Sildenafil Pfizer 50 mg film-coated tablets

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Sildenafil

제공처:

Pfizer Healthcare Ireland

ATC 코드:

G04BE03

INN (국제 이름):

Sildenafil

복용량:

50 milligram(s)

약제 형태:

Film-coated tablet

처방전 유형:

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

치료 영역:

sildenafil

승인 상태:

Marketed

승인 날짜:

2012-07-06

환자 정보 전단

Page 1 of 6 Pfleet: 2020-0061670
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SILDENAFIL PFIZER 25 MG FILM-COATED TABLETS
SILDENAFIL PFIZER 50 MG FILM-COATED TABLETS
SILDENAFIL PFIZER 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 an

제품 특성 요약

Health Products Regulatory Authority
14 December 2020
CRN009Z52
Page 1 of 11
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 monohydrate, 2mg per 50mg tablet.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
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 _
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 and 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 should be considered.
Based on efficacy and tolerability,