Brintellix 10mg film-coated tablets

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Vortioxetine hydrobromide

Boleh didapati daripada:

Lundbeck Malaysia Sdn. Bhd.

INN (Nama Antarabangsa):

Vortioxetine hydrobromide

Unit dalam pakej:

14tablet Tablets; 28tablet Tablets

Dikeluarkan oleh:

H.LUNDBECK A/S

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
BRINTELLIX FILM-COATED TABLETS
Vortioxetine (5mg, 10mg, 15mg and 20mg)
1
WHAT IS IN THIS LEAFLET
1.
What Brintellix is used for
2.
How Brintellix works
3.
Before you use Brintellix
4.
How to use Brintellix
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Brintellix
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT BRINTELLIX
IS USED FOR
Brintellix is used to treat major
depressive episodes in adults.
HOW BRINTELLIX WORKS
Brintellix contains the active substance
vortioxetine. It belongs to a group of
medicines called antidepressants.
Brintelix 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.
BEFORE YOU USE BRINTELLIX
_When you must not use it _
-
if you are allergic to vortioxetine or
any of the other ingredients of this
medicine (listed in section Product
Description).
-
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.
_Before you start use it _
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).
•
sumatriptan and similar
medicines with active substance
names ending in “triptans” (used
to treat migraine).
Taking these medicines together
with Brintellix may cause serotonin
syndrome. This syndrome may be
associated with hallucinations,
involuntary twitching, accelerated
heartbeat, high blood pressure,
fever, nausea and diarrhoea.
-
have had fits (seizures).
Your doctor will treat you
cautiously if you have a history of
fits or have unstable fit
disorders/epilepsy. Fits

Ciri produk

PHYSICIAN INFORMATION LEAFLET
BRINTELLIX 5MG FILM-COATED TABLETS
BRINTELLIX 10MG FILM-COATED TABLETS
BRINTELLIX 15MG FILM-COATED TABLETS
BRINTELLIX 20MG FILM-COATED TABLETS
1.
NAME OF MEDICINAL PRODUCT
Brintellix 5mg film-coated tablets
Brintellix 10mg film-coated tablets
Brintellix 15mg film-coated tablets
Brintellix 20mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
5MG FILM-COATED TABLETS
Each film-coated tablet contains vortioxetine hydrobromide equivalent
to 5mg vortioxetine.
For the full list of excipients, see section 6.1
10MG FILM-COATED TABLETS
Each film-coated tablet contains vortioxetine hydrobromide equivalent
to 10mg
vortioxetine.
For the full list of excipients, see section 6.1
15MG FILM-COATED TABLETS
Each film-coated tablet contains vortioxetine hydrobromide equivalent
to 15mg
vortioxetine.
For the full list of excipients, see section 6.1
20MG FILM-COATED TABLETS
Each film-coated tablet contains vortioxetine hydrobromide equivalent
to 20mg
vortioxetine.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
5mg Film-coated Tablets:
Pink, almond-shaped (5 x 8.4mm) film-coated tablet engraved with
“TL” on one side and “5”
on the other side.
10mg Film-coated Tablets:
Yellow, almond-shaped (5 x 8.4mm) film-coated tablet engraved with
“TL” on one side and
“10” on the other side.
15mg Film-coated Tablets:
Orange, almond-shaped (5 x 8.4mm) film-coated tablet engraved with
“TL” on one side and
“15” on the other side.
20mg Film-coated Tablets:
Red, almond-shaped (5 x 8.4mm) 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 the individual patient response, the dose may be
increased to a maximum of
20 mg