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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Salmeterol; FLUTICASONE PROPIONATE

Available from:

Elpen Pharmaceutical Co. Inc.

ATC code:

R03AK; R03AK06

INN (International Name):

Salmeterol; FLUTICASONE PROPIONATE

Dosage:

50/500 microgram(s)

Pharmaceutical form:

Inhalation powder, pre-dispensed

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

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

Authorization status:

Not marketed

Authorization date:

2013-05-03

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE
USER
FLAMERIO 50 MICROGRAM/250 MICROGRAM/DOSE INHALATION POWDER, PRE-
DISPENSED
FLAMERIO 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 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 Flamerio is and what it is used for
2.
What you need to know before you use Flamerio
3.
How to use Flamerio
4.
Possible side effects
5.
How to store Flamerio
6.
Contents of the pack and other information
1.
WHAT FLAMERIO IS AND WHAT IT IS USED FOR
Flamerio 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)
Flamerio at a dose of 50/500 micrograms, reduces the number of flare
ups of
COPD.
You must use Flamerio every day as directed by your doctor. This will
make sure that
it works properly in controlling your asthma or COPD.
FLAMERIO HELPS TO STOP BREATHLESSNESS AND WHEEZINESS COMING ON.
HOWEVER
FLAMERIO 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’)
2
INHALER, SUCH AS SALBUTAMOL

Summary of Product characteristics

Health Products Regulatory Authority
31 January 2020
CRN008HY9
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Flamerio 50 microgram/500 microgram/dose, inhalation powder,
pre-dispensed
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-dispensed dose of Flamerio contains.
50 micrograms of salmeterol (as salmeterol xinafoate) and 500
micrograms of fluticasone propionate.
Excipient with known effect:
24.427 mg of lactose per dose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed.
White powder.
Flamerio contains two medicines packed in the two blisters of the
single dose foil strips (double-blister strips), which are stored
in the inhalation device Elpenhaler.
Each dose is pre-dispensed in one double-blister strip.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Flamerio is indicated in adults only Asthma
Flamerio 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.
Chronic ObstructivePulmonaryDisease (COPD)
Flamerio 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
Flamerio is forinhalation use only.
Posology
Patients should be made aware that Flamerio must be used daily for
optimum benefit, even whenasymptomatic.
Health Products Regulatory Authority
31 January 2020
CRN008HY9
Page 2 of 16
Patients should be regularly reassessed by a doctor,so that the
strength of Flameriothey are receiving remainsoptimal and is
only changed on medical advice. THE DOSE SHOULDBE TITRATEDTO THE
LOWEST DOS