Beclazone 50 micrograms CFC-Free Inhaler Pressurised Inhalation Solution

Land: Malta

Taal: Engels

Bron: Medicines Authority

Werkstoffen:

BECLOMETASONE DIPROPIONATE

Beschikbaar vanaf:

Norton Waterford IDA Industrial Park, Waterford, Ireland

ATC-code:

R03BA01

INN (Algemene Internationale Benaming):

BECLOMETASONE DIPROPIONATE 50 µg

farmaceutische vorm:

PRESSURISED INHALATION, SOLUTION

Samenstelling:

BECLOMETASONE DIPROPIONATE 50 µg

Prescription-type:

POM

Therapeutisch gebied:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Autorisatie-status:

Withdrawn

Autorisatie datum:

2006-09-22

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BECLAZONE
® 50, 100, 250 MICROGRAMS CFC-FREE INHALER PRESSURISED INHALATION
SOLUTION
Beclometasone Dipropionate Anhydrous
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.
-
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. Seesection 4.
WHAT IS IN THIS LEAFLET
1.
What Beclazone CFC-Free Inhaler is and what it is used for
2.
What you need to know before you use Beclazone CFC-Free Inhaler
3.
How to use Beclazone CFC-Free Inhaler
4.
Possible side effects
5.
How to store Beclazone CFC-Free Inhaler
6.
Contents of the pack and other information
1.
WHAT BECLAZONE CFC-FREE INHALER IS AND WHAT IT IS USED FOR
_Effect _
Beclazone CFC-Free Inhaler contains Beclometasone Dipropionate, which
belongs to a group of medicines
called corticosteroids. Beclometasone dipropionate works on your lungs
to help prevent asthma attacks by
reducing the swelling and irritation in the walls of the small air
passages. This eases your breathing problems.
Very little corticosteroid gets absorbed into your body. This medicine
is not the same type of steroid used by
body-builders and athletes to increase their performance.
_Usage _
Beclazone CFC-Free Inhalers are used to PREVENT asthma in adults,
adolescents and children aged 7 to 12
years. This type of medicine is known as a ‘preventer’. You must
keep on taking this type of medicine
regularly, even when you do not seem to have your asthma symptoms.
DO NOT USE Beclazone CFC-Free Inhalers to relieve an asthma attack,
wheezing or breathlessness. You will
probably need a different kind of medicine in a different colo

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Beclazone 50 micrograms CFC-Free Inhaler Pressurised Inhalation
Solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One metered dose contains 50 micrograms beclometasone dipropionate.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Pressurised Inhalation, Solution.
Pressurised container fitted with a metering valve and an actuator.
The colour of the actuator is beige with a brown dust cap.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylactic treatment of mild, moderate, and severe persistent
asthma.
Beclazone 50 micrograms CFC-Free Inhaler is indicated in adults,
adolescents and children aged 7-12
years.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The preparation is intended for oral inhalation only. For optimum
results, beclometasone dipropionate
inhaler should be used regularly. The initial dose of inhaled
beclometasone dipropionate should be
appropriate to the severity of the disease.
The dose should be titrated to the lowest dose at which effective
control of asthma is maintained.
_Adults _
The dose range is from 50 mcg twice daily to 500 mcg twice daily
(maximum daily dose 1000 mcg)
depending on the patient's asthma severity.
The maintenance dose is normally 200-400mcg per day in divided doses.
If necessary, higher doses
of up to 1000 micrograms per day may be used.
_Paediatric population (7-12 years) _
The dose range is from 50 mcg twice daily to 100 mcg twice daily
(maximum daily dose 200 mcg per
day) depending on the patient's asthma severity.
Beclazone 50 micrograms CFC-Free Inhaler is not recommended for use in
children under seven years
due to insufficient data on safety and efficacy.
When asthma symptoms remain under satisfactory control the dose may be
gradually reduced to the
minimum effective dose to maintain symptom control.
The therapeutic effect occurs after a few days’ treatment and
reaches its maximum after 2-3 weeks.
When transferring a patient to Beclazone CFC-Free Inhaler from othe