Stalpex 50 microgram/500 microgram/dose inhalation powder, pre-dispensed

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Fluticasone propionate; Salmeterol

Available from:

Glenmark Arzneimittel GmbH

ATC code:

R03AK06

INN (International Name):

Fluticasone propionate; Salmeterol

Dosage:

50/500 microgram(s)

Pharmaceutical form:

Powder for Inhalation

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

salmeterol and fluticasone

Authorization date:

2019-02-08

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
STALPEX 50 MICROGRAM/500 MICROGRAM/DOSE INHALATION POWDER,
PRE-DISPENSED
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 Stalpex is and what it is used for
2.
What you need to know before you use Stalpex
3.
How to use Stalpex
4.
Possible side effects
5.
How to store Stalpex
6.
Contents of the pack and other information
1.
WHAT STALPEX IS AND WHAT IT IS USED FOR
Stalpex 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
•
Chronic Obstructive Pulmonary Disease (COPD), reduces the number of
flare ups of COPD
symptoms.
You must use Stalpex every day as directed by your doctor. This will
make sure that it works properly
in controlling your asthma or COPD.
STALPEX HELPS TO STOP BREATHLESSNESS AND WHEEZINESS COMING ON. HOWEVER
STALPEX 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’) INHALER, SUCH AS SALBUTAMOL.
YOU SHOULD ALWAYS HAVE YOUR FAST-
ACTING ‘RESCUE’ INHALER WITH YOU.
STALPEX SHOULD ONLY BE USED TO TREAT ASTHMA

Summary of Product characteristics

Health Products Regulatory Authority
11 February 2019
CRN008K3X
Page 1 of 23
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Stalpex 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 47 micrograms of salmeterol (as salmeterol xinafoate) and 460
micrograms of
fluticasone propionate. This corresponds to a pre-dispensed dose of 50
micrograms
of salmeterol (as salmeterol xinafoate) and 500 micrograms fluticasone
propionate.
Excipient(s) with known effect:
Each dose contains lactose up to 13.3 milligram.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed.
Molded plastic inhaler containing a foil strip with 60 regularly
placed blisters.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Asthma_
STALPEX IS INDICATED FOR USE IN PATIENTS WITH SEVERE ASTHMA 12 YEARS
OF AGE AND
OLDER ONLY.
Stalpex is indicated in the regular treatment of patients with SEVERE
asthma where
use of a combination product (long-acting β2 agonist and inhaled
corticosteroid) is
appropriate:

patients not adequately controlled on a lower strength corticosteroid
combination product
or
patients already adequately controlled on an inhaled corticosteroid in
a high
strength and a long-acting β2 agonist.
_Chronic Obstructive Pulmonary Disease (COPD)_
Stalpex is indicated for the symptomatic treatment of patients with
COPD, with a
Health Products Regulatory Authority
11 February 2019
CRN008K3X
Page 2 of 23
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
Stalpex is indicated in adults and adolescents 12 years of age and
older only.
Stalpex is not indicated for use in children younger than 12 years of
age.
Posology
Route of administration: Inhalation use.
Patients should be made aware tha