Serevent Diskus Inhalation Powder 50mcg

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

SALMETEROL

Available from:

Glaxo SmithKline Ireland Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland

ATC code:

R03AC12

INN (International Name):

SALMETEROL 50 µg

Pharmaceutical form:

INHALATION POWDER, PRE-DISPENSED

Composition:

SALMETEROL 50 µg

Prescription type:

POM

Therapeutic area:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Authorization status:

Withdrawn

Authorization date:

2017-12-15

Patient Information leaflet

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.

Serevent Diskus helps to stop breathlessness and wheezing coming on.
It does
not work once you are breathless or wheezy. If that happens, you need
to use a
fast acting ‘reliever’ medicine, such as salbutamol.

Serevent is supplied to you in an inhaler called the diskus. You
breathe the
medicine directly into your lungs.

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 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