Beclazone 200 micrograms CFC-Free Inhaler, Pressurised Inhalation Solution

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Beclometasone dipropionate anhydrous

Предлага се от:

Norton Waterford

АТС код:

R03BA; R03BA01

INN (Международно Name):

Beclometasone dipropionate anhydrous

дозиране:

200 microgram(s)

Лекарствена форма:

Pressurised inhalation, solution

Вид предписание :

Product subject to prescription which may be renewed (B)

Терапевтична област:

Glucocorticoids; beclometasone

Статус Оторизация:

Marketed

Дата Оторизация:

1997-11-14

Листовка

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
BECLAZONE ® 200 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 or pharmacist.
-
This medicine has been prescribed for you. Do not pass it to others.
It may harm them, even if their
symptoms 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.
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
Beclazone CFC-Free Inhaler contains the active substance beclometasone
dipropionate, which belongs to a
group of medicines called corticosteroids (often just called
steroids). A very small dose of steroid is needed
when it is inhaled. This is because it is inhaled straight to your
lungs.
Beclazone CFC-Free Inhaler works by reducing swelling and irritation
in the lungs. It has what is called an
‘anti-inflammatory action’.
Beclazone CFC-Free Inhaler helps to prevent asthma attacks in people
who need regular treatment. This is
why it is sometimes called a 'preventer'. It needs to be used
regularly, every day.
Beclazone CFC-Free Inhaler will not help treat sudden asthma attacks
where you feel breathless.
• A different medicine is used for treating sudden attacks (called a
‘reliever’).
• If you have more than one medicine, be careful not to confuse
them.
Beclazone CFC-Free Inhaler is supplied to you in an inhaler. You
breathe the medicine directly into your
lungs.
Beclazone CFC-

Данни за продукта

Health Products Regulatory Authority
20 September 2023
CRN00DNWW
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Beclazone 200 micrograms CFC-Free Inhaler, Pressurised Inhalation
Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered dose contains 200 micrograms beclometasone dipropionate.
Excipient with known effect:
Each metered dose contains 5.13 mg alcohol (ethanol).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pressurised Inhalation, Solution.
The product is a colourless solution which is to be administered by
inhalation using an appropriate delivery device (metered
dose inhaler) in which it is supplied.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Severe asthma requires regular medical assessment as death may occur.
Patients with severe asthma have constant symptoms
and frequent exacerbations, with limited physical capacity, and PEF
values below 60% predicted at baseline with greater than
30% variability, usually not returning entirely to normal after a
bronchodilator. These patients will require high dose inhaled
(see section 4.2) or oral corticosteroid therapy. Sudden worsening of
symptoms may require increased corticosteroid dosage
which should be administered under urgent medical supervision.
_Adults: _
Prophylactic management in:
Mild asthma (PEF values greater than 80% predicted at baseline with
less than 20% variability): Patients requiring intermittent
symptomatic bronchodilator asthma medication on more than an
occasional basis.
Moderate asthma (PEF values 60 - 80% predicted at baseline with 20 -
30% variability): Patients requiring regular asthma
medication and patients with unstable or worsening asthma on other
prophylactic therapy or bronchodilator alone.
Severe asthma (PEF values less than 60% predicted at baseline with
greater than 30% variability): Patients with severe chronic
asthma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The preparation is intended for oral inhalation only.
Patients should be made aware of t