Becloneb 400 micrograms/1 ml nebuliser suspension

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

BECLOMETASONE DIPROPIONATE

Boleh didapati daripada:

Chiesi Farmaceutici S.p.A.

Kod ATC:

R03BA; R03BA01

INN (Nama Antarabangsa):

BECLOMETASONE DIPROPIONATE

Dos:

400 mcg/1 millilitre(s)

Borang farmaseutikal:

Nebuliser suspension

Jenis preskripsi:

Product subject to prescription which may be renewed (B)

Kawasan terapeutik:

Glucocorticoids; beclometasone

Status kebenaran:

Not marketed

Tarikh kebenaran:

2005-03-18

Risalah maklumat

1
Leaflet V(0.1) 12.2016
B. PACKAGE LEAFLET
2
Leaflet V(0.1) 12.2016
PACKAGE LEAFLET: INFORMATION FOR THE USER
BECLONEB
® 400 MICROGRAMS NEBULISER SUSPENSION
BECLONEB
® 800 MICROGRAMS NEBULISER SUSPENSION
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 or pharmacist.
-
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 or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
IN THIS LEAFLET:
1.
What BECLONEB
®
is and what it is used for
2.
What you need to know before you use BECLONEB
®
3.
How to use BECLONEB
®
4.
Possible side effects
5.
How to store BECLONEB
®
6.
Contents of the pack and other information
1. WHAT BECLONEB® IS AND WHAT IT IS USED FOR
BECLONEB
®
contains the active substance beclometasone dipropionate. It belongs
to a group of medicines
called corticosteroids which have an anti-inflammatory action reducing
the swelling and irritation in the
walls of the airways (e.g. nose, lungs), and so ease breathing
problems.
BECLONEB
®
is indicated to treat asthma in adults and children up to 18 years of
age when the use of
pressurised or dry powder inhalers is unsatisfactory or inappropriate.
BECLONEB
®
is also indicated to treat recurrent wheezing in children up to 5
years of age.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE BECLONEB
®
DO NOT USE BECLONEB
®
:

If you are allergic to the active substance or any of the other
ingredients of this medicine listed in section
6.
WARNINGS AND PRECAUTIONS
Talk to you doctor or pharmacist before using BECLONEB
®
if any of the following applies to you:

You are being, or have ever been, treated for tuberculosis (TB).

Your condition seems to be getting worse. Pe

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Becloneb 400 micrograms/1 ml nebuliser suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml single dose container contains 400 micrograms beclometasone
dipropionate anhydrous.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nebuliser suspension.
A white or almost white suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
BECLONEB
®
is indicated for the:
maintenance treatment
of
asthma,
when the
use of
pressurised metered dose or
dry powder
inhalers
is
unsatisfactory or inappropriate, in adults and children up to 18 years
of age;
treatment of recurrent wheezing in children up to 5 years of age (see
sections 4.2 and 4.4 paediatric population).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The starting dose of nebulised beclometasone dipropionate should take
into account
the frequency and severity of
symptoms.
The recommended initial doses are:
Adults and adolescents (from 12 years of age) :
800-1,600 micrograms twice daily
(total daily dose: 1600 – 3200 micrograms)
Children (up 11 years of age):
400-800 micrograms twice daily
(total daily dose: 800 – 1600 micrograms)
Normally, a daily dose of 3200 micrograms in adults and adolescents
and 1600 micrograms in children up to 11 years
of age should not be exceeded.
After improvement of control of asthma or wheezing, the total daily
dose should be reduced to the lowest effective dose
and a once daily dosing can be applied.
In patients with asthma,
BECLONEB
®
must be used regularly on a daily basis; the duration of treatment
should be
defined on the basis of symptoms.
In children with recurrent wheezing, if no treatment benefit of is
observed within 2-3 months, BECLONEB
®
should be
discontinued. In addition, the duration of treatment of recurrent
wheezing should not exceed 3 months, unless diagnosis
of asthma is likely to avoid an unnecessary long-term exposure (see
section 4.4).
Method of administration
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