Ventolin Diskus 200 micrograms Inhalation Powder, pre-dispensed

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Salbutamol

Fáanlegur frá:

GlaxoSmithKline (Ireland) Limited

ATC númer:

R03AC; R03AC02

INN (Alþjóðlegt nafn):

Salbutamol

Skammtar:

200 microgram(s)

Lyfjaform:

Inhalation powder, pre-dispensed

Gerð lyfseðils:

Product subject to prescription which may be renewed (B)

Lækningarsvæði:

Selective beta-2-adrenoreceptor agonists; salbutamol

Leyfisstaða:

Marketed

Leyfisdagur:

1996-12-13

Upplýsingar fylgiseðill

Reason for update: Type IAIN – PRAC Recommendation
HPRA Approval date: 19/01/2024
Text Date: 02/11/2023
PIL Issue 5 Draft1
- 1 -
GSK LOGO
PACKAGE LEAFLET: INFORMATION FOR THE USER
VENTOLIN DISKUS
200 micrograms
Inhalation Powder, pre-dispensed
SALBUTAMOL (AS SULFATE)
[PRODUCT PICTURE WITH PART DESCRIPTIONS]
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 Diskus is and what it is used for
2
What you need to know before you use Ventolin Diskus
3
How to use Ventolin Diskus
4
Possible side effects
5
How to store Ventolin Diskus
6
Contents of the pack and other information
1
WHAT VENTOLIN DISKUS IS AND WHAT IT IS USED FOR
Ventolin Diskus 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 Diskus is used to treat breathing problems in adults,
adolescents and children
over 4 years of age with asthma and other conditions such as chronic
bronchitis and
emphysema. 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.
2
WHAT YOU NEED TO KNOW BEFORE YOU USE VENTOLIN DISKUS
DO NOT USE VENTOLIN DISKUS:

if you are allergic to salbutamol sulfate or the other

Vara einkenni

Health Products Regulatory Authority
27 February 2024
CRN00F2MV
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ventolin Diskus 200 micrograms Inhalation Powder, pre-dispensed
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each blister contains 200 micrograms of salbutamol (as sulfate).
Excipients: Lactose monohydrate 12.26 mg/blister
For the full list of excipients, _see section 6.1_
3 PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed.
White powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Ventolin Diskus is indicated in adults, adolescents and children over
4 years of age.
Ventolin Diskus 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 Diskus is administered by the inhaled route only, to be
breathed in through the mouth.
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 corticosteroid therapy
should be considered.
As there may be adverse effects associated with excessive dosing, the
dosage or frequency of administration should only be
increased on medical advice.
Salbutamol has a duration of action of 4 to 6 hours in most patients.
Patients' inhaler technique should be checked to ensure that the
device is used at maximum efficiency.
ADULTS AND ADOLESCENTS:
_Relief of acute bronchospasm_:
200 micrograms as required.
On demand use of Ventolin Diskus should not exceed four times daily.
Reliance on such supplementary use or a sudden
increase in dose indicates deteriorating asthma (see Section 4.4).
Prevention of allergen or exercise-induced bronchospasm:
200 micrograms before ch