Tadigra 20mg 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; 4 Tablets; 8 Tablets

Dikeluarkan oleh:

NOVUGEN PHARMA SDN. BHD.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
TADIGRA 20MG FILM COATED TABLETS
Tadalafil 20mg
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 is a treatment for 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.
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.
BEFORE YOU USE TADIGRA
−
_When you must not use it _
Do not take Tadigra if you:
•
are allergic to tadalafil or any of
the
other
ingredients
of
this
medicine
(see
section
Product
Description).
•
are taking any form of organic
nitrate or nitric oxide donors such
as amyl nitrite. This is a group of
medicines (“nitrates”) used in the
treatment of angina pectoris
(“chest pain”). Tadigra has been
shown to increase the effects of
these medicines. If you are taking
any form of nitrate or are unsure
tell your doctor.
•
have
serious
heart
disease
or
recently had a heart attack within
the last 90 days.
•
recently had a stroke within

Ciri produk

1.
NAME OF THE MEDICINAL PRODUCT
Tadigra 20mg Film Coated Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg of Tadalafil. Excipient with known effect:
Each coated tablet contains 290.800 mg lactose (as monohydrate). For
the full list of excipients, see
section List of excipients.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Yellow, almond-shaped biconvex film coated tablet debossed with
“N” on one side and “44” 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.
Tadigra is not indicated for use by women.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_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 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 20MG FILM COATED TABLETS
Special populations
_Elderly men _
Dose adjustments are not required in elderly patients.
_Men with renal impairment _
Dose adjustments are not required in patients with mild to moderate
renal impairment. For patients with
severe renal impairment 10 mg is the maximum recommended dose.
Once-a-day dosing of tadalafil is
not recommended in patients with se