Sibefil 50 mg chewable tablets

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SILDENAFIL

Available from:

PharmSol Europe Limited The Victoria Centre Unit 2, Lower Ground Floor, Valletta Road, Mosta MST 9012 , Malta

ATC code:

G04BE03

INN (International Name):

SILDENAFIL 50 mg

Pharmaceutical form:

CHEWABLE TABLET

Composition:

SILDENAFIL 50 mg

Prescription type:

POM

Therapeutic area:

UROLOGICALS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2021-02-02

Patient Information leaflet

PIL - Sibefil chewable tablets
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SIBEFIL 25 MG CHEWABLE TABLETS
SIBEFIL 50 MG CHEWABLE TABLETS SIBEFIL 100 MG CHEWABLE 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, 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 Sibefil is and what it is used for
2.
What you need to know before you take Sibefil
3.
How to take Sibefil
4.
Possible side effects
5.
How to store Sibefil
6.
Contents of the pack and other information
1.
WHAT SIBEFIL IS AND WHAT IT IS USED FOR
Sibefil
contains
the
active
substance
sildenafil
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.
Sibefil will only help you to get an
erection if you are sexually stimulated.
Sibefil 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 SIBEFIL
DO NOT TAKE SIBEFIL:
­
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
certain, ask your doctor or pharmacist.
­
If yo

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sibefil 25 mg chewable tablets
Sibefil 50 mg chewable tablets
Sibefil 100 mg chewable tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sibefil 25 mg contains 25 mg sildenafil formed in situ from 35.12 mg
sildenafil citrate.
Sibefil 50 mg contains 50 mg sildenafil formed in situ from 70.24 mg
sildenafil citrate.
Sibefil 100 mg contains 100 mg sildenafil formed in situ from 140.48
mg sildenafil citrate.
Excipients with known effect
Sibefil 25 mg: Each chewable tablet contains 2.15 mg of aspartame,
70.457 mg of lactose monohydrate
and 0.702 mg of sodium.
Sibefil 50 mg: Each chewable tablet contains 4.30 mg of aspartame,
140.915 mg of lactose monohydrate
and 1.404 mg of sodium.
Sibefil 100 mg: Each chewable tablet contains 8.60 mg of aspartame,
281.83 mg of lactose monohydrate
and 2.808 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Chewable tablet
Sibefil 25 mg: White, triangular, biconvex, embossed with “25” on
one side
with diameter of 7.3 x 7.0 +
0.2 mm, nominal thickness 3.7±0.3 mm
Sibefil 50 mg: White, triangular, biconvex, embossed with “50” on
one side with diameter of 8.8 x 8.6 +
0.2 mm, nominal thickness 4.7±0.3 mm
Sibefil 100 mg: White, triangular, biconvex, embossed with “100”
on one side with diameter of 11.8 x
11.6 + 0.2 mm, nominal thickness 5.8±0.3 mm
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Sibefil 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 Sibefil to be effective, sexual stimulation is required.
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Use in adults _
2
The recommended dose is 50 mg taken as needed approximately one hour
before sexual activity.
The tablets should be chewed before swallowed.
Based on efficacy and tolerability, the dose may be increased to 100
mg or decreased to 25 mg. The
maximum recommended dose is 10