Flutiform 125 microgram/5 microgram per metered dose pressurised inhalation, suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

FLUTICASONE PROPIONATE; Formoterol fumarate

Available from:

IMED Healthcare Ltd.

ATC code:

R03AK; R03AK11

INN (International Name):

FLUTICASONE PROPIONATE; Formoterol fumarate

Dosage:

125/5 µg/µg

Pharmaceutical form:

Pressurised inhalation, suspension

Therapeutic area:

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

Authorization date:

2021-04-23

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
_FLUTIFORM_
_® _
125 MICROGRAM/5 MICROGRAM PER METERED DOSE PRESSURISED INHALATION,
SUSPENSION
_FLUTIFORM_
_® _
250 MICROGRAM/10 MICROGRAM PER METERED DOSE 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 _inhaler is and what it is used for
2. What you need to know before you use _FLUTIFORM _inhaler
3. How to use _FLUTIFORM _inhaler
4. Possible side effects
5. How to store _FLUTIFORM _inhaler
6. Contents of the pack and other information.
1. WHAT _FLUTIFORM _INHALER IS AND WHAT IT IS USED FOR
Please note: - _FLUTIFORM _pressurised inhalation, suspension is the
product name, however throughout
this leaflet it is shortened to _FLUTIFORM _inhaler. Sometimes this
may refer to a specific strength.
_FLUTIFORM _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 to improve your breathing.
It is advised that you should use
this medicine every day as directed by your

Summary of Product characteristics

Health Products Regulatory Authority
14 December 2021
CRN00CNWL
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flutiform 125 microgram/5 microgram per metered dose 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.
_Product imported from Czech Republic _
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
As per PA1688/013/002
5 PHARMACOLOGICAL PROPERTIES
As per PA1688/013/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Sodium Cromoglicate
Ethanol Anhydrous
Apaflurane HFA 227
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf-life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
In use shelf – life: 3 months after opening the foil pouch.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Health Products Regulatory Authority
14 December 2021
CRN00CNWL
Page 2 of 2
Do not store above 25°C. Do not refrigerate or freeze. If the inhaler
is exposed to freezing conditions then the patient must be
advised to allow the inhaler to warm at room temperature for 30
minutes then re-prime the inhaler (see section 4.2).
The canister contains a pressurised liquid. Do not expose to
temperatures higher than 50°C. Do not puncture, break or burn,
even when apparently empty.
6.5 NATURE AND CONTENTS OF CONTAINER
120 actuations per inhaler.
The actuator is white with a grey integr