Sildenafil ratiopharm

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

sildenafil

Available from:

Ratiopharm GmbH

ATC code:

G04BE03

INN (International Name):

sildenafil

Therapeutic group:

Urologicals

Therapeutic area:

Erectile Dysfunction

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 to be effective, sexual stimulation is required.

Product summary:

Revision: 19

Authorization status:

Authorised

Authorization date:

2009-12-23

Patient Information leaflet

29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SILDENAFIL RATIOPHARM 25 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 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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Sildenafil ratiopharm is and what it is used for
2.
What you need to know before you take Sildenafil ratiopharm
3.
How to take Sildenafil ratiopharm
4.
Possible side effects
5.
How to store Sildenafil ratiopharm
6.
Contents of the pack and other information
1.
WHAT SILDENAFIL RATIOPHARM IS AND WHAT IT IS USED FOR
WHAT SILDENAFIL RATIOPHARM IS
Sildenafil ratiopharm contains the active substance sildenafil which
belongs to a group of medicines
called phosphodiesterase type 5 (PDE5) inhibitors. This medicine
allows an erection to last long
enough for you to satisfactorily complete sexual activity. It reduces
the action of the natural chemical
in your body, which makes erections go away. Sildenafil ratiopharm
will only work when you are
sexually stimulated.
WHAT SILDENAFIL RATIOPHARM IS USED FOR
Sildenafil ratiopharm 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 BEFORE YOU TAKE SILDENAFIL RATIOPHARM
DO
NOT TAKE SILDENAFIL RATIOPHARM
-
if you are allergic to sildenafil or any of the other ingredients of
this medicine (listed in section
6).
-
if you are taking medicines that contain nitrates (e.g. glycerol
trinitrate) or nitric oxide donors
(e.g. amyl nitrite, also called “

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Sildenafil ratiopharm 25 mg film-coated tablets
Sildenafil ratiopharm 50 mg film-coated tablets
Sildenafil ratiopharm 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sildenafil ratiopharm 25 mg film-coated tablets
Each film-coated tablet contains sildenafil citrate equivalent to 25
mg of sildenafil.
Sildenafil ratiopharm 50 mg film-coated tablets
Each film-coated tablet contains sildenafil citrate equivalent to 50
mg of sildenafil.
Sildenafil ratiopharm 100 mg film-coated tablets
Each film-coated tablet contains sildenafil citrate equivalent to 100
mg of sildenafil.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Sildenafil ratiopharm 25 mg film-coated tablets
White to off-white, oblong film-coated tablet with edge.
Sildenafil ratiopharm 50 mg film-coated tablets
White to off-white, oblong film-coated tablet with edge and score line
on one side. The tablet can be
divided into equal doses.
Sildenafil ratiopharm 100 mg film-coated tablets
White to off-white, oblong film-coated tablet with edge and score line
on one side. The tablet can be
divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sildenafil ratiopharm 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 to be effective, sexual stimulation is
required.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
_Use in adults _
The recommended dose is 50 mg taken as needed approximately one hour
before sexual activity.
Based on efficacy and tolerability, 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
day. If sildenafil is taken with food, the onset of activity may be
delayed compared to the fasted state
(see section 5.2).
3
_Special populations _
_ _
Elderl