Ventolin Evohaler

Ülke: Malta

Dil: İngilizce

Kaynak: Medicines Authority

Aktif bileşen:

SALBUTAMOL

Mevcut itibaren:

Glaxo Wellcome UK Limited

ATC kodu:

R03AC02

INN (International Adı):

SALBUTAMOL

Farmasötik formu:

PRESSURISED INHALATION

Kompozisyon:

SALBUTAMOL 100 µg

Reçete türü:

POM

Terapötik alanı:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2005-09-09

Bilgilendirme broşürü

Reason for update: Addition of Evreux site to the PIL text as an
alternative site of manufacture
MHRA Approval Date: TBC
Text Date: 16/11/2015
Text Issue and Draft No: Issue 5 draft 1
- 1 -
GSK LOGO
PACKAGE LEAFLET: INFORMATION FOR THE USER
VENTOLIN
® EVOHALER
® 100 micrograms
SALBUTAMOL 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 about your illness or your medicine,
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 used to treat breathing problems in people with
asthma and similar
conditions. This includes relieving and preventing asthma brought on
by exercise or other
“triggers”. These are things, which bring on asthma symptoms in
some people. Common
triggers include house dust, pollen, cats, dogs and cigarette smoke.
Ventolin Evohaler contains a propellant called HFA 134a. This is less
harmful to the
environment than older inhalers. Older inhalers may taste differently
to Ventolin Evohaler.
This will m

Ürün özellikleri

Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ventolin Evohaler 100 micrograms
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ventolin Evohaler is a pressurised metered-dose inhaler delivering 100
micrograms of
salbutamol (as Salbutamol Sulfate BP) per actuation. Ventolin Evohaler
contains a
new propellant (HFA 134a) and does not contain any
chlorofluorocarbons.
3.
PHARMACEUTICAL FORM
Aerosol
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Ventolin Evohaler is indicated in adults, adolescents and children
aged 4 to 11 years.
For babies and children under 4 years of age, see sections 4.2 and
5.1.
Ventolin Evohaler provides short-acting (4 to 6 hour) bronchodilation
with fast onset
(within 5 minutes) in reversible airways obstruction.
It is particularly suitable for the relief and prevention of asthma
symptoms. It should
be used to relieve symptoms when they occur, and to prevent them in
those
circumstances recognised by the patient to precipitate an asthma
attack (e.g. before
exercise or unavoidable allergen exposure).
Ventolin Evohaler is particularly valuable as relief medication in
mild, moderate or
severe asthma, provided that reliance on it does not delay the
introduction and use of
regular inhaled corticosteroid therapy.
4.2
Posology and method of administration
Page 2 of 11
Ventolin Evohaler is for oral inhalation use only. Ventolin Evohaler
may be used
with a Volumatic™ spacer device by patients who find it difficult to
synchronise
aerosol actuation with inspiration of breath.
Adults (including the elderly):
For the relief of acute asthma symptoms including bronchospasm, one
inhalation (100
micrograms) may be administered as a single minimum starting dose.
This may be
increased to two inhalations if necessary. To prevent allergen- or
exercise-induced
symptoms, two inhalations should be taken 10-15 minutes before
challenge.
For chronic therapy, two inhalations up to four times a day.
_ _
Paediatric Population
_Relief of acute bronchospasm _
The usual dosage for children