Serevent Evohaler 25 micrograms per actuation pressurised inhalation suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SALMETEROL XINAFOATE

Available from:

Imbat Limited

ATC code:

R03AC12

INN (International Name):

SALMETEROL XINAFOATE

Dosage:

25 microgram(s)

Pharmaceutical form:

Pressurised inhalation, suspension

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

salmeterol

Authorization status:

Authorised

Authorization date:

2011-08-05

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
SEREVENT™ EVOHALER™
25 MICROGRAMS PER ACTUATION PRESSURISED INHALATION, SUSPENSION
(Salmeterol)
Your medicine is available using the name Serevent Evohaler 25
micrograms per actuation pressurised
inhalation, suspension but will be referred to as Serevent Evohaler
throughout this leaflet.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
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. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.
•
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
WHAT SEREVENT EVOHALER IS AND WHAT IT IS USED FOR
2.
BEFORE YOU USE SEREVENT EVOHALER
3.
HOW TO USE SEREVENT EVOHALER
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE SEREVENT EVOHALER
6.
FURTHER 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 i

Summary of Product characteristics

Health Products Regulatory Authority
18 October 2019
CRN009DT8
Page 1 of 11
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 a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pressurised inhalation suspension
_Product imported from Poland:_
White to off white suspension sealed in an aluminium canister in a
green actuator.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Regular symptomatic add-on treatment of reversible airways obstruction
in patients with asthma, including those with
nocturnal asthma, who are inadequately controlled on inhaled
corticosteroidsin accordance with current treatment guidelines.
Treatment of chronic obstructive pulmonary disease (COPD). Prevention
of exercise-induced asthma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Serevent Evohaler is for inhalation use only.
Serevent Evohaler should be used regularly. The full benefits of
treatment will be apparent after several doses of the medicinal
product. As there may be adverse reactions associated with excessive
dosing with this class of medicinal product, the dosage
or frequency of administration should only be increased on medical
advice.
Recommended Doses:
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 25 micrograms of salmeterol twice daily may
be of benefit.
_Children aged 4 years and older:_
Two actuations of 25 micrograms salmeterol twice daily.
Health Products Regulatory Authority
18 October 2019
CRN009DT8
Page 2 of 11
_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 saf