Sildenafil Pfizer 100mg film-coated Tablets

Country: Մալթա

language: անգլերեն

source: Medicines Authority

active_ingredient:

SILDENAFIL

MAH:

Pfizer Hellas S.A.

ATC_code:

G04BE03

INN:

SILDENAFIL

pharmaceutical_form:

FILM-COATED TABLET

composition:

SILDENAFIL 100 milligram(s)

prescription_type:

POM

therapeutic_area:

UROLOGICALS

authorization_status:

Authorised

authorization_date:

2011-03-18

PIL

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

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sildenafil Pfizer 25 mg film-coated tablets
Sildenafil Pfizer 50 mg film-coated tablets
Sildenafil Pfizer 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg, 50 mg or 100 mg of sildenafil (as citrate)
Excipient with known effect: Lactose monohydrate
1 mg per 25 mg tablet
2 mg per 50 mg tablet
4 mg per 100 mg tablet.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
25 mg: White to off-white, rounded diamond-shaped tablets, of
dimensions 9.2 x 6.7 mm,
marked “25”on one side.
50 mg: White to off-white, rounded diamond-shaped tablets, of
dimensions 11.2 x 8.1 mm,
marked “50” on one side.
100 mg: White to off-white, rounded diamond-shaped tablets, of
dimensions 14.1 x 10.2 mm,
marked “100” on one 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 Pfizer 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 Pfizer 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