Sidena 25 mg tablets

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Sildenafil

Dostupno od:

Rowex Ltd

ATC koda:

G04BE; G04BE03

INN (International ime):

Sildenafil

Doziranje:

25 milligram(s)

Farmaceutski oblik:

Tablet

Tip recepta:

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

Područje terapije:

Drugs used in erectile dysfunction; sildenafil

Status autorizacije:

Marketed

Datum autorizacije:

2009-10-09

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SIDENA 25 MG TABLETS
SIDENA 50 MG TABLETS
SIDENA 100 MG 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 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
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,
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 SIDENA
DO NOT TAKE SIDENA
-
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. Tell your doctor if you are taking any of these
medicines which are often given for
relief of angina pectoris (or “chest pain”). If you are not
certain, ask your doctor or pharmacist.
-
if you are using any of the medicines known as nitric oxide donors
such as amyl nitrite

Svojstava lijeka

Health Products Regulatory Authority
02 August 2022
CRN00CZ92
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sidena 25 mg tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg of sildenafil (as citrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Tablet
Sidena 25 mg tablet is a light blue, round, slightly dotted tablet
with breaking notch on one side and debossment “25” on the
other side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
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. 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).
Special populations
_Elderly_
Dosage adjustments are not required in elderly patients (≥ 65 years
old).
_Renal impairment_
The dosing recommendations described in "Use in adults" apply to
patients with mild to moderate renal impairment (creatinine
clearance = 30-80 mL/min).
Since sildenafil clearance is reduced in patients with severe renal
impairment (creatinine clearance < 30 mL/min) a 25 mg dose
should be considered. Based on efficacy and tolerability, the dose may
be increased step-wise to 50 mg up to 100 mg as
necessary.
Health Products Regulatory Authority
02 August 2022
CRN00CZ92
Page 2 of 12
_Hepatic impairment_
Since sildenafil clearance is reduced in patients with hep