Seretide Diskus forte 50 mikrogram/500 mikrogram/dos Inhalationspulver, avdelad dos

Страна: Швеція

мова: шведська

Джерело: Läkemedelsverket (Medical Products Agency)

Активний інгредієнт:

flutikasonpropionat; salmeterolxinafoat

Доступна з:

Cross Pharma AB

Код атс:

R03AK06

ІПН (Міжнародна Ім'я):

fluticasone propionate; salmeterol

Дозування:

50 mikrogram/500 mikrogram/dos

Фармацевтична форма:

Inhalationspulver, avdelad dos

Склад:

laktosmonohydrat Hjälpämne; salmeterolxinafoat 72,5 mikrog Aktiv substans; flutikasonpropionat 500 mikrog Aktiv substans

Тип рецепту:

Receptbelagt

Терапевтична области:

Salmeterol och flutikason

Статус Авторизація:

Avregistrerad

Дата Авторизація:

2006-06-27

інформаційний буклет

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
Seretide Diskus mite 50 microgram/100 microgram/ dose inhalation
powder, pre-dispensed
Seretide Diskus 50 microgram/250 microgram/ dose inhalation powder,
pre-dispensed
Seretide Diskus forte 50 microgram/500 microgram/ dose inhalation
powder, pre-dispensed
[To be completed nationally]
salmeterol/fluticasone propionate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Seretide is and what it is used for
2.
What you need to know before you use Seretide
3.
How to use Seretide
4.
Possible side effects
5.
How to store Seretide
6.
Contents of the pack and other information
1.
WHAT SERETIDE IS AND WHAT IT IS USED FOR
Seretide contains two medicines, salmeterol and fluticasone
propionate:
•
Salmeterol is a long-acting bronchodilator. Bronchodilators help the
airways in the lungs to stay
open. This makes it easier for air to get in and out. The effects last
for at least 12 hours.
•
Fluticasone propionate is a corticosteroid which reduces swelling and
irritation in the lungs.
The doctor has prescribed this medicine to help prevent breathing
problems such as:
•
Asthma
•
Chronic Obstructive Pulmonary Disease (COPD). Seretide Diskus, at a
dose of 50/500
micrograms, reduces the number of flare ups of COPD symptoms.
You must use Seretide every day as directed by your doctor. This will
make sure that it works properly
in controlling your asthma or COPD.
SERETIDE HELPS TO STOP BREATHLESSNESS AND WHEEZINESS COMING ON.
HOWEVER SERETIDE SHOULD NO

Характеристики продукта

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Seretide Diskus mite 50 microgram/100 microgram/ dose inhalation
powder, pre-dispensed.
Seretide Diskus 50 microgram/250 microgram/ dose inhalation powder,
pre-dispensed.
Seretide Diskus forte 50 microgram/500 microgram/ dose inhalation
powder, pre-dispensed.
[To be completed nationally]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single inhalation provides a delivered dose (the dose leaving the
mouthpiece) of 47 micrograms
of salmeterol (as salmeterol xinafoate) and 92, 231 or 460 micrograms
of fluticasone propionate. This
corresponds to a pre-dispensed dose of 50 micrograms of salmeterol (as
salmeterol xinafoate) and
100, 250 or 500 micrograms fluticasone propionate.
Excipients with known effect:
Each delivered dose contains up to 12.5 mg of lactose (as
monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed.
Moulded plastic device containing a foil strip with 28 or 60 regularly
placed blisters.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ASTHMA_
Seretide is indicated in the regular treatment of asthma where use of
a combination product
_ _
(long-
acting

2
agonist
_ _
and inhaled corticosteroid) is
_ _
appropriate:
-
patients not adequately controlled with inhaled corticosteroids and
‘as needed’ inhaled
short-acting

2
agonist
or
-
patients already adequately controlled on both inhaled corticosteroid
and long-acting

2
agonist.
Note: Seretide 50 microgram /100 microgram strength is not appropriate
in adults and children with
severe asthma.
_CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)_
2
Seretide is indicated for the symptomatic treatment of patients with
COPD, with a FEV
1
<60%
predicted normal (pre-bronchodilator) and a history of repeated
exacerbations, who have significant
symptoms despite regular bronchodilator therapy.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
Route of administration: Inhalation use.
Patients should be made aware that