Zimbus Breezhaler

Land: Den Europæiske Union

Sprog: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv bestanddel:

Glycopyrronium bromide, Indacaterol (acetate), Mometasone furoate

Tilgængelig fra:

Novartis Europharm Limited

ATC-kode:

R03AL

INN (International Name):

indacaterol, glycopyrronium, mometasone furoate

Terapeutisk gruppe:

Drugs for obstructive airway diseases,

Terapeutisk område:

Asthma

Terapeutiske indikationer:

Maintenance treatment of asthma in adults whose disease is not adequately controlled.

Produkt oversigt:

Revision: 4

Autorisation status:

Authorised

Autorisation dato:

2020-07-03

Indlægsseddel

44
B. PACKAGE LEAFLET
45
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZIMBUS BREEZHALER 114 MICROGRAMS/46 MICROGRAMS/136 MICROGRAMS
INHALATION POWDER, HARD
CAPSULES
indacaterol/glycopyrronium/mometasone furoate
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, pharmacist or
nurse.
-
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 Zimbus Breezhaler is and what it is used for
2.
What you need to know before you use Zimbus Breezhaler
3.
How to use Zimbus Breezhaler
4.
Possible side effects
5.
How to store Zimbus Breezhaler
6.
Contents of the pack and other information
Instructions for use of Zimbus Breezhaler inhaler
1.
WHAT ZIMBUS BREEZHALER IS AND WHAT IT IS USED FOR
WHAT ZIMBUS BREEZHALER IS AND HOW IT WORKS
Zimbus Breezhaler contains three active substances:
-
indacaterol
-
glycopyrronium
-
mometasone furoate
Indacaterol and glycopyrronium belong to a group of medicines called
bronchodilators. They work in
different ways to relax the muscles of the small airways in the lungs.
This helps to open the airways
and makes it easier for air to get in and out of the lungs. When they
are taken regularly, they help the
small airways to remain open.
Mometasone furoate belongs to a group of medicines called
corticosteroids (or steroids).
Corticosteroids reduce the swelling and irritation (inflammation) in
the small airways in the lungs and
so gradually ease breathing problems. Corticosteroids also help to
prevent attacks of asthma.
WHAT ZIMBUS BREEZHALER IS USED FOR
Zimbus Breezhaler is used regularly as treatment for asthma in adults.
Asthma is a serious, long-term

Produktets egenskaber

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Zimbus Breezhaler 114 micrograms/46 micrograms/136 micrograms
inhalation powder, hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 150 mcg of indacaterol (as acetate), 63 mcg of
glycopyrronium bromide
equivalent to 50 mcg of glycopyrronium and 160 mcg of mometasone
furoate.
Each delivered dose (the dose that leaves the mouthpiece of the
inhaler) contains 114 mcg of
indacaterol (as acetate), 58 mcg of glycopyrronium bromide equivalent
to 46 mcg of glycopyrronium
and 136 mcg of mometasone furoate.
Excipient(s) with known effect
Each capsule contains 25 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, hard capsule (inhalation powder).
Capsules with green transparent cap and uncoloured transparent body
containing a white powder, with
the product code “IGM150-50-160” printed in black above two black
bars on the body and with the
product logo printed in black and surrounded by a black bar on the
cap.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Zimbus Breezhaler is indicated as a maintenance treatment of asthma in
adult patients not adequately
controlled with a maintenance combination of a long-acting beta
2
-agonist and a high dose of an
inhaled corticosteroid who experienced one or more asthma
exacerbations in the previous year.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is one capsule to be inhaled once daily.
The maximum recommended dose is 114 mcg/46 mcg/136 mcg once daily.
Treatment should be administered at the same time of the day each day.
It can be administered
irrespective of the time of the day. If a dose is missed, it should be
taken as soon as possible. Patients
should be instructed not to take more than one dose in a day.
_Special populations _
_Elderly population_
No dose adjustment is required in elderly patients (65 years of age or
older) (see section 5.2).
_Renal impairment_
No dose