Ibicar 100 Beclometasone Pressurised Inhalation BP 100mcgActuation

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

BECLOMETHASONE DIPROPIONATE

Boleh didapati daripada:

Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.

INN (Nama Antarabangsa):

BECLOMETHASONE DIPROPIONATE

Unit dalam pakej:

1units Units

Dikeluarkan oleh:

Glenmark Pharmaceuticals Limited

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
IBICAR 100
_®_
_ _
BECLOMETASONE PRESSURISED INHALATION BP 100 MCG/ACTUATION
WHAT IS IN THIS LEAFLET
1.
What Ibicar 100 is used for
2.
How Ibicar 100 works
3.
Before you use Ibicar 100
4.
How to use Ibicar 100
5.
While you are using it
6.
Side Effects
7.
Storage
and
Disposal
of
Ibicar 100
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT IBICAR 100 IS USED FOR
Ibicar
100
contains
beclometasone
dipropionate, which is one of a group
of medicines known as glucocorticoid.
Beclometasone Inhaler is used in the
prophylactic management of asthma.
HOW IBICAR 100 WORKS
The
anti-inflammatory
effect
of
Beclometasone dipropionate plays an
important
role
in
the
efficacy
of
Beclometasone
dipropionate
in
controlling symptoms and improving
lung
function
in
asthma.
It
is
a
pressurized, metered-dose spray is for
oral
inhalation
use
only.
Beclometasone inhaler is not indicated
for the
immediate relief of
asthma
attacks.
BEFORE YOU USE IBICAR 100
_- When you must not use it _
Do not use Ibicar 100 if you are
allergic (hypersensitive) to:

Beclometasone Dipropionate

any of the other ingredients of
Do not use Ibicar 100 if any of the
above apply to you. If you are not sure,
talk to your doctor, nurse or pharmacist
before using Ibicar 100.
_- Before you start to use it _
Check with your doctor, nurse or
pharmacist
before
taking
your
medicine if:

you are suffering from active or
latent pulmonary tuberculosis.

your asthma seems to be getting
worse.
Perhaps
you
are
more
wheezy and short of breath than
usual,
your
‘reliever’
inhaler
seems to be less effective, you
require
more
puffs
from
your
‘reliever’ inhaler than usual, or you
do not seem to be getting better.
Your doctor may need to increase
the dose of your steroid inhaler or
give you a course of steroid tablets,
or
change
your
treatment
altogether.
If
you
have
had
an
infection in your chest your doctor
may
prescribe
a
course
of
antibiotics.

when
transferring

Ciri produk

For the use only of a Registered Medical Practitioner or
a Hospital or a Laboratory
Beclometasone Pressurised Inhalation BP
100 mcg/actuation
100
SAME SIZE ARTWORK
LEAFLET: 225 mm x 270 mm
FOLDING SIZE: 38 mm x 135 mm
135 mm
38 mm
25 mm
PE00000 MY
PANTONE
BLACK PROCESS C
SUPERSEDES
ARTWORK CODE:
PANTONE SHADE
ICONGRAPHICS CODE:
PHARMACODE:
GRAIN DIRECTION
SPACE FOR
PHARMACODE
SPACE FOR
PHARMACODE
SPACE FOR
PHARMACODE
SPACE FOR
PHARMACODE
SPACE FOR
PHARMACODE
SPACE FOR
PHARMACODE
COMPOSITION
BECLOMETASONE PRESURRISED INHALATION BP 100 MCG
Each actuation delivers :
Beclometasone Dipropionate Anhydrous Ph. Eur 100 µg
Ethanol BP 14.0%w/w (20%v/v)
DESCRIPTION
Clear Solution filled in aluminium aerosol can with silver ferrule
valve provided with actuator suitable for oral inhalation, when
actuated a metered spray is produced.
DOSAGE FORM
Inhalation Aerosol
PHARMACOLOGY
PHARMACODYNAMICS
Beclometasone
dipropionate
is
a
synthetic
glucocorticoid.
Glucocorticoids have multiple anti-inflammatory effects inhibiting
both inflammatory cells and release of inflammatory mediators. It is
presumed that these anti-inflammatory actions play an important
role in the efficacy of Beclometasone dipropionate in controlling
symptoms and improving lung function in asthma, although the
exact mechanism of action of Beclometasone in the lungs is
unknown. It is hydrolysed via esterase enzymes to the active
metabolite, Beclometasone-17-monopropionate (B-17-MP) which
probably acts topically at the site of deposition in the bronchial
tree
after inhalation. Inhaled Beclometasone at recommended doses
reduces
systemic
exposure
compared
to
oral
administration
thereby
minimizing
systemic
side
effects,
including
pituitary
adrenal suppression.
PHARMACOKINETICS
When administered via inhalation, Beclometasone dipropionate is
hydrolysed in the lungs to the active metabolite, B-17-MP prior to
systemic circulation and is further metabolized during its passage
through the liver. When administered orally in healthy male
volunteers, the bioavailability of Beclo