Sildenafil Actavis
Country: European Union
Language: English
Source: EMA (European Medicines Agency)
Patient Information leaflet
(PIL)
13-11-2023
Summary of Product characteristics
(SPC)
13-11-2023
Public Assessment Report
(PAR)
11-05-2015
Active ingredient:
sildenafil
Available from:
Actavis Group PTC ehf
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 Actavis to be effective, sexual stimulation is required.
Product summary:
Revision: 17
Authorization status:
Authorised
Authorization date:
2009-12-10
Patient Information leaflet
30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SILDENAFIL ACTVIS 25 MG, 50 MG AND 100 MG FILM-COATED TABLETS
SILDENAFIL ACTAVIS 25 MG FILM-COATED TABLETS
SILDENAFIL ACTAVIS 50 MG FILM-COATED TABLETS
SILDENAFIL ACTAVIS 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 Actavis is and what it is used for
2.
What you need to know before you take Sildenafil Actavis
3.
How to take Sildenafil Actavis
4.
Possible side effects
5.
How to store Sildenafil Actavis
6.
Contents of the pack and other information
1.
WHAT SILDENAFIL ACTAVIS IS AND WHAT IT IS USED FOR
Sildenafil Actavis 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 Actavis
will only help you to get an erection if you are sexually stimulated.
Sildenafil Actavis 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 ACTAVIS
DO NOT TAKE SILDENAFIL ACTAVIS
-
If you are allergic to sildenafil or any of the other ingredients of
this medicine (listed in section
6).
-
If you are taking medicines called nitrates, as the combination may
lead to a dangerous fall in
your blood pressure
Read the complete document
Summary of Product characteristics
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Sildenafil Actavis 25 mg film-coated tablets
Sildenafil Actavis 50 mg film-coated tablets
Sildenafil Actavis 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sildenafil citrate equivalent to 25, 50 or 100 mg
of sildenafil.
Excipient with known effect
Sildenafil Actavis 25 mg tablets
Each tablet contains 62.38 mg lactose (as monohydrate).
Sildenafil Actavis 50 mg tablets
Each tablet contains 124.76 mg lactose (as monohydrate).
Sildenafil Actavis 100 mg tablets
Each tablet contains 249.52 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Sildenafil Actavis 25 mg film-coated tablets
Sildenafil Actavis 25 mg film-coated tablets are blue elliptical,
biconvex, 10.0 x 5.0 mm and marked
“SL25” on one side.
Sildenafil Actavis 50 mg film-coated tablets
Sildenafil Actavis 50 mg film-coated tablets are blue elliptical,
biconvex, 13.0 x 6.5 mm and marked
“SL50” on one side.
Sildenafil Actavis 100 mg film-coated tablets
Sildenafil Actavis 100 mg film-coated tablets are blue elliptical,
biconvex, 17.0 x 8.5 mm and marked
“SL100” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sildenafil Actavis 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 Actavis 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.
3
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 Actavis is taken with food, the onset of activity
may be delayed compared to the
fasted state (see section 5.2)
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