PULMICORT Turbuhaler 100 microgram/dose

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

budesonide, Quantity: 100 microgram/actuation

Available from:

AstraZeneca Pty Ltd

Pharmaceutical form:

Insufflation

Composition:

Excipient Ingredients:

Administration route:

Inhalation

Units in package:

single plastic container, 200 dose

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Treatment of bronchial asthma. INDICATIONS AS AT 3 June 1994: Treatment of bronchial asthma. May also be used when replacement or reduction in oral steroid therapy is desired.

Product summary:

Visual Identification: CONTAINER Plastic container, light-brown turning grip 'BUDESONIDE 100' embossed base. PRODUCT White to off-white rounded granules which disintegrate to fine powder upon slight pressure."; Container Type: Inhaler - dry powder; Container Material: Plastic; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

1991-07-31

Patient Information leaflet

PULMICORT
®
_Budesonide_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions ask about Pulmicort. It
does not contain all the information
that is known about Pulmicort.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Pulmicort
against the benefits 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 PULMICORT IS
USED FOR
Pulmicort is inhaled into the lungs
for the treatment of asthma. Asthma
is a disease where the airways of
your lungs become narrow and
inflamed (red and swollen), making it
difficult to breathe. This may be due
to an allergy to house dust mites,
smoke, air pollution or other things
that irritate your lungs.
Pulmicort contains budesonide. This
belongs to a family of medicines
called corticosteroids, which are used
to reduce inflammation in many parts
of the body.
Pulmicort acts directly on your
airways to reduce inflammation. This
helps to improve your condition and
to prevent asthma attacks from
occurring.
It is a "preventer" and needs to be
taken regularly.
Pulmicort may also be used to treat
croup in infants and children.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY PULMICORT HAS
BEEN PRESCRIBED FOR YOU.
Your doctor may prescribe it for
another reason.
Pulmicort is not addictive.
Pulmicort is available only with a
doctor's prescription.
BEFORE YOU USE
PULMICORT
_WHEN YOU MUST NOT USE IT_
DO NOT USE PULMICORT IF YOU HAVE
AN ALLERGY TO:
•
any medicine containing
budesonide
•
any ingredients listed at the end
of this leaflet.
Some of the symptoms of an allergic
reaction may include:
•
rash, itching or hives on the skin
•
shortness of breath, wheezing or
difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body.
DO NOT USE PULMICORT AFTER THE
EXPIRY DATE (EXP) PRINTED ON THE
PACK O

Summary of Product characteristics

1 of 12
AUSTRALIAN PRODUCT INFORMATION
PULMICORT
®
TURBUHALER
® & PULMICORT
®
RESPULES
®
(BUDESONIDE)
1
NAME OF THE MEDICINE
Budesonide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Pulmicort Turbuhaler:_
Pulmicort Turbuhaler contains only budesonide as the active
ingredient;
either 100 μg, 200 μg or 400 μg per dose (metered dose).
_Pulmicort Respules_
: Pulmicort Respules contain budesonide 0.5 mg in 2 mL or 1 mg in 2 mL
as
the active ingredient. For the full list of Pulmicort Respules
excipients, see Section 6.1.
3
PHARMACEUTICAL FORM
_Pulmicort Turbuhaler:_
powder for inhalation. Pulmicort Turbuhaler is a breath activated
multiple
dose dry powder inhaler.
_Pulmicort Respules_
: Pulmicort Respules nebulising suspension for inhalation is a white
to off-
white suspension in plastic single dose units.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of bronchial asthma.
Pulmicort may also be used when replacement or reduction in oral
steroid therapy is desirable.
Pulmicort Respules can be used for the treatment of acute
laryngotracheobronchitis (croup) in
infants and children.
4.2
DOSE AND METHOD OF ADMINISTRATION
BRONCHIAL ASTHMA
_PULMICORT TURBUHALER _
_Initially, or during periods of severe asthma or while reducing oral
corticosteroids _
_Adults: _
400 to 2400 μg daily divided into 2 to 4 administrations. In less
severe cases 400 to 800 μg
daily may be sufficient.
Once daily dosing may be considered in adult patients with mild asthma
who require a dose of up to
400 μg budesonide per day. The dose may then be given either in the
morning or the evening.
_Children: _
200 to 400 μg daily, divided into 2 to 4 administrations. Severe
cases may require daily
doses up to 800 μg. This dose has been reported not to affect adrenal
function in children.
2 of 12
_Maintenance _
The maintenance dose should be individualised and should be the lowest
dose, which leaves the
patient symptom-free. Recommended doses are 100-400 μg daily; this
may be given as a twice
daily dose, or as a once daily dose given i