Brintellix

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Vortioxetine

Available from:

H. Lundbeck A/S

ATC code:

N06AX26

INN (International Name):

vortioxetine

Therapeutic group:

Psychoanaleptics,

Therapeutic area:

Depressive Disorder, Major

Therapeutic indications:

Treatment of major depressive episodes in adults.

Product summary:

Revision: 23

Authorization status:

Authorised

Authorization date:

2013-12-18

Patient Information leaflet

72
B. PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BRINTELLIX 5 MG FILM-COATED TABLETS
vortioxetine
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.
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 sleep), reduced
appetite, difficulty in
concentrating, feelings of worthlessness, loss of interest in
favourite activities, feeling of being slowed
down.
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 monoamine oxidase
inhibitors or selective MAO-A inhibitors. Ask your doctor if you are
uncertain.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Brintellix if you:
-
are taking medicines with a so-called serotonergic effect, such as:
-
tramadol and similar medicines (strong painkillers).
-
sumatr

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
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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 (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.
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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 dep