SEREVENT EVOHALER 25 Microgram Pressurised Inhalation Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SALMETEROL XINAFOATE

Available from:

LTT Pharma Limited

ATC code:

R03AC12

INN (International Name):

SALMETEROL XINAFOATE

Dosage:

25 Microgram

Pharmaceutical form:

Pressurised Inhalation Suspension

Administration route:

inhalation use

Units in package:

8ml

Prescription type:

Product subject to prescription which may be renewed (B)

Manufactured by:

Glaxo Wellcome Production

Therapeutic group:

Selective beta-2-adrenoreceptor agonists

Therapeutic area:

Selective beta-2-adrenoreceptor agonists

Therapeutic indications:

It is indicated for the regular symptomatic add-on treatment of reversible airways obstruction in patients with asthma, including those with nocturnal asthma, who are inadequately controlled on inhaled corticosteroids in accordance with current treatment guidelines. Serevent is also indicated in the prevention of exercise-induced asthma

Authorization status:

Authorised

Authorization date:

2015-03-06

Patient Information leaflet

WHAT SEREVENT EVOHALER LOOKS LIKE AND 
CONTENTS OF THE PACK
Pressurised inhalation, suspension. 
The pressurised canister contains a white to off
white suspension for inhalation.
THE PARALLEL PRODUCT AUTHORISATION HOLDER IS:
LTT Pharma Limited, Unit 18, Oxleasow Road,
East Moons Moat, Redditch, Worcestershire, 
B98 0RE, UK.
REPACKAGED BY:
Lexon (UK) Limited, Unit 18, Oxleasow Road, 
East Moons Moat, Redditch, Worcestershire, 
B98 0RE, UK.
THE MANUFACTURER IS:
Glaxo Wellcome Production, Zone Idustrielle 2,
Rue Lavoisier 23, F-27000 Evreux, France
THIS MEDICINAL PRODUCT IS AUTHORISED IN THE
MEMBER STATES OF THE EEA UNDER THE FOLLOWING
NAMES:
Austria                Serevent Evohaler
Belgium              Serevent Evohaler
Denmark            Serevent
Estonia               Serevent
Hungary             Serevent Evohaler
Iceland               Serevent
Ireland                Serevent Evohaler
Lithuania            Serevent
Luxembourg       Serevent Evohaler
Malta                  Serevent Evohaler
Netherlands        Serevent 25 Inhalator CFK vrij,       
suspensie 25 microgram /dosis
Norway               Serevent
Poland                Serevent
Slovak Republic  Serevent Inhaler N
Slovenia             Serevent 25 μg/vpih inhalacijska  
suspenzija pod tlakom
Sweden              Serevent Evohaler
United Kingdom  Serevent Evohaler
Serevent, Evohaler and Volumatic are registered
trademarks of the GlaxoSmithKline Group of
Companies.
PPA1562/149/001
Revision date: 16/12/2014
Blind or partially sighted?
Is this leaflet hard to see or read? 
Phone LTT Pharma Limited, 
Tel: [phone] 
for help.
VERY RARE (AFFECTS LESS THAN 1 PERSON IN 10,000):
• 
BREATHING DIFFICULTIES OR WHEEZING THAT GETS 
WORSE STRAIGHT AFTER TAKING SEREVENT. If this
happens stop using your Serevent Evohaler. 
Use your fast-acting ‘reliever’ inhaler to help 
your breathing and TELL YOUR DOCTOR STRAIGHT
AWAY.
•

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Serevent Evohaler 25 micrograms per actuation pressurised inhalation suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One metered dose (ex-valve) contains 25 micrograms salmeterol (as xinafoate). This is equivalent to a delivered dose
(ex-actuator) of 21 micrograms salmeterol (as xinafoate).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pressurised inhalation suspension
_Product imported from Hungary._
White to off white suspension sealed in an aluminium canister in a green actuator.
4 CLINICAL PARTICULARS
As per PA1077/047/005
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/047/005
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 for this product shall be the date shown on the device and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 30° C.
Replace the mouthpiece cover firmly and snap it into position.
Pressurised container. Do not expose to temperatures higher than 50°C. Do not puncture, break or burn even when
apparently empty.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 06/03/2015_
_CRN 2156970_
_page number: 1_
6.5 NATURE AND CONTENTS OF CONTAINER
The suspension is contained in an internally lacquered, 8ml aluminium alloy pressurised container sealed with a
metering valve. The containers are fitted into plastic actuators incorporating an atomising mouthpiece and fitted with
dustcaps. One pressurised container delivers 120 actuations.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR WASTE M