Beclospin 400 micrograms/1 ml nebuliser suspension

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Beclometasone dipropionate

Verfügbar ab:

Chiesi Farmaceutici S.p.A.

ATC-Code:

R03BA; R03BA01

INN (Internationale Bezeichnung):

Beclometasone dipropionate

Dosierung:

400 millilitre(s)

Darreichungsform:

Nebuliser suspension

Verschreibungstyp:

Product subject to prescription which may be renewed (B)

Therapiebereich:

Glucocorticoids; beclometasone

Berechtigungsstatus:

Not marketed

Berechtigungsdatum:

2005-03-18

Gebrauchsinformation

1
Leaflet V(1.1) 01.2018 – Beclospin -400
B. PACKAGE LEAFLET
2
Leaflet V(1.1) 01.2018 – Beclospin -400
PACKAGE LEAFLET: INFORMATION FOR THE USER
BECLOSPIN 400 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 Beclospin is and what it is used for
2.
What you need to know before you use Beclospin
3.
How to use Beclospin
4.
Possible side effects
5.
How to store Beclospin
6.
Contents of the pack and other information
1. WHAT BECLOSPIN IS AND WHAT IT IS USED FOR
Beclospin 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.
Beclospin 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.
Beclospin is also indicated to treat recurrent wheezing in children up
to 5 years of age.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE BECLOSPIN
DO NOT USE BECLOSPIN:

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 Beclospin 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. Perhaps you are more wheezy
and shor

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Beclospin 400 micrograms/1 ml nebuliser suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 1 ml single dose unit 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
BECLOSPIN
®
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,
BECLOSPIN
®
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, BECLOSPIN
®
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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