Bispec-5 (Solifenacin Succinate Tablets 5mg)
Country: Մալայզիա
language: անգլերեն
source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PIL active_ingredient:
SOLIFENACIN SUCCINATE
MAH:
CIPLA MALAYSIA SDN BHD
INN:
SOLIFENACIN SUCCINATE
units_in_package:
1 x 10 Tablets
manufactured_by:
CIPLA LTD
PIL
BISPEC-5 & BISPEC-10 TABLETS _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
SOLIFENACINE SUCCINATE (5 MG AND 10 MG)
____________________________________________________________________________________
Page | 1
WHAT IS IN THIS LEAFLET
1.
What Bispec is used for
2.
How Bispec works
3.
Before you take Bispec
4.
How to take Bispec
5.
While you are taking Bispec
6.
Side effects
7.
Storage and Disposal of Bispec
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT BISPEC IS USED FOR
Bispec 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 BISPEC WORKS
The active substance of Bispec 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.
BEFORE YOU TAKE BISPEC
-
_When you must not take it _
Do not take Bispec:
•
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
(listed
in
_Product _
_Description_
).
•
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 Bispec from
the
body
(for
example,
ketoconazole)
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SPC
_For the use of a Registered Medical Practitioner or a Hospital or a
Laboratory only OR for _
_Specialist Use only _
_ _
BISPEC – 5 (SOLIFENACIN SUCCINATE TABLETS 5MG)
BISPEC – 10 (SOLIFENACIN SUCCINATE TABLETS 10MG)
Solifenacin Succinate
COMPOSITION
BISPEC – 5
Each film coated tablet contains:
Solifenacin Succinate ………….5 mg
(Corresponding to Solifenacin 3.8 mg)
Colour: Yellow oxide of iron & Titanium dioxide
BISPEC – 10
Each film coated tablet contains:
Solifenacin Succinate ………….10 mg
(Corresponding to Solifenacin 7.5 mg)
Colour: Red oxide of iron & Titanium dioxide
DOSAGE FORM
Film coated tablets
PRODUCT DESCRIPTION
BISPEC – 5
Light yellow coloured, round, biconvex, film coated tablets debossed
with ‘C’ and ‘259’ on
one side and plain on the other.
BISPEC – 10
Light pink colored, round, biconvex film coated tablets debossed with
'C' and '261' on one
side and plain on the other.
PHARMACOLOGY
_PHARMACODYNAMICS _
Pharmacotherapeutic group: Urinary antispasmodics,
ATC code: G04B DO8.
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
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 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
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