SILDENAFIL PFIZER 50 Milligram Film Coated Tablet

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

SILDENAFIL CITRATE

Dostupné s:

LTT Pharma Limited

INN (Mezinárodní Name):

SILDENAFIL CITRATE

Dávkování:

50 Milligram

Léková forma:

Film Coated Tablet

Druh předpisu:

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

Stav Autorizace:

Authorised

Datum autorizace:

0000-00-00

Informace pro uživatele

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.
Your medicine is called Sildenafil Pfizer 50mg film-coated tablets but
will be
referred to as Sildenafil Pfizer throughout this leaflet.
Please note that the leaflet also contains information about other
strengths
of the medicine, Sildenafil Pfizer 25mg film-coated tablets and
Sildenafil
Pfizer 100mg film-coated tablets
IN THIS LEAFLET:
What Sildenafil Pfizer is and what it is used for   
What you need to know before you take Sildenafil Pfizer
How to take Sildenafil Pfizer
Possible side effects 
How to store Sildenafil Pfizer 
Contents of the pack and other information
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.
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 t

Charakteristika produktu

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sildenafil Pfizer 50 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 50 mg of sildenafil (as citrate)
Excipient with known effect: Lactose
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Film-coated tablet.
_Product imported from the UK._
White to off-white, rounded diamond-shaped tablets of dimensions 11.2 x 8.1mm marked “50” 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 patients_
Dosage adjustments are not required in elderly patients ( 65 years old).
_Patients with 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.
_Patie