ALVESCO 80 Microgram Pressurised Inhalation Soln

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CICLESONIDE

Available from:

Takeda GmbH

ATC code:

R03BA08

INN (International Name):

CICLESONIDE

Dosage:

80 Microgram

Pharmaceutical form:

Pressurised Inhalation Soln

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

Glucocorticoids

Authorization status:

Authorised

Authorization date:

2007-12-19

Patient Information leaflet

PACKAGE LEAFLET: 
INFORMATION FOR THE USER
ALVESCO 40, 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.
The ACTIVE INGREDIENT in this medicine is 
ciclesonide. (For the OTHER INGREDIENTS, 
see Section 6).
WHAT ALVESCO IS USED FOR:
This medicine is prescribed to control 
persistent asthma in adult and adolescent 
patients (12 years old and more).
It 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

Summary of Product characteristics

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.
_For a full list of excipients, see section 6.1._
3 PHARMACEUTICAL FORM
Pressurised inhalation, solution
Clear and colourless.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
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 sec 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 of asthma control. If patients find that
short-acting relief bronchodilator treatment becomes less
effective, or they need more inhalations than usual, medical attention
must be