Priligy 60 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Dapoxetine

Available from:

A. Menarini Pharmaceuticals Ireland Ltd

ATC code:

G04BX; G04BX14

INN (International Name):

Dapoxetine

Dosage:

60 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Other urologicals; dapoxetine

Authorization status:

Marketed

Authorization date:

2012-03-02

Patient Information leaflet

1
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 clearly) or

Summary of Product characteristics

Health Products Regulatory Authority
19 October 2021
CRN00CDL5
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Priligy 60 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains dapoxetine hydrochloride equivalent
to 60 mg dapoxetine.
Excipient with known effect: 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 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 INDICATIONS
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.
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 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 pati