Vardegin 20 mg Filmdragerad tablett

Kraj: Szwecja

Język: szwedzki

Źródło: Läkemedelsverket (Medical Products Agency)

Składnik aktywny:

vardenafilhydrokloridtrihydrat

Dostępny od:

Krka d.d., Novo mesto

Kod ATC:

G04BE09

INN (International Nazwa):

vardenafilhydrokloridtrihydrat

Dawkowanie:

20 mg

Forma farmaceutyczna:

Filmdragerad tablett

Skład:

vardenafilhydrokloridtrihydrat 23,7 mg Aktiv substans

Typ recepty:

Receptbelagt

Status autoryzacji:

Avregistrerad

Data autoryzacji:

2017-03-30

Ulotka dla pacjenta

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VARDEGIN 5 MG FILM-COATED TABLETS
VARDEGIN 10 MG FILM-COATED TABLETS
VARDEGIN 20 MG FILM-COATED TABLETS
Vardenafil
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 Vardegin is and what it is used for
2.
What you need to know before you take Vardegin
3.
How to take Vardegin
4.
Possible side effects
5.
How to store Vardegin
6.
Contents of the pack and other information
1.
WHAT VARDEGIN IS AND WHAT IT IS USED FOR
Vardegin contains vardenafil, a member of a class of medicines called
phosphodiesterase type 5
inhibitors. They are used for the treatment of erectile dysfunction in
adult men, a condition which
implies difficulties in getting or keeping an erection.
At least one in ten men has trouble getting or keeping an erection at
some time. There may be physical
or psychological causes, or a mixture of both. Whatever the cause is,
due to muscle and blood vessel
changes not enough blood stays in the penis to make it hard and keep
it hard.
Vardegin will only work when you are sexually stimulated. It reduces
the action of the natural
chemical in your body which makes erections go away. Vardegin allows
an erection to last long
enough for you to satisfactorily complete sexual activity.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VARDEGIN
DO NOT TAKE VARDEGIN:
-
if you are allergic to vardenafil or any of the other ingredients of
this medicine (listed in section
6).
Signs of an allergic reaction include a rash, itching, swollen face or
lips and shortness of
breath.

Charakterystyka produktu

1.
NAME OF THE MEDICINAL PRODUCT
Vardegin 5 mg film-coated tablets
Vardegin 10 mg film-coated tablets
Vardegin 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
5 mg film-coated tablets:
Each film-coated tablet contains 5 mg vardenafil (as vardenafil
hydrochloride trihydrate).
10 mg film-coated tablets:
Each film-coated tablet contains 10 mg vardenafil (as vardenafil
hydrochloride trihydrate).
20 mg film-coated tablets:
Each film-coated tablet contains 20 mg vardenafil (as vardenafil
hydrochloride trihydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
5 mg film-coated tablets:
Orange-brown, round, slightly biconvex, film-coated tablets with
bevelled edges, engraved with 5 on
one side, 5.5 mm in diameter.
10 mg film-coated tablets:
Orange-brown, oval, slightly biconvex, film-coated tablets, scored on
one side and engraved with 10
on the other side, dimensions 10.5 mm x 5.5 mm. The tablet can be
divided into equal doses.
20 mg film-coated tablets:
Orange-brown, round, biconvex, film-coated tablets with bevelled
edges, scored on one side and
engraved with 20 on the other side, 10 mm in diameter. The tablet can
be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of erectile dysfunction in adult men. Erectile dysfunction
is the inability to achieve or
maintain a penile erection sufficient for satisfactory sexual
performance.
In order for Vardegin to be effective, sexual stimulation is required.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Use in adult men
The recommended dose is 10 mg taken as needed approximately 25 to 60
minutes before sexual
activity. Based on efficacy and tolerability the dose may be increased
to 20 mg or decreased to 5 mg.
The maximum recommended dose is 20 mg. The maximum recommended dosing
frequency is once
per day. Vardegin can be taken with or without food. The onset of
activity may be delayed if taken
with a high fat meal (see section 5.2).
Special populations
_Elderly