ALVESCO

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CICLESONIDE

Available from:

AstraZeneca UK Limited

ATC code:

R03BA08

INN (International Name):

CICLESONIDE

Dosage:

160 Microgram

Pharmaceutical form:

Pressurised Inhalation Soln

Prescription type:

Product subject to prescription which may be renewed (B)

Therapeutic area:

ciclesonide

Authorization status:

Marketed

Authorization date:

2005-02-18

Summary of Product characteristics

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.
_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 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 of asthma control. If patients find that
short-acting relief bronchodilator treatment becomes less
effective, or they need more inhalations than usual, medical attention
m