Sidena 50 mg Tablets

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Sildenafil

Verfügbar ab:

Rowex Ltd

ATC-Code:

G04BE; G04BE03

INN (Internationale Bezeichnung):

Sildenafil

Dosierung:

50 milligram(s)

Darreichungsform:

Tablet

Verschreibungstyp:

Product subject to prescription which may not be renewed (A)

Therapiebereich:

Drugs used in erectile dysfunction; sildenafil

Berechtigungsstatus:

Marketed

Berechtigungsdatum:

2009-10-09

Gebrauchsinformation

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
• Always take this medicine exactly as described in this leaflet or
as your pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or
nurse.
• 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.
• You must talk to a doctor if you have taken Sidena as directed and
were not able to get or keep an erection firm
enough for sex.
WHAT IS IN THIS LEAFLET
1. What Sidena is and what it is used for
2. What you need to know before you take Sidena
3. How to take Sidena
4. Possible side effects
5. How to store Sidena
6. Contents of the pack and other information
PACKAGE LEAFLET: INFORMATION FOR THE USER
SIDENA 50 MG TABLETS
sildenafil
Continued on the next page
››
1
WHAT
SIDENA IS AND WHAT IT IS
USED FOR
Sidena 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. Sidena will only help you to get an
erection if you are sexually stimulated.
Sidena is a treatment for adult men with erectile
dysfunction.
Erectile dysfunction, also known as impotence, is an
inability to achieve or maintain an erection that is
firm enough to have sex. Erections depend on many
different factors, including proper blood flow to the
penis. Reduced blood flow to the penis may cause
erectile dysfunction. Erectile dysfunction can affect
men differently. Some cannot achieve an erection.
Others may achieve an erection, but not firm enough
for having sex or they may lose the erection before or
during sex.
2
WHAT YOU NEED TO KNOW BEFORE YOU
TAKE SIDENA
DO NOT TAKE
SIDENA
:
• if you do not have an erection problem
• if you are all

Fachinformation

Health Products Regulatory Authority
26 October 2022
CRN00D789
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sidena 50 mg Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of sildenafil (as citrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Sidena 50 mg Tablet is a light blue, round, slightly dotted tablet
with cross breaking notch on one side and debossment “50”
on the other side.
The tablet can be divided into four equal doses.
Only intake of the whole tablet or concomitant intake of two quarters
is covered by posology.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sildenafil 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. 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).
Patients should be advised that they may need to take Sidena a number
of times on different occasions (a maximum of one 50
mg tablet per day), before they can achieve a penile erection
satisfactory for sexual activity. If after several attempts on
different dosing occasions patients are still not able to achieve a
penile erection sufficient for satisfactory sexual activity, they
should be advised to consult a doctor.
Special populations
_Elderly_
Dosage adjustments are not required in elderly patients (≥ 65 years
old).
_Renal impairment_
Health Products Regulatory Authority
26 October 2022
CRN00D789
Page 2 of 13
No dosage adjustments are required for patients with mild to moderate
renal impairment. However, since sildenafil clearance is
reduced in individuals with se