Ventolin Evohaler 100 micrograms pressurised inhalation, suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Salbutamol

Available from:

GlaxoSmithKline (Ireland) Limited

ATC code:

R03AC; R03AC02

INN (International Name):

Salbutamol

Dosage:

100 microgram(s)/dose

Pharmaceutical form:

Pressurised inhalation, suspension

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Selective beta-2-adrenoreceptor agonists; salbutamol

Authorization status:

Marketed

Authorization date:

1999-10-01

Patient Information leaflet

Reason for update: Type IAIN – PRAC Recommendation
HPRA Approval date: 19/01/2024
Text Date: 02/11/2023
Text Issue 4 Draft 1
- 1 -
GSK LOGO
PACKAGE LEAFLET: INFORMATION FOR THE USER
VENTOLIN EVOHALER
100 MICROGRAMS PRESSURISED INHALATION SUSPENSION
salbutamol (as sulfate)
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, nurse 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, nurse or pharmacist.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1
What Ventolin Evohaler is and what it is used for
2
What you need to know before you use Ventolin Evohaler
3
How to use Ventolin Evohaler
4
Possible side effects
5
How to store Ventolin Evohaler
6
Contents of the pack and other information
1
WHAT VENTOLIN EVOHALER IS AND WHAT IT IS USED FOR
Ventolin Evohaler contains a medicine called salbutamol. This belongs
to a group of
medicines called fast-acting bronchodilators.

Bronchodilators help the airways in your lungs to stay open. This
makes it easier
for air to get in and out.

They help to relieve chest tightness, wheezing and cough.
Ventolin Evohaler is for use in adults, adolescents and children. For
babies and
children under 4 years of age, see section 3.
Ventolin Evohaler is used to help prevent and treat breathing problems
in people with
asthma and chronic obstructive airways disease. Ventolin Evohaler
contains a propellant
called Norflurane. This is less harmful to the environment than older
inhalers. Older inhalers
may taste differently to Ventolin Evohaler. This will make no
difference to how your medicine
works.
2
WHAT YOU NEED TO KNOW BEFORE YOU USE VENTOLIN EVOHALER
DO NOT USE VENTOLIN EVOHALER:

Summary of Product characteristics

Health Products Regulatory Authority
27 February 2024
CRN00F2MV
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ventolin Evohaler 100 micrograms pressurised inhalation, suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose contains 100 micrograms of Salbutamol (as sulfate)
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pressurised inhalation suspension
Pressurised inhalation suspension supplied in an aluminium can with
metering valve and a blue actuator.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ventolin is indicated in adults, adolescents and children. For babies
and children under 4 years of age, see sections 4.2 and 5.1.
Ventolin Evohaler is indicated for the treatment or prevention of
bronchospasm. It provides short acting (four hours)
bronchodilation in reversible airways obstruction due to asthma and
chronic obstructive pulmonary disease (COPD) such as
chronic bronchitis and emphysema. For patients with asthma salbutamol
may be used to relieve symptoms when they occur
and to prevent them prior to a known trigger.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Ventolin Evohaler is administered by the inhaled route only, to be
breathed in through the mouth.
Salbutamol has a duration of action of 4 to 6 hours in most patients.
Increasing use of beta-2agonists may be a sign of worsening asthma.
Under these conditions a reassessment of the patient's
therapy plan may be required and concomitant corticosteroid therapy
should be considered.
In patients who find co-ordination of a pressurised metered-dose
inhaler difficult, a spacer may be used with Ventolin Evohaler.
As there may be adverse effects associated with excessive dosing, the
dosage or frequency of administration should only be
increased on medical advice.
Patients' inhaler technique should be checked to make sure that
aerosol actuation is synchronised with inspiration of breath for
optimum delivery of the drug to the lungs.
ADULTS AND ADOLESCENTS (CHILDREN 12 YEARS AND OVER)
_R