Sildenafil 50mg film-coated Tablets

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

SILDENAFIL

Tilgjengelig fra:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC-kode:

G04BE03

INN (International Name):

SILDENAFIL 50 mg

Legemiddelform:

FILM-COATED TABLET

Sammensetning:

SILDENAFIL 50 mg

Resept typen:

POM

Terapeutisk område:

UROLOGICALS

Autorisasjon status:

Authorised

Autorisasjon dato:

2013-08-08

Informasjon til brukeren

PAGE 1 OF 6
PACKAGE LEAFLET: INFORMATION FOR THE USER
SILDENAFIL 50 MG FILM-COATED TABLETS
SILDENAFIL 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 is and what it is used for
2.
What you need to know before you take Sildenafil
3.
How to take Sildenafil
4.
Possible side effects
5.
How to store Sildenafil
6.
Contents of the pack and other information
1.
WHAT SILDENAFIL IS AND WHAT IT IS USED FOR
Sildenafil contains the active substance sildenafil which 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 will only help
you to get an erection if you are sexually stimulated.
Sildenafil 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
DO NOT TAKE SILDENAFIL:
-
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 you are using any of the medicinesk

Preparatomtale

PAGE 13 OF 13
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sildenafil 50 mg film-coated tablets
Sildenafil 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 50 mg Sildenafil (as sildenafil
citrate).
Each film-coated tablet contains 100 mg Sildenafil (as sildenafil
citrate).
Excipient with known effect:
Each 50 mg film-coated tablet contains 3.7 mg lactose monohydrate.
Each 100 mg film-coated tablet contains 7.3 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Sildenafil 50 mg film-coated tablets
White to off-white, round (9.6 mm diameter), biconvex film-coated
tablets debossed with “SL” on one
side and 50 on the other side.
Sildenafil 100 mg film-coated tablets
White to off-white, round (11.2 mm diameter), biconvex film-coated
tablets debossed with “SL” on
one side and 100 on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Sildenafil 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 to be effective, sexual stimulation is
required.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
USE IN ADULTS
The recommended dose is 50mg taken as needed approximately one hour
before sexual activity. Based
on efficacy and tolerability, the dose may be increased to 100mg or
decreased to 25mg. The maximum
recommended dose is 100 mg. The maximum recommended dosing frequency
is once per day. If
Sildenafil 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).
PAGE 13 OF 13
Since sildenafil clearance is