Sildenafil Jubilant 50mg coated Tablets

País: Malta

Idioma: inglés

Fuente: Medicines Authority

Ingredientes activos:

SILDENAFIL

Disponible desde:

Jubilant Pharmaceuticals nv Axxes Business Park, Guldensporenpark 22 – Block C, 9820 Merelbeke, Belgium

Código ATC:

G04BE03

Designación común internacional (DCI):

SILDENAFIL 50 mg

formulario farmacéutico:

FILM-COATED TABLET

Composición:

SILDENAFIL 50 mg

tipo de receta:

POM

Área terapéutica:

UROLOGICALS

Estado de Autorización:

Withdrawn

Fecha de autorización:

2013-04-09

Información para el usuario

Jubilant Pharmaceuticals nv 
Sildenafil Jubilant 25 mg film-coated tablets 
Sildenafil Jubilant 50 mg film-coated tablets 
Sildenafil Jubilant 100 mg film-coated tablets 

PIL – p. 1/7 

January 2014 

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT 

SILDENAFIL JUBILANT 25 MG FILM-COATED TABLETS 
SILDENAFIL JUBILANT 50 MG FILM-COATED TABLETS 
SILDENAFIL JUBILANT 100 MG FILM-COATED TABLETS 

Sildenafil  

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 signs of illness 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 Sildenafil Jubilant is and what it is used for 
2. 
What you need to know before you take Sildenafil Jubilant  
3. 
How to take Sildenafil Jubilant  
4. 
Possible side effects 
5. 
How to store Sildenafil Jubilant  
6. 
Contents of the pack and other information 

1. 
WHAT SILDENAFIL JUBILANT IS AND WHAT IT IS USED FOR 

Sildenafil Jubilant contains the active substance sildenafil which
belongs to a group of 
medicines called phosphodiesterase type 5 (PDE5) inhibitors. It works
by helping to 
relax the blood vessels in your penis, allowing blood to flow into
your penis when you 
get sexually excited. Sildenafil Jubilant will only help you to get
an erection if you are 
sexually stimulated.  

Sildenafil Jubilant is a treatment for adult men with erectile
dysfunction, sometimes 
known as impotence. This is when a man cannot get, or keep a hard,
erect penis 
suitable for sexual activity. 

2. 
WHAT YOU NEED TO KNOW BEFO

Ficha técnica

Jubilant Pharmaceuticals nv 
Sildenafil Jubilant 25 mg film-coated tablets 
Sildenafil Jubilant 50 mg film-coated tablets 
Sildenafil Jubilant 100 mg film-coated tablets 

SPC – p. 1/16 

January 2014 

SUMMARY OF THE PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Sildenafil Jubilant 25 mg film-coated tablets 
Sildenafil Jubilant 50 mg film-coated tablets 
Sildenafil Jubilant 100 mg film-coated tablets 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each tablet contains 25 mg of sildenafil (as citrate). 
Each tablet contains 50 mg of sildenafil (as citrate). 
Each tablet contains 100 mg of sildenafil (as citrate). 

Excipient with known effect:  
Each tablet contains 1.8 mg lactose monohydrate. 
Each tablet contains 3.6 mg lactose monohydrate. 
Each tablet contains 7.2 mg lactose monohydrate. 

For the full list of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 

Film-coated tablet. 

Sildenafil Jubilant 25 mg film-coated tablets  are white coloured,
oval shaped, 
biconvex, film coated tablets, of 2.9 mm thickness, 10.4 mm length
and 5.6 mm 
width, plain on one side and debossed with ‘B9’ on one the other
side. 

Sildenafil Jubilant 50 mg film-coated tablets  are white coloured,
oval shaped, 
biconvex, film coated tablets, of 3.8 mm thickness, 12.8 mm length
and 7.4 mm 
width, plain on one side and debossed with ‘C1’ on one the other
side. 

Sildenafil Jubilant 100 mg film-coated tablets  are white coloured,
oval shaped, 
biconvex, film coated tablets, of 5.0 mm thickness, 16.2 mm length
and 8.1 mm 
width, plain on one side and debossed with ‘436’ on one the other
side. 

4. CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Sildenafil Jubilant is indicated in adult men with erectile
dysfunction, which is 
the inability to achieve or maintain a penile erection sufficient
for satisfactory 
sexual performance. 

In order for Sildenafil Jubilant to be effective, s