VESIFIX 5 MG FILM COATED TABLET

Specifications

Therapeutic area

Urology

Manufacturer

NOBEL ILAC SANAYII VE TICARET A.S, Turkey

Visa Number

VN-22807-21

Issuing date

24/08/2021

Applicant company

Ambica International Corporation

Active ingredient

Solifenacin succinate

Content

5 mg

Indication

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

Dosage

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).

Shelf life

24

Dosage Form

Film coated tablet

Package

3 blisters × 10 FCT