Floebb 125 mikrogram per puff Inhalationsspray, suspension

Страна: Швеция

Язык: шведский

Источник: Läkemedelsverket (Medical Products Agency)

Активный ингредиент:

flutikasonpropionat

Доступна с:

Viatris Limited

код АТС:

R03BA05

ИНН (Международная Имя):

fluticasone propionate

дозировка:

125 mikrogram per puff

Фармацевтическая форма:

Inhalationsspray, suspension

состав:

flutikasonpropionat 125 mikrog Aktiv substans

Тип рецепта:

Receptbelagt

Обзор продуктов:

Förpacknings: Spraybehållare, 120 doser

Статус Авторизация:

Godkänd

Дата Авторизация:

2016-03-17

тонкая брошюра

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FLOEBB 50 MICROGRAMS PER ACTUATION PRESSURISED INHALATION, SUSPENSION
FLOEBB 125 MICROGRAMS PER ACTUATION PRESSURISED INHALATION, SUSPENSION
FLOEBB 250 MICROGRAMS PER ACTUATION PRESSURISED INHALATION, SUSPENSION
fluticasone propionate
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 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 asthma
nurse. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET
1. What Floebb is and what it is used for
2. What you need to know before you use Floebb
3. How to use Floebb
4. Possible side effects
5. How to store Floebb
6. Contents of the pack and other information
1.
WHAT FLOEBB IS AND WHAT IT IS USED FOR
Floebb contains the active substance fluticasone propionate.
Fluticasone is a corticosteroid
(often just called steroid). It has an anti-inflammatory action which
reduces asthma-related
swelling and irritation in the lungs. Only a very small dose of
steroid is needed because it is
inhaled straight into your lungs.
Your doctor has prescribed this medicine to help prevent breathing
problems such as asthma.
Fluticasone propionate is sometimes called a ‘preventer’.
Floebb is not used to treat Chronic Obstructive Pulmonary Disease
(COPD).
You must use Floebb every day as directed by your doctor, even if you
are not currently
experiencing any breathing problems. This will make sure that it works
properly in
controlling your asthma. It takes 4-7 days for this medicine to work
fully.
FLOEBB
HELPS TO PREVENT BREATHLESSNESS AND WHEEZING. IT DOES NOT RELIEVE
SUDDEN
ATTACKS OF BREATHLESSNESS OR WH

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Floebb 50 micrograms per actuation pressurised inhalation, suspension.
Floebb 125 micrograms per actuation pressurised inhalation,
suspension.
Floebb 250 micrograms per actuation pressurised inhalation,
suspension.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose (ex-valve) contains 50 micrograms of fluticasone
propionate.
This is equivalent to a delivered dose (ex-actuator) of 44 micrograms
of fluticasone
propionate.
Each metered dose (ex-valve) contains 125 micrograms of fluticasone
propionate.
This is equivalent to a delivered dose (ex-actuator) of 110 micrograms
of fluticasone
propionate.
Each metered dose (ex-valve) contains 250 micrograms fluticasone
propionate. This
is equivalent to a delivered dose (ex-actuator) of 220 micrograms
fluticasone
propionate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pressurised inhalation, suspension.
Floebb is supplied in a pressurised aluminium multidose canister,
fitted with a
metering valve.
The canister contains a white to off-white suspension.
The canisters are fitted into light orange plastic actuators fitted
with white dust caps.
The canisters are fitted into orange plastic actuators fitted with
white dust caps.
The canisters are fitted into dark brown plastic actuators fitted with
white dust caps.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fluticasone propionate given by inhalation offers prophylactic
treatment for mild,
moderate and severe asthma.
_Adults and adolescents over 16 years:_
Floebb 50/125/250 micrograms is indicated in adults and adolescents
over 16 years of
age for the prophylactic treatment of asthma.
_Children aged over 4 years up to 12 years and adolescents aged 13 to
16 years:_
Only the lowest strength of this inhaled corticosteroid, Floebb 50
micrograms, is
authorised for use in these young age groups.
Floebb 50 micrograms is indicated in any child (aged over 4 years up
to 12 years) and
adolescents (aged 13 to 16 years) with asthm