Alvesco 80 micrograms pressurised inhalation, solution

Ország: Írország

Nyelv: angol

Forrás: HPRA (Health Products Regulatory Authority)

Aktív összetevők:

Ciclesonide

Beszerezhető a:

Covis Pharma Europe B.V.

ATC-kód:

R03BA; R03BA08

INN (nemzetközi neve):

Ciclesonide

Adagolás:

80 microgram(s)

Gyógyszerészeti forma:

Pressurised inhalation, solution

Terápiás terület:

Glucocorticoids; ciclesonide

Engedélyezési státusz:

Marketed

Engedély dátuma:

2017-05-19

Betegtájékoztató

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALVESCO , 80 AND 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.
•

Termékjellemzők

Health Products Regulatory Authority
29 September 2021
CRN00CCKS
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Alvesco 80 micrograms pressurised inhalation, solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 actuation (delivered dose from the mouthpiece) contains 80
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
Clear and colourless.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Alvesco is indicated in treatment to control persistent asthma in
adults and adolescents (12 years and older).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The medicinal product is for inhalation use only.
Posology
Dosing recommendation for adults and adolescents:
The recommended dose of Alvesco is 160 micrograms once daily, which
leads to asthma control in the majority of patients. In
patients with severe asthma and while reducing or discontinuing oral
corticosteroids, a higher dose of up to 640mcg/day
(given as 320mcg twice daily) may be used (see section 5.1). Patients
should be given a dose of inhaled ciclesonide which is
appropriate to the severity of their disease. Symptoms start to
improve with Alvesco within 24 hours of treatment. Once control
is achieved, the dose of Alvesco should be individualised and titrated
to the minimum dose needed to maintain good asthma
control. Dose reduction to 80 micrograms once daily may be an
effective maintenance dose for some patients.
Alvesco should preferably be administered in the evening although
morning dosing of Alvesco has also been shown to be
effective. The final decision on evening or morning dosing should be
left to the discretion of the physician.
Patients with severe asthma are at risk of acute attacks and should
have regular assessments of their asthma control including
pulmonary function tests. Increasing use of short-acting
bronchodilators to relieve asthma symptoms indicates deterioration