Solifenacin succinate 10 mg film-coated tablets

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Solifenacin succinate

Disponível em:

Accord Healthcare Ireland Ltd.

Código ATC:

G04BD; G04BD08

DCI (Denominação Comum Internacional):

Solifenacin succinate

Dosagem:

10 milligram(s)

Forma farmacêutica:

Film-coated tablet

Tipo de prescrição:

Product subject to prescription which may be renewed (B)

Área terapêutica:

Drugs for urinary frequency and incontinence; solifenacin

Status de autorização:

Marketed

Data de autorização:

2016-03-04

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER
SOLIFENACIN SUCCINATE 5 MG FILM-COATED TABLETS
SOLIFENACIN SUCCINATE 10 MG FILM-COATED TABLETS
Solifenacin succinate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, or pharmacist or
nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor, or pharmacist or
nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Solifenacin succinate film-coated tablets is and what it is used
for
2.
What you need to know before you take Solifenacin succinate
film-coated tablets
3.
How to take Solifenacin succinate film-coated tablets
4.
Possible side effects
5.
How to store Solifenacin succinate film-coated tablets
6.
Contents of the pack and other information
1.
WHAT SOLIFENACIN SUCCINATE FILM-COATED TABLETS IS AND WHAT IT IS USED
FOR
The active substance of Solifenacin succinate film-coated tablets
belongs to the group called
anticholinergics. These medicines are used to reduce the activity of
an overactive bladder. This
enables you to wait longer before having to go to the bathroom and
increases the amount of
urine that can be held by your bladder.
Solifenacin succinate film-coated tablets is used to treat the
symptoms of a condition called
overactive bladder. These symptoms include: having a strong, sudden
urge to urinate without
prior warning, having to urinate frequently or wetting yourself
because you could not get to the
bathroom in time.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE SOLIFENACIN SUCCINATE
FILM-COATED TABLETS
DO NOT TAKE SOLIFENACIN SUCCINATE FILM-COATED TABLETS
•
if you are allergic to solifenacin succinate or any of the other
ingredients of this medicine
(listed in s

Características técnicas

Health Products Regulatory Authority
17 July 2020
CRN008R55
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solifenacin succinate 10 mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg solifenacin succinate,
equivalent to 7.5 mg solifenacin.
Excipient(s) with known effect: lactose monohydrate 100.5 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
Solifenacin succinate 10 mg Film-coated Tablets: Light pink coloured,
round, approximately 7.1 mm in diameter, biconvex, film
coated tablets, debossed with “EG” on one side and “2” on
other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Solifenacin succinate film-coated tablets is indicated in 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.
Special Populations:
Older people
No dose adjustment is necessary for older people.
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).
Patients treated with potent inhibitors of cytochrome P450 3A4
The maximum dose of Solifenacin succinate film-coated tablets should
be limited to 5 mg when treated simultaneously with
ketoconazole or therapeutic d