VARDENAFIL ACCORD
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
30-06-2018
Summary of Product characteristics
(SPC)
30-06-2018
Active ingredient:
VARDENAFIL HYDROCHLORIDE TRIHYDRATE
Available from:
Accord Healthcare Limited
ATC code:
G04BE09
INN (International Name):
VARDENAFIL HYDROCHLORIDE TRIHYDRATE
Dosage:
10 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product subject to prescription which may not be renewed (A)
Therapeutic area:
vardenafil
Authorization status:
Authorised
Authorization date:
2017-07-07
Patient Information leaflet
PACKAGE LEAFLET: INFORMATION FOR THE USER
VARDENAFIL ACCORD 5 MG FILM-COATED TABLETS
VARDENAFIL ACCORD 10 MG FILM-COATED TABLETS
VARDENAFIL ACCORD 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 Accord is and what it is used for
2.
What you need to know before you take Vardenafil Accord
3.
How to take Vardenafil Accord
4.
Possible side effects
5.
How to store Vardenafil Accord
6.
Contents of the pack and other information
1.
WHAT VARDENAFIL ACCORD IS AND WHAT IT IS USED FOR
Vardenafil Accord 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.
Vardenafil Accord 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 Accord allows an erection
to last long enough for you to satisfactorily complete sexual
activity.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VARDENAFIL ACCORD
DO NOT TAKE VARDENAFIL ACCORD
If you are allergic to vardenafil or any of the other ingredients of
this medicine (listed
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Vardenafil Accord 10 mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg vardenafil (as hydrochloride
trihydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Beige coloured, round shaped, approximately 6.8 mm in diameter,
biconvex, film-coated tablets debossed with 'FA2'
on one side and plain on 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 Vardenafil Accord 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 Accord 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
Read the complete document
