Becotide Evohaler 250 micrograms, Pressurised Inhalation Solution

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Beclometasone dipropionate

Dostupné z:

GlaxoSmithKline (Ireland) Limited

ATC kód:

R03BA; R03BA01

INN (Medzinárodný Name):

Beclometasone dipropionate

Dávkovanie:

250 microgram(s)

Forma lieku:

Pressurised inhalation, solution

Typ predpisu:

Product subject to prescription which may be renewed (B)

Terapeutické oblasti:

Glucocorticoids; beclometasone

Stav Autorizácia:

Marketed

Dátum Autorizácia:

2007-01-07

Príbalový leták

Reason for Update: Ethanol Excipient update
Market: IE
Agency Approval Date:
Text Date: 23/03/2022
Issue No.: 9 Draft No.: 1
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BECOTIDE EVOHALER 50, 100 AND 250 MICROGRAMS
Pressurised Inhalation Solution
(Beclometasone dipropionate)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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.
WHAT IS IN THIS LEAFLET
:
1.
What Becotide Evohaler is and what it is used for
2.
What you need to know before you use Becotide Evohaler
3.
How to use Becotide Evohaler
4.
Possible side effects
5.
How to store Becotide Evohaler
6.
Contents of the pack and other information.
1.
WHAT BECOTIDE EVOHALER IS AND WHAT IT IS USED FOR
Becotide contains the active substance beclometasone dipropionate.
Beclometasone dipropionate 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.
Becotide works by reducing swelling and irritation in the lungs. It
has what is called an ‘anti-inflammatory
action’.
Becotide 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.
Becotide 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.
Becotide is supplied to you in an inhaler. You breathe the medicine
di

Súhrn charakteristických

Health Products Regulatory Authority
20 September 2022
CRN00CVH5
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Becotide Evohaler 250 micrograms, Pressurised Inhalation Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One metered dose contains 250 micrograms Beclometasone Dipropionate
Excipient with known effect:
One metered dose contains 8.93 mg of ethanol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pressurised Inhalation, Solution
Clear and colourless solution in an aluminium canister with a valve.
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.
_Children:_
Children who require prophylactic asthma medication.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Becotide Evohaler is for oral inhalation use only.
Patients should be made aware of the prophylactic nature of therapy
with inhaled beclometasone