Vivanza
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
28-02-2022
Karatteristiċi tal-prodott
(SPC)
28-02-2022
Rapport ta 'Valutazzjoni Pubblika
(PAR)
28-02-2022
Ingredjent attiv:
vardenafil
Disponibbli minn:
Bayer AG
Kodiċi ATC:
G04BE09
INN (Isem Internazzjonali):
vardenafil
Grupp terapewtiku:
Urologicals
Żona terapewtika:
Erectile Dysfunction
Indikazzjonijiet terapewtiċi:
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 Vivanza to be effective, sexual stimulation is required.Vivanza is not indicated for use by women.
Sommarju tal-prodott:
Revision: 28
L-istatus ta 'awtorizzazzjoni:
Withdrawn
Data ta 'l-awtorizzazzjoni:
2003-03-04
Fuljett ta 'informazzjoni
47
B.
PACKAGE LEAFLET
Medicinal product no longer authorised
48
PACKAGE LEAFLET: INFORMATION FOR THE USER
VIVANZA 5 MG FILM-COATED TABLETS
vardenafil
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 Vivanza is and what it is used for
2.
What you need to know before you take Vivanza
3.
How to take Vivanza
4.
Possible side effects
5.
How to store Vivanza
6.
Contents of the pack and other information
1.
WHAT VIVANZA IS AND WHAT IT IS USED FOR
Vivanza 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.
Vivanza will only work when you are sexually stimulated. It reduces
the action of the natural chemical
in your body which makes erections go away. Vivanza allows an erection
to last long enough for you to
satisfactorily complete sexual activity.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VIVANZA
DO NOT TAKE VIVANZA
-
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.
-
If you are taking me
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Vivanza 5 mg film-coated tablets.
Vivanza 10 mg film-coated tablets
Vivanza 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet of 5 mg film-coated tablets contains 5 mg of vardenafil
(as hydrochloride).
Each tablet of 10 mg film-coated tablets contains 10 mg of vardenafil
(as hydrochloride).
Each tablet of 20 mg film-coated tablets contains 20 mg of vardenafil
(as hydrochloride).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Vivanza 5 mg film-coated tablets
Orange round tablets marked with ’v’ on one side and “5” on
the other side.
Vivanza 10 mg film-coated tablets
Orange round tablets marked with ’v’ on one side and “10” on
the other side.
Vivanza 20 mg film-coated tablets
Orange round tablets marked with ’v’ on one side and “20” on
the other 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 Vivanza 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.
Vivanza 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 startin
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