PRILIGY 30 MG FILM COATED-TABLETS

Country: Malaysia

Language: English

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

Active ingredient:

DAPOXETINE HYDROCHLORIDE

Available from:

A. MENARINI SINGAPORE PTE. LTD.

INN (International Name):

DAPOXETINE HYDROCHLORIDE

Units in package:

6Tablet Tablets; 3Tablet Tablets; 1Tablet Tablets

Manufactured by:

Menarini - Von Heyden Gmbh, Leipziger

Patient Information leaflet

_Consumer Medication_
_ _
_Information Leaflet (RiMUP)_
1
PRILIGY
60MG AND 30MG FILM COATED TABLETS
_Dapoxetine Hydrochloride (60mg & 30mg) _
_ _
WHAT IS IN THIS LEAFLET
1.
What Priligy is used for
2.
How Priligy works
3.
Before you use Priligy
4.
How to use Priligy
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Priligy
8.
Product Description
9.
Manufacturer
10.
Product Registration holder
WHAT PRILIGY IS USED FOR
PRILIGY is indicated for the treatment
of premature ejaculation (PE) in men
18 to 64 years of age, who have all of
the following:
•
An
intravaginal
ejaculatory
latency time (IELT) of less than
two minutes
•
Persistent or recurrent ejaculation
with
minimal
sexual
stimulation
before,
on,
or
shortly
after
penetration and before the patient
wishes
•
Marked
personal
distress
or
interpersonal
difficulty
as
a
consequence of PE
•
Poor control over ejaculation HOW PRILIGY WORKS
PRILIGY
containing
the
active
ingredients dapoxetine, is a type of drug
called
a
selective
serotonin
reuptake
inhibitor (SSRI) and belongs to a group
of drugs
known as other
urologicals.
PRILIGY
increases
your
time
to
ejaculation
and
can
improve
your
control over ejaculation and reduce your
distress
over
how
fast
you
ejaculate.
This may improve your satisfaction with
sexual intercourse.
BEFORE YOU USE PRILIGY
_WHEN YOU MUST NOT USE IT_
Do not take Priligy if you have an
allergy to:
•
Any
medicine
containing
dapoxetine
•
Any of the ingredients listed at the
end of this leaflet.
Symptoms of an allergic reaction may
include rash, itching, or hives on the
skin, shortness of breath, wheezing or
difficulty
breathing,
swelling
of
the
face, lips, tongue or other parts of the
body.
DO NOT TAKE PRILIGY:
•
If
you
are
taking
a
MAOI
(monoamine
oxidase
inhibitor)
used to treat depression, or have
taken a MAOI within the last 14
days.
•
If you are taking thioridazine used
to
treat
schizophrenia,
or
have
taken thioridazine within the last
14 days.
•
If
you
are
taking
a
selective
serotonin
reuptake
inhibitor
(SSRI),

Summary of Product characteristics

1
NAME OF THE MEDICINAL PRODUCT
PRILIGY (dapoxetine hydrochloride)
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each PRILIGY 30 mg film-coated tablet contains 30 mg of dapoxetine
base (33.60 mg
dapoxetine hydrochloride).
Each PRILIGY 60 mg film-coated tablet contains 60 mg of dapoxetine
base
(67.20 mg
dapoxetine hydrochloride).
The
chemical
name
is
(+)-(S)-N,
N-dimethyl-(
α
)-[2-(1-naphthalenyloxy)
ethyl]-
benzenemethanamine hydrochloride.
For excipients, see List of Excipients.
PHARMACEUTICAL FORM
PRILIGY Tablets are round, convex, film-coated tablets.
30 mg: light grey tablets debossed with “30” inside a triangle on
one side 60 mg:
grey tablets debossed with “60” inside a triangle on one side
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
PRILIGY is indicated for the treatment of premature ejaculation (PE)
in men 18 to
64
years of age, who have all of the following:
•
An intravaginal ejaculatory latency time (IELT) of less than two
minutes; and
•
Persistent or recurrent ejaculation with minimal sexual stimulation
before, on,
or
shortly after penetration and before the patient wishes; and
•
Marked personal distress or interpersonal difficulty as a consequence
of PE; and
•
Poor control over ejaculation.
POSOLOGY AND METHOD OF ADMINISTRATION
_Precautions to be taken before handling or administering the
medicinal product_
_ _
Before treatment is initiated, see Special Warnings and Precautions
for Use regarding
orthostatic hypotension.
2
_ADULT MEN (18 TO 64 YEARS OF AGE)_
The recommended starting dose for all patients is 30 mg, taken as
needed approximately
1 to 3 hours prior to sexual activity. Treatment with Priligy should
not be initiated with the
60 mg dose.
Priligy is not intended for continuous daily use. Priligy should be
taken only when sexual
activity is
anticipated. Priligy must
not
be
taken
more
frequently than
once
every 24
hours.
If the individual response to 30 mg is insufficient and the patient
has not experienced
moderate or severe adverse reactions or prodromal symptoms suggestive
of syn