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

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SALMETEROL XINAFOATE, FLUTICASONE PROPIONATE

Available from:

Mylan Ireland Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland

ATC code:

R03AK06

INN (International Name):

SALMETEROL XINAFOATE 25 µg FLUTICASONE PROPIONATE 250 µg

Pharmaceutical form:

PRESSURISED INHALATION, SUSPENSION

Composition:

SALMETEROL XINAFOATE 25 µg FLUTICASONE PROPIONATE 250 µg

Prescription type:

POM

Therapeutic area:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Authorization status:

Authorised

Authorization date:

2017-01-27

Patient Information leaflet

Page
1
of
11
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

Summary of Product characteristics

Page
1
of
20
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sirdupla 25 microgram/125 microgram per metered dose pressurised
inhalation, suspension.
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 125
micrograms of fluticasone
propionate. This is equivalent to a delivered dose (ex actuator) of 21
micrograms of salmeterol
and 110 micrograms of fluticasone propionate.
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 mauve dustcaps.
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.
Page
2
of
20
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/f