VESICARE 5 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

SOLIFENACIN SUCCINATE

Available from:

CTS LTD

ATC code:

G04BD08

Pharmaceutical form:

FILM COATED TABLETS

Composition:

SOLIFENACIN SUCCINATE 5 MG

Administration route:

PER OS

Prescription type:

Required

Manufactured by:

ASTELLAS PHARMA EUROPE B.V, THE NETHERLANDS

Therapeutic group:

SOLIFENACIN

Therapeutic area:

SOLIFENACIN

Therapeutic indications:

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.

Authorization date:

2021-11-30

Patient Information leaflet

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Summary of Product characteristics

- 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