Vardenafil 20mg tablets

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)

Viambatanisho vya kazi:

Vardenafil hydrochloride trihydrate

Inapatikana kutoka:

Zentiva Pharma UK Ltd

ATC kanuni:

G04BE09

INN (Jina la Kimataifa):

Vardenafil hydrochloride trihydrate

Kipimo:

20mg

Dawa fomu:

Oral tablet

Njia ya uendeshaji:

Oral

Darasa:

No Controlled Drug Status

Dawa ya aina:

Valid as a prescribable product

Bidhaa muhtasari:

BNF: 07040500; GTIN: 8594739230958 8594739230965

Taarifa za kipeperushi

PACKAGE LEAFLET: INFORMATION FOR THE USER
VARDENAFIL 5 MG TABLETS
VARDENAFIL 10 MG TABLETS
VARDENAFIL 20 MG 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 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
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 and shortness of breath.
-
If you are ta

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Vardenafil 20 mg tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg of vardenafil (as hydrochloride).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Tablet.
Vardenafil 20 mg is presented as 9 mm orange, round, biconvex tablets
marked “20” 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 dose of 5 mg should be considered. Based on tolerability and
efficacy
the dose may be increased to 10