Flutiform 50 microgram5 microgram per actuation pressurised inhalation suspension

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

FLUTICASONE PROPIONATE; FORMOTEROL FUMARATE

Boleh didapati daripada:

MUNDIPHARMA PHARMACEUTICALS SDN. BHD.

INN (Nama Antarabangsa):

FLUTICASONE PROPIONATE; FORMOTEROL FUMARATE

Unit dalam pakej:

1units Units

Dikeluarkan oleh:

Recipharm HC Limited

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
FLUTIFORM
®
INHALER
Fluticasone propionate/ formoterol fumarate dihydrate
Page 1
Flutiform
®
50 microgram /5 microgram, per actuation pressurised inhalation,
suspension
Flutiform
®
125 microgram /5 microgram per actuation pressurised inhalation,
suspension
Flutiform
®
250 microgram /10 microgram per actuation pressurised inhalation,
suspension
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE.
•
Keep this leaflet. You may need to read it
again.
•
If you have any further questions, ask your
doctor or pharmacist.
•
This medicine has been prescribed for you.
Do not pass it on to others. It may harm them,
even if their symptoms are the same as yours.
•
If any of the side effects become serious, or
if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist.
WHAT IS IN THIS LEAFLET
1.
What
_FLUTIFORM_
®
inhaler is and what it is
used for
2.
How
_FLUTIFORM_
®
inhaler works
3.
Before you use
_FLUTIFORM_
®
inhaler
4.
How to use
_FLUTIFORM_
®
inhaler
5.While you are using
_FLUTIFORM_
®
inhaler
6.
Possible side effects
7.
Storage
and
disposal
of
_FLUTIFORM_
®
inhaler
8.
Product description
9.
Manufacturer
10.
Marketing Authorization Holder
11.
Date of revision
WHAT _FLUTIFORM_
® INHALER IS AND WHAT IT IS
USED FOR
Please note:-
_FLUTIFORM_
®
pressurized
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
pressurized
inhalation, suspension) which contains two
active
ingredients;
fluticasone
propionate
and formoterol fumarate dihydrate.
This medicine helps to prevent breathing
problems such as asthma and helps to stop
you
becoming
breathless
and
wheezy.
However, it does not work if you are already
having an asthma attack i.e. you are already
breathless and wheezing. You will need to
use a fast acting ‘reliever’ medicine such as
salbutamol if this h

Ciri produk

R01107
720x200mm (CPRO-1-54) (L) V2
z
_ITEM DESCRIPTION:_
_MANUFACTURER / PACKER:_
_CREATED BY:_
_DATE CREATED:_
_VERSION:_
_POR NO.:_
COLOUR(S):
NON-PRINTING COLOURS
PINK
BLUE
PURPLE
BUFF
_PACKAGI NG _
_ARTWORK _
_TEAM_
_Bard Pharmaceuticals Ltd._
_Cambridge Science Park, Milton Road, _
_Cambridge CB4 0GW, UK_
_Tel: [phone]_
CG
31 MAR 2022
1
V11-2019
_PREFIXES_
N/A
_ITEM CODE 2:_
N/A
_DIMENSIONS FOLDED:_
40x200mm
_DIMENSIONS:_
720X200mm
_SECURITY CODE NO.:_
801
_SECURITY CODE TYPE:_
Pharmacode
_PATTERN REPEAT (MM):_
N/A
_UNWIND NO.:_
N/A
_DRAWING NO.:_
N/A
_PMS NO.:_
N/A
_TEMPLATE NO.:_
720x200mm (CPRO-1-54) (L) V2
FLUTIFORM INH 50-5MCG 125-5MCG 250-
10MCG PIL MY BN R01107
RECIPHARM
(FLUTIFORM)
12224
Black
PMS 280
PMS 1505
MINIMUM FONT SIZE:
7pt
FLUTIFORM INH 50-5MCG 125-5MCG 250-10MCG PIL MY BN R01107 V1.indd 1
FLUTIFORM INH 50-5MCG 125-5MCG 250-10MCG PIL MY BN R01107 V1.indd 1
31/03/2022 12:51
31/03/2022 12:51
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 inha