Tadigra 5mg Film Coated Tablets

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Tadalafil

Boleh didapati daripada:

NOVUGEN PHARMA SDN. BHD.

INN (Nama Antarabangsa):

Tadalafil

Unit dalam pakej:

2 Tablets; 10 Tablets; 30 Tablets; 30 Tablets; 10 Tablets

Dikeluarkan oleh:

NOVUGEN PHARMA SDN. BHD.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
TADIGRA 5MG FILM COATED TABLETS
Tadalafil 5mg
1
WHAT IS IN THIS LEAFLET
1.
What Tadigra is used for
2.
How Tadigra works
3.
Before you use Tadigra
4.
How to use Tadigra
5.
While you are using Tadigra
6.
Side effects
7.
Storage and Disposal of
Tadigra
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT TADIGRA IS USED FOR
Tadigra 5 mg is used to treat adult
men with:
•
ERECTILE
DYSFUNCTION
.
This
is
when a man cannot get, or keep a
hard,
erect
penis
suitable
for
sexual activity. Tadigra has been
shown
to significantly
improve
the
ability
of
obtaining
a hard
erect
penis
suitable
for
sexual
activity.
•
urinary
symptoms
associated
with a common condition called
BENIGN
PROSTATIC
HYPERPLASIA
.
This is when the prostate gland
gets bigger with age. Symptoms
include difficulty in starting to
pass
water,
a
feeling
of
not
completely emptying the bladder
and a more frequent need to pass
water even at night.
HOW TADIGRA WORKS
Tadigra
contains
the
active
ingredient tadalafil which belongs
to
a
group
of
medicines
called
phosphodiesterase type 5 inhibitors
(PDE 5 inhibitors).
Following
sexual
stimulation
Tadigra works by helping the blood
vessels
in
your
penis
to
relax,
allowing
the
flow
of
blood
into
your
penis.
The
result
of
this
is
improved erectile function. Tadigra
will not help you if you do not have
erectile dysfunction. It is important
to
note
that
Tadigra
for
the
treatment
of
erectile
dysfunction
does not work if there is no sexual
stimulation. You and your partner
will need to engage in foreplay, just
as you would if you were not taking
a medicine for erectile dysfunction.
Tadigra
improves
blood
flow
to,
and
relaxes,
the
muscles
of,
the
prostate
and
bladder
which
may
reduce
symptoms
of
benign
prostatic hyperplasia. Tadigra has
been
shown
to
improve
these
urinary symptoms as early as 1-2
weeks after starting treatment.
BEFORE YOU USE TADIGRA
−
_When you must not use it _
Do not take Tadigra if you:
•

Ciri produk

1.
NAME OF THE MEDICINAL PRODUCT
Tadigra 5mg Film Coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5mg of Tadalafil. Excipient with known effect:
Each coated tablet contains 305.800 mg lactose (as monohydrate). For
the full list of excipients, see
section List of excipients.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Light yellow, almond-shaped biconvex film coated tablet debossed with
“N” on one side and “45” on
other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of erectile dysfunction in adult males.
In order for tadalafil to be effective for the treatment of erectile
dysfunction, sexual stimulation is
required.
Treatment of the signs and symptoms of benign prostatic hyperplasia in
adult males.
Tadigra is not indicated for use by women.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Erectile dysfunction in adult men _
In general, the recommended dose is 10 mg taken prior to anticipated
sexual activity and with or without
food.
In those patients in whom tadalafil 10 mg does not produce an adequate
effect, 20 mg might be tried.
It may be taken at least 30 minutes prior to sexual activity.
The maximum dose frequency is once per day.
Tadalafil 10 and 20 mg is intended for use prior to anticipated sexual
activity and it is not recommended
for continuous daily use.
In patients who anticipate a frequent use of Tadigra (i.e., at least
twice weekly) a once daily regimen
with the lowest doses of Tadigra might be considered suitable, based
on patient choice and the
physician’s judgement.
In these patients the recommended dose is 5 mg taken once a day at
approximately the same time of
day.
The appropriateness of continued use of the daily regimen should be
reassessed periodically.
TADIGRA 5MG FILM COATED TABLETS
_Benign prostatic hyperplasia in adult men _
The recommended dose is 5 mg, taken at approximately the same time
every day with or without food.
For adult men being treated for both benign prostatic hyperplasia and
erectile dysfunction the