ALVESCO 80 INHALER (120 PUFFS)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CICLESONIDE

Boleh didapati daripada:

DKSH MALAYSIA SDN BHD

INN (Nama Antarabangsa):

CICLESONIDE

Unit dalam pakej:

1Units Units

Dikeluarkan oleh:

Kindeva Drug Delivery Limited

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
ALVESCO INHALER
Ciclesonide (80mcg/actuation, 160mcg/actuation)
1
WHAT IS IN THIS LEAFLET
1.
What Alvesco is used for
2.
How Alvesco works
3.
Before you use Alvesco
4.
How to use Alvesco
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
Alvesco
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT ALVESCO IS USED FOR
Alvesco is a preventer
medication in the treatment of
asthma that has to be taken
everyday and which becomes
active only after it has been
inhaled into your lungs.
HOW ALVESCO WORKS
Alvesco contains the active
ingredient ciclesonide.
Ciclesonide belongs to a group
of medicines called
corticosteroid. Alvesco is
prescribed to control persistent
asthma in adult, adolescents
and children over 6 years.
It helps you to breathe more
easily by decreasing the
symptoms of your asthma and
by lessening the chances of an
asthma attack. The effect
builds up over a period of time,
so this medicine needs to be
taken every day, even when
you are feeling well.
BEFORE YOU USE ALVESCO
_-_
_When you must not use it_
You should not take Alvesco if
you:
•
Are allergic to ciclesonide
or any of the other
ingredients of this
medicine. (see section
PRODUCT DESCRIPTION).
•
Are pregnant or plan to
become pregnant. Consult
your doctor first, as
he/she will consider the
risk and benefit of you
taking Alvesco if you are
pregnant.
•
Are breast-feeding or plan
to breastfeed. It is not
known if Alvesco passes
into your breast milk. You
and your doctor should
decide if you will take
Alvesco or breastfeed.
You should not do both
without first talking with
your doctor.
_-_
_Before you start to use it_
Before you take Alvesco, tells
your doctor if you:
•
Have ever been treated, or
are currently being
treated, for pulmonary
tuberculosis (TB), fungal,
viral or bacterial
infections
•
Have severe asthma.
Alvesco is not indicated
in the treatment of severe
or acute episodes of
asthma. If you have
severe asthma, your
doctor

Ciri produk

PRESENTATIONS
ALVESCO
®
80 mcg inhaler is a metered-dose inhaler which
delivers 80 micrograms of ciclesonide per actuation.
ALVESCO
®
160 mcg Inhaler is a metered-dose inhaler which
delivers 160 micrograms of ciclesonide per actuation.
INDICATIONS
Alvesco
®
is indicated as prophylactic treatment of asthma in adults,
adolescents and children over 6 years.
DOSAGE AND ADMINISTRATION
The recommended dose range for adults, elderly patients and
adolescents over 12 years of age with mild to moderate asthma is
160 to 640 mcg per day.
In severe asthma, this dose range may be increased to 1280 mcg per
day. The recommended dose range for children over 6 years is 80 mcg
to 160 mcg per day. For once daily dosing, Alvesco
®
should preferably
be administered in the evening although morning dosing of Alvesco
®
has also been shown to be effective. The final decision on morning or
evening dosing should be left to the discretion of the physician.
Symptoms start to improve with Alvesco
®
within 24 hours of treatment.
Once control is achieved, the dose of Alvesco
®
should be individualized
and titrated to the minimum dose needed to maintain good asthma
control.
Alvesco
®
can be used with or without a spacer (i.e., AeroChamber Plus
TM
).
Specific patient groups:
There is no need to adjust the dose in elderly patients or those with
hepatic or renal impairment.
Adolescent and adult patients taking chronic oral corticosteroid
therapy:
When transferring a patient from an oral steroid to Alvesco
®
, the patient
should be in a relatively stable phase. A high dose of Alvesco
®
should
be given in combination with the oral steroid for about 10 days.
Then the oral steroid should be gradually reduced no faster than
2.5 mg/day on a weekly basis to the lowest possible level.
INSTRUCTIONS FOR USE/HANDLING
Patients need to be instructed how to use the inhaler correctly. If
the
inhaler is new or has not been used for one week or more, three puffs
should be released into the air. No shaking is necessary as this is a
solution aerosol. Instruc