Flutiform 125micrograms/dose / 5micrograms/dose inhaler

Krajina: Spojené kráľovstvo

Jazyk: angličtina

Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktívna zložka:

Formoterol fumarate dihydrate; Fluticasone propionate

Dostupné z:

Napp Pharmaceuticals Ltd

ATC kód:

R03AK11

INN (Medzinárodný Name):

Formoterol fumarate dihydrate; Fluticasone propionate

Dávkovanie:

5microgram/1dose ; 125microgram/1dose

Forma lieku:

Pressurised inhalation

Spôsob podávania:

Inhalation

Trieda:

No Controlled Drug Status

Typ predpisu:

Valid as a prescribable product

Prehľad produktov:

BNF: 03020000; GTIN: 5012854075122

Príbalový leták

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
_FLUTIFORM_
_®_
_ _50 MICROGRAM /5 MICROGRAM, 125 MICROGRAM /5 MICROGRAM
AND 250 MICROGRAM /10 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
asthma nurse.

This medicine has been prescribed for you. 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 asthma
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 doctor or asthma nu

Súhrn charakteristických

OBJECT 1
FLUTIFORM 50 MICROGRAM/5 MICROGRAM PER
ACTUATION PRESSURISED INHALATION, SUSPENSION
Summary of Product Characteristics Updated 05-Aug-2015 | Napp
Pharmaceuticals Limited
1. Name of the medicinal product
_FLUTIFORM_
®
50 microgram/5 microgram, 125 microgram/5 microgram and 250
microgram/10 microgram
per actuation pressurised inhalation, suspension.
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
micrograms of fluticasone propionate
and 4.5 micrograms 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
micrograms of fluticasone propionate
and 4.5 micrograms 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
micrograms of fluticasone propionate
and 9.0 micrograms of formoterol fumarate dihydrate.
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 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
ago