CIATUFF 20 (TADALAFIL TABLETS 20MG)

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

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

Δραστική ουσία:

Tadalafil

Διαθέσιμο από:

SYNERRV SDN BHD

INN (Διεθνής Όνομα):

Tadalafil

Μονάδες σε πακέτο:

1 x 4 Tablets; 2 x 4 Tablets

Κατασκευάζεται από:

Aurobindo Pharma Limited, Unit-VII (SEZ)

Φύλλο οδηγιών χρήσης

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
CIATUFF 10 (TADALAFIL TABLETS 10MG)
CIATUFF 20 (TADALAFIL TABLETS 20MG)
Tadalafil Tablets (10mg, 20 mg)
1
WHAT IS IN THIS LEAFLET
1.
What CIATUFF is used for
2.
How CIATUFF works
3.
Before you use CIATUFF
4.
How to use CIATUFF
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of CIATUFF
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT CIATUFF IS USED FOR
CIATUFF 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.
CIATUFF has been shown to
significantly improve the ability of
obtaining a hard erect penis suitable
for sexual activity.
HOW CIATUFF WORKS
CIATUFF contains the active
ingredient tadalafil which belongs to a
group of medicines called
phosphodiesterase type 5 inhibitors
(PDE 5 inhibitors).
Following sexual stimulation
CIATUFF 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.
CIATUFF will not help you if you do
not have erectile dysfunction. It is
important to note that CIATUFF 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 CIATUFF
_- When you must not use it _
Do not take CIATUFF if you:
•
are allergic to tadalafil or any of the
other ingredients of this medicine
•
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”).
CIATUFF 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

Αρχείο Π.Χ.Π.

NAME OF DRUG PRODUCT
:
Tadalafil Tablets 10 mg
Tadalafil Tablets 20 mg
(TRADE) NAME OF PRODUCT
:
CIATUFF 10
CIATUFF 20
STRENGTH
:
10 mg and 20 mg
PHARMACEUTICAL DOSAGE FORM
:
Tablet
QUALITATIVE AND QUANTITATIVE COMPOSITIONS:
_Tadalafil Tablets 10 mg: _Each film-coated tablet contains 10 mg of
Tadalafil Ph. Eur.
_Tadalafil Tablets 20 mg: _Each film-coated tablet contains 20 mg of
Tadalafil Ph. Eur.
PHARMACEUTICAL FORM
_Tadalafil Tablets 10 mg_: Light yellow colored, oval shaped,
film-coated tablets debossed with ‘10’ on one
side and ‘TL’ on other side.
_Tadalafil Tablets 20 mg_: Yellow colored, oval shaped, film-coated
tablets debossed with ‘20’ on one side
and ‘TL’ on other side.
CLINICAL PARTICULARS
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.
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 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_