Becotide Evohaler 250 micrograms, Pressurised Inhalation Solution

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Beclometasone dipropionate

제공처:

Imbat Limited

ATC 코드:

R03BA; R03BA01

INN (국제 이름):

Beclometasone dipropionate

복용량:

250 microgram(s)

약제 형태:

Pressurised inhalation, solution

처방전 유형:

Product subject to prescription which may be renewed (B)

치료 영역:

Glucocorticoids; beclometasone

승인 상태:

Authorised

승인 날짜:

2013-10-25

환자 정보 전단

Page 1 of 2
BECOTIDE
TM EVOHALER
TM
250 MICROGRAMS
PRESSURISED INHALATION SOLUTION
(beclometasone dipropionate)
PACKAGE LEAFLET: INFORMATION FOR THE USER
Your medicine is available using the name Becotide Evohaler 250
micrograms Pressurised Inhalation
Solution, but will be referred to as Becotide throughout this leaflet.
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.
IN THIS LEAFLET:
1.
WHAT BECOTIDE IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BECOTIDE
3.
HOW TO USE BECOTIDE
4.
POSSIBLE SIDE EFFECTS
5.
HOW TO STORE BECOTIDE
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT BECOTIDE IS AND WHAT IT IS USED FOR
Becotide contains the medicine 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
directly into

제품 특성 요약

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Becotide Evohaler 250 micrograms, Pressurised Inhalation Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each metered actuation contains 250 micrograms beclometasone
dipropionate.
Also contains ethanol.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pressurised Inhalation Solution
_Product imported from: Italy & Spain_
Clear and colourless pressurised inhalation solution in an aluminium
canister with a valve
4 CLINICAL PARTICULARS
As per PA1077/042/009
5 PHARMACOLOGICAL PROPERTIES
As per PA1077/042/009
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Norflurane (HFA 134a)
Ethanol
Glycerol
6.2 INCOMPATIBILITIES
Not applicable
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer package of the product on
the market in the country of origin.
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6.4 SPECIAL PRECAUTIONS FOR STORAGE
The canister contains a pressurised liquid. Do not pierce the
canister. Do not expose to temperatures higher than 50°C.
Replace the mouthpiece cover firmly and click it into position.
Do not store above 30°C.
Protect from light.
Do not refrigerate or freeze.
As with most inhaler medications in pressurised canisters, the
therapeutic effect of this medicine may decrease when
th