Sirdupla Pressurised Inhalation Suspension 25mcg/125mcg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE

Available from:

Generics UK Limited

ATC code:

R03AK06

INN (International Name):

SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE

Pharmaceutical form:

PRESSURISED INHALATION, SUSPENSION

Composition:

SALMETEROL XINAFOATE 25 µg; FLUTICASONE PROPIONATE 125 µg

Prescription type:

POM

Therapeutic area:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Authorization status:

Authorised

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SIRDUPLA
25 MICROGRAM/125 MICROGRAM PER METERED DOSE
pressurised inhalation, suspension
25 MICROGRAM/250 MICROGRAM PER METERED DOSE
pressurised inhalation, suspension
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.
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 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.
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 YOU NEED TO USE A FAST-
ACT

Summary of Product characteristics

1
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 or 250
micrograms of fluticasone propionate.
This is equivalent to a delivered dose (ex actuator) of 21 micrograms
of salmeterol and 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 white plastic actuators incorporating an
atomising orifice and fitted with mauve
or 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 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
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
Route of administration: Inhalation use.
Patients should be made aware that Sirdupla must be used daily for
optimum benefit, even when
asymptomatic.
2
Patients should be regularly reassessed by a doctor, so that the
strength of Sirdupla 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: SIRDUPLA
IS ONLY AVAILABLE IN TWO
STRENGTHS, IT IS NOT AVAILABLE IN A LOWER STRENGTH PRODUCT CONTAINING SALMETEROL 25
MICROGRA