Sildenafil Mylan 25 mg film-coated tablets

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Sildenafil

Available from:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC code:

G04BE; G04BE03

INN (International Name):

Sildenafil

Dosage:

25 milligram(s)

Pharmaceutical form:

Film-coated tablet

Prescription type:

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

Therapeutic area:

Drugs used in erectile dysfunction; sildenafil

Authorization status:

Not marketed

Authorization date:

2010-11-19

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SILDENAFIL MYLAN 25 MG FILM-COATED TABLETS
SILDENAFIL MYLAN 50 MG FILM-COATED TABLETS
SILDENAFIL MYLAN 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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4
WHAT IS IN THIS LEAFLET
1.
What Sildenafil Mylan is and what it is used for
2.
What you need to know before you take Sildenafil Mylan
3.
How to take Sildenafil Mylan
4.
Possible side effects
5.
How to store Sildenafil Mylan
6.
Contents of the pack and other information
1.
WHAT SILDENAFIL MYLAN IS AND WHAT IT IS USED FOR
Sildenafil Mylan belongs to a group of medicines called
phosphodiesterase type 5 (PDE 5) 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 Mylan will only help you to
get an erection if you are
sexually stimulated.
Sildenafil Mylan 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 MYLAN
DO NOT TAKE SILDENAFIL MYLAN
-
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”). If you are not
cert

Summary of Product characteristics

Health Products Regulatory Authority
05 August 2022
CRN00CZD5
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sildenafil Mylan 25 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg of sildenafil as sildenafil citrate
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet
Blue film-coated, round biconvex tablets debossed with ‘M’ on one
side and ‘SL over 25’ on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sildenafil Mylan 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 Mylan 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.
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 should be considered.
Based on efficacy and tolerability, the dose may be increased
step-wise to 50 mg up to 100 mg as necessary.
_Paediatric population_
Sildenafil Mylan is not indicated for individuals below 18 years of
a