Laboratorios Cinfa S.A., Spain

TV TPI CO. LTD.

Solifenacin succinate

5mg

18 months

Film-coated tablet

Box of 3 blisters x 10 FCT

840110431923

27/10/2023

Urology

Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome.

● 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 solifenacin in children have not yet been established. Therefore, Solifenacin should not be used in children.
● 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 Pharmacokinetic properties).
● 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 Pharmacokinetic properties).
● Potent inhibitors of cytochrome P450 3A4
The maximum dose of solifenacin should be limited to 5 mg when treated simultaneously with ketoconazole or therapeutic doses of other potent CYP3A4 inhibitors e.g. ritonavir, nelfinavir, itraconazole (see Section Drug interactions and incompatibilities).