Alvesco 80 Inhaler

Země: Malta

Jazyk: angličtina

Zdroj: Medicines Authority

Aktivní složka:

CICLESONIDE

Dostupné s:

Takeda GmbH Byk-Gulden-Str. 2, D-78467 Konstanz, Germany

ATC kód:

R03BA08

INN (Mezinárodní Name):

CICLESONIDE 80 µg

Léková forma:

PRESSURISED INHALATION, SOLUTION

Složení:

CICLESONIDE 80 µg

Druh předpisu:

POM

Terapeutické oblasti:

DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES

Stav Autorizace:

Withdrawn

Datum autorizace:

2009-12-15

Informace pro uživatele

 
Page 1 of 8 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

ALVESCO 40, 80 AND 160 INHALER 
CICLESONIDE 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. 
- 
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. Do not pass it on
to others. It may harm them, even 
if their symptoms are the same as yours. 
- 
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, 
please tell your doctor or pharmacist. 

IN THIS LEAFLET the information is arranged as follows:  
1. 
What Alvesco is and what it is used for 
2. 
Before you use Alvesco (This section contains important information
for your safety) 
3. 
How to use Alvesco 
4. 
Possible side effects 
5. 
How to store Alvesco 
6. 
Further 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 YOUR RELIEVER INHALER.  _

2. 
BEFORE YOU USE ALVESCO 

DO NOT USE A

Charakteristika produktu

 
Page 1 of 8 
1. 
NAME OF THE MEDICINAL PRODUCT 

Alvesco

80 Inhaler 
_ _

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. 

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. However in severe asthmatics, a 12 week study
has shown that a dose of 
640 micrograms/day (given 320 micrograms twice daily) has
demonstrated a reduction in the frequency of 
exacerbations but without an improvement in lung function (see
section 5.1). 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. 

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. 

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, o