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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SALMETEROL XINAFOATE; Fluticasone propionate

Available from:

PCO Manufacturing Ltd.

ATC code:

R03AK; R03AK06

INN (International Name):

SALMETEROL XINAFOATE; Fluticasone propionate

Dosage:

25/250 microgram(s)/dose

Pharmaceutical form:

Pressurised inhalation, suspension

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:

Authorised

Authorization date:

2004-02-06

Patient Information leaflet

_ _
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
SERETIDE
® 125 EVOHALER
® 25 MICROGRAM/125 MICROGRAM PER METERED
DOSE, PRESSURISED INHALATION, SUSPENSION
SERETIDE
® 250 EVOHALER
® 25 MICROGRAM/250 MICROGRAM PER METERED
DOSE, PRESSURISED INHALATION, SUSPENSION
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 Seretide is and what it is used for
2.
What you need to know before you use Seretide
3.
How to use Seretide
4.
Possible side effects
5.
How to store Seretide
6.
Contents of the pack and other information
1.
WHAT SERETIDE IS AND WHAT IT IS USED FOR
Seretide 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 every day as directed by your doctor. This will
make sure that it works
properly in controlling your asthma.
SERETIDE HELPS TO STOP BREATHLESSNESS AND WHEEZINESS COMING ON.
HOWEVER SERETIDE
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 YO

Summary of Product characteristics

Health Products Regulatory Authority
30 August 2023
CRN00DPNT
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
_Product imported from Belgium and Greece:_
Pressurised inhalation, suspension.
The canister contains a white to off white suspension.
The canisters are fitted into purple plastic actuators incorporating
an atomising orifice and fitted with dustcaps.
4 CLINICAL PARTICULARS
As per PA1077/046/006
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/046/006
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Propellant: 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 on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C. Do not refrigerate or freeze.
The canister contains a pressurised liquid.
Do not expose to temperatures higher than 50°C, protect from direct
sunlight.
Do not puncture, pierce or burn the canister even when apparently
empty.
As with most inhaled medicinal products in pressurised containers, the
therapeutic effect of this medicinal product may
decrease when the container is cold.
Health Products Regulatory Authority
30 August 2023
CRN00DPNT
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
An overlabelled outer container has enclosed the suspension contained
in an internally lacquered, 8 ml aluminium alloy
pressurised container sealed with a metering valve. The containers are
fitted into plastic actuators incorporating a