Beclazone 250 micrograms CFC-Free Inhaler Pressurised Inhalation Solution

Страна: Мальта

мова: англійська

Джерело: Medicines Authority

Активний інгредієнт:

BECLOMETASONE DIPROPIONATE

Доступна з:

Norton Waterford IDA Industrial Park, Waterford, Ireland

Код атс:

R03BA01

ІПН (Міжнародна Ім'я):

BECLOMETASONE DIPROPIONATE 250 µg

Фармацевтична форма:

PRESSURISED INHALATION, SOLUTION

Склад:

BECLOMETASONE DIPROPIONATE 250 µg

Тип рецепту:

POM

Терапевтична области:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Статус Авторизація:

Withdrawn

Дата Авторизація:

2006-09-22

інформаційний буклет

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

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Beclazone 250 micrograms CFC-Free Inhaler Pressurised Inhalation
Solution
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
One metered dose contains 250 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 wine with a pink dust cap.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Beclazone 250 micrograms CFC-Free Inhaler is indicated for those
asthmatic patients who have been
shown to require high doses of beclometasone dipropionate to control
their symptoms. It may also be
indicated for those patients whose asthma is no longer controlled by
maximum maintenance doses of
bronchodilators and lower doses of BDP. Some patients with severe
asthma require oral
corticosteroid therapy in addition to BDP_ _for the adequate control
of their symptoms. Many of these
patients may, on transfer to Beclazone 250 micrograms CFC-Free
Inhaler, be able to reduce
significantly, or eliminate their requirement for additional oral
corticosteroids.
Beclazone 250 micrograms CFC-Free Inhaler is indicated in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The preparation is intended for oral inhalation only. For optimum
results, beclometasone dipropionate
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
up to 1000mcg daily in divided doses may be used.
When asthma symptoms remain under satisfactory control the dose may be
gradually reduced to the
minimum