Quemed 10 mg Tablets

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

SOLIFENACIN SUCCINATE

Boleh didapati daripada:

PHARMENG TECHNOLOGY SDN. BHD.

INN (Nama Antarabangsa):

SOLIFENACIN SUCCINATE

Unit dalam pakej:

30 Tablets; 100 Tablets

Dikeluarkan oleh:

PRO.MED.CS Praha a.s.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
QUEMED 5 MG TABLETS
QUEMED 10 MG TABLETS
Solifenacin succinate (5mg / 10mg)
1
WHAT IS IN THIS LEAFLET
1.
What Quemed is used for
2.
How Quemed works
_3._
_ _
Before you use Quemed
_ _
4.
How to use Quemed
5.
While you are using Quemed
6.
Side effects
_7._
_ _
Storage
and
Disposal
of
Quemed
_ _
8.
Product Description
9.
Manufacturer
10.
Product
Registration
Holder
and Distributor
11.
Date of revision
12.
Serial Number
WHAT QUEMED IS USED FOR
Quemed
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 QUEMED WORKS
The active substance of Quemed
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 QUEMED_ _
-
_When you must not use it _
DO NOT TAKE QUEMED
-
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
moderate
live

Ciri produk

QUEMED 5 MG TABLETS
QUEMED 10 MG TABLETS
Solifenacin succinate
DESCRIPTION
Film-coated tablet.
Quemed 5 mg: yellow round biconvex film-coated tablets, plain on both
sides, diameter 6 mm, without
break line.
Quemed 10 mg: pink round biconvex film-coated tablets, plain on both
sides, diameter 7 mm, without
break-line.
COMPOSITION
Quemed 5 mg: each film-coated tablet contains 5 mg of solifenacin
succinate.
Quemed 10 mg: each film-coated tablet contains 10 mg of solifenacin
succinate.
List of excipients:
Tablet core: Lactose monohydrate, Maize starch, Talc, Magnesium
stearate.
Tablet coating:
Quemed 5 mg: Opadry yellow OY 32823 (Hypromellose 6cP, Titanium
dioxide, Macrogol 400, Ferric
oxide Yellow, Ferric oxide Red)
Quemed 10 mg: Opadry white 03B28796 (Hypromellose 6cP, Titanium
dioxide, Macrogol 400), Opadry
brown 02F23883 (Hypromellose 5cP, Titanium dioxide, Macrogol 6000,
Ferric oxide Yellow, Ferric oxide
Red)
PHARMACODYNAMICS
Pharmacotherapeutic group: Urinary antispasmodics, ATC code: G04BD08.
Mechanism of action
Solifenacin is a competitive, specific cholinergic-receptor
antagonist.
The urinary bladder is innervated by parasympathetic cholinergic
nerves. Acetylcholine contracts the
detrusor smooth muscle through muscarinic receptors of which the M
3
subtype is predominantly involved.
Solifenacin is a competitive inhibitor of the muscarinic M
3
subtype receptor. In addition, solifenacin showed
to be a specific antagonist for muscarinic receptors by displaying low
or no affinity for various other
receptors and ion channels.
PHARMACOKINETICS
Absorption
After intake of solifenacin tablets, maximum solifenacin plasma
concentrations (C
max
) are reached after 3
to 8 hours. The t
max
is independent of the dose. The C
max
and area under the curve (AUC) increase in
proportion to the dose between 5 to 40 mg. Absolute bioavailability is
approximately 90%. Food intake
does not affect the C
max
and AUC of solifenacin.
Distribution
The apparent volume of distribution of solifenacin following
intravenous administration is abo