PRILIGY dapoxetine 30 mg (as hydrochloride) film-coated tablet blister pack

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

dapoxetine hydrochloride, Quantity: 33.6 mg (Equivalent: dapoxetine, Qty 30 mg)

Tilgjengelig fra:

A Menarini Australia Pty Ltd

INN (International Name):

dapoxetine hydrochloride

Legemiddelform:

Tablet, film coated

Sammensetning:

Excipient Ingredients: croscarmellose sodium; titanium dioxide; colloidal anhydrous silica; magnesium stearate; lactose monohydrate; iron oxide yellow; microcrystalline cellulose; hypromellose; triacetin; iron oxide black

Administreringsrute:

Oral

Enheter i pakken:

6 tablets, 18 tablets, 3 tablets, 1 tablet (sample pack)

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

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.

Produkt oppsummering:

Visual Identification: Light grey, circular, convex, film-coated tablets debossed with "30" inside a triangle on one side and blank on the other side; Container Type: Blister Pack; Container Material: PVC/PE/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Autorisasjon status:

Licence status A

Autorisasjon dato:

2010-09-02

Informasjon til brukeren

WARNING:
PRILIGY can make you faint. You may experience warning symptoms such
as nausea, dizziness or light-headedness before
you faint. Immediately lie down or sit down with your head between
your knees if you feel nauseous, dizzy or light-headed
until the symptoms pass. This will prevent falls and injury. (see
While you are taking PRILIGY and Side Effects).
Do not take more than one PRILIGY tablet once every 24 hours due to
the increased risk of fainting.
PRILIGY
®
_dapoxetine hydrochloride_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about PRILIGY.
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 taking PRILIGY
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT PRILIGY IS USED
FOR
PRILIGY is a treatment for
premature ejaculation (PE) in men 18
to 64 years old who have all of the
following:
•
ejaculation in less than 2 minutes
following vaginal penetration, on
most occasions, with little
stimulation and before the man
wishes to; and
•
marked personal distress and
interpersonal difficulty as a result
of premature ejaculation
(premature ejaculation troubles
the man and his partner); and
•
poor control over ejaculation.
PRILIGY contains the active
ingredient dapoxetine and is a type of
drug called a selective serotonin
reuptake inhibitor (SSRI) and it is
also known as a urological medicine.
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 THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This me

Preparatomtale

WARNING-SYNCOPE: Patients on PRILIGY need to be made aware that they
could experience
syncope at any time with or without prodromal symptoms during their
treatment with PRILIGY.
Syncope characterized as loss of consciousness has been reported in
clinical trials and is
considered medicinal product-related. A dose-response relationship
is suggested. Prodromal
symptoms (such as nausea, dizziness or light-headedness) often
preceded the syncope. Patients
should be counselled about the importance of maintaining adequate
hydration, and about how to
recognise and act upon prodromal signs and symptoms (see section 4.4
SPECIAL WARNINGS
AND PRECAUTIONS FOR USE) to decrease the likelihood of serious injury
associated with falls
due to loss of consciousness. Patients must not take more than one
tablet once every 24 hours
due to increased risk.
AUSTRALIAN PRODUCT INFORMATION –
PRILIGY

DAPOXETINE HYDROCHLORIDE TABLET
Priligy PI vA07-0
Page 1 of 25
1. NAME OF THE MEDICINE
Dapoxetine (as hydrochloride)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
PRILIGY is available as 30 mg tablets. Each PRILIGY 30 mg film-coated
tablet contains 30 mg
of dapoxetine base (as hydrochloride).
Excipient with known effect: Contains lactose.
For the full list of excipients, see section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
PRILIGY 30 mg: light grey film-coated tablets debossed with “30”
inside a triangle on one side.
4. CLINICAL PARTICULARS
4.1 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.
Priligy PI vA07-0
Page 2 of 25
4.2 DOSE AND METHOD OF ADMINISTRATION
For oral use. Tablets shou