Beclazone 50 micrograms 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 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 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 coloured
pack fo

Summary of Product characteristics

Health Products Regulatory Authority
15 July 2022
CRN00CN9W
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Beclazone 50 micrograms CFC-Free Inhaler Pressurised Inhalation
Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose contains 50 micrograms beclometasone dipropionate.
Excipient with known effect:
Each metered dose contains 2.09 mg alcohol (ethanol).
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. Patients should
be made aware of the prophylactic nature of therapy with
inhaled beclometasone dipropionate and that it should be taken
regularly even when they are asymptomatic. 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.
If patients find that short-acting relief bronchodilator treatment
becomes less effective or they need more inhalations than
usual, medical attention must be sought.
_Adults and children over 12 years of age_
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 200-400 mcg per day in divided doses.
If necessary, higher doses of up to 1000 micrograms
per day may be used.
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