Země: Indonésie
Jazyk: indonéština
Zdroj: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
SOLIFENACIN SUCCINATE
COMBIPHAR - Indonesia
SOLIFENACIN SUCCINATE
10 MG
TABLET
DUS, 3 BLISTER @ 10 TABLET
ASTELLAS PHARMA EUROPE B.V - Netherland
2016-01-22
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 Přečtěte si celý dokument