Solifenacinesuccinaat Tiefenbacher 10 mg, filmomhulde tablet

Negara: Belanda

Bahasa: Belanda

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

Bahan aktif:

SOLIFENACINESUCCINAAT 10 mg/stuk SAMENSTELLING overeenkomend met ; SOLIFENACINE 7,6 mg/stuk

Tersedia dari:

Alfred Tiefenbacher (GmbH & Co. KG) Van-der-Smissen- Strasse 1 22767 HAMBURG (DUITSLAND)

Kode ATC:

G04BD08

INN (Nama Internasional):

SOLIFENACINESUCCINAAT 10 mg/stuk SAMENSTELLING overeenkomend met ; SOLIFENACINE 7,6 mg/stuk

Bentuk farmasi:

Filmomhulde tablet

Komposisi:

HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; LACTOSE 1-WATER ; MACROGOL 6000 ; MAGNESIUMSTEARAAT (E 470b) ; MAÏSZETMEEL ; PROPYLGALLAAT (E 310) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171),

Rute administrasi :

Oraal gebruik

Area terapi:

Solifenacin

Ringkasan produk:

Hulpstoffen: HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE ROOD (E 172); LACTOSE 1-WATER; MACROGOL 6000; MAGNESIUMSTEARAAT (E 470b); MAÏSZETMEEL; PROPYLGALLAAT (E 310); SILICIUMDIOXIDE (E 551); TALK (E 553 B); TITAANDIOXIDE (E 171);

Tanggal Otorisasi:

2016-01-27

Selebaran informasi

2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SOLIFENACINESUCCINAAT TIEFENBACHER
5 mg filmomhulde tablet
SOLIFENACINESUCCINAAT TIEFENBACHER
10 mg filmomhulde tablet
Solifenacin succinaat
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 Tiefenbacher is and what it is used for
2.
What you need to know before you take Solifenacinesuccinaat
Tiefenbacher
3.
How to take Solifenacinesuccinaat Tiefenbacher
4.
Possible side effects
5.
How to store Solifenacinesuccinaat Tiefenbacher
6.
Contents of the pack and other information
1.
WHAT SOLIFENACINESUCCINAAT TIEFENBACHER IS AND WHAT IT IS USED FOR
The active substance Solifenacin 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 Tiefenbacher 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
TIEFENBACHER
DO NOT TAKE SOLIFENACINESUCCINAAT TIEFENBACHER
-
if you have an inability to pass water or to empty your bladder
completely (urinary retention)
-
if you have a severe stomach or bowel condition (including toxic
megacolon, a complication associated
w

Karakteristik produk

2
1.
NAME OF THE MEDICINAL PRODUCT
Solifenacinesuccinaat Tiefenbacher 5 mg, filmomhulde tablet
Solifenacinesuccinaat Tiefenbacher 10 mg, filmomhulde tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Solifenacinesuccinaat Tiefenbacher 5 mg, filmomhulde tablet:
Each tablet contains 5 mg solifenacin succinate, corresponding to 3.8
mg solifenacin.
Excipient(s) with known effect: lactose monohydrate (128.7 mg)
Solifenacinesuccinaat Tiefenbacher 10 mg, filmomhulde tablet:
Each tablet contains 10 mg solifenacin succinate, corresponding to 7.5
mg solifenacin.
Excipient(s) with known effect: lactose monohydrate (123.7 mg)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Solifenacinesuccinaat Tiefenbacher 5 mg, filmomhulde tablet:
Each 5 mg tablet is a pink coloured, round (8 mm diameter), biconvex
film-coated tablets embossed with ‘5’
on one side.
Solifenacinesuccinaat Tiefenbacher 10 mg filmomhulde tablet:
Each 10 mg tablet is a red-brown coloured, round (8 mm diameter),
biconvex film-coated tablets embossed
with ‘10’ on one 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 solifenacin in children have not yet been
established. Therefore, solifenacin
should not be used in children.
_ _
_Patients with renal impairment _
3
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 impairmen