Levitra
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
04-12-2023
Produktets egenskaber
(SPC)
04-12-2023
Offentlige vurderingsrapport
(PAR)
29-03-2016
Aktiv bestanddel:
vardenafil
Tilgængelig fra:
Bayer AG
ATC-kode:
G04BE09
INN (International Name):
vardenafil
Terapeutisk gruppe:
Urologicals
Terapeutisk område:
Erectile Dysfunction
Terapeutiske indikationer:
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 Levitra to be effective, sexual stimulation is required.Levitra is not indicated for use by women.
Produkt oversigt:
Revision: 33
Autorisation status:
Authorised
Autorisation dato:
2003-03-06
Indlægsseddel
48
B.
PACKAGE LEAFLET
49
PACKAGE LEAFLET: INFORMATION FOR THE USER
LEVITRA 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 Levitra is and what it is used for
2.
What you need to know before you take Levitra
3.
How to take Levitra
4.
Possible side effects
5.
How to store Levitra
6.
Contents of the pack and other information
1.
WHAT LEVITRA IS AND WHAT IT IS USED FOR
Levitra 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.
Levitra will only work when you are sexually stimulated. It reduces
the action of the natural chemical in
your body which makes erections go away. Levitra allows an erection to
last long enough for you to
satisfactorily complete sexual activity.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE LEVITRA
DO NOT TAKE LEVITRA
-
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 medicines containing nitrates, such as gl
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Levitra 5 mg film-coated tablets
Levitra10 mg film-coated tablets
Levitra 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.
Levitra 5 mg film-coated tablets
Orange round tablets marked with the BAYER-cross on one side and
“5” on the other side.
Levitra 10 mg film-coated tablets
Orange round tablets marked with the BAYER-cross on one side and
“10” on the other side.
Levitra 20 mg film-coated tablets
Orange round tablets marked with the BAYER-cross 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 Levitra 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.
Levitra 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
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