Lonfilis F.C. Tablets 20mg (tadalafil)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Tadalafil

Boleh didapati daripada:

MEDISPEC (M) SDN.BHD

INN (Nama Antarabangsa):

Tadalafil

Unit dalam pakej:

1x4 Tablets

Dikeluarkan oleh:

STANDARD CHEM & PHARM CO LTD

Risalah maklumat

LONFILIS F.C. TABLETS 20MG (TADALAFIL)
Tadalafil 20mg
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Lonfilis_
is used for
2.
How
_Lonfilis_
works
3.
Before you use
_Lonfilis_
4.
How to use
_Lonfilis_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Lonfilis_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _LONFILIS_ IS USED FOR
Tadalafil under the name of
_Lonfilis_
is
used
to
treat
erectile
dysfunction
(impotence).
HOW _LONFILIS_ WORKS
_Lonfilis_
relaxes
muscles
of
the
blood
vessels
and
increases
blood
flow
to
particular areas of the body.
BEFORE YOU USE _LONFILIS_
-
_When you must not use it _
You should not take tadalafil if you are :
•
allergic to tadalafil or to any of the
other excipients of
_Lonfilis_
.
•
Taking medications which contain
nitrates or guanylate cyclase
stimulators (eg. riociguat)
•
have heart disease including heart
attack, chest pain, heart failure,
uncontrolled or low blood pressure,
rapid heartbeat
•
have stroke within the last 6 months
•
lost of vision due to non-arteritic
anterior ischaemic optic neuropathy
(NAION) (loss of blood flow to the
optic nerve)
_Pregnancy and lactation _
_Lonfilis _
is not to be taken by women. Do
not use
_Lonfilis_
if you are pregnant or
plan
to
become
pregnant
or
breast
feeding.
_ Before you start to use it _
Let the doctor check and confirm if you
have erectile dysfunction.
Tell your doctor if you have ever had:
_ _
•
heart
disease or
heart
rhythm
problems;
•
a heart attack or stroke;
•
chest
pain,
high
or low
blood
pressure;
•
liver or kidney disease (or if you are
on dialysis);
•
vision loss
•
a
physical
deformity
of
the
penis
(such as Peyronie's disease), or an
erection lasting longer than 4 hours;
or
•
health
problems
that
make
sexual
activity unsafe
•
hearing loss
•
taking CYP3A4 inhibitors such as
ritonavir,
saquinavir,
ketoconazole,
itraconazole,
and
erythromycin
or
PDE5 inhibitors
•
problems when taking lactose
-

Ciri produk

Page 1 of 13
1.
NAME OF THE MEDICINAL PRODUCT
Lonfilis F.C. Tablets 20mg (tadalafil)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20mg tadalafil.
3.
PHARMACEUTICAL FORM
The 20mg tablets are yellow olive-shaped film-coated tablet. The
tablet was debossed with "SD" and score
line on one side, and "956" on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of erectile dysfunction in adult males. In order for
tadalafil to be effective, sexual
stimulation is required.
Tadalafil is not indicated for use by women.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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 tadalafil (i.e., at least
twice weekly) a once daily regimen
with the lowest doses of tadalafil 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 dose may be decreased to 2.5 mg once a day based on
individual tolerability.
The appropriateness of continued use of the daily regimen should be
reassessed periodically.
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
Page 2 of 13
tadalafil is not recommended in patients with severe renal impairment.
Men with hepatic impairment
The recommended dose of tadalafil is 10 mg taken prior to anticipate