Alvesco 80 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:

80microgram/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: 5060065110019

Bilgilendirme broşürü

WHAT ALVESCO CONTAINS
- The ACTIVE INGREDIENT is ciclesonide.
Each actuation (delivered dose from the
mouthpiece) contains 80 micrograms of
ciclesonide.
- The OTHER INGREDIENTS ARE Norflurane
(HFA-134a); Ethanol anhydrous.
WHAT ALVESCO LOOKS LIKE AND CONTENTS OF THE
PACK
Alvesco consists of a clear, colourless inhalation
solution contained in a pressurised aluminium
canister. The canister is contained in a plastic
inhaler which has a brown body and a
reddish-brown removable cap.
PACK SIZE: Inhaler with 120 accurately measured
PUFFS.
Each inhaler contains enough for 120 puffs.
Depending on the number of puffs per day your
physician has recommended you to use:
•
the inhaler with 120 puffs contains enough
medication for two to four months.
MANUFACTURER AND LICENCE HOLDER
Manufactured by AstraZeneca AB, Global External
Sourcing (GES), Astraallen, Gartunaporten,
SE-15185 Sodertalje, Sweden and is procured
from within the EU and repackaged by the Product
Licence Holder: Lexon (UK) Limited, Unit 18,
Oxleasow Road, East Moons Moat, Redditch,
Worcestershire, B98 0RE.
PL 15184/2430
Alvesco is a registered trademark of COVIS
PHARMA B.V.
Leaflet revision date: 18/10/21
Blind or partially sighted?
Is this leaflet hard to see
or read? Phone Lexon
(UK) Limited,
Tel: [phone] to
obtain the leaflet in a
format suitable for you
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.
•
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 called Alvesco 80 Inhaler and
will be referred to as Alvesco throughout the rest
of this leaflet. Please note that the leaflet also
contain

Ürün özellikleri

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