Solifen Film Coated Tablets 5mg

País: Malasia

Idioma: inglés

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

Ingredientes activos:

SOLIFENACIN SUCCINATE

Disponible desde:

MEDISPEC (M) SDN.BHD

Designación común internacional (DCI):

SOLIFENACIN SUCCINATE

Unidades en paquete:

3x10 Tablets

Fabricado por:

GETZ PHARMA (PVT) LIMITED

Información para el usuario

SOLIFEN FILM COATED TABLETS 5MG
Solifenacin Succinate (5mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Solifen_
is used for
2.
How
_Solifen_
works
3.
Before you use
_Solifen_
4.
How to use
_Solifen_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Solifen_
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT _SOLIFEN_ IS USED FOR
Solifen is used to treat the symptoms of
overactive
bladder.
These
symptoms
include needing to rush to the toilet to
urinate
without
warning,
needing
to
urinate
frequently,
or
wetting
yourself
because you did not get to the toilet in
time.
HOW _SOLIFEN_ WORKS
Solifen belongs to a group of medicines
called
anticholinergic
medicines.
It
works by acting on specialised cells to
reduce the activity of your bladder and
help you control your bladder.
BEFORE YOU USE _SOLIFEN _
-
_When you must not use it _
•
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 Solifen from the body (for
example,
ketoconazole).
Your
doctor or pharmacist will have
informed you if this is the case.
Inform your doctor if you have or
ever had any of the above mentioned
conditions
before
treatment
with
Solifen starts.
_ _
_Pregnancy and lactation _
You should not use Solifen if you are
pregnant unless clear

Ficha técnica

SOLIFEN FILM COATED TABLETS 5MG
(Solifenacin succinate)
5mg Film-Coated Tablets
DESCRIPTION
Solifen Tablet 5mg is available as white oblong, biconvex shaped film
coated tablet plain on both
sides.
QUALITATIVE & QUANTITATIVE COMPOSITIONS
SOLIFEN (Solifenacin succinate) is available for oral administration
as:
SOLIFEN Tablets 5mg
Each film-coated tablet contains:
Solifenacin succinate ... 5mg
CLINICAL PHARMACOLOGY
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.
Reported in vitro and in vivo pharmacological studies indicate that
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
After oral administration of solifenacin succinate, it is absorbed
from the gastrointestinal tract,
with the peak plasma concentrations reaching after 3 to 8 hours and a
bioavailability of about 90%.
There is no effect of food on the pharmacokinetics of solifenacin.
Solifenacin succinate is about
98% bound to plasma proteins principally to (alpha1)-acid
glycoprotein. It is highly distributed to
non-CNS tissues, having a mean steady-state volume of distribution of
600L. Solifenacin succinate
is extensively metabolised in the liver mainly by the cytochrome P450
isoenzyme CYP3A4, and
has a terminal half-life of 45-68hours. Solifenacin succinate is
excreted mainly as metabolites in
urine and feces.
THERAPEUTIC INDICATIONS
Symptomatic treatment of urge incontinence and/or increased urinary
frequency and urgency as
may occur in patients with overactive bladder syndrome.
DOSAGE AND ADMINISTRATION
_Adults, including the elderly _
The recommended dose is 5 mg solifenacin succinate once daily. If