Vizarsin

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

sildenafil

Saatavilla:

Krka, d.d., Novo mesto

ATC-koodi:

G04BE03

INN (Kansainvälinen yleisnimi):

sildenafil

Terapeuttinen ryhmä:

Urologicals

Terapeuttinen alue:

Erectile Dysfunction

Käyttöaiheet:

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 Vizarsin to be effective, sexual stimulation is required.

Tuoteyhteenveto:

Revision: 19

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2009-09-21

Pakkausseloste

66
B. PACKAGE LEAFLET
67
PACKAGE LEAFLET: INFORMATION FOR THE USER
VIZARSIN 25 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 Vizarsin is and what it is used for
2.
What you need to know before you take Vizarsin
3.
How to take Vizarsin
4.
Possible side effects
5.
How to store Vizarsin
6.
Contents of the pack and other information
1.
WHAT VIZARSIN IS AND WHAT IT IS USED FOR
Vizarsin 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. Vizarsin will only help
you to get an erection if you are sexually stimulated.
Vizarsin 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 VIZARSIN
DO NOT TAKE VIZARSIN
-
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 medicines known as nitric oxide donors
such as amyl nitrite

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Vizarsin 25 mg film-coated tablets
Vizarsin 50 mg film-coated tablets
Vizarsin 100 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains sildenafil citrate equivalent to 25
mg, 50 mg or 100 mg sildenafil.
Excipient with known effect:
_Vizarsin 25 mg film-coated tablets_
Each film-coated tablet contains 1.9 mg lactose (as monohydrate).
_Vizarsin 50 mg film-coated tablets_
Each film-coated tablet contains 3.8 mg lactose (as monohydrate).
_Vizarsin 100 mg film-coated tablets_
Each film-coated tablet contains 7.6 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Vizarsin 25 mg film-coated tablets: White, oblong tablets, marked
“25” on one side.
Vizarsin 50 mg film-coated tablets: White, oblong tablets, marked
“50” on one side.
Vizarsin 100 mg film-coated tablets: White, oblong tablets, marked
“100” on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vizarsin 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 Vizarsin 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 Vizarsin 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).
3
_Renal impairment:_
The dosing recommendations described in ‘Use in adults’ apply to
patients with mild to moderate
renal impairment (creat