Sildenafil Mylan 50mg film-coated Tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SILDENAFIL CITRATE

Available from:

Mylan Ireland Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

ATC code:

G04BE03

INN (International Name):

SILDENAFIL CITRATE 50 mg

Pharmaceutical form:

FILM-COATED TABLET

Composition:

SILDENAFIL CITRATE 50 mg

Prescription type:

POM

Therapeutic area:

UROLOGICALS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2020-02-24

Patient Information leaflet

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PACKAGE LEAFLET
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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”)

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sildenafil Mylan 25 mg film-coated tablets
Sildenafil Mylan 50 mg film-coated tablets
Sildenafil Mylan 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 25 mg of sildenafil as sildenafil citrate
Each tablet contains 50 mg of sildenafil as sildenafil citrate
Each tablet contains 100 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.
Blue film-coated, round biconvex tablets debossed with ‘M’ on one
side and ‘SL over 50’ on
the other side.
Blue film-coated, round biconvex tablets debossed with ‘M’ on one
side and ‘SL over 100’ 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).
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_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 c