Seretide 250 Evohaler 25 microgram/250 microgram/dose pressurised inhalation, suspension

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Dostupné z:

Imbat Limited

ATC kód:

R03AK; R03AK06

INN (Medzinárodný Name):

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Dávkovanie:

25 microgram/250 microgram(s)/dose

Forma lieku:

Pressurised inhalation, suspension

Typ predpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

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

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2011-03-25

Príbalový leták

Page 1 of 2
PACKAGE LEAFLET: INFORMATION FOR THE USER
Your medicine is available using the name Seretide 250 Evohaler
25 micrograms /250 microgram/dose pressurised inhalation, suspension
but will be referred to
as Seretide Evohaler throughout this leaflet.
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.
WHAT IS IN THIS LEAFLET:
1.
WHAT SERETIDE EVOHALER IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SERETIDE EVOHALER
3.
HOW TO USE SERETIDE EVOHALER
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE SERETIDE EVOHALER
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT SERETIDE EVOHALER IS AND WHAT IT IS USED FOR
Seretide Evohaler 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.
You must use Seretide Evohaler every day as directed by your doctor.
This will make sure that it
works properly in controlling your asthma.
SERETIDE EVOHALER HELPS TO STOP BREATHLESSNESS AND WHEEZINESS COMING
ON. HOWEVER
SERETIDE EVOHALER 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 AL

Súhrn charakteristických

Health Products Regulatory Authority
14 August 2019
CRN00924P
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Seretide 250 Evohaler 25 microgram/250 microgram/dose pressurised
inhalation, suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose (ex valve) contains: 25 micrograms of salmeterol (as
salmeterol xinafoate) and 250 micrograms of
fluticasone propionate. This is equivalent to a delivered dose (ex
actuator) of 21 micrograms of salmeterol and 220 micrograms
of fluticasone propionate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pressurised inhalation, suspension.
_Product imported from Austria, Romania, Italy & Spain_
The canister contains a white to off white suspension.
4 CLINICAL PARTICULARS
As per PA1077/046/006
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/046/006
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Norflurane (HFA 134a).
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer package of the product as
marketed in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
The canister contains a pressurised liquid. Do not expose to
temperatures higher than 50°C, protect from direct sunlight.
Do not pierce or burn the canister even when empty.
As with most inhaled medicinal products in pressurised canisters, the
therapeutic effect of this medicinal product may decrease
when the canister is cold.
Health Products Regulatory Authority
14 August 2019
CRN00924P
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
A pressurised container sealed with a metering valve.
_ _
The container is fitted into a plastic actuator incorporating an
atomising mouthpiece and fitted with a dustcap.
The canister has a counter attached to it, which shows how many
actuations of medicine are left. The number will show
through a window in the back of the plastic actuator.
Pack size: 1 x 120 actuations
6.6 SPECIAL PRECAUTIONS FOR DISP