Brintell