Ibicar S (Salbutamol 100 mcgactuation and Beclometasone 50 mcgactuation) Pressurised Inhalation

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

BECLOMETHASONE DIPROPIONATE; SALBUTAMOL SULPHATE

Boleh didapati daripada:

Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.

INN (Nama Antarabangsa):

BECLOMETHASONE DIPROPIONATE; SALBUTAMOL SULPHATE

Unit dalam pakej:

1units Units

Dikeluarkan oleh:

Glenmark Pharmaceuticals Ltd.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
IBICAR S
(Salbutamol 100 mcg/actuation and Beclometasone 50 mcg/actuation
Pressurised Inhalation)
1
WHAT IS IN THIS LEAFLET?
1.
What Ibicar S is used for
2.
How Ibicar S works
3.
Before you use Ibicar S
4.
How to use Ibicar S
5.
While you are using it
6.
Side effects
7.
Storage and disposal
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT IBICAR S IS USED FOR?
Ibicar
S
Inhaler
contains
Salbutamol
and
Beclometasone
dipropionate.
Salbutamol,
this
belongs to a group of medicines
called
fast
acting
bronchodilators
and
Beclometasone
dipropionate
which
is
one
of
a
group
of
medicines
known
as
corticosteroids.
It
is
used
for
treatment
of
reversible
airways
obstruction.
HOW IBICAR S WORKS

Salbutamol
works
as
bronchodilators
help
the
airways in your lungs to stay
open. This makes it easier for
air to get in and out. They help
to
relieve
chest
tightness,
wheezing and cough.

Beclometasone
dipropionate
works deep in your lungs to
make
breathing
easier
by
reducing
the
inflammation,
swelling and irritation in the
airways. It needs to be taken
regularly
every
day,
even
if
you have no symptoms.
BEFORE YOU USE IBICAR S
-
WHEN YOU MUST NOT USE IT
Do not use Ibicar S Inhaler if you:

Are allergic to actives or any
of the other ingredients

Are suffering from a sudden
attack of breathlessness. It will
not
help.
Use
a
quick-acting
‘reliever’
inhaler
for
this
purpose and carry it with you
at all times.
-
BEFORE YOU START TO USE IT
You should use properly the inhaler
to ensure that the drug reaches the
target area within the lungs. You
have
to
use
Ibicar
S
regularly,
every day, for optimum benefit.
You have to inform to your doctor
for
regular
reassessment
so
that
your
continued
corticosteroid
therapy has been reviewed.
Talk to your doctor before you start
to use this medicine if:

You are steroid-dependent, so
that
they
may
start
therapy
with
Beclomethasone
dipropionate.

You
are
suffering
from
tuberculosis (TB) no

Ciri produk

COMPOSITION:
EACH ACTUATION DELIVERS:
Salbutamol Sulphate BP equivalent
to Salbutamol
100 mcg
Beclometasone Dipropionate
Anhydrous Ph. Eur
50 mcg
Ethanol BP
3.5% w/w (5.23% v/v) (2.52 mg)
DOSAGE FORM
Inhalation aerosol
DESCRIPTION
White to off white colour suspension filled in aluminium
aerosol can with silver ferrule valve provided with
actuator suitable for oral inhalation when actuated a
metered spray is produced.
PHARMACOLOGY
PHARMACODYNAMICS
SALBUTAMOL:
Salbutamol is a selective beta-2 adrenoceptor agonist.
At therapeutic doses it act on the beta-2 adrenoceptors
of bronchial muscle.
BECLOMETASONE DIPROPIONATE:
Beclomethasone dipropionate given by inhalation has
a potent glucocorticoid anti-inflammatory action within
the lungs.
PHARMACOKINETICS
There
is
no
evidence
that
the
administration
of
salbutamol
and
beclomethasone
dipropionate
together by the inhaled route in any way affects the
pharmacokinetics
of
either
component.
For
pharmacokinetic purposes therefore each component
can be considered separately.
SALBUTAMOL:
Salbutamol administered intravenously has a half-life
of 4 to 6 hours and is cleared partly renally and partly by
metabolism to the inactive 4'-O-sulphate (phenolic
sulphate) which is also excreted primarily in the urine.
The faeces are a minor route of excretion. The majority
of a dose of salbutamol given intravenously, orally or by
inhalation is excreted within 72 hours. Salbutamol is
bound to plasma proteins to the extent of 10%.
After administration by the inhaled route, between
10 and 20% of the dose reaches the lower airways.
The remainder is retained in the delivery system or
deposited in the oropharynx from where it is swallowed.
The fraction deposited in the airways is absorbed into
the pulmonary tissues and circulation but it is not
metabolized by the lung. On reaching the systemic
circulation
it
becomes
accessible
to
hepatic
metabolism and is excreted, primarily in the urine, as
unchanged drug and as phenolic sulphate.
The swallowed portion of an inhaled dose is absorbed
from
the
gastr