Brintellix 10mg tablets

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Vortioxetine hydrobromide

Διαθέσιμο από:

Lundbeck Ltd

Φαρμακολογική κατηγορία (ATC):

N06AX26

INN (Διεθνής Όνομα):

Vortioxetine hydrobromide

Δοσολογία:

10mg

Φαρμακοτεχνική μορφή:

Tablet

Οδός χορήγησης:

Oral

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 04030400; GTIN: 5702157142187

Φύλλο οδηγιών χρήσης

BRINTELLIX 5 MG FILM-COATED TABLETS
BRINTELLIX 10 MG FILM-COATED TABLETS
BRINTELLIX 15 MG FILM-COATED TABLETS
BRINTELLIX 20 MG FILM-COATED TABLETS
Vortioxetine
▼ This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how
to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Brintellix is and what it is used for
2.
What you need to know before you take Brintellix
3.
How to take Brintellix
4.
Possible side effects
5.
How to store Brintellix
6.
Contents of the pack and other information
1.
WHAT BRINTELLIX IS AND WHAT IT IS USED FOR
Brintellix contains the active substance vortioxetine. It belongs to a
group of medicines called
antidepressants and you have been given this medicine to treat your
depression.
Brintellix has been shown to reduce the broad range of depressive
symptoms, including sadness, inner
tension (feeling anxious), sleep disturbances (reduced sleep), reduced
appetite, difficulty in
concentrating, feelings of worthlessness, loss of interest in
favourite activities, feeling of being slowed
down.
Brintellix is used to treat major depressive episodes in adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE BRINTELLIX
DO NOT TAKE BRINTELLIX:
-
if you are allergic to vortioxetine 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 monoamin

Αρχείο Π.Χ.Π.

OBJECT 1
BRINTELLIX TABLETS 5, 10 AND 20MG
Summary of Product Characteristics Updated 26-Jan-2017 | Lundbeck
Limited
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
1. Name of the medicinal product
Brintellix 5 mg film-coated tablets
Brintellix 10 mg film-coated tablets
Brintellix 15 mg film-coated tablets
Brintellix 20 mg film-coated tablets
2. Qualitative and quantitative composition
Brintellix 5 mg film-coated tablets
Each film-coated tablet contains vortioxetine hydrobromide equivalent
to 5 mg vortioxetine.
Brintellix 10 mg film-coated tablets
Each film-coated tablet contains vortioxetine hydrobromide equivalent
to 10 mg vortioxetine.
Brintellix 15 mg film-coated tablets
Each film-coated tablet contains vortioxetine hydrobromide equivalent
to 15 mg vortioxetine.
Brintellix 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
Brintellix 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.
Brintellix 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.
Brintellix 15 mg film-coated tablets
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 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.
4.2 Posology and method of administration
Posology
The starting and recommended dos