Vardenafil 5 mg film-coated tablets

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

VARDENAFIL HYDROCHLORIDE TRIHYDRATE

متاح من:

Accord Healthcare Ireland Ltd.

ATC رمز:

G04BE09

INN (الاسم الدولي):

VARDENAFIL HYDROCHLORIDE TRIHYDRATE

جرعة:

5 milligram(s)

الشكل الصيدلاني:

Film-coated tablet

المجال العلاجي:

vardenafil

الوضع إذن:

Not marketed

تاريخ الترخيص:

2020-09-11

نشرة المعلومات

2
PACKAGE LEAFLET: INFORMATION FOR THE USER
VARDENAFIL 5 MG FILM-COATED TABLETS
VARDENAFIL 10 MG FILM-COATED TABLETS
VARDENAFIL 20 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 Vardenafil is and what it is used for
2.
What you need to know before you take Vardenafil
3.
How to take Vardenafil
4.
Possible side effects
5.
How to store Vardenafil
6.
Contents of the pack and other information
1.
WHAT VARDENAFIL IS AND WHAT IT IS USED FOR
Vardenafil 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 have 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.
Vardenafil will only work when you are sexually stimulated. It reduces
the action of the natural
chemical in your body which makes erections go away. Vardenafil allows
an erection to last long
enough for you to satisfactorily complete sexual activity.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VARDENAFIL
DO NOT TAKE VARDENAFIL
-
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 a

خصائص المنتج

Health Products Regulatory Authority
18 September 2020
CRN008MXQ
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vardenafil 5 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5.926 mg of vardenafil hydrochloride trihydrate,
equivalent to 5 mg of vardenafil.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Light yellow round tablets marked ´A719´ 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 Vardenafil 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. Vardenafil 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 dose may subsequently be increased.
The maximum dose recommended in patients with
moderate hepatic impairment (Child-Pugh B) is 10 mg (see sections 4.3
and 5.2).
_Renal impairment_
No dose adjustment is required in patients with mild to moderate renal
impairment.
In patients with severe renal impairment (creatinine clearance <30
ml/min), a starting d