Enerzair Breezhaler (Indacaterol AcetateGlycopyrronium BromideMometasone Furoate) 1505080mcg Inhalation Powder Hard Capsules

Kraj: Malezja

Język: angielski

Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Składnik aktywny:

Mometasone furoate; Indacaterol acetate; Glycopyyronium bromide

Dostępny od:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (International Nazwa):

Mometasone furoate; Indacaterol acetate; Glycopyyronium bromide

Sztuk w opakowaniu:

30 Capsules and 1 inhaler Units

Wyprodukowano przez:

Siegfried Barbera, S.L.

Ulotka dla pacjenta

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
ENERZAIR
® BREEZHALER
® INHALATION POWDER HARD CAPSULES
Indacaterol Acetate, Glycopyrronium Bromide and Mometasone Furoate
(150/50/80 and 150/50/160
micrograms)
_________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1. What Enerzair Breezhaler is used
for
2. How Enerzair Breezhaler works
3. Before you use Enerzair
Breezhaler
4. How to use Enerzair Breezhaler
5. While you are using it
6. Side effects
7. Storage and Disposal of Enerzair
Breezhaler
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of Revision
11. Instructions for use of Enerzair
Breezhaler Inhaler.
WHAT ENERZAIR BREEZHALER IS USED
FOR
Enerzair Breezhaler is used regularly
as treatment for asthma in adults.
Asthma is a serious, long-term lung
disease where the muscles around the
smaller airways become tight
(bronchoconstriction) and inflamed.
Symptoms come and go and include
shortness of breath, wheezing, chest
tightness and cough.
You should use Enerzair Breezhaler
every day and not only when you
have breathing problems or other
symptoms of asthma. This will ensure
that it controls your asthma properly.
Do not use this medicine to relieve a
sudden attack of breathlessness or
wheezing.
If you have any questions about how
Enerzair Breezhaler works or why
this medicine has been prescribed for
you, ask your doctor.
HOW ENERZAIR BREEZHALER WORKS
Enerzair 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
an

Charakterystyka produktu

Novartis
Page 2
Malaysia Package Leaflet
11-Mar-2021
Enerzair Breezhaler
1.
NAME OF THE MEDICINAL PRODUCT
Enerzair Breezhaler 150/50/80 micrograms inhalation powder, hard
capsules
Enerzair Breezhaler 150/50/160 micrograms inhalation powder, hard
capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Enerzair Breezhaler 150/50/80 micrograms inhalation powder, hard
capsules
Enerzair Breezhaler hard capsules are for oral inhalation only. They
are also supplied with an
Enerzair Breezhaler inhalation device to permit oral inhalation of the
contents of the capsule
shell.
Each capsule contains 173 micrograms of indacaterol acetate equivalent
to 150 micrograms of
indacaterol, 63 micrograms of glycopyrronium bromide (glycopyrrolate)
equivalent to 50
micrograms glycopyrronium and 80 micrograms mometasone furoate.
The delivered dose (the dose that leaves the mouthpiece of the
inhaler) for 114/46/68 micrograms
is equivalent to 114 micrograms indacaterol, 46 micrograms
glycopyrronium, and 68 micrograms
mometasone furoate.
Enerzair Breezhaler 150/50/160 micrograms inhalation powder, hard
capsules
Enerzair Breezhaler hard capsules are for oral inhalation only. They
are also supplied with an
Enerzair Breezhaler inhalation device to permit oral inhalation of the
contents of the capsule
shell.
Each capsule contains 173 micrograms of indacaterol acetate equivalent
to 150 micrograms of
indacaterol, 63 micrograms of glycopyrronium bromide (glycopyrrolate)
equivalent to 50
micrograms glycopyrronium and 160 micrograms of mometasone furoate.
The delivered dose (the dose that leaves the mouthpiece of the
inhaler) for 114/46/136
micrograms is equivalent to 114 micrograms indacaterol, 46 micrograms
glycopyrronium and
136 micrograms 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).
Enerzair Breezhaler 150 /50/80 micrograms inhalation powder, hard
capsules
Capsules