Seretide 250 Diskus 50 microgram/250 microgram/dose inhalation powder, pre-dispensed

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE

Mevcut itibaren:

Primecrown 2010 Limited

ATC kodu:

R03AK; R03AK06

INN (International Adı):

SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE

Doz:

50/250mcg microgram(s)

Farmasötik formu:

Inhalation powder, pre-dispensed

Reçete türü:

Product subject to prescription which may be renewed (B)

Terapötik alanı:

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

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2017-08-25

Bilgilendirme broşürü

PACKAGE LEAFLET: INFORMATION FOR THE USER
SERETIDE
® 250 DISKUS
®
50 microgram/250 microgram/dose inhalation powder, pre-dispensed
SERETIDE
® 500 DISKUS
®
50 microgram/500 microgram/dose inhalation powder, pre-dispensed
(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 symptoms and 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 NOT BE USED TO RELIEVE A SUDDEN ATTACK OF
BREATHLESSNESS OR WHEEZING. IF THIS HAPPENS YOU NEED TO USE A FAST-
AC

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Seretide 250 Diskus 50 microgram/250 microgram/dose inhalation powder,
pre-dispensed.
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 231 micrograms of fluticasone propionate.
This corresponds to a pre-dispensed dose of 50
micrograms of salmeterol (as salmeterol xinafoate) and 250 micrograms
fluticasone propionate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed.
_Product imported from Bulgaria_
Moulded plastic device containing a foil strip with 60 regularly
placed blisters.
4 CLINICAL PARTICULARS
As per PA1077/046/002
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/046/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Excipient: Lactose monohydrate (which contains milk proteins).
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf-life expiry date of this product is the date shown on the
container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30°C.
6.5 NATURE AND CONTENTS OF CONTAINER
The inhalation powder is contained in blisters held on a formed PVC
coated base, with a peelable foil laminate lid. The
strip is contained in a moulded purple plastic device.
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