Sildenafil Torrent 50mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SILDENAFIL

Available from:

Torrent Pharma GmbH Südwestpark 50, 90459 Nürnberg, Germany

ATC code:

G04BE03

INN (International Name):

SILDENAFIL 50 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

SILDENAFIL 50 mg

Prescription type:

POM

Therapeutic area:

UROLOGICALS

Authorization status:

Withdrawn

Authorization date:

2013-01-02

Patient Information leaflet

Sildenafil Torrent 25 mg - 50 mg - 100 mg film-coated tablets –
AT/H/0408/001-003/DC  
Page 1 
MT pl 
mt/p/004/13/3 

PACKAGE LEAFLET: INFORMATION FOR THE USER 

SILDENAFIL TORRENT 25 MG FILM-COATED TABLETS 
SILDENAFIL TORRENT 50 MG FILM-COATED TABLETS 
SILDENAFIL TORRENT 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, please ask your doctor
or pharmacist. 
  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 or pharmacist. This includes any possible side effects 
not listed in this leaflet. 

WHAT IS IN THIS LEAFLET 
1. What Sildenafil Torrent is and what it is used for 
2. What you need to know before you take Sildenafil Torrent 
3. How to take Sildenafil Torrent 
4. Possible side effects 
5. How to store Sildenafil Torrent 
6. Contents of the pack and other information 

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

Sildenafil Torrent 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 Torrent will only help you
to get an erection if you are sexually 
stimulated. You should not take Sildenafil Torrent if you do not have
erectile dysfunction. You should 
not take Sildenafil Torrent if you are a woman. 

Sildenafil Torrent is a treatment for 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 BEFORE YO

Summary of Product characteristics

SmPC_Sildenafil 
1
SUMMARY OF PRODUCT CHARACTERISTICS 

1. NAME OF THE MEDICINAL PRODUCT 

Sildenafil Torrent 25 mg film-coated tablets 
Sildenafil Torrent 50 mg film-coated tablets 
Sildenafil Torrent 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) 
For the full list of excipients, see section 6.1. 

3. PHARMACEUTICAL FORM 

Film-coated tablet. 
Sildenafil Torrent 25 mg film-coated tablets 
Blue, round (diameter approx. 7.1 mm), biconvex, film coated
tablets, debossed with ‘86’on one side 
and plain on the other side 

Sildenafil Torrent 50 mg film-coated tablets 
Blue, round (diameter approx. 9.6 mm), biconvex, film coated
tablets, debossed with ‘8’ Bisect ‘7’ on 
one side and plain on the other side. The tablet can be divided into
equal doses. 

Sildenafil Torrent 100 mg film-coated tablets 
Blue, round (diameter approx. 12.3 mm), biconvex, film coated
tablets, debossed with ‘8’ Bisect ‘8’ 
on one side and plain on the other side. The tablet can be divided
into equal doses. 

_ _
4. CLINICAL PARTICULARS 

4.1 THERAPEUTIC INDICATIONS 

Treatment of men with erectile dysfunction, which is the
inability to achieve or maintain a penile 
erection sufficient for satisfactory sexual performance. 

In order for Sildenafil Torrent to be effective, sexual stimulation is
required. 

4.2 POSOLOGY AND METHOD OF ADMINISTRATION 

For oral use. 
_ _
USE IN ADULTS: 
The recommended dose is 50 mg taken as needed approximately one
hour before sexual activity. 
Based on efficacy and toleration, the dose may be increased to
100 mg or decreased to 25 mg. The 
maximum recommended dose is 100 mg. The maximum recommended dosing
frequency is once per 
SmPC_Sildenafil 
2
day. If Sildenafil Torrent is taken wit