Flutiform K-haler 125 microgram/5 microgram per actuation pressurised inhalation, suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fluticasone propionate; Formoterol fumarate dihydrate

Available from:

Mundipharma Pharmaceuticals Limited

ATC code:

R03AK; R03AK11

INN (International Name):

Fluticasone propionate; Formoterol fumarate dihydrate

Dosage:

125 µg/5 µg/actuation

Pharmaceutical form:

Pressurised inhalation, suspension

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics; formoterol and fluticasone

Authorization status:

Marketed

Authorization date:

2018-01-26

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
_FLUTIFORM_
_®_
_ K-HALER_
_®_
_ _50 MICROGRAM /5 MICROGRAM PER ACTUATION PRESSURISED INHALATION,
SUSPENSION,
AND
_FLUTIFORM_
_®_
_ K-HALER_
_®_
_ _125 MICROGRAM /5 MICROGRAM PER ACTUATION PRESSURISED INHALATION,
SUSPENSION
fluticasone propionate/formoterol fumarate dihydrate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, pharmacist or
nurse.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What
_FLUTIFORM K-HALER _
is and what it is used for
2.
What you need to know before you use
_FLUTIFORM K-HALER _
3.
How to use
_FLUTIFORM K-HALER _
4.
Possible side effects
5.
How to store
_FLUTIFORM K-HALER _
6.
Contents of the pack and other information
1.
WHAT _FLUTIFORM K-HALER _IS AND WHAT IT IS USED FOR
Please note:-
_FLUTIFORM K-HALER_
pressurised inhalation, suspension is the full name of the product,
however throughout
this leaflet it is referred to as
_FLUTIFORM K-HALER _
or simply as an inhaler, sometimes together with a reference
to a specific strength.
_FLUTIFORM K-HALER _
is an inhaler (a pressurised inhalation suspension) which contains two
active ingredients:

Fluticasone propionate which belongs to a group of medicines called
steroids. Steroids help to reduce
swelling and inflammation in the lungs.

Formoterol fumarate dihydrate which belongs to a group of medicines
called long-acting beta
2
agonists.
Long-acting beta
2
agonists are long-acting bronchodilators which help the airways in
your lungs to stay
open, making it easier for you to breathe.
Together these two active ingredients help

Summary of Product characteristics

Health Products Regulatory Authority
25 June 2021
CRN009ZSG
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flutiform K-haler 125 microgram/5 microgram per actuation pressurised
inhalation, suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose (ex-valve) contains:
· 125 micrograms of fluticasone propionate and 5 micrograms of
formoterol fumarate dihydrate. This is equivalent to a
delivered dose (ex-actuator) of approximately 115 micrograms of
fluticasone propionate and 4.5 micrograms of formoterol
fumarate dihydrate.
Excipient with known effect
Each actuation contains 1 mg ethanol.
For the 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 sealed inside a pale grey breath-triggered actuator
with an integrated dose indicator and an orange mouthpiece cover.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This fixed-dose combination of fluticasone propionate and formoterol
fumarate (Flutiform K-haler) 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 K-haler is indicated in adults and adolescents aged 12 years
and above.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Patients will need to be trained on the use of the inhaler and their
asthma should be regularly reassessed by a doctor, so that
the strength of Flutiform K-haler they are receiving remains optimal
and is only changed on medical advice. The dose should
be titrated to the lowest dose at which effective control of symptoms
is maintained. Once control of asthma is achieved with
the lowest strength of Flutiform K-haler admin