Solifenacinesuccinaat betapharm 10 mg filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

SOLIFENACINESUCCINAAT SAMENSTELLING overeenkomend met ; SOLIFENACINE

Beschikbaar vanaf:

Betapharm Arzneimittel GmbH Kobelweg 95 D-86156 AUGSBURG (DUITSLAND)

ATC-code:

G04BD08

INN (Algemene Internationale Benaming):

SOLIFENACINESUCCINAAT COMPOSITION corresponding to ; SOLIFENACIN

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MACROGOL 8000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; TALK (E 553 B) ; TITAANDIOXIDE (E 171)

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Solifenacin

Autorisatie datum:

2019-04-10

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SOLIFENACINESUCCINAAT BETAPHARM 5 MG FILMOMHULDE TABLETTEN
SOLIFENACINESUCCINAAT BETAPHARM 10 MG FILMOMHULDE TABLETTEN
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.
-
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. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Solifenacinesuccinaat betapharm is and what it is used for
2.
What you need to know before you take Solifenacinesuccinaat betapharm
3.
How to take Solifenacinesuccinaat betapharm
4.
Possible side effects
5.
How to store Solifenacinesuccinaat betapharm
6.
Contents of the pack and other information
1.
WHAT SOLIFENACINESUCCINAAT BETAPHARM IS AND WHAT IT IS USED FOR
The active substance of Solifenacinesuccinaat betapharm belongs to the
group of 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.
Solifenacinesuccinaat betapharm 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 SOLIFENACINESUCCINAAT BETAPHARM
DO NOT TAKE SOLIFENACINESUCCINAAT BETAPHARM
-
if you are allergic to solifenacin succinate or any of the other
ingredients of this medicine (listed in
section 6).
-
if you are unable to pass water or to empty your bladder completely
(urinary retenti

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Solifenacinesuccinaat betapharm 5 mg filmomhulde tabletten
Solifenacinesuccinaat betapharm 10 mg filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mg film-coated tablet contains 5 mg solifenacin succinate,
corresponding to 3.8 mg
solifenacin.
Each 10 mg film-coated tablet contains 10 mg solifenacin succinate,
corresponding to 7.5 mg
solifenacin.
Excipients with known effect: each 5 mg film-coated tablet contains 50
mg lactose monohydrate;
each 10 mg film-coated tablet contains 100 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
The 5 mg tablet is a light yellow coloured, round, biconvex,
film-coated tablet of approximately 5.6
mm diameter, debossed with ‘D5’ on the one side and plain on the
other side.
The 10 mg tablet is a light pink coloured, round, biconvex,
film-coated tablet of approximately 7.7
mm diameter, debossed with ‘D6’ on the one side and plain on one
the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Solifenacinesuccinaat betapharm is indicated in adults for the
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 _
Safety and effectiveness in children have not yet been established.
Therefore,
Solifenacin
should not
be used in children.
Special Populations
_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).
_Patien