VESICARE

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

SOLIFENACIN SUCCINATE

Tersedia dari:

COMBIPHAR - Indonesia

INN (Nama Internasional):

SOLIFENACIN SUCCINATE

Dosis:

5 MG

Bentuk farmasi:

TABLET

Unit dalam paket:

DUS, 3 BLISTER @ 10 TABLET

Diproduksi oleh:

ASTELLAS PHARMA EUROPE B.V - Netherland

Tanggal Otorisasi:

2016-01-22

Karakteristik produk

1
NAME OF THE MEDICINAL PRODUCT
Vesicare

5 mg Tablet
Vesicare

10 mg Tablet
QUALITATIVE AND QUANTITATIVE COMPOSITION OF ACTIVE SUBSTANCE
Active ingredients: solifenacin succinate
Vesicare

5 mg Tablet : each tablet contains 5 mg of solifenacin succinate
formulated for oral
administration.
Vesicare

10 mg Tablet : each tablet contains 10 mg of solifenacin succinate
formulated for oral
administration.
PHARMACEUTICAL FORM
Film coated tablets:
Each 5 mg tablet is light- yellow tablet marked with company logo, and
“150”.
Each 10 mg tablet is light- pink tablet marked with company logo, and
“151”.
INDICATIONS
Symptomatic treatment of urge incontinence and/or increased urinary
frequency and urgency as
may occur in patients with overactive bladder syndrome.
CONTRA-INDICATIONS
Solifenacin succinate is contraindicated in
-
patients with urinary retention, severe gastrointestinal condition
(including toxic
megacolon), myasthenia gravis or narrow-angle glaucoma, and in
patients at risk for these
conditions
-
patients hypersensitive to the active substance or to any of the
excipients
-
patients undergoing haemodialysis
-
Patients with severe hepatic impairment
-
Patients with severe renal impairment or moderate hepatic impairment
and who are on
treatment with a potent CYP3A4 inhibitor, e.g. ketoconazole
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
-
RISK OF URINARY RETENTION:
Solifenacin succinate should be administered with caution to patients
with clinically significant
bladder outflow obstruction because of the risk of urinary retention
-
GASTROINTESTINAL
OBSTRUCTIVE
DISORDERS
AND
DECREASED
GASTROINTESTINAL
MOTILITY
(INCLUDING RISK OF GASTRIC RETENTION):
Solifenacin succinate should be administered
with caution to patients
with
gastrointestinal
obstructive disorders and decreased gastrointestinal motility
-
QT PROLONGATION AND TORSADE DE POINTES:
QT prolongation and Torsade de Pointes have been observed in patients
with risk factors, such as
pre-existing long QT syndrome and hypokalaemia
-
ANGIOEDE