Vardenafil STADA 5 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

VARDENAFILHYDROCHLORIDE 3-WATER SAMENSTELLING overeenkomend met ; VARDENAFIL

Beschikbaar vanaf:

Stada Arzneimittel AG Stadastrasse 2-18 61118 BAD VILBEL (DUITSLAND)

ATC-code:

G04BE09

INN (Algemene Internationale Benaming):

VARDENAFILHYDROCHLORIDE 3-WATER COMPOSITION corresponding to ; VARDENAFIL

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1) ; CROSPOVIDON (E 1202) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 4000 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMWATERSTOFCARBONAAT (E 500 (II)) ; POLYVINYLALCOHOL (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Vardenafil

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); COPOLYMEER VAN ETHYLACRYLAAT-METHACRYLZUUR (1:1); CROSPOVIDON (E 1202); IJZEROXIDE GEEL (E 172); IJZEROXIDE ROOD (E 172); MACROGOL 4000; MAGNESIUMSTEARAAT (E 470b); NATRIUMWATERSTOFCARBONAAT (E 500 (II)); POLYVINYLALCOHOL (E1203); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Autorisatie datum:

2017-11-27

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
VARDENAFIL STADA 5 MG FILMOMHULDE TABLETTEN
VARDENAFIL STADA 10 MG FILMOMHULDE TABLETTEN
VARDENAFIL STADA 20 MG FILMOMHULDE TABLETTEN
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 [Product name] is and what it is used for
2. What you need to know before you take [Product name]
3. How to take [Product name]
4. Possible side effects
5. How to store [Product name]
6. Contents of the pack and other information
1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
[Product
name]
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.
[Product name] will only work when you are sexually stimulated. It
reduces the action of the
natural chemical in your body which makes erections go away. [Product
name] allows an
erection to last long enough for you to satisfactorily complete sexual
activity.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE [PRODUCT NAME]
DO NOT TAKE [PRODUCT NAME]
•
If you are allergic to vardenafil or any of the other ingredients of
this medicine (listed in
section 6). Signs of an aller

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Vardenafil STADA 5 mg filmomhulde tabletten
Vardenafil STADA 10 mg filmomhulde tabletten
Vardenafil STADA 20 mg filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg of vardenafil (as vardenafil hydrochloride
trihydrate).
Each tablet contains 10 mg of vardenafil (as vardenafil hydrochloride
trihydrate).
Each tablet contains 20 mg of vardenafil (as vardenafil hydrochloride
trihydrate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
Light yellow round film-coated tablets of 6 mm marked ´A719´ on one
side.
Light yellow round film-coated tablets of 7 mm marked ´A721´ on one
side.
Light yellow round film-coated tablets of 8.5 mm marked ´A723´ on
one side.
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 [Product name] 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. [Product name] 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 (≥ 65 years old)
Dose adjustments are not required in elderly patients. However, an
increase to a maximum
20 mg dose should be carefully considered depending on the individual
tolerability (see
sections 4.4 and 4.8).
Hepatic impairment
A starting dose of 5 mg should be considered in patients with mild and
moderate hepatic
impairment (Child-Pugh A-B). Based on tolerability and efficacy, the
dos