SOFCARE 5mg Tablet

Țară: Malaezia

Limbă: engleză

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

Ingredient activ:

SOLIFENACIN SUCCINATE

Disponibil de la:

MEDISPEC (M) SDN.BHD

INN (nume internaţional):

SOLIFENACIN SUCCINATE

Unități în pachet:

10 x 3 Tablets

Produs de:

UNISON LABORATORIES CO.LTD

Prospect

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_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
SOFCARE 5MG/10MG TABLET
Solifenacin succinate (5 mg and 10 mg) 1
WHAT IS IN THIS LEAFLET
1.
What Sofcare is used for
2.
How Sofcare works
3.
Before you use Sofcare
4.
How to use Sofcare
5.
While you are using it
6.
Side effects
7.
Storage and Disposal
of Sofcare
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT SOFCARE IS USED FOR
Sofcare 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 SOFCARE WORKS
The active substance of Sofcare belongs
to the group of anticholinergics which is
Solifenacin succinate. 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.
BEFORE YOU USE SOFCARE
_- When you must not use it _
Do not take Sofcare:
•
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 with ulcerative colitis)
•
if
you
suffer
from
the
muscle
disease
called
myasthenia
gravis,
which
can
cause
an
extreme
weakness of certain muscles
•
if
you
suffer
from
increased
pressure in the eyes, with gradual
loss of eye sight (glaucoma)
•
if you are allergic to Solifenacin or
any of the other ingredients of this
medicine
•
if
you
are
undergoing
kidney
dialysis
•
if you have severe liver disease
•
if you suffer from severe kidney
disease
or moderate
liver
disease
and
at
the
same
time
are
being
treated
with
medicines
that
may
decrease
the
removal
of
Sofcare
from
the
body
(for
example,
Ketoconazole).
Your
doctor
or
pharmacist will have informed you
if this is the case.
Inform your

Caracteristicilor produsului

1 of 5
SOFCARE 5 MG
TABLET
SOFCARE 10 MG
TABLET
Each film coated tablet contains:
SOLIFENACIN SUCCINATE 5 MG
SOLIFENACIN SUCCINATE 10 MG
PRODUCT DESCRIPTION:
_5 MG: _Light yellow, round, biconvex, film coated tablet with
engraved 5 on one side and plain on the other side_ _
_10 MG: _Light pink, oblong, biconvex, film coated tablet with
engraved 10 on one side and plain on the other side
_ _
MECHANISM OF ACTION:
_PHARMACOLOGY _
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 M3 subtype is
predominantly involved. Solifenacin is a
competitive inhibitor of the muscarinic M3 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
tested.
_PHARMACOKINETICS _
Absorption
After intake of Solifenacin, 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 about 600 L. Solifenacin
is to a great extent (approximately 98%) bound to plasma proteins,
primarily
α
1
-acid glycoprotein.
Biotransformation
Solifenacin is extensively metabolized by the liver, primarily by
cytochrome P450 3A4 (CYP3A4). However,
alternative metabolic pathways exist, that can contribute to the
metabolism of Solifenacin. The systemic clearance of
Solifenacin is about 9.5 L/h and the terminal half life of Solifenacin
is 45-68 hours. After oral dosing, one
pharmacologically active (4_R_-hydroxy Solifenacin) and three inactive
metabolites (_N_-glucuronide, _N_-oxide and 4_R_-
hyd