Serevent Evohaler 25 micrograms per actuation pressurised inhalation suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Salmeterol

Available from:

GlaxoSmithKline (Ireland) Limited

ATC code:

R03AC; R03AC12

INN (International Name):

Salmeterol

Dosage:

25 Mcg/Acutuation

Pharmaceutical form:

Pressurised inhalation, suspension

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Selective beta-2-adrenoreceptor agonists; salmeterol

Authorization status:

Marketed

Authorization date:

2006-08-25

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
SEREVENT
EVOHALER 25 MICROGRAMS
PER ACTUATION (PER PUFF)
Pressurised inhalation, suspension
salmeterol
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.
IN THIS LEAFLET
:
1.
What Serevent Evohaler is and what it is used for
2.
What you need to know before you use Serevent Evohaler
3.
How to use Serevent Evohaler
4.
Possible side effects
5.
How to store Serevent Evohaler
6.
Contents of the pack and other information
1.
WHAT SEREVENT EVOHALER IS AND WHAT IT IS USED FOR

Serevent Evohaler contains the medicine salmeterol. It is a
‘long-acting bronchodilator’. It helps the
airways in the lungs to stay open. This makes it easier for air to get
in and out. The effects are usually
felt within 10 to 20 minutes and last for 12 hours or more.

The doctor has prescribed it to help prevent breathing problems. These
could be caused by asthma.
Taking Serevent Evohaler regularly will help prevent asthma attacks.
This also includes asthma brought
on by exercise or that happens only at night.

Taking Serevent Evohaler regularly will also help prevent breathing
problems caused by other chest
illnesses such as chronic obstructive pulmonary disease (COPD).

Serevent Evohaler helps to stop breathlessness and wheezing coming on.
It does not work once you are
breathless or wheezy. If that happens you need to use a fast-acting
‘reliever’ medicine, such as
salbutamol.

Serevent Evohaler is supplied to you in an inhaler. You breathe the
medicine directly into your lungs.

Serevent Evoh

Summary of Product characteristics

Health Products Regulatory Authority
08 October 2019
CRN009D3T
Page 1 of 9
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.
White to off white suspensionsealed in an aluminium canister in a
green actuator.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ASTHMA
Serevent 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.
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Serevent is indicated in the treatment of patients with COPD.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Asthma _
_Adults and adolescents 12 years and older: _
Two actuations of 25 micrograms salmeterol twice daily.
In asthma patients with more severe airways obstruction up to four
inhalations of salmeterol twice daily may be of benefit.
_Children aged 4 years and older: _
Two actuations of 25 micrograms salmeterol twice daily.
_Children below 4 years of age: _
Serevent Evohaler is not recommended for use in children below four
years of age due to insufficient data on safety and
efficacy.
_COPD _
_Adults aged 18 years and over: _
Two actuations of 25 micrograms salmeterol twice daily.
Health Products Regulatory Authority
08 October 2019
CRN009D3T
Page 2 of 9
_Paediatric population _
There is no relevant indication for use of Serevent Evohaler in the
paediatric population in the indication for COPD.
Special populations
There is no need to adjust th