FLUTICASONE CIPLA INHALER fluticasone propionate 125 microgram/actuation inhalation pressurised aerosol can metered dose

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

fluticasone propionate, Quantity: 125 microgram/actuation

Available from:

Cipla Australia Pty Ltd

INN (International Name):

fluticasone propionate

Pharmaceutical form:

Inhalation, pressurised

Composition:

Excipient Ingredients: norflurane

Administration route:

Inhalation

Units in package:

120 metered doses

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For use in the prophylactic management of asthma in adults and adolescents over 16 years of age.

Product summary:

Visual Identification: A rigid aluminium container, fitted with a metered dose valve, containing a white homogeneous suspension, fitted with a plastic actuator with a white body and yellow coloured cap.; Container Type: Aerosol Can - Metered Dose; Container Material: Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-02-21

Patient Information leaflet

FLUTICASONE CIPLA INHALER
125 MICROGRAM AND 250 MICROGRAM MDI
_Fluticasone propionate_
Fluticasone Cipla Inhaler
CONSUMER
MEDICINE
INFORMATION
Please
read
this
leaflet
carefully
before
you
start
using
Fluticasone
Cipla
Inhaler.
______________________
WHAT IS IN THIS LEAFLET
_________________
This
leaflet
answers
some
common
questions
about
Fluticasone Cipla Inhaler. It
does
not
contain
all
of
the
available information.
It does not take the place of
talking
to
your
doctor
or
pharmacist.
All medicines have risks and
benefits.
Your
doctor
has
weighed the risks of you using
Fluticasone
Cipla
Inhaler
against
the
benefits
this
medicine is expected to have
for you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT TAKING THIS MEDICINE,
ASK
YOUR
DOCTOR
OR
PHARMACIST.
KEEP
THIS
LEAFLET
WITH
THE
MEDICINE.
You may need to read it again.
WHAT
FLUTICASONE
CIPLA
INHALERS ('PUFFERS') ARE USED
FOR
You may know your Inhaler
better as a 'puffer'. Fluticasone
Cipla
puffers
contain
a
medicine
called
fluticasone
propionate.
This
medicine
belongs
to
a
group
of
medicines
known
as
corticosteroids,
frequently
called 'steroids'. They are not
'anabolic steroids' which are
the
steroids
sometimes
misused by athletes.
Your Fluticasone Cipla puffer
provides a measured amount
of steroid for you to breathe
into your lungs. By using your
Fluticasone
Cipla
puffer
regularly
every
day,
the
medicine reduces the swelling
and irritation in the walls of
the small air passages in your
lungs.
Your Fluticasone Cipla puffer
contains the type of asthma
medicine
known
as
a
'preventer'. It does not give
immediate
relief
from
an
asthma attack and may take up
to a week to start to work. If
your shortness of breath or
wheeze
does
not
get
better
after 7 days, tell your doctor.
When used every day, your
Fluticasone Cipla puffer helps
to
ease
breathing
problems
and prevent asthma attacks.
This medicine is only one part
of a general plan to help you
manage
your
asthma.
You
should discuss this plan with
your doctor. You may also be
using a 'reliever puffer'. Keep
using
it
according
to
y

Summary of Product characteristics

AUSTRALIAN
PRODUCT
INFORMATION
-
FLUTICASONE
CIPLA
INHALER
(FLUTICASONE PROPIONATE) PRESSURISED INHALATION
1
NAME OF THE MEDICINE
Fluticasone propionate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
FLUTICASONE CIPLA INHALER contains a pressurised inhalation
suspension, delivering either 125 or
250 micrograms of fluticasone propionate per actuation.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Pressurised inhalation.
A rigid aluminium container, fitted with a metered dose valve,
containing a white homogeneous
suspension, fitted with a plastic actuator with a white body and
yellow coloured cap.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
For use in the prophylactic management of asthma in adults and
adolescents over 16 years of age.
4.2
DOSE AND METHOD OF ADMINISTRATION
Note: 50 micrograms per actuation inhaler for children and adolescents
at 1 to 15 year old can be available
from other brand/s. Other dosage forms such as Accuhaler, disks and
diskhaler can be available from other
brand/s.
Fluticasone propionate has a marked anti-inflammatory effect in the
lungs. It reduces symptoms and
exacerbations of asthma in patients receiving either no prophylactic
treatment or other available antiasthma
therapy.
Fluticasone Cipla Inhaler is administered via the inhaled route only.
It is intended that each prescribed dose
is given by a minimum of 2 inhalations.
In patients who find co-ordination of a pressurised metered-dose
inhaler difficult, a spacer may be used
with Fluticasone Cipla Inhaler.
Patients should be made aware of the prophylactic nature of therapy
with inhaled fluticasone propionate
and that it should be taken regularly even when they are asymptomatic.
The onset of therapeutic effect is
within 4 to 7 days.
If patients find that relief with short-acting bronchodilator
treatment becomes less effective or they need
more inhalations than usual, medical attention must be sought.
The dosage of fluticasone propionate should be adjusted according to
the individual respo