Beclazone 50 micrograms Easi-Breathe CFC-Free Inhaler Pressurised Inhalation Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

BECLOMETASONE DIPROPIONATE

Available from:

Norton Waterford

ATC code:

R03BA; R03BA01

INN (International Name):

BECLOMETASONE DIPROPIONATE

Dosage:

50 Mcg/Acutuation

Pharmaceutical form:

Pressurised inhalation, solution

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Glucocorticoids; beclometasone

Authorization status:

Marketed

Authorization date:

1997-11-14

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BECLAZONE 50, 100, 250 MICROGRAMS EASI-BREATHE
 CFC-FREE INHALER PRESSURISED INHALATION SOLUTION
Beclometasone dipropionate
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. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Beclazone Easi-Breathe

CFC-Free Inhaler is and what it is used for
2.
What you need to know before you use Beclazone Easi-Breathe

CFC-Free Inhaler
3.
How to use Beclazone Easi-Breathe

CFC-Free Inhaler
4.
Possible side effects
5.
How to store Beclazone Easi-Breathe

CFC-Free Inhaler
6.
Contents of the pack and other information
1
WHAT BECLAZONE EASI-BREATHE
 CFC-FREE INHALER IS AND WHAT IT IS USED
FOR
_Effect _
Beclazone Easi-Breathe

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 Easi-Breathe

CFC-Free Inhaler is 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
Easi-Breathe

CFC-Free

Summary of Product characteristics

Health Products Regulatory Authority
01 November 2019
CRN009FL1
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Beclazone 50 micrograms Easi-Breathe 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 a
breath-operated actuator. The colour of the actuator is cream with a
brown dust cap.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prophylactic treatment of mild, moderate, and severe persistent
asthma.
Beclazone 50 micrograms Easi-Breathe 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 1000mcg daily in
divided doses 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 Easi-Breathe 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 aft