Alvesco 160 micrograms pressurised inhalation, solution

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

Ciclesonide

Disponibbli minn:

IMED Healthcare Ltd.

Kodiċi ATC:

R03BA; R03BA08

INN (Isem Internazzjonali):

Ciclesonide

Għamla farmaċewtika:

Pressurised inhalation, solution

Żona terapewtika:

Glucocorticoids; ciclesonide

Data ta 'l-awtorizzazzjoni:

2022-01-21

Fuljett ta 'informazzjoni

PACKAGE LEAFLET: INFORMATION FOR THE USER
ALVESCO 160 MICROGRAMS PRESSURISED INHALATION,
SOLUTION
CICLESONIDE
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, pharmacist or
nurse. This includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Alvesco is and what it is used for
2. What you need to know before you use Alvesco
3. How to use Alvesco
4. Possible side effects
5. How to store Alvesco
6. Contents of the pack and other information
1. WHAT ALVESCO IS AND WHAT IT IS USED FOR
WHAT ALVESCO IS:
Alvesco is a clear and colourless aerosol spray for you to breathe in
through your mouth and into your
lungs. It is a Preventer medication (corticosteroid) that has to be
taken every day and which becomes active
only after it has been inhaled into your lungs.
WHAT ALVESCO IS USED FOR:
Alvesco is used to treat persistent asthma in adult and adolescent
patients (12 years old and more).
HOW ALVESCO WORKS
Alvesco helps you to breathe more easily by decreasing the symptoms of
your asthma and
by lessening
the
chances of an asthma attack. The effect builds up over a period of
time, so this medicine
needs to be taken every day, even when you are feeling well.
_THIS MEDICINE IS NOT SUITABLE FOR USE IN AN ACUTE ATTACK OF
BREATHLESSNESS. FOR QUICK RELIEF FROM SUCH _
_AN ATTACK, USE ONLY YOUR RELIEVER INHALER._
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ALVESCO
DO NOT USE ALVESCO
if you are allergic to ciclesonide or any of the other ingredients of
this medicine. (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Alvesco.
• BEFORE BEGINNING treatmen

Karatteristiċi tal-prodott

Health Products Regulatory Authority
11 May 2023
CRN00DJQD
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Alvesco 160 micrograms pressurised inhalation, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 actuation (delivered dose from the mouthpiece) contains 160
micrograms of ciclesonide.
Excipient(s) with known effect:
1 actuation contains 4.7 mg of ethanol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pressurised inhalation, solution
Product imported from _Czech Republic and Bulgaria:_
Clear and colourless.
4 CLINICAL PARTICULARS
As per PA22986/001/002
5 PHARMACOLOGICAL PROPERTIES
As per PA22986/001/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Norflurane (HFA-134a)
Ethanol, anyhdrous
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.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
The container contains a pressurised liquid. Do not expose to
temperatures higher than 50°C.
The container should not be punctured, broken or burnt even when
apparently empty.
6.5 NATURE AND CONTENTS OF CONTAINER
The inhaler comprises a pressurised container made from aluminium and
is sealed with a metering valve, mouthpiece and cap.
60 metered actuations
Health Products Regulatory Authority
11 May 2023
CRN00DJQD
Page 2 of 2
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL OF A USED MEDICINAL PRODUCT OR
WASTE MATERIALS DERIVED FROM SUCH MEDICINAL
PRODUCT AND OTHER HANDLING OF THE PRODUCT
Patients should be carefully instructed in the proper use of their
inhaler (see Patient Information Leaflet).
As with most inhaled medicinal products in pressurised containers, the
therapeutic effect of this medicinal product may
decrease when the container is cold. However, Alvesco delivers a
consistent dose from –10°C to 40°C.
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of
in acco