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

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

SALMETEROL XINAFOATE; Fluticasone propionate

Διαθέσιμο από:

GlaxoSmithKline (Ireland) Limited

Φαρμακολογική κατηγορία (ATC):

R03AK; R03AK06

INN (Διεθνής Όνομα):

SALMETEROL XINAFOATE; Fluticasone propionate

Δοσολογία:

50 mcg/250 microgram(s)

Φαρμακοτεχνική μορφή:

Inhalation powder, pre-dispensed

Τρόπος διάθεσης:

Product subject to prescription which may be renewed (B)

Θεραπευτική περιοχή:

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

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

1999-01-22

Φύλλο οδηγιών χρήσης

1
GSK LOGO
PACKAGE LEAFLET: INFORMATION FOR THE USER
Seretide 100 Diskus 50 microgram/100 microgram/dose inhalation powder,
pre-dispensed
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 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

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
17 August 2020
CRN009RDW
Page 1 of 16
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 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 β
2
agonist and
inhaled corticosteroid) is appropriate:
- patients not adequately controlled with inhaled corticosteroids and
‘as needed’ inhaled short acting β
2
agonist
or
- patients already adequately controlled on both inhaled
corticosteroid and long-acting β
2
agonist.
Note: Seretide 50microgram /100 microgram strength is not appropriate
in adults and children with severe asthma.
_CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)_
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: For inhalation use.
Patients should be made aware that Seretide Diskus must be used daily
for optimum benefit, even when asymptomatic.
Patients should be regularly reassessed by a doctor, so that the
stren