Cialis 5mg Film-Coated Tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

TADALAFIL

Boleh didapati daripada:

ZUELLIG PHARMA SDN BHD

INN (Nama Antarabangsa):

TADALAFIL

Unit dalam pakej:

28tablet Tablets; 14tablet Tablets

Dikeluarkan oleh:

Lilly del Caribe Inc.,

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
CIALIS 5 MG FILM-COATED TABLETS
Tadalafil 5 mg
WHAT IS IN THIS LEAFLET
1.
What Cialis is used for
2.
How Cialis works
3.
Before you use Cialis
4.
How to use Cialis
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Cialis
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT CIALIS IS USED FOR
Cialis 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.
Cialis
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 CIALIS WORKS
Cialis contains the active ingredient
tadalafil which belongs to a group of
medicines
called
phosphodiesterase
type 5 inhibitors (PDE 5 inhibitors).
Following
sexual
stimulation
Cialis
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.
Cialis will not help you if you do not
have
erectile
dysfunction.
It
is
important to note that Cialis 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.
Cialis
improves
blood
flow
to,
and
relaxes, the muscles of, the prostate
and
bladder
which
may
reduce
symptoms
of
benign
prostatic
hyperplasia. Cialis has been shown to
improve
these urinary
symptoms
as
early
as
1-2
weeks
after
starting
treatment.
BEFORE YOU USE CIALIS
-
_When you must not use it _
Do not take Cialis if you:
•
are allergic to tadalafil or any of the
ot

Ciri produk

Cialis 5 mg _PI_EUSPC _28 Jan 2021_05 May 2021
1.
NAME OF THE MEDICINAL PRODUCT
CIALIS 5 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 5 mg tadalafil.
Excipient with known effect:
Each coated tablet contains 121 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Light yellow and almond shaped tablets, marked "C 5" on one 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.
CIALIS 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 CIALIS (i.e., at least
twice weekly) a once daily regimen
with the lowest doses of CIALIS 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
Cialis 5 mg _PI_EUSPC _28 Jan 2021_05 May 2021
day.
The appropriateness of continued use of the daily regimen should be
reassessed periodically.
_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
recommende