Alvesco 160 mikrogram/dos Inhalationsspray, lösning

Nazione: Svezia

Lingua: svedese

Fonte: Läkemedelsverket (Medical Products Agency)

Principio attivo:

ciklesonid

Commercializzato da:

Orifarm AB

Codice ATC:

R03BA08

INN (Nome Internazionale):

ciclesonide

Dosaggio:

160 mikrogram/dos

Forma farmaceutica:

Inhalationsspray, lösning

Composizione:

ciklesonid 0,16 mg Aktiv substans; etanol, vattenfri Hjälpämne

Tipo di ricetta:

Receptbelagt

Stato dell'autorizzazione:

Avregistrerad

Data dell'autorizzazione:

2018-05-30

Foglio illustrativo

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALVESCO 80 AND 160 MCG INHALER
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 colorless 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
treatment with thi

Scheda tecnica

1.
NAME OF THE MEDICINAL PRODUCT
Alvesco 160 Inhaler
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
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 of asthma control. If
patients find that short-acting
relief bronchodilator treatment becomes less effective, or they need
more inhalations than