Bricanyl Turbuhaler

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Terbutaline sulfate 0.5mg

Available from:

AstraZeneca Limited

INN (International Name):

Terbutaline sulfate 0.5 mg

Dosage:

0.5 mg/dose

Pharmaceutical form:

Powder for inhalation

Composition:

Active: Terbutaline sulfate 0.5mg

Units in package:

Inhaler, metered, 200 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

AstraZeneca AB

Product summary:

Package - Contents - Shelf Life: Inhaler, metered, - 200 dose units - 24 months from date of manufacture stored at or below 30°C

Authorization date:

1987-05-27

Patient Information leaflet

Bricanyl

Turbuhaler CMI 151222
Copyright
1(5)
BRICANYL
®
TURBUHALER
®
TERBUTALINE SULPHATE, 200 MICROGRAMS PER DELIVERED DOSE
(CORRESPONDING TO 250 ΜG METERED DOSE).
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions people ask about
BRICANYL TURBUHALER. It does
not contain all the information that is known about BRICANYL
TURBUHALER. It does not take the place of
talking to your doctor or pharmacist. All medicines have risks and
benefits. Your doctor will have
weighed the risks of you taking BRICANYL TURBUHALER against the
benefits they expect it will have for
you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again.
WHAT BRICANYL TURBUHALER IS USED FOR
BRICANYL TURBUHALER contains terbutaline sulphate. Terbutaline is a
bronchodilator and belongs to a
group of medicines called beta-2-agonists. BRICANYL TURBUHALER is used
to open up the airways in
people with asthma, bronchitis and other breathing problems so that
they can breathe more easily. It
can also be used BEFORE exercise to keep the airways open if you start
to wheeze or have trouble
breathing each time you exert yourself.
BRICANYL TURBUHALER IS A 'RELIEVER' DRUG AND YOU SHOULD ONLY USE IT
WHEN YOU NEED IT.
However, your doctor may prescribe this medicine for another use. Ask
your doctor if you want more
information.
BRICANYL TURBUHALER widens the airways which makes it easier to
breathe. When you breathe in
through the mouthpiece of the inhaler your breath carries the medicine
to your lungs.
BRICANYL TURBUHALER is not addictive.
BRICANYL TURBUHALER is only available with a doctor’s prescription.
BEFORE YOU USE BRICANYL TURBUHALER
_WHEN YOU MUST NOT USE IT_
_ _
DO NOT USE BRICANYL IF YOU HAVE AN ALLERGY TO ANY MEDICINE CONTAINING
TERBUTALINE OR LACTOSE
(120 INHALATIONS TURBUHALER ONLY).
Some of the symptoms of an allergic reaction may include:
•
rash, itching or hives on the skin
•
shortness of

Summary of Product characteristics

B
RICANYL
T
URBUHALER
Data Sheet 250220
Copyright
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
B
RICANYL
T
URBUHALER
®
,
Inhalation powder 200 micrograms/ inhalation (delivered
dose).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
There are two versions of Bricanyl Turbuhaler, each delivering
(ex-mouthpiece)
200 μg of terbutaline sulphate per inhalation (delivered dose):

Original M2 Turbuhaler version: labelled as the metered dose 250 μg
terbutaline
sulphate per inhalation.

M3 Turbuhaler version: labelled as the delivered dose 200 μg
terbutaline
sulphate per inhalation (corresponding to 250 μg metered dose)
Each delivered dose contains: Terbutaline sulphate 200 µg (which
corresponds to
250 µg metered dose).
Excipient with known effect

M2 Turbuhaler: None

M3 Turbuhaler: each delivered dose contains approximately 700 µg of
lactose
monohydrate.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Relief
of
bronchospasm
occurring
in
bronchial
asthma,
bronchitis
and
other
bronchopulmonary conditions where bronchospasm is a complicating
factor.
Acute
prophylaxis
in
situations
known
to
induce
bronchospasm, e.g.
exercise-
induced asthma.
4.2
DOSE AND METHOD OF ADMINISTRATION
If long term use of terbutaline is proposed, particularly if the
patient is asked to take
terbutaline in conjunction with other medications, objective pulmonary
function testing
(for example, by peak flow meter or spirometer) may be useful as part
of assessment
of the efficacy of treatment.
B
RICANYL
T
URBUHALER
Data Sheet 151222
Copyright
2
B
RICANYL
T
URBUHALER
is inspiratory flow driven and hence there is no need to co-
ordinate the release of the dose and the inhalation as with a
pressurised inhaler.
When inhaling, the substance follows the inspired air into the
airways. Treatment
with B
RICANYL
T
URBUHALER
is effective even during an acute asthmatic attack.
The
dosage
of
inhaled
terbutaline
via
B
RICANYL
T
URBUHALER
should
be
individualised. B