Serevent Diskus, 50 micrograms per metered dose, inhalation powder, pre-dispensed

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Salmeterol

Available from:

GlaxoSmithKline (Ireland) Limited

ATC code:

R03AC; R03AC12

INN (International Name):

Salmeterol

Dosage:

50 microgram(s)

Pharmaceutical form:

Inhalation powder, pre-dispensed

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Selective beta-2-adrenoreceptor agonists; salmeterol

Authorization status:

Marketed

Authorization date:

1997-01-21

Patient Information leaflet

Reason for update: Type 1A variation to remove Ware as Batch Release
Site (no impact to PIL artwork)
Market: IE
Agency Approval Date: N/A T1A
Text Date: 09/02/2021
Text Issue and Draft No.: Issue 6 draft 1
GSK LOGO
PACKAGE LEAFLET: INFORMATION FOR THE USER
SEREVENT DISKUS
50 MICROGRAM PER METERED DOSE inhalation powder, pre-dispensed
SALMETEROL (AS XINAFOATE)
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 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 or pharmacist. This
includes any
possible side-effects not listed in this leaflet. See section 4.
IN THIS LEAFLET:
1
What Serevent Diskus is and what it is used for
2
What you need to know before you use Serevent Diskus
3
How to use Serevent Diskus
4
Possible side effects
5
How to store Serevent Diskus
6
Contents of the pack and other information
1
WHAT SEREVENT DISKUS IS AND WHAT IT IS USED FOR
•
Serevent Diskus contains the medicine salmeterol. It is a
‘long-acting
bronchodilator’. It helps the airways in the lungs to stay open.
This makes it
easier for air to get in and out. The effects are usually felt within
10 to 20 minutes
and last for 12 hours or more.
•
The doctor has prescribed it to help prevent breathing problems. These
could be
caused by asthma. Taking Serevent Diskus regularly will help prevent
asthma
attacks. This also includes asthma brought on by exercise or at night.
•
Taking Serevent Diskus regularly will also help prevent breathing
problems
caused by other chest illnesses such as Chronic Obstructive Pulmonary
Disease
(COPD), chronic bronchitis and emphysema.
Reason for update: Type 1A variation to remove Ware as Batch Release
Site (no impact to PIL artwork)
Market: IE
Agency Approval

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Serevent Diskus, 50 micrograms per metered dose, inhalation powder,
pre-dispensed
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Serevent Diskus is a moulded plastic device containing a foil strip
with regularly placed blisters each containing 50
micrograms of salmeterol as salmeterol xinafoate.
Excipient with known effect:
Lactose monohydrate (which contains milk protein).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Inhalation powder, pre-dispensed (Inhalation Powder).
A moulded plastic device containing a foil blisterstrip with
individual doses of a white inhalation powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Salmeterol is a long acting beta-2-agonist and should be used only as
an adjunct to corticosteroids in the management
of asthma. With optimal background steroid therapy, salmeterol can
offer additional symptomatic treatment. Patients
must be warned not to stop therapy or reduce it without medical
advice, even if they feel better on salmeterol.
_Adults_
Salmeterol provides long-lasting (12 hour) bronchodilation in
reversible airways obstruction due to asthma, chronic
bronchitis, emphysema and Chronic Obstructive Pulmonary Disease
(COPD). It is suitable for long-term regular,
twice-daily treatment to control symptoms, but in view of its slower
onset of action (10 to 20 minutes), it should not be
used to relieve acute asthmatic symptoms, for which a faster acting
(within 5 minutes) inhaled bronchodilator (e.g.
salbutamol) should be given.
Serevent is indicated when a regular bronchodilator is required, and
to prevent night-time symptoms and/or day-time
fluctuations caused by reversible airways obstruction (e.g. before
exercise or unavoidable allergen challenge).
Regular treatment of reversible airways obstruction in asthma
including long lasting prevention of exercise-induced
bronchospasm.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Serevent Diskus is administered by the inhaled route only.
In order to gain