FLUTIFORM® PRESSURISED INHALATION SUSPENSION 250 MICROGRAM10 MICROGRAM PER ACTUATION

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Fluticasone Propionate; Formoterol Fumarate Dihydrate

Available from:

MUNDIPHARMA PHARMACEUTICALS PTE. LTD.

ATC code:

R03AK07

Dosage:

250 mcg/actuation

Pharmaceutical form:

AEROSOL, METERED

Composition:

Fluticasone Propionate 250 mcg/actuation; Formoterol Fumarate Dihydrate 10 mcg/actuation

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

Prescription Only

Manufactured by:

Recipharm HC Limited

Authorization status:

ACTIVE

Authorization date:

2014-05-19

Patient Information leaflet

1 
NAME OF THE MEDICINAL PRODUCT 

_FLUTIFORM_
®

50 microgram/5 microgram, 125 microgram/5 microgram and 
250 microgram/10 microgram per actuation pressurised inhalation,
suspensions. 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each metered dose (ex-valve) contains: 

•  50 micrograms of fluticasone propionate and 5 micrograms
of formoterol fumarate dihydrate.  

This is equivalent to a delivered dose
(ex-actuator) of approximately 46 microgram of 

fluticasone propionate/4.5 microgram of formoterol fumarate dihydrate. 
•  125 micrograms of fluticasone propionate and 5 micrograms
of formoterol fumarate dihydrate.  

This is equivalent to a delivered dose
(ex-actuator) of approximately 115 microgram of 

fluticasone propionate/4.5 microgram of formoterol fumarate dihydrate. 
•  250 micrograms of fluticasone propionate and 10 micrograms
of formoterol fumarate dihydrate.  

This is equivalent to a delivered dose
(ex-actuator) of approximately 230 microgram of 

fluticasone propionate/9.0 microgram of formoterol fumarate dihydrate. 

For a full list of excipients, see section 6.1. 

3 
PHARMACEUTICAL FORM 

Pressurised inhalation, suspension 

The canister contains white to off white liquid
suspension.  The canister is in a white actuator with a 
grey integrated dose indicator and a light grey mouthpiece
cover. 

4 
CLINICAL PARTICULARS 

4.1  THERAPEUTIC INDICATIONS 

This fixed-dose combination of fluticasone propionate and
formoterol fumarate (_FLUTIFORM_
®_ _
inhaler) 
is indicated in the regular treatment of asthma where the use
of a combination product (an inhaled 
corticosteroid and a long-acting 
β
2 
agonist) is appropriate: 

• 
For patients not adequately controlled with inhaled corticosteroids
and ‘as required’ inhaled 

short-acting 
β
2 
agonis

Summary of Product characteristics

1
NAME OF THE MEDICINAL PRODUCT
_FLUTIFORM_
®
50 microgram/5 microgram, 125 microgram/5 microgram and
250 microgram/10 microgram per actuation pressurised inhalation,
suspensions.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose (ex-valve) contains:
•
50 micrograms of fluticasone propionate and 5 micrograms of formoterol
fumarate dihydrate.
This is equivalent to a delivered dose (ex-actuator) of approximately
46 microgram of
fluticasone propionate/4.5 microgram of formoterol fumarate dihydrate.
•
125 micrograms of fluticasone propionate and 5 micrograms of
formoterol fumarate dihydrate.
This is equivalent to a delivered dose (ex-actuator) of approximately
115 microgram of
fluticasone propionate/4.5 microgram of formoterol fumarate dihydrate.
•
250 micrograms of fluticasone propionate and 10 micrograms of
formoterol fumarate dihydrate.
This is equivalent to a delivered dose (ex-actuator) of approximately
230 microgram of
fluticasone propionate/9.0 microgram of formoterol fumarate dihydrate.
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Pressurised inhalation, suspension
The canister contains white to off white liquid suspension. The
canister is in a white actuator with a
grey integrated dose indicator and a light grey mouthpiece cover.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This fixed-dose combination of fluticasone propionate and formoterol
fumarate (
_FLUTIFORM_
®
inhaler)
is indicated in the regular treatment of asthma where the use of a
combination product (an inhaled
corticosteroid and a long-acting β
2
agonist) is appropriate:
•
For patients not adequately controlled with inhaled corticosteroids
and ‘as required’ inhaled
short-acting β
2
agonist.
Or
•
For patients already adequately controlled on both an inhaled
corticosteroid and a long-acting
β
2
agonist.
_FLUTIFORM_
_® _
50 microgram
_/_
5 microgram is indicated in adults, adolescents and children aged 5
years and above.
_FLUTIFORM_
_® _
125 microgram
_/_
5 microgram is indicated in adul