Vardenafil Zentiva 10mg film-coated tablets

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

vardenafil

Available from:

Zentiva

ATC code:

G04BE09

INN (International Name):

vardenafil

Dosage:

10mg

Pharmaceutical form:

Film-coated tablets

Administration route:

Oral use

Units in package:

Packs of: 2, 4, 8, 12 and 24 film-coated tablets

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

Zentiva k.s

Therapeutic group:

Urologicals, Drugs used in erectile dysfunction

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.

Authorization status:

Authorised

Authorization date:

2015-03-30

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER 

VARDENAFIL ZENTIVA 5 MG FILM-COATED TABLETS 
VARDENAFIL ZENTIVA 10 MG FILM-COATED TABLETS 
VARDENAFIL ZENTIVA 20 MG FILM-COATED TABLETS 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 

The name of your medicine is Vardenafil Zentiva 5mg, 10mg and
20mg film-coated tablets 
(called vardenafil throughout this leaflet). It 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 will only work when you are sexually stimulated. It
reduces the action of the natural

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 

Vardenafil Zentiva 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. 

Yellow-orange round tablets of size approx. 6 mm, embossed with
“10” on 
one side and with decorative line on the other side. The score line
is only to 
facilitate for ease of swallowing and not to divide into equal
doses. 

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
– 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 population (> 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