SEREVENT ACCUHALER salmeterol 50 micrograms (as xinafoate) powder for inhalation blister pack

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

salmeterol xinafoate, Quantity: 72.5 microgram/actuation (Equivalent: salmeterol, Qty 50 microgram/actuation)

Available from:

GlaxoSmithKline Australia Pty Ltd

Pharmaceutical form:

Inhalation, powder for

Composition:

Excipient Ingredients: lactose monohydrate

Administration route:

Inhalation

Units in package:

1 x 60 blisters, 1 x 28 blisters

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

INDICATIONS AS AT 5th OCTOBER 1995: Long-term regular treatment of reversible airways obstruction in asthma (including nocturnal asthma and exercise-induced asthma), in patients aged four years or more who are receiving inhaled or oral corticosteroids. It should not be used in patients whose asthma can be managed by occasional use of short-acting inhaled beta 2 agonists. INDICATION AS AT 13TH JANUARY 1997 - ADULTS: Salmeterol is suitable for long-term regular treatment of reversible airways obstruction in asthma (including nocturnal asthma and exercise-induced asthma), in patients who are receiving inhaled or oral corticosteroids. It should not be used in patients whose asthma can be managed by occasional use of short-acting inhaled beta-2 agonists. Salmeterol also provides long-lasting (12 hours) bronchodilation for the reversible component of airways obstruction due to chronic obstructive pulmonary disease (COPD). CHILDREN AGED 4 YEARS AND OVER: Long-term regular treatment of reversible airways obstruction in asthma (including nocturnal asthma and exercised-induced asthma), in patients who are receiving inhaled or oral corticosteroids. It should not be used in patients whose asthma can be managed by occasional use of short-acting inhaled beta-2 agonists.

Product summary:

Visual Identification: Two tone green, circular device in moulded plastic approx 8.5cm in diameter and approx 3cm high, with a dose counter indicating the number of doses remaining.; Container Type: Blister Pack; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1995-10-31

Patient Information leaflet

SEREVENT
ACCUHALER
_salmeterol xinafoate_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about SEREVENT
ACCUHALER. It does not contain
all of the available information.
It does not take the place of talking to
your doctor or pharmacist (also
known as a chemist).
All medicines have benefits and
risks. Sometimes new risks are found
even when a medicine has been used
for many years. Your doctor has
weighed the risks of you using
SEREVENT ACCUHALER against
the expected benefits it will have for
you.
If you have any concerns about
taking this medicine, or experience
any difficulties during or after using
this medicine, tell your doctor or
pharmacist.
This medicine is only one part of a
general plan to help you manage your
asthma. You should discuss this plan
with your doctor. Your doctor should
check the treatment of your asthma
regularly.
KEEP THIS LEAFLET WITH YOUR
SEREVENT ACCUHALER.
You may need to read it again.
WHAT SEREVENT
ACCUHALER IS USED
FOR
The medicine in SEREVENT
ACCUHALER is known as a
bronchodilator. A bronchodilator
keeps the breathing tubes in your
lungs open and relieves the
symptoms of asthma and other chest
conditions.
When used as your doctor has told
you, SEREVENT ACCUHALER
helps you to breathe more easily.
SEREVENT ACCUHALER gives
relief, for up to twelve hours, from
chest tightness or wheeze due to
asthma, or other chest conditions in
adults namely chronic obstructive
pulmonary disease (COPD). You
should use SEREVENT
ACCUHALER regularly every day,
twice daily, in the morning and in the
evening.
The medicine in SEREVENT
ACCUHALER does not start
working as quickly as a 'reliever'
medicine such as VENTOLIN.
YOU SHOULD ALWAYS CARRY A
'RELIEVER' MEDICINE WITH YOU. IF YOU
HAVE AN ASTHMA ATTACK, USE YOUR
'RELIEVER' MEDICINE, NOT YOUR
SEREVENT ACCUHALER.
If you have asthma, your doctor will
tell you to use a 'preventer' medicine
(like an inhaled corticosteroid)
regularly every day as well as
SEREVENT ACCUHALER. If you
have COPD, your doctor will advise

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
SEREVENT ACCUHALER (SALMETEROL XINAFOATE) POWDER FOR
INHALATION
1
NAME OF THE MEDICINE
Salmeterol xinafoate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SEREVENT ACCUHALER is a moulded plastic device containing a foil strip
with regularly
placed blisters. Each blister contains 50 micrograms of salmeterol, as
salmeterol xinafoate.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Powder for inhalation.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ADULTS:
Salmeterol is suitable for long-term regular treatment of reversible
airways obstruction in
asthma (including nocturnal asthma and exercise-induced asthma), in
patients who are
receiving inhaled or oral corticosteroids. It should not be used in
patients whose asthma can
be managed by occasional use of short-acting inhaled beta-2 agonists.
Salmeterol also provides long-lasting (12 hour) bronchodilation for
the reversible component
of airways obstruction due to chronic obstructive pulmonary disease
(COPD).
CHILDREN AGED 4 YEARS AND OVER:
Long-term regular treatment of reversible airways obstruction in
asthma (including nocturnal
asthma and exercise-induced asthma), in patients who are receiving
inhaled or oral
corticosteroids. It should not be used in patients whose asthma can be
managed by
occasional use of short-acting inhaled beta-2 agonists.
4.2
DOSE AND METHOD OF ADMINISTRATION
In order to gain full therapeutic benefit regular usage of salmeterol
is recommended in the
treatment of reversible airways obstruction. The full benefits will be
apparent after the first
few doses of the drug. The bronchodilator effects of salmeterol
usually last for 12 hours, this
is particularly useful in the treatment of nocturnal symptoms in
asthma and COPD and in the
management of exercise-induced asthma. In the management of
exercise-induced asthma,
it is not appropriate to use salmeterol immediately before exercise as
the onset of action of
salmeterol occurs usually in 10-30 minutes and the full benefi