BRINTELLIX 15 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

VORTIOXETINE AS HYDROBROMIDE

متاح من:

LUNDBECK ISRAEL LTD.

ATC رمز:

N06AX26

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

VORTIOXETINE AS HYDROBROMIDE 15 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

H.LUNDBECK A/S, DENMARK

المجال العلاجي:

VORTIOXETINE

الخصائص العلاجية:

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

تاريخ الترخيص:

2020-03-31

نشرة المعلومات

PHARMACIST’S REGULATIONS (PREPARATIONS)
PATIENT LEAFLET IN ACCORDANCE WITH
1986
The medicine is marketed according to doctor’s prescription only.
BRINTELLIX, COATED TABLETS
5 MG, 10 MG, 15 MG, 20 MG
COMPOSITION: the active ingredient and its quantity:
_ Brintellix 5 mg: Each coated tablet contains 5 mg _Vortioxetine (as
hydrobromide)
_Brintellix 10 mg: Each coated tablet contains 10 mg _Vortioxetine (as
hydrobromide)
_Brintellix 15 mg: Each coated tablet contains 15 mg _Vortioxetine (as
hydrobromide)
_Brintellix 20 mg: Each coated tablet contains 20 mg _Vortioxetine (as
hydrobromide)
INACTIVE INGREDIENTS: See section 6
-
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THIS
MEDICINE. This
leaflet contains essential information about this medicine. If you
have any
further question, consult your doctor or pharmacist.
-
This medicine was prescribed to treat your illness. Do not pass it on
to
others. It may harm them even if it seems to you that their illness is
similar to
your own.
1.
WHAT IS THE MEDICINE BEING USED FOR?
Brintellix belongs to a group of medicines called antidepressants and
you have been
given this medicine to treat your depression.
Brintellix is used to treat major depressive episodes in adults.
Brintellix has been shown to reduce the broad range of depressive
symptoms,
including sadness, inner tension (feeling anxious), sleep
disturbances, reduced
appetite, difficulty in concentrating, feelings of worthlessness, loss
of interest in
favourite activities, feeling of being slowed down.
2. BEFORE USING THIS MEDICINE
DO NOT TAKE THIS MEDICINE IF:
_-_You are sensitive (allergic) to the active ingredient or any of the
other ingredients of this
medicine (listed in section 6).
- if you are taking other medicines for depression known as
non-selective monoamine oxidase
inhibitors or selective MAO-A inhibitors. Ask your doctor if you are
uncertain.
WARNINGS AND PRECAUTIONS
BEFORE USING BRINTELLIX, TELL YOUR DOCTOR IF YOU:
- are taking medicines with a so-called serotonergic effect, such as:
- trama

خصائص المنتج

1
1.
NAME OF THE MEDICINAL PRODUCT
Brintellix 5, 10, 15 and 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains vortioxetine hydrobromide equivalent
to 5, 10, 15 and 20 mg
vortioxetine.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL
FORM
Film-coated tablet.
Brintellix 5 mg: Pink, almond-shaped (5 x 8.4 mm) film-coated tablet
engraved with “TL” on one side
and “5” on the other side.
Brintellix 10 mg:
Yellow, almond-shaped (5 x 8.4 mm) film-
coated tablet engraved with “TL” on one
side and “10” on the other side.
Brintellix 15 mg:
Orange, almond-shaped (5 x 8.4 mm) film-
coated tablet engraved with “TL” on one
side and “15” on the other side.
Brintellix 20 mg: 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.
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
symptoms (see section 4.8). However, there is insufficient data to
provide specific recommendations
for a tapering schedule for patients treated with Brintellix.
Special populations
_ _
_Elderly patients _
2
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 vorti