Seretide 250 Evohaler 25 microgram/250 microgram/dose pressurised inhalation, suspension

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

SALMETEROL XINAFOATE; Fluticasone propionate

Mevcut itibaren:

GlaxoSmithKline (Ireland) Limited

ATC kodu:

R03AK06

INN (International Adı):

SALMETEROL XINAFOATE; Fluticasone propionate

Doz:

25/250 microgram(s)/dose

Farmasötik formu:

Pressurised inhalation, suspension

Reçete türü:

Product subject to prescription which may be renewed (B)

Terapötik alanı:

salmeterol and fluticasone

Yetkilendirme durumu:

Marketed

Yetkilendirme tarihi:

2001-02-21

Bilgilendirme broşürü

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Seretide Evohaler 25 microgram/50 microgram per metered dose
pressurised inhalation, suspension
Seretide Evohaler 25 microgram/125 microgram per metered dose
pressurised inhalation, suspension
Seretide Evohaler 25 microgram/250 microgram per metered dose
pressurised inhalation, suspension
[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.
You must use Seretide every day as directed by your doctor. This will
make sure that it works properly
in controlling your asthma.
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-ACTING ‘RELIEVER’ (‘RESCUE’) INH

Ürün özellikleri

Health Products Regulatory Authority
16 October 2023
CRN00DTMF
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Seretide 250 Evohaler 25 microgram/250 microgram/dose pressurised
inhalation, suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose (ex valve) contains:
25 micrograms of salmeterol (as salmeterol xinafoate)and 50, 125 or
250 micrograms of fluticasone propionate. This is
equivalent to a delivered dose (ex actuator) of 21 micrograms of
salmeterol and 44, 110 or 220 micrograms of fluticasone
propionate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pressurised inhalation, suspension.
The canister contains a white to off white suspension.
The canisters are fitted into purple plastic actuators incorporating
an atomising orifice and fitted with dustcaps.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Posology_
Route of administration: Inhalation use.
Patients should be made aware that Seretide Evohaler must be used
daily for optimum benefit, even when asymptomatic.
Patients should be regularly reassessed by a doctor, so that the
strength of Seretide they are receiving remains optimal and is
only changed on medical advice. THE DOSE SHOULD BE TITRATED TO THE
LOWEST DOSE AT WHICH EFFECTIVE CONTROL OF SYMPTOMS
IS MAINTAINED. WHERE THE CONTROL OF SYMPTOMS IS MAINTAINED WITH THE LOWEST STRENGTH OF THE COMBINATION GIVEN TWICE
DAILY THEN THE NEXT STEPCOULD INCLUDE A TEST OF
INHALED CORTICOSTEROID ALONE. As an alternative, patients requiring a
long- acting β2 agonist could be titrated to Seretide given
once daily i