CALIBERI

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

TADALAFIL

Tersedia dari:

ABBOTT INDONESIA - Indonesia

INN (Nama Internasional):

TADALAFIL

Dosis:

10.00 MG

Bentuk farmasi:

ORODISPERSIBLE FILM

Unit dalam paket:

DUS, 4 SACHET @ 1 ORODISPERSIBLE FILM

Diproduksi oleh:

CTCBIO INC - Republic Of Korea

Tanggal Otorisasi:

2019-12-31

Karakteristik produk

CALIBERI
® TADALAFIL
1.
NAME OF THE MEDICINAL PRODUCT
CALIBERI
®
5 mg, 10 mg and 20 mg orodispersible films.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each orodispersible film contains 5 mg, 10 mg or 20 mg tadalafil.
Excipients: Each orodispersible film contains 0,2; 0,4 or 0,8 mg
sucralose. For a full list of
excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Orodispersible film.
The 5 mg, 10 mg and 20 mg orodispersible films are light yellow
orodispersible films.
4.
CLINICAL PARTICULARS
4.1.
THERAPEUTIC INDICATIONS
Treatment of erectile dysfunction in adult men (ED).
4.2.
POSOLOGY AND METHOD OF ADMINISTRATION
Method of administration:
CALIBERI
®
is available as 5 mg, 10 mg and 20 mg orodispersible films for oral
use.
POSOLOGY:
USE IN ADULT MEN
ERECTILE DYSFUNCTION
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.
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 CALIBERI
®
(i.e., at least twice weekly) a once
daily regimen with the lowest doses of CALIBERI
®
might be considered suitable, based
on patient choice and the physician's judgment.
In these patients the recommended dose is 5 mg taken once a day at
approximately the
same time of day.
The
appropriateness
of
continued
use
of
the
daily
regimen
should
be
reassessed
periodically.
DISETUJUI OLEH BPOM : 21/11/2019
EREG10034611800025 EREG10034611800026
EREG10034611800027 EREG10034611800028
EREG10034611800029 EREG10034611800030
EREG10034611800031 EREG10034611800032
EREG10034611800033
USE IN ELDERLY MEN
Dosage adjustments are not required in elderly patients.
USE IN MEN WITH IMPAIRED RENAL FUNCTION
Dosage adjustments are not required in patients with mild to moderate
renal im