Ventolin Evohaler 100 micrograms Pressurised Inhalation, suspension

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

SALBUTAMOL SULFATE

Commercializzato da:

Imbat Limited

Codice ATC:

R03AC; R03AC02

INN (Nome Internazionale):

SALBUTAMOL SULFATE

Dosaggio:

100 microgram(s)

Forma farmaceutica:

Pressurised inhalation, suspension

Tipo di ricetta:

Product subject to prescription which may be renewed (B)

Area terapeutica:

Selective beta-2-adrenoreceptor agonists; salbutamol

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2007-06-08

Foglio illustrativo

Page 1 of 2
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:

if you are allergic to salbutamol sulfate or the other ingredient of
this medicine, listed in
section 6.
WARNI

Scheda tecnica

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 a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Pressurised inhalation suspension
_Product imported from Greece and Romania_:
Pressurised inhalation suspension supplied in an aluminium can with
metering valve and a two tone blue plastic
actuator and dustcap.
_Product imported from The UK:_
Pressurised inhalation suspension supplied in an aluminium can with
metering valve and a two tone blue plastic
actuator and dustcap. There is an embossed letter “V” on the
plastic case and ridged touch pad.
4 CLINICAL PARTICULARS
As per PA1077/049/010
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/049/010
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Romania: Norflurane (1, 1, 1, 2 – Tetrafluoroethane, HFA 134a)
Greece: Norflurane (Hydrofluoralkane (HFA) 134a)
UK: 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
Store below 30°C.
Protect from direct sunlight
Do not refrigerate or freeze.
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