Vesicare tablets film-coated

Țară: Armenia

Limbă: engleză

Sursă: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Ingredient activ:

solifenacin (solifenacin succinate)

Disponibil de la:

Astellas Pharma Europe B.V.

Codul ATC:

G04BD08

INN (nume internaţional):

solifenacin (solifenacin succinate)

Dozare:

5mg

Forma farmaceutică:

tablets film-coated

Unități în pachet:

(10/1x10/) in blister, (30/3x10/) in blister

Tip de prescriptie medicala:

Prescription

Statutul autorizaţiei:

Registered

Data de autorizare:

2016-08-29

Caracteristicilor produsului

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Vesicare
TM
5 mg, film-coated tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Vesicare
TM
5 mg film-coated tablet:
Each tablet contains 5 mg solifenacin succinate, corresponding to 3.8
mg solifenacin.
Excipient(s) with known effect: lactose monohydrate (107.5 mg) For
the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Vesicare
TM
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.
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.
_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 of Vesicare 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 4.5).
3
Method of administration
Vesicare sho