Priligy 30mg film-coated Tablets

Land: Malta

Sprache: Englisch

Quelle: Medicines Authority

Wirkstoff:

DAPOXETINE

Verfügbar ab:

A. Menarini Pharmaceuticals Ireland Limited Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co Dublin, Ireland

ATC-Code:

G04BX14

INN (Internationale Bezeichnung):

DAPOXETINE 30 mg

Darreichungsform:

FILM-COATED TABLET

Zusammensetzung:

DAPOXETINE 30 mg

Verschreibungstyp:

POM

Therapiebereich:

UROLOGICALS

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2012-02-20

Gebrauchsinformation

Page 1 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
PRILIGY 30 MG FILM
−
COATED TABLETS
PRILIGY 60 MG FILM
−
COATED TABLETS
dapoxetine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their symptoms are the same as yours.
•
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Priligy is and what it is used for
2.
What you need to know before you take Priligy
3.
How to take Priligy
4.
Possible side effects
5.
How to store Priligy
6.
Contents of the pack and other information
1.
WHAT PRILIGY IS AND WHAT IT IS USED FOR
Priligy contains an active substance called ‘dapoxetine’. This
belongs to a group of medicines
called ‘selective serotonin reuptake inhibitors’ (SSRIs). Priligy
may also be known as a ‘urological’
medicine.
Priligy increases the time it takes to ejaculate and can improve the
control over the ejaculation. This
may reduce the frustration or worry about fast ejaculation.
Priligy is used to treat premature ejaculation in adult men aged 18 to
64 years.
Premature ejaculation is when a man ejaculates with little sexual
stimulation and before the man
wants. This can cause problems for the man and may cause problems in
sexual relationships.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE PRILIGY
DO NOT TAKE PRILIGY
•
if you are allergic to dapoxetine or any of the other ingredients of
this medicine (listed in
section 6)
•
if you have heart problems, such as heart failure or problems with the
heart rhythm
•
if you have a history of fainting
•
if you have ever had mania (symptoms include feeling over
−
excited, irritable or not being
able to think clea

Fachinformation

Page 1 of 19
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Priligy 30 mg film
−
coated tablets
Priligy 60 mg film
−
coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film
−
coated tablet contains dapoxetine hydrochloride equivalent to 30 mg or
60 mg
dapoxetine.
Excipient with known effect:
Lactose. Each 30 mg tablet contains 45.88 mg of lactose. Each 60 mg
tablet contains 91.75 mg of
lactose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film
−
coated tablet.
The 30 mg film
−
coated tablets are light grey, round, convex, approximately 6.5 mm in
diameter and
debossed with “30” inside a triangle on one side.
The 60 mg film
−
coated tablets are grey, round, convex, approximately 8 mm in diameter
and
debossed with “60” inside a triangle on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATION
Priligy is indicated for the treatment of premature ejaculation (PE)
in adult men aged 18 to 64 years.
Priligy should only be prescribed to patients who meet all the
following criteria:
•
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; and
•
A history of premature ejaculation in the majority of intercourse
attempts over the prior
6 months.
Priligy should be administered only as on-demand treatment before
anticipated sexual activity.
Priligy should not be prescribed to delay ejaculation in men who have
not been diagnosed with PE.
Page 2 of 19
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adult men (aged 18 to 64 years) _
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