Sildenafil 25 mg film-coated tablets

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Sildenafil

متاح من:

Accord Healthcare Ireland Ltd.

ATC رمز:

G04BE; G04BE03

INN (الاسم الدولي):

Sildenafil

جرعة:

25 milligram(s)

الشكل الصيدلاني:

Film-coated tablet

المجال العلاجي:

Drugs used in erectile dysfunction; sildenafil

الوضع إذن:

Not marketed

تاريخ الترخيص:

2019-08-02

نشرة المعلومات

2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SILDENAFIL 25 MG, 50 MG AND 100 MG FILM-COATED
TABLETS
SILDENAFIL 25 MG FILM-COATED
TABLETS
SILDENAFIL 50 MG FILM-COATED
TABLETS
SILDENAFIL 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 is and what it is used for
2.
What you need to know before you take Sildenafil
3.
How to take Sildenafil
4.
Possible side effects
5.
How to store Sildenafil
6.
Contents of the pack and other information
1.
WHAT SILDENAFIL IS AND WHAT IT IS USED FOR
Sildenafil 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 will only help
you to get an erection if you are sexually stimulated.
Sildenafil 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 DO NOT TAKE SILDENAFIL
-
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”).

خصائص المنتج

Health Products Regulatory Authority
07 August 2019
CRN008LKX
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sildenafil 25 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains sildenafil citrate equivalent to 25 mg of
sildenafil.
Excipients with known effect
Each 25 mg tablet contains 62.38 mg lactose (as monohydrate) and 0.480
mg of sodium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Sildenafil 25 mg film-coated tablets are blue elliptical, biconvex,
10.0 x 5.0 mm and marked "SL25" on one side.
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.
_Hepatic impairment_
Since sildenafil clearance is reduced in patients with hepatic
impairment (e.g. cirrhosis) a 25 mg dose shoul