CIASTAR YELLOW

국가: 인도네시아

언어: 인도네시아어

출처: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

유효 성분:

TADALAFIL

제공처:

SOHO INDUSTRI PHARMASI - Indonesia

INN (International Name):

TADALAFIL

복용량:

20.0 MG

약제 형태:

ORAL DISSOLVING FILM

패키지 단위:

DUS @ 4 POUCH @ 1 ODF

Manufactured by:

SEOUL PHARMA CO.,LTD - Republic Of Korea

승인 날짜:

2019-10-30

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
CIASTAR YELLOW Oral Dissolving Film
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CIASTAR YELLOW Oral Dissolving Film:
-
Each film contains tadalafil 10 mg
-
Each film contains tadalafil 20 mg
3.
PHARMACEUTICAL FORM
CIASTAR YELLOW Oral Dissolving Film
Tadalafil 10 mg:
-
Yellow, rectangular oral dissoving film.
-
Dimension of film is 4.40 cm
2
(2.2 cm x 2.0 cm x 100 µm).
CIASTAR YELLOW Oral Dissolving Film
Tadalafil 20 mg:
-
Yellow, rectangular oral dissoving film.
-
Dimension of film is 8.64 cm
2
(3.2 cm x 2.7 cm x 110 µm).
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Treatment of erectile dysfunction in adult men.
4.2
Posology and method of administration
Posology
-
Use in adult men

The recommended dose is 10 mg taken prior to anticipated sexual
activity and
without regard to 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 dosing frequency is once per day.
Continuous daily use of the medication is strongly discouraged because
the long
term safety after prolonged daily dosing has not been established and
also because
the effect of tadalafil usually lasts for longer than one day.
-
Use in elderly men

Dosage adjustments are not required in elderly patients.
DISETUJUI OLEH BPOM: 14/10/2019
ID: EREG10006111800026
EREG10006111800027

-
Use in men with impaired renal function
Dosage
adjustments
are
not
required
in
patients
with
mild
to
moderate
renal
impairment. For patient with severe renal impairment 10 mg is the
maximum
recommended dose.
-
Use in men with impaired hepatic function

The recommended dose of tadalafil is 10 mg taken prior to anticipated
sexual
activity and without regard to food. There is limited clinical data on
the safety of
tadalafil in patients with severe hepatic insufficiency (Child-Pugh
Class C); if
prescribed, a careful individual benefit/risk evaluation should be
undertaken b