Ventamol CFC-Free 100 micrograms Pressurised Inhalation, Suspension

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

SALBUTAMOL SULFATE

Available from:

Norton Waterford

ATC code:

R03AC; R03AC02

INN (International Name):

SALBUTAMOL SULFATE

Dosage:

100 microgram(s)

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:

Not marketed

Authorization date:

2005-04-15

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
VENTAMOL CFC-FREE 100 MICROGRAMS
PRESSURISED INHALATION, SUSPENSION
salbutamol
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.
•
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. WHAT VENTAMOL INHALER IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE VENTAMOL INHALER
3. HOW TO USE VENTAMOL INHALER
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE VENTAMOL INHALER
6. CONTENTS OF THE PACK AND OTHER INFORMATION
1. WHAT VENTAMOL INHALER IS AND WHAT IT IS USED FOR
Your medicine is called Ventamol CFC-Free Pressurised Inhalation,
Suspension (referred to as
Ventamol Inhaler throughout this leaflet). It contains a substance
called salbutamol, which belongs to
a class of medicines called bronchodilators.
Bronchodilators are used to prevent and treat BRONCHOSPASM (sudden
narrowing of the tubes to the
lungs caused by muscle spasm) by opening up the air passages in the
lungs for up to 4 – 6 hours after
administration.
Ventamol Inhaler is used to treat:
•
ASTHMA
•
CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), such as chronic
bronchitis and emphysema.
If you suffer from asthma, Ventamol Inhaler can be used to both manage
the symptoms before they
occur and to relieve symptoms once they occur.
This type of medicine is known as a “reliever”. You may be using
another medicine to prevent you
from having an asthma attack (a “preventer”). You can safely use
your preventer with your Ventamol
Inhaler.
Ventamol Inhaler is for use in adults, adolescents and children (see
section 3, “How to

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ventamol CFC-Free 100 micrograms Pressurised Inhalation, Suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Salbutamol sulphate equivalent to 100 micrograms salbutamol per
metered dose
Excipients with known effect:
Each metered dose contains 3.93 mg ethanol anhydrous.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pressurised inhalation, suspension.
Pressurised container fitted with a metering valve.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ventamol
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.
Ventamol is indicated in adults, adolescents and children. For babies
and children under 4 years of age, see sections 4.2
and 5.1.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Ventamol 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-2 agonists may be a sign of worsening asthma.
Under these conditions a reassessment
of the
patient's therapy plan may be required and concomitant
glucocorticosteroid therapy should be considered.
In patients who find co-ordination of a pressurised metered-dose
inhaler difficult, a spacer may be used with Ventamol.
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)
_Relief of acute bronchospasm_:
100 or 200 micrograms.
H