Sametec Airmaster 50 microgram/ 500 microgram/ dose, inhalation powder, pre-dispensed

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

SALMETEROL XINAFOATE; Fluticasone propionate

Διαθέσιμο από:

Clonmel Healthcare Ltd

Φαρμακολογική κατηγορία (ATC):

R03AK06

INN (Διεθνής Όνομα):

SALMETEROL XINAFOATE; Fluticasone propionate

Δοσολογία:

50/500 microgram(s)

Φαρμακοτεχνική μορφή:

Inhalation powder, pre-dispensed

Θεραπευτική περιοχή:

salmeterol and fluticasone

Καθεστώς αδειοδότησης:

Marketed

Ημερομηνία της άδειας:

2021-03-05

Φύλλο οδηγιών χρήσης

Page 1 of 9
PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SAMETEC AIRMASTER 50 MICROGRAM/100 MICROGRAM/ DOSE INHALATION POWDER,
PRE-DISPENSED
SAMETEC AIRMASTER 50 MICROGRAM/250 MICROGRAM/ DOSE INHALATION POWDER,
PRE-DISPENSED
SAMETEC AIRMASTER 50 MICROGRAM/500 MICROGRAM/ DOSE INHALATION POWDER,
PRE-DISPENSED
salmeterol/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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Sametec Airmaster is and what it is used for
2.
What you need to know before you use Sametec Airmaster
3.
How to use Sametec Airmaster
4.
Possible side effects
5.
How to store Sametec Airmaster
6.
Contents of the pack and other information
1.
WHAT SAMETEC AIRMASTER IS AND WHAT IT IS USED FOR
Sametec Airmaster 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.
SAMETEC AIRMASTER IS USED TO TREAT ADULTS AND ADOLESCENTS 12 YEARS OF
AGE AND OLDER.
The doctor has prescribed this medicine to help prevent breathing
problems such as:
•
Asthma
or
•
Chronic Obstructive Pulmonary Disease (COPD). Sametec Airmaster, at a
dose of
50/500 micrograms, reduces the number of flare ups of COPD symptoms.
You must use Sametec Airmaster everyday as directed by your doctor.
This will make sure that it
w

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
08 October 2021
CRN00CD5C
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sametec Airmaster 50 microgram/ 500 microgram/ dose, inhalation
powder, pre-dispensed
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single inhalation provides a delivered dose (the dose leaving the
mouthpiece) of 43 micrograms of salmeterol (as
salmeterol xinafoate) and 432 micrograms of fluticasone propionate.
This corresponds to a pre-metered dose of
50 micrograms of salmeterol (as salmeterol xinafoate) and 500
micrograms fluticasone propionate.
Excipient with known effect
Each delivered dose contains approximately 13 milligrams 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 60 regularly
placed blisters. Each blister contains pre-dispensed dose of
white to off white inhalation powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Sametec Airmaster is indicated in adults and adolescents 12 years of
age and older.
_ASTHMA_
Sametec Airmaster 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: Sametec Airmaster 50 microgram /100 microgram strength is not
appropriate in adults and children with severe asthma.
_CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)_
Sametec Airmaster 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
Patients are to be made aware that Sametec Airmaster must