Atectura Breezhaler (Indacaterol Acetate/Mometasone Furoate) 150/80mcg Inhalation Powder Hard Capsules

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

MOMETASONE FUROATE; Indacaterol Acetate

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

MOMETASONE FUROATE; Indacaterol Acetate

Unit dalam pakej:

10 Capsules and 1 Inhaler Units; 30 Capsules and 1 Inhaler Units

Dikeluarkan oleh:

NOVARTIS PHARMA STEIN AG

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
ATECTURA
® BREEZHALER
® INHALATION POWDER HARD CAPSULES
Indacaterol Acetate and Mometasone Furoate (150/80, 150/160 and
150/320 micrograms)
_________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1. What Atectura Breezhaler is used
for
2. How Atectura Breezhaler works
3. Before you use Atectura
Breezhaler
4. How to use Atectura Breezhaler
5. While you are using it
6. Side effects
7. Storage and Disposal of Atectura
Breezhaler
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of Revision
11. Instructions for use of Atectura
Breezhaler Inhaler.
WHAT ATECTURA BREEZHALER IS USED
FOR
Atectura Breezhaler is used regularly
as treatment for asthma in adults and
adolescents (12 years of age and
older).
Asthma is a serious, long-term lung
disease where the muscles
surrounding 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 Atectura 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
Atectura Breezhaler works or why
this medicine has been prescribed for
you, ask your doctor.
HOW ATECTURA BREEZHALER WORKS
Atectura 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
sma

Ciri produk

Novartis
Page 2
Malaysia Package Leaflet
05-Mar-2020 Corr.10-Jun-2020
Atectura Breezhaler
_ _
_ _
1.
NAME OF THE MEDICINAL PRODUCT
Atectura Breezhaler 150 micrograms/80 micrograms inhalation powder,
hard capsules
Atectura Breezhaler 150 micrograms/160 micrograms inhalation powder,
hard capsules
Atectura Breezhaler 150 micrograms/320 micrograms inhalation powder,
hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Atectura Breezhaler 150 micrograms/80 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.
Atectura Breezhaler 150 micrograms/160 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.
Atectura Breezhaler 150 micrograms/320 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).
Atectura Breezhaler 150 micrograms/80 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.
Novartis
Page 3
Malaysia Package Leaflet
05-Mar-2020 Corr.10-Jun-2020
Atectura Breezhaler
_ _
_ _
At