PRISTIQ 50 MG EXTENDED- RELEASE TABLETS

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DESVENLAFAXINE SUCCINATE MONOHYDRATE

Boleh didapati daripada:

PFIZER (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

DESVENLAFAXINE SUCCINATE MONOHYDRATE

Unit dalam pakej:

28Tablet Tablets

Dikeluarkan oleh:

PFIZER IRELAND PHARMACEUTICALS

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP_
)
PRISTIQ
® EXTENDED-RELEASE TABLETS
Desvenlafaxine succinate (50 mg, 100 mg)
1
WHAT IS IN THIS LEAFLET
1.
What PRISTIQ is used for
2.
How PRISTIQ works
3.
Before you use PRISTIQ
4.
How to use PRISTIQ
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of PRISTIQ
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT PRISTIQ IS USED FOR
PRISTIQ is used in the treatment of
major depressive disorder (MDD).
HOW PRISTIQ WORKS
PRISTIQ belongs to a class of
medications called
serotonin-noradrenaline reuptake
inhibitors (SNRIs). Serotonin and
noradrenaline are chemical messengers
that allow certain nerves in the brain to
work. PRISTIQ tablets potentiate the
effects of these two messengers. Experts
think this is how it helps to restore your
feeling of wellness.
BEFORE YOU USE PRISTIQ
-
_When you must not use it _
Do not take PRISTIQ
-
if you are allergic to desvenlafaxine,
venlafaxine or any of the other
ingredients of this medicine;
-
if you are also taking, or have taken
within the last 14 days, any
medicines known as Monoamine
oxidase inhibitors (MAOIs), used to
treat depression or Parkinson’s
disease. Taking a reversible MAOI
together with PRISTIQ or in whom
intravenous methylene blue has been
administered can cause serious or
even life-threatening side effects.
Also, you must wait at least 7 days
after you stop taking PRISTIQ
before you take any MAOI.
_Pregnancy and lactation _
You should use PRISTIQ only after
discussing the potential benefits and the
potential risks to your unborn child with
your doctor.
PRISTIQ crosses the human placenta. If
you are taking this medicine during
pregnancy, your baby may not feed
properly, have trouble breathing, or may
encounter prolonged hospitalization. If
your baby has these symptoms when it is
born and you are concerned, contact your
doctor who will be able to advise you.
Consuming PRISTIQ during pregnancy
may cause high blood pressure,
sometimes associa

Ciri produk

Pfizer Confidential
1
PFIZER
PRISTIQ
®
DESVENLAFAXINE SUCCINATE
1.
NAME OF THE MEDICINAL PRODUCT
PRISTIQ
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
50 mg
Each extended-release tablets contains 75.87 mg of desvenlafaxine
succinate equivalent to 50 mg
desvenlafaxine.
100 mg
Each extended-release tablets contains 151.77 mg of desvenlafaxine
succinate equivalent to
100 mg desvenlafaxine.
3.
PHARMACEUTICAL FORM
50 mg extended-release tablets
Light pink, square (pyramid, one sided), film coated tablets debossed
“W” over '50' on the flat side.
100 mg extended-release tablets
Reddish orange, square (pyramid, one sided), film coated tablets
debossed “W” over '100' on the
flat side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PRISTIQ, a selective serotonin and norepinephrine reuptake inhibitor
(SNRI), is indicated for the
treatment of major depressive disorder (MDD). The efficacy of PRISTIQ
has been established in
four 8-week, placebo controlled studies of outpatients who met DSM-IV
criteria for major depressive
disorder.
A major depressive episode (DSM-IV) implies a prominent and relatively
persistent (nearly every
day for at least 2 weeks) depressed or dysphoric mood that usually
interferes with daily functioning,
and includes at least 5 of the following 9 symptoms: depressed mood,
loss of interest in usual
activities, significant change in weight and/or appetite, insomnia or
hypersomnia, psychomotor
agitation or retardation, increased fatigue, feelings of guilt or
worthlessness, slowed thinking or
impaired concentration, or a suicide attempt or suicidal ideation.
The efficacy of PRISTIQ in maintaining a response in major depressive
disorder for up to 24 weeks
following
12
weeks
of
acute
treatment
was
demonstrated
in
a
placebo-controlled
trial.
Nevertheless, the physician who elects to use PRISTIQ for extended
periods, i.e., beyond 9
months, should continue to periodically re-evaluate the long-term
usefulness of the drug for the
individual patients.
Pfizer Confidential
2
4.2
POSOLOGY AND METHOD OF AD