Priligy

Riik: Uus-Meremaa

keel: inglise

Allikas: Medsafe (Medicines Safety Authority)

Toimeaine:

Dapoxetine hydrochloride 67.2mg equivalent to dapoxetine 60 mg;  

Saadav alates:

A. Menarini New Zealand Pty Ltd

INN (Rahvusvaheline Nimetus):

Dapoxetine hydrochloride 67.2 mg (= dapoxetine 60 mg)

Annus:

60 mg

Ravimvorm:

Film coated tablet

Koostis:

Active: Dapoxetine hydrochloride 67.2mg equivalent to dapoxetine 60 mg   Excipient: Colloidal silicon dioxide Croscarmellose sodium Coating powder Grey 3 Lactose monohydrate as a spray-ried mixture of lactose monohydrate & microcrystalline cellulose Magnesium stearate Microcrystalline cellulose as a spray-ried mixture of lactose monohydrate & microcrystalline cellulose

Ühikuid pakis:

Blister pack, PVC/PE/PVC/Al, 1 tablet

Klass:

Prescription

Retsepti tüüp:

Prescription

Valmistatud:

Olon SpA

Näidustused:

PRILIGY is indicated for the treatment of premature ejaculation (PE) in men 18 to 64 years of age, who have all of the following: · 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.

Toote kokkuvõte:

Package - Contents - Shelf Life: Blister pack, PVC/PE/PVC/Al Sample pack - 1 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PE/PVC/Al - 3 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PE/PVC/Al Sample pack - 3 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PE/PVC/Al - 6 tablets - 36 months from date of manufacture stored at or below 25°C - Blister pack, PVC/PE/PVC/Al - 18 tablets - 36 months from date of manufacture stored at or below 25°C

Loa andmise kuupäev:

2007-12-14

Infovoldik

PRILIGY
PRILIGY
®
TABLETS
_dapoxetine hydrochloride_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about
PRILIGY tablets. It does not contain all the available
information. It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has
weighed the risks of you being given PRILIGY against
the benefits this medicine is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING PRILIGY
ASK YOUR DOCTOR.
KEEP THIS LEAFLET WHILE YOU ARE TAKING PRILIGY
.
You may need to read it again.
WHAT PRILIGY IS USED FOR
PRILIGY is a treatment for men 18 to 64 years old
with
frequent
premature
ejaculation
(PE),
which
troubles the man and affects the relationship with his
sexual partner.
PE is a common sexual disorder in
which
ejaculation
happens
with
minimal
sexual
stimulation before, on, or shortly after penetration, and
before the man wishes it.
PRILIGY, containing the active ingredient 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.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT
WHY PRILIGY HAS BEEN PRESCRIBED FOR YOU.
THIS MEDICINE IS
AVAILABLE ONLY WITH A
DOCTOR’S
PRESCRIPTION.
BEFORE YOU TAKE PRILIGY
WHEN YOU MUST NOT USE IT:
DO NOT TAKE PRILIGY IF YOU ARE ALLERGIC 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.

If you are taking a MAOIs (monoamine oxidase
inhibitors) used to treat depression, or have taken a
MAOIs within the last 14 days.

If
you
are
taki

Toote omadused

CCDS
1
PRILIGY
DATA SHEET
NAME OF THE DRUG
Dapoxetine hydrochloride
DESCRIPTION
Dapoxetine hydrochloride is a selective serotonin reuptake inhibitors
(SSRIs). It belongs to
the pharmacotherapeutic group of other urologicals (ATC code G04BX14).
PRILIGY is available as 30 mg and 60 mg tablets. Each PRILIGY 30 mg
film-coated tablet contains
30 mg of dapoxetine base (as hydrochloride). Each PRILIGY 60 mg
film-coated tablet contains 60
mg
of
dapoxetine
base
(as
hydrochloride).
Inactive
ingredients:
lactose,
cellulose-microcrystalline,
croscarmellose
sodium,
silica-colloidal
anhydrous,
magnesium
stearate, hypromellose, titanium dioxide, iron oxide black, iron oxide
yellow
Dapoxetine hydrochloride is a white to slightly yellow powder. It is
freely soluble in methanol,
propylene glycol, some organic solvents (eg. N,N-dimethylformamide)
and slightly soluble in
ethanol.
The
chemical
name
is
(+)-(S)-N,
N-dimethyl-(
)-[2-(1-naphthalenyloxy)
ethyl]-
benzenemethanamine hydrochloride.
Dapoxetine hydrochloride has the following chemical structure:
. HCl
C
21
H
23
NO.HCl
MW: 341.88
CAS: 129938-20-1
PHARMACOLOGY
PHARMACODYNAMICS
Mechanism of action
The mechanism of action of dapoxetine in premature ejaculation is
presumed to be linked to the
inhibition
of
neuronal
reuptake
of
serotonin
and
the
subsequent
potentiation
of
the
neurotransmitter's action at pre- and post-synaptic receptors.
Human ejaculation is primarily mediated by the sympathetic nervous
system. The ejaculatory
pathway
originates
from
a
spinal
reflex
centre,
mediated
by
the
brain
stem,
which
is
influenced initially by a number of nuclei in the brain (medial
preoptic and paraventricular nuclei).
In
the
rat,
dapoxetine
inhibits
the
ejaculatory
expulsion
reflex
by
acting
at
a
supraspinal level with the lateral paragigantocellular nucleus (LPGi)
as a necessary brain structure
for
the
effect.
Post
ganglionic
sympathetic
fibres
that
innervate
the
seminal
vesicles, vas deferens, prostate, bulbourethral muscles, and bladder
neck cause them to contract
in
a
coordinated
fashio