Alvesco 160 inhaler

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Ciclesonide

Mevcut itibaren:

Covis Pharma GmbH

ATC kodu:

R03BA08

INN (International Adı):

Ciclesonide

Doz:

160microgram/1dose

Farmasötik formu:

Pressurised inhalation

Uygulama yolu:

Inhalation

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: 03020000; GTIN: 5060065110026 5060065110040

Bilgilendirme broşürü

PACKAGE LEAFLET: INFORMATION FOR THE USER ALVESCO® 160 INHALER
(ciclesonide)
Your medicine is known by the above name but will be referred to as
Alvesco
throughout this leaflet.
This medicine is available in other strengths.
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 YOUR RELIEVER
INHALER._
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ALVESCO
DO NOT USE ALVESCO
if you are allerg

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
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.
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 must be sought. In this situation, pati