Sirdupla 25 microgram/250 microgram per metered dose pressurised inhalation, suspension

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

SALMETEROL XINAFOATE; Fluticasone propionate

Tilgjengelig fra:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC-kode:

R03AK; R03AK06

INN (International Name):

SALMETEROL XINAFOATE; Fluticasone propionate

Dosering :

25mcg/250 microgram(s)

Legemiddelform:

Pressurised inhalation, suspension

Terapeutisk område:

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

Autorisasjon status:

Marketed

Autorisasjon dato:

2017-02-03

Informasjon til brukeren

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SIRDUPLA
25 MICROGRAM/125 MICROGRAM PER METERED DOSE PRESSURISED INHALATION,
SUSPENSION
25 MICROGRAM/250 MICROGRAM PER METERED DOSE PRESSURISED INHALATION,
SUSPENSION
Salmeterol (as xinafoate)/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 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 Sirdupla is and what it is used for
2.
What you need to know before you use Sirdupla
3.
How to use Sirdupla
4.
Possible side effects
5.
How to store Sirdupla
6.
Contents of the pack and other information
1.
WHAT SIRDUPLA IS AND WHAT IT IS USED FOR
Sirdupla contains two active substances, 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 glucocorticosteroid which reduces swelling
and irritation in the lungs.
SIRDUPLA IS INDICATED FOR USE IN ADULTS 18 YEARS OF AGE AND OLDER
ONLY.
SIRDUPLA IS NOT INDICATED FOR USE IN CHILDREN 12 YEARS OF AGE AND
YOUNGER OR ADOLESCENTS 13 TO 17
YEARS OF AGE.
The doctor has prescribed this medicine to help prevent breathing
problems such as asthma.
You must use Sirdupla every day as directed by your doctor. This will
make sure that it works properly in
controlling your asthma.
SIRDUPLA HELPS TO STOP BREATHLESSNESS AND WHEEZINESS COMING ON.
HOWEVER SIRDUPLA SHOULD NOT BE
USED TO RELIEVE A SUDDEN ATTACK OF BREATHLESSNESS OR WHEEZING. IF THIS
HAPPENS YO

Preparatomtale

Health Products Regulatory Authority
25 September 2020
CRN0097RT
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sirdupla 25 microgram/250 microgram per metered dose pressurised
inhalation, suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose (ex valve) contains:
25 micrograms of salmeterol (as salmeterol xinafoate) and 250
micrograms of fluticasone propionate. This is equivalent to a
delivered dose (ex actuator) of 21 micrograms of salmeterol and 220
micrograms of fluticasone propionate.
Excipients with known effect:
This medicinal product contains 0.73 mg of alcohol per inhalation.
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 white plastic actuators incorporating an
atomising orifice and fitted with burgundy dustcaps.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sirdupla is indicated in the regular treatment of asthma where use of
a combination product (long- acting β
2
agonist and
inhaled glucocorticosteroid) is appropriate:

- patients not adequately controlled with inhaled glucocorticosteroids
and 'as needed' inhaled short-acting β
2
agonist or

- patients already adequately controlled on both inhaled
glucocorticosteroid and long-acting β
2
agonist.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Sirdupla is indicated in adults 18 years of age and older only.
Sirdupla is not indicated for use in children, 12 years of age and
younger or adolescents, 13 to 17 years of age.
Posology
Patients should be made aware that salmeterol/fluticasone propionate
must be used daily for optimum benefit, even when
asymptomatic.
Patients should be regularly reassessed by a doctor, so that the
strength of salmeterol/fluticasone propionate 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. TO NOTE: SIRD