Krajina: Indonézia
Jazyk: indonézština
Zdroj: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
TADALAFIL
SOHO INDUSTRI PHARMASI - Indonesia
TADALAFIL
10.0 MG
ORAL DISSOLVING FILM
DUS @ 4 POUCH @ 1 ODF
SEOUL PHARMA CO.,LTD - Republic Of Korea
2019-10-30
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 Prečítajte si celý dokument