Solifenacin succinate 10mg film-coated tablets

Riik: Iirimaa

keel: inglise

Allikas: HPRA (Health Products Regulatory Authority)

Toimeaine:

Solifenacin succinate

Saadav alates:

Generics (UK) Limited

ATC kood:

G04BD; G04BD08

INN (Rahvusvaheline Nimetus):

Solifenacin succinate

Annus:

10 milligram(s)

Ravimvorm:

Film-coated tablet

Manustamisviis:

oral use

Ühikuid pakis:

3, 5, 10, 20, 30, 30 x 1, 50, 60, 90, 100, 200 tablets

Retsepti tüüp:

Product subject to prescription which may be renewed (B)

Terapeutiline rühm:

Urologicals, drugs for urinary frequency and incontinence

Terapeutiline ala:

Drugs for urinary frequency and incontinence; solifenacin

Näidustused:

Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in patients with overactive bladder syndrome.

Volitamisolek:

Not marketed

Loa andmise kuupäev:

2015-10-09

Infovoldik

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SOLIFENACIN SUCCINATE MYLAN 5 MG FILM-COATED TABLETS
SOLIFENACIN SUCCINATE MYLAN 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.
-
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 Solifenacin succinate Mylan is and what it is used for
2.
What you need to know before you take Solifenacin succinate Mylan
3.
How to take Solifenacin succinate Mylan
4.
Possible side effects
5.
How to store Solifenacin succinate Mylan
6.
Contents of the pack and other information
1.
WHAT SOLIFENACIN SUCCINATE MYLAN IS AND WHAT IT IS USED FOR
Solifenacin succinate Mylan contains the active substance solifenacin,
which 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.
Solifenacin succinate Mylan 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 MYLAN
DO NOT TAKE SOLIFENACIN SUCCINATE MYLAN:
-
if you are allergic to solifenacin or any of the other ingredients of
this medicine (listed in
section 6)
-
if you have an inability to pass water or to empty your bladder
completely (urinary retention)
-
if you

Toote omadused

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Solifenacin succinate 10mg film-coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 10 mg of solifenacin succinate,
corresponding to 7.5 mg solifenacin.
Excipient with known effect
Each-film coated tablet contains 113 mg of lactose (as lactose
monohydrate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet (Tablet).
Pink, film-coated, approximately 7.6 mm, round, biconvex tablet
debossed with “M” on one side of the tablet and “SF”
over “10” on the other 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 succinate 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).
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