Bemrist Breezhaler

Land: Den europeiske union

Språk: engelsk

Kilde: EMA (European Medicines Agency)

Aktiv ingrediens:

indacaterol, Mometasone furoate

Tilgjengelig fra:

Novartis Europharm Limited 

ATC-kode:

R03AK

INN (International Name):

indacaterol, mometasone

Terapeutisk gruppe:

Drugs for obstructive airway diseases,

Terapeutisk område:

Asthma

Indikasjoner:

Bemrist Breezhaler is indicated as a maintenance   treatment of asthma in adults and adolescents 12 years of age and older not adequately controlled with inhaled corticosteroids and inhaled short acting beta2-agonists.

Produkt oppsummering:

Revision: 6

Autorisasjon status:

Authorised

Autorisasjon dato:

2020-05-30

Informasjon til brukeren

51
B. PACKAGE LEAFLET
52
PACKAGE LEAFLET: INFORMATION FOR THE USER
BEMRIST BREEZHALER 125 MICROGRAMS/62.5 MICROGRAMS INHALATION POWDER,
HARD CAPSULES
BEMRIST BREEZHALER 125 MICROGRAMS/127.5 MICROGRAMS INHALATION POWDER,
HARD CAPSULES
BEMRIST BREEZHALER 125 MICROGRAMS/260 MICROGRAMS INHALATION POWDER,
HARD CAPSULES
indacaterol/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 Bemrist Breezhaler is and what it is used for
2.
What you need to know before you use Bemrist Breezhaler
3.
How to use Bemrist Breezhaler
4.
Possible side effects
5.
How to store Bemrist Breezhaler
6.
Contents of the pack and other information
Instructions for use of Bemrist Breezhaler inhaler
1.
WHAT BEMRIST BREEZHALER_ _IS AND WHAT IT IS USED FOR
WHAT BEMRIST BREEZHALER_ _IS AND HOW IT WORKS
Bemrist Breezhaler
_ _
contains two active substances called indacaterol and mometasone
furoate.
Indacaterol belongs to a group of medicines called bronchodilators. It
relaxes 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 it is taken regularly, it helps 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 BEMRIST BREEZHALER IS USED FOR
Bemris

Preparatomtale

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Bemrist Breezhaler 125 micrograms/62.5 micrograms inhalation powder,
hard capsules
Bemrist Breezhaler 125 micrograms/127.5 micrograms inhalation powder,
hard capsules
Bemrist Breezhaler 125 micrograms/260 micrograms inhalation powder,
hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bemrist Breezhaler 125 micrograms/62.5 micrograms inhalation powder,
hard capsules
Each capsule contains 150 mcg of indacaterol (as acetate) and 80 mcg
of mometasone furoate.
Each delivered dose (the dose that leaves the mouthpiece of the
inhaler) contains 125 mcg of
indacaterol (as acetate) and 62.5 mcg of mometasone furoate.
Bemrist Breezhaler 125 micrograms/127.5 micrograms inhalation powder,
hard capsules
Each capsule contains 150 mcg of indacaterol (as acetate) and 160 mcg
of mometasone furoate.
Each delivered dose (the dose that leaves the mouthpiece of the
inhaler) contains 125 mcg of
indacaterol (as acetate) and 127.5 mcg of mometasone furoate.
Bemrist Breezhaler 125 micrograms/260 micrograms inhalation powder,
hard capsules
Each capsule contains 150 mcg of indacaterol (as acetate) and 320 mcg
of mometasone furoate.
Each delivered dose (the dose that leaves the mouthpiece of the
inhaler) contains 125 mcg of
indacaterol (as acetate) and 260 mcg of mometasone furoate.
Excipient(s) with known effect
Each capsule contains approximately 25 mg of lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, hard capsule (inhalation powder).
Bemrist Breezhaler 125 micrograms/62.5 micrograms inhalation powder,
hard capsules
Transparent (uncoloured) capsules containing a white powder, with the
product code “IM150-80”
printed in blue above one blue bar on the body and with the product
logo printed in blue and
surrounded by two blue bars on the cap.
Bemrist Breezhaler 125 micrograms/127.5 micrograms inhalation powder,
hard capsules
Transparent (uncoloured) capsules containing a white powder, with