Alvesco 80 inhaler

Երկիր: Միացյալ Թագավորություն

Լեզու: անգլերեն

Աղբյուրը: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ակտիվ բաղադրիչ:

Ciclesonide

Հասանելի է:

Mawdsley-Brooks & Company Ltd

ATC կոդը:

R03BA08

INN (Միջազգային անվանումը):

Ciclesonide

Դոզան:

80microgram/1dose

Դեղագործական ձեւ:

Pressurised inhalation

Կառավարման երթուղին:

Inhalation

Դաս:

No Controlled Drug Status

Ռեկվիզորի տեսակը:

Valid as a prescribable product

Ապրանքի ամփոփագիր:

BNF: 03020000

Տեղեկատվական թերթիկ

PATIENT INFORMATION LEAFLET
ALVESCO
® 80 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.
Your medicine is available by using the above name but will be
referred to
as Alvesco throughout the leaflet. Alvesco Inhaler is also available
in
other strengths.
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.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE ALVESCO
DO NOT USE ALVESCO
if you are allergic (hypersensitive) to ciclesonide or any of the
other
ingredients of this medicine (listed in section 6).
TAKE SPECIAL CARE WITH ALVESC

Ապրանքի հատկությունները

SUMMARY OF PRODUCT CHARACTERISTICS
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.
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, patien