LIFSAR PULMOJET 50/500 Microgram Powder for Inhalation

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SALMETEROL XINAFOATE, FLUTICASONE PROPIONATE

Available from:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATC code:

R03AK06

INN (International Name):

SALMETEROL XINAFOATE, FLUTICASONE PROPIONATE

Dosage:

50/500 Microgram

Pharmaceutical form:

Powder for Inhalation

Administration route:

Inhalation use

Units in package:

one PulmoJet inhaler with 60 inha

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic group:

Adrenergics, inhalants; Adrenergics in combination with corticosteroids or other drugs, excl. anticholinergics.

Therapeutic area:

Adrenergics in combination with corticosteroids or other drugs, excl. Anticholinergics

Therapeutic indications:

Lifsar Pulmojet is indicated for the symptomatic treatment of adults with Chronic Obstructive Pulmonary Disease (COPD) with a FEV1 < 60% predicted normal (pre-bronchodilator) and a history of repeated exacerbations and who have significant symptoms despite regular bronchodilator therapy.

Authorization status:

Authorised

Authorization date:

2015-11-27

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
LIFSAR PULMOJET 50 MICROGRAM/500 MICROGRAM PER METERED DOSE
INHALATION POWDER
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 Lifsar Pulmojet is and what it is used for
2.
What you need to know before you use Lifsar Pulmojet
3.
How to use Lifsar Pulmojet
4.
Possible side effects
5.
How to store Lifsar Pulmojet
6.
Contents of the pack and other information
1. WHAT LIFSAR PULMOJET IS AND WHAT IT IS USED FOR
Lifsar Pulmojet is an inhaler that contains two active ingredients,
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 to prevent breathing
problems associated with
Chronic Obstructive Pulmonary Disease (COPD). Lifsar Pulmojet reduces
the number of flare
ups of symptoms related to COPD.
You must use Lifsar Pulmojet every day, as prescribed by your doctor.
This will ensure that
the medicine works properly in controlling these symptoms.
LIFSAR PULMOJET HELPS TO STOP BREATHLESSNESS AND WHEEZINESS COMING ON.
HOWEVER, LIFSAR
PULMOJET SHOULD NOT BE USED TO RELIEVE A SUDDEN ATTACK OF
BREATHLESSNESS OF WHEEZING. IF THIS
2/12
HAPPENS YOU NEED TO USE A FAST-ACTING “RELIEVER” (“RESCUE”)
INHALER, SUCH A

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Lifsar Pulmojet 50 microgram/500 microgram /dose inhalation powder
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single inhalation provides a delivered dose (the dose leaving the
mouthpiece) of 45 micrograms of salmeterol (as
salmeterol xinafoate) and 465 micrograms of fluticasone propionate.
This corresponds to a metered dose of 50
micrograms of salmeterol (as salmeterol xinafoate) and 500 micrograms
of fluticasone propionate.
Excipient with known effect: contains up to 7 milligrams of lactose
monohydrate per metered dose.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder
The inhaler contains white powder. The inhaler body is grey and white
with a grey base and mouthpiece, a white cover
and a purple or grey bottom lid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lifsar Pulmojet is indicated for the symptomatic treatment of adults
with Chronic Obstructive Pulmonary Disease
(COPD) with a FEV
1
< 60% predicted normal (pre-bronchodilator) and a history of repeated
exacerbations and who
have significant symptoms despite regular bronchodilator therapy.
Lifsar Pulmojet is intended for use by adults 18 years of age and
older only.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Route of administration;_ Inhalation use._
Patients should be made aware that Lifsar Pulmojet must be used
regularly, every day for optimum benefit, even when
asymptomatic.
LIFSAR PULMOJET IS AVAILABLE IN THE STRENGTH OF 50 MICROGRAMS OF
SALMETEROL AND 500 MICROGRAMS OF FLUTICASONE
PROPIONATE PER METERED DOSE ONLY.
RECOMMENDED DOSES
Adults:
One inhalation of 50 micrograms salmeterol and 500 micrograms
fluticasone propionate twice daily.
Special patient groups
There is no need to adjust the dose in elderly patients or in those
with renal impairment. There are no data available for
use of Lifsar Pulmojet in patients with hepatic impairment.
Paediatric population
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