CIALIS 20MG FILM-COATED TABLET

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:

4Tablet Tablets; 8 Tablet Tablets; 4 Tablet Tablets

Dikeluarkan oleh:

Lilly del Caribe Inc.,

Risalah maklumat

CIALIS 20 MG FILM-COATED TABLETS
Tadalafil 20 mg
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
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 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. Cialis
has been shown to significantly
improve the ability of obtaining a hard
erect penis suitable for sexual activity.
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.
BEFORE YOU USE CIALIS
_- When you must not use it _
Do not take Cialis 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”). Cialis
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 the last 6
months.
•
have low blood pr

Ciri produk

1.
NAME OF THE MEDICINAL PRODUCT
CIALIS 20 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 20 mg tadalafil.
Excipient with known effect:
Each coated tablet contains 233 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Yellow and almond shaped tablets, marked "C 20" on one 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.
CIALIS 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 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
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 tadalafil is
not recommended in patients with severe renal impairment (see sections
4.4 and 5.2).
_Men with hepatic impairment_
T