Pajjiż: Iżrael
Lingwa: Ingliż
Sors: Ministry of Health
SOLIFENACIN SUCCINATE
CTS LTD
G04BD08
FILM COATED TABLETS
SOLIFENACIN SUCCINATE 10 MG
PER OS
Required
ASTELLAS PHARMA EUROPE B.V, THE NETHERLANDS
SOLIFENACIN
SOLIFENACIN
Vesicare is indicated for symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome.
2021-11-30
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- 1 - SUMMARY OF PRODUCT CHARACTERISTICS (SMPC) 1. NAME OF THE MEDICINAL PRODUCT Vesicare ® 5 mg, film-coated tablet Vesicare ® 10 mg, film-coated tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Vesicare 5 mg film-coated tablet: Each tablet contains 5 mg solifenacin succinate, corresponding to 3.8 mg solifenacin. Vesicare 10 mg film-coated tablet: Each tablet contains 10 mg solifenacin succinate, corresponding to 7.5 mg solifenacin. For a full list of excipients, see Section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. Vesicare 5 mg film-coated tablet: Each 5 mg tablet is a round, light-yellow tablet marked with the logo and “150” on the same side. Vesicare 10 mg film-coated tablet: Each 10 mg tablet is a round, light-pink tablet marked with the logo and “151”on the same side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY _Adults, including the elderly _ The recommended dose is 5 mg solifenacin succinate once daily. If needed, the dose may be increased to 10 mg solifenacin succinate once daily. _paediatric population _ The safety and efficacy of Vesicare in children have not yet been established. Therefore, Vesicare should not be used in children. - 2 - _Patients with renal impairment _ No dose adjustment is necessary for patients with mild to moderate renal impairment (creatinine clearance > 30 ml/min). Patients with severe renal impairment (creatinine clearance ≤ 30 ml/min) should be treated with caution and receive no more than 5 mg once daily (see Section 5.2). _Patients with hepatic impairment _ No dose adjustment is necessary for patients with mild hepatic impairment. Patients with moderate hepatic impairment (Child-Pugh score of 7 to 9) should be treated with caution and receive no more than 5 mg once daily (see Section 5.2). _Potent inhibitors of cytochrome P450 3A4 _ The maximum dose Aqra d-dokument sħiħ