SILDENAFIL ACCORD

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SILDENAFIL CITRATE

Available from:

Accord Healthcare Limited

ATC code:

G04BE03

INN (International Name):

SILDENAFIL CITRATE

Dosage:

25 Milligram

Pharmaceutical form:

Film Coated Tablet

Prescription type:

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

Therapeutic area:

sildenafil

Authorization status:

Marketed

Authorization date:

2011-05-06

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE
USER
Sildenafil Accord 25mg
Film Coated Tablets
Sildenafil Accord 50 mg
Film Coated Tablets
Sildenafil Accord 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, please 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 tablet is and what it is used for
2. What you need to know before you take
Sildenafil tablets
3. How to take Sildenafil tablets
4. Possible side effects
5. How to store Sildenafil tablets
6. Contents of the pack and other information 1. WHAT SILDENAFIL TABLET IS AND
WHAT IT IS USED FOR
Sildenafil tablets 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 tablets will only help you to get an
erection if you are sexually stimulated.
Sildenafil tablets are used to treat 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 TABLETS
DO NOT TAKE SILDENAFIL TABLETS
− If you are allergic (hypersensitive) to sildenafil
or any of the other ingredients of Sildenafil
tablets (see section 6).
− If you are taking medicines called nitrates, as
the combination may cause a potentially
dangerous decrease in your blood pressure. Tell
your doctor if you are taking any of these
medicines which are often given for relief

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sildenafil Accord 25mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 25 mg of sildenafil (as citrate)
Excipient(s) with known effect: 0.3 mg of lactose monohydrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Blue, almond shaped, biconvex, film coated tablets, debossed with
‘25’ on one side and plain on other side.
4 CLINICAL PARTICULARS
4.1 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 tablets 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
toleration, 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
tablets is taken with food,
the onset
of
activity may be delayed compared to the fasted state (see section
5.2).
_Use in the elderly:_
Dosage adjustments are not required in elderly patients (
65 years old).
_Use in patients with impaired renal function:_
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 toleration, the
dose may be increased to 50 mg and 100 mg.
_Use in patients with impaired hepatic function:_
Since sildenafil
clearance is reduced in patients with hepatic impairment
(e.g.
cirrhosis)
a 25 mg dose should be
considered. Based on efficacy and toleration, the dose may be
increased to 50 mg and 100 mg as necessa