Beclazone 100 micrograms CFC-Free Inhaler

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Beclometasone dipropionate 100ug;  

Available from:

Teva Pharma (New Zealand) Limited

INN (International Name):

Beclometasone dipropionate 100 µg

Dosage:

100 mcg/dose

Pharmaceutical form:

Aerosol inhaler, metered dose

Composition:

Active: Beclometasone dipropionate 100ug   Excipient: Ethanol Norflurane

Units in package:

Aerosol, metered inhaler, actuator, 200 dose units

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sicor (Societa Italiana Corticosteroidi) Srl

Product summary:

Package - Contents - Shelf Life: Aerosol, metered inhaler, actuator - 200 dose units - 36 months from date of manufacture stored at or below 25°C. do not refrigerate, freeze, puncture or burn.

Authorization date:

2003-04-02

Patient Information leaflet

NEW ZEALAND CONSUMER MEDICINE INFORMATION
BECLAZONE® 50, 100, 250 MICROGRAMS CFC-FREE INHALER
BECLOMETASONE DIPROPIONATE 50, 100, OR 250 MICROGRAMS PER METERED
DOSE (“PUFF”)
Please read this leaflet carefully before you start using Beclazone
CFC-Free Inhaler.
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Beclazone CFC-Free
Inhaler. It does not
contain all the available information. 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 using
Beclazone CFC-Free Inhaler, 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. YOU MAY NEED TO READ IT AGAIN.
WHAT BECLAZONE CFC-FREE INHALER IS USED FOR
Beclazone CFC-Free Inhaler is used to help prevent asthma in adults,
adolescents and
children over 7 years of age. It contains a medicine called
beclometasone dipropionate, which
belongs to a family of medicines called corticosteroids. Inhaled
corticosteroids are not the same
as anabolic steroids used by some body-builders and athletes. Your
Beclazone CFC-Free
Inhaler delivers very small amounts of inhaled corticosteroid straight
to your lungs, where it
works by reducing inflammation (swelling and irritation) in the small
airways. This helps you to
breathe easier and helps
to prevent asthma attacks. This kind of medicine is known as a
‘Preventer’. It must be used everyday as directed by your doctor
even if you have no asthma
symptoms.
Beclazone CFC-Free Inhaler may take a few days to start to work. Do
not stop using your
inhaler unless a doctor tells you to.
Beclazone CFC-Free Inhaler does not give immediate relief from an
asthma attack. Do not use
Beclazone CFC-Free Inhaler to relieve wheezing or breathlessness - you
may have been given
a different kind of inhaler medicine, called a 'Reliever’, for that.
Your doctor may have told you
to use a Reliever inhaler in addition to your Beclazone C

Summary of Product characteristics

Version 1.2
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
BECLAZONE 50 micrograms CFC-Free Inhaler
BECLAZONE 100 micrograms CFC-Free Inhaler
BECLAZONE 250 micrograms CFC-Free Inhaler
(beclometasone dipropionate inhaler, CFC-Free, 50 mcg, 100 mcg and 250
mcg)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose delivers 50 mcg, 100 mcg or 250 mcg beclometasone
dipropionate.
Excipient with known effect:
ethanol (anhydrous)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pressurised inhalation, suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Beclometasone dipropionate provides effective anti-inflammatory action
in the lungs and offers
preventive background treatment of asthma.
Severe asthma requires regular medical assessment as death may occur.
Patients with severe
asthma have constant symptoms and frequent exacerbations, with limited
physical capacity, and PEF
values below 60% predicted at baseline with greater than 30%
variability, usually not returning
entirely
to
normal
after
a
bronchodilator.
These
patients
will
require
high
dose inhaled (see
section 4.2 Dose and method of administration) or oral corticosteroid
therapy. Sudden worsening of
symptoms may require increased corticosteroid dosage which should be
administered under urgent
medical supervision.
_Adults _
Prophylactic management in:
Mild asthma (PEF values greater than 80% predicted at baseline with
less than 20% variability):
Patients
requiring intermittent
symptomatic bronchodilator
asthma medication on more than an
occasional basis.
Moderate asthma (PEF values 60-80% predicted at baseline with 20-30%
variability): Patients
requiring regular asthma medication and patients with unstable or
worsening asthma on other
prophylactic therapy or bronchodilator alone.
Severe asthma (PEF values less than 60% predicted at baseline with
greater than 30% variability):
Patients with severe chronic asthma. On transfer to high dose inhaled
beclometasone dipropionate,
many patients who are dependent on systemic corticoster