BESOMID 100 MCG ACTUATION HFA- METERED DOSE INHALER

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Beclometasone dipropionate

Boleh didapati daripada:

STERILINE SDN. BHD.

INN (Nama Antarabangsa):

Beclometasone dipropionate

Unit dalam pakej:

1Units Units

Dikeluarkan oleh:

MIDAS CARE PHARMACEUTICALS PVT. LTD.

Risalah maklumat

BESOMID 100 MCG/ ACTUATION HFA-
METERED DOSE INHALER
Beclometasone Dipropionate (100mcg/ actuation)
_ _
_ _
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Besomid
_ _
is used for
2.
How Besomid works
3.
Before you use Besomid
4.
How to use Besomid
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Besomid
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT BESOMID IS USED FOR
Besomid is used to help prevent the
symptoms of asthma.
HOW BESOMID WORKS
The active ingredient, beclometasone
dipropionate, is one of a group of
Medicines called corticosteroids which
are often referred to simply as steroids.
Besomid reduces the swelling and
irritation in the walls of the small air
passages in the lungs and so ease
breathing problems.
BEFORE YOU USE BESOMID
-
_When you must not use it _
If you are pregnant, trying for a baby or
breast-feeding. There are a risk of
growth retardation and cleft palate to
the baby.
If you have ever had lung tuberculosis
(TB).
If you have ever had an allergic
reaction to Beclomethasone or any
ingredients listed at the end of the
leaflet.
-
_Before you start use it _
Some medicines are not suitable for
people with certain conditions, and
sometimes a medicine can only be used
if extra care is taken.
Some medicine may increase the effect
of Besomid and your doctor may wish
to monitor you carefully if you are
taking these medicines (including some
medicines for HIV such as cobicistat).
-
_Taking other medicine _
If you are taking or using any other
medicines. This includes any medicines
you are taking which are available to
buy without a prescription, such as
herbal and complementary medicines.
_ _
HOW TO USE BESOMID
-
_How much to use _
If this is a new inhaler or if you have
not used your inhaler for one week or
more, it must be tested before use by
removing the mouthpiece cover and
pressing down on the canister inside the
inhaler. Release one puff into the air,
away from you.
For adult, 1 inhalatio

Ciri produk

may need to be re-instated without
delay during periods of stress. It may
be advisable to provide such patients
with a supply of oral steroid to use in
emergency, for example when the
asthma worsens as a result of a chest
infection. The dose of this product
should be increased at this time and
then gradually reduced to the
maintenance level after the systemic
steroid has been discontinued.
Discontinuation of systemic steroids
may cause exacerbation of allergic
diseases such as atopic eczema and
rhinitis. These should be treated as
required with antihistamine and topical
therapy.
INTERACTIONS WITH OTHER
MEDICAMENTS
Beclomethasone is less dependent on
CYP3A metabolism than some other
corticosteroids, and in general
interactions are unlikely; however the
possibility of systemic effects with
concomitant use of strong CYP3A
inhibitors (e.g. cobicistat) cannot be
excluded, and therefore caution and
appropriate monitoring is advised with
the use of such agents
PREGNANCY AND LACTATION
There is inadequate evidence of safety
in human pregnancy. In animals,
systemic administration of relatively
high doses can cause abnormalities of
foetal development including growth
retardation and cleft palate. There may
therefore be a very small risk of such
effects in the human foetus. However,
inhalation of beclometasone
dipropionate into the lungs avoids the
high level of exposure that occurs with
administration by systemic routes. The
use of beclometasone in pregnancy
requires that the possible benefits of
the drug be weighed against the
possible hazards. The drug has been in
widespread use for many years without
apparent ill consequence. It is probable
that beclometasone is excreted in milk.
However, given the relatively low doses
used by the inhalation route, the levels
are likely to be low. In mothers breast
feeding their baby the therapeutic
benefits of the drug should be weighed
against the potential hazards to mother
and baby.
ADVERSE EFFECTS
It can cause nausea, cough and give
unpleasant taste and smell.
Candidiasis of the t