Priligy Tablet 60mg

País: Cingapura

Língua: inglês

Origem: HSA (Health Sciences Authority)

Ingredientes ativos:

Dapoxetine eqv to dapoxetine hydrochloride 67.20mg

Disponível em:

A. MENARINI SINGAPORE PTE. LTD.

Código ATC:

G04BX14

Dosagem:

60mg

Forma farmacêutica:

TABLET, FILM COATED

Composição:

Dapoxetine eqv to dapoxetine hydrochloride 67.20mg 60mg

Via de administração:

ORAL

Tipo de prescrição:

Prescription Only

Fabricado por:

MENARINI - VON HEYDEN GmbH

Status de autorização:

ACTIVE

Data de autorização:

2010-11-09

Folheto informativo - Bula

1

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: Lactose 

For a 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 and debossed with
“30” inside a triangle 
on one side. 
The 60 mg film

coated tablets are grey, round, convex 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 men 18 to 64 years of age. 

The following conditions were fulfilled in the
clinical studies of PE: 


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. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

For oral use. Tablets should be swallowed whole to avoid the
bitter taste. It is recommended that 
tablets be taken with at least one full glass of water.
Patients should be cautioned to avoid situations 
where injury could
result, including driving or operating hazardous machinery,
should syncope or its 
prodromal symptoms such as dizziness or lightheadedness
occur (see section 4.4). 

Adult men (18 to 64 years of age) 

Before treatment is initiated, the physician should obtain
a careful medical history focusing on past 
orthostatic events and also p

Características técnicas

1
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
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 and debossed with
“30” inside a triangle
on one side.
The 60 mg film

coated tablets are grey, round, convex 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 men 18 to 64 years of age.
The following conditions were fulfilled in the clinical studies of PE:

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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral use. Tablets should be swallowed whole to avoid the bitter
taste. It is recommended that
tablets be taken with at least one full glass of water. Patients
should be cautioned to avoid situations
where injury could result, including driving or operating hazardous
machinery, should syncope or its
prodromal symptoms such as dizziness or lightheadedness occur (see
section 4.4).
Adult men (aged 18 to 64 years)
Before treatment is initiated, the physician should obtain a careful
medical history focusing on past
orthostatic events and also perform an orthostatic test (blood
pressure and pulse rate, supine and
standing). If the patient discloses a history suggestive of
orthostatic reactions or an orthostatic test
shows this kind of reaction, treatment with Priligy should be avoided.
The recomme