Renaxin 5mg Film Coated Tablets

Land: Malaysia

Sprog: engelsk

Kilde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Aktiv bestanddel:

SOLIFENACIN SUCCINATE

Tilgængelig fra:

NOVUGEN PHARMA SDN. BHD.

INN (International Name):

SOLIFENACIN SUCCINATE

Enheder i pakken:

10 Tablets; 30 Tablets; 60 Tablets; 100 Tablets; 500 Tablets; 1000 Tablets; 14 Tablets; 28 Tablets; 56 Tablets; 84 Tablets; 112 Tablets; 168 Tablets

Fremstillet af:

NOVUGEN PHARMA SDN. BHD.

Indlægsseddel

_Consumer Medication Information Leaflet (RiMUP) _
RENAXIN FILM COATED TABLETS
Solifenacin Succinate 5mg, 10mg
1
WHAT IS IN THIS LEAFLET
1.
What Renaxin is used for
2.
How Renaxin works
3.
Before you use Renaxin
4.
How to use Renaxin
5.
While you are using Renaxin
6.
Side effects
7.
Storage and Disposal of Renaxin
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT RENAXIN IS USED FOR
Renaxin 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.
HOW RENAXIN WORKS
Renaxin contains an active ingredient,
Solifenacin Succinate which belongs
to the group of anticholinergics. These
medicines
are
used
to
reduce
the
activity of an overactive bladder. By
relaxing the muscles in the bladder, it
improves your ability to control your
urination. 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.
BEFORE YOU USE RENAXIN
−
_When you must not use it _
_ _
DO NOT TAKE RENAXIN:
−
if
you
are
allergic
to
active
substance
or
any
of
the
other
ingredients of this medicine,
−
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 an acute
form of colonic distension (toxic
megacolon);
a
complication
associated
with
an
inflammatory
bowel
disease
that
causes
long
lasting
inflammation
and
ulcers
(sores)
in
your
digestive
tract
(ulcerative colitis),
−
if
you
suffer
from
the
muscle
disease,
which
can
cause
an
extreme
weakness
of
certain
muscles (myasthenia gravis),
−
if you suffer from increased pressure
in the eyes, with gradual loss of eye
sight (glaucoma),
−
if
you
are
undergoing
kidney
dialysis,
−
if you have severe liver disease,
−
if you suffer from severe kidney
disease
or

Produktets egenskaber

1. NAME OF THE MEDICINAL PRODUCT
Renaxin 5mg Film Coated Tablets
Renaxin 10mg Film Coated Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
RENAXIN 5MG FILM COATED TABLETS: Each tablet contains 5mg of
Solifenacin
Succinate.
RENAXIN
10MG
FILM
COATED
TABLETS:
Each
tablet
contains
10mg
of
Solifenacin Succinate.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film Coated Tablets.
RENAXIN 5MG FILM COATED TABLETS: Light yellow, round shaped film
coated
tablets debossed with “N” on one side and “25” other side.
RENAXIN 10MG FILM COATED TABLETS: Light pink, round shaped film coated
tablets debossed with “N” on one side and “24” 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
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
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 solifenacin should be limited to 5 mg when treated
simultaneously
with
ketoconazole
or
therapeutic
doses
of
other
potent
CYP3A4 inhibitors e.g