Ultibro Breezhaler 110/50mcg Inhalation Powder Hard Capsule

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

GLYCOPYRRONIUM BROMIDE; Indacaterol maleate

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

GLYCOPYRRONIUM BROMIDE; Indacaterol maleate

Unit dalam pakej:

30 capsules & 1 inhaler units Capsules

Dikeluarkan oleh:

NOVARTIS FARMACEUTICA S.A.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
ULTIBRO
® BREEZHALER
®
INHALATION POWDER
HARD CAPSULES
Indacaterol Maleate and Glycopyrronium Bromide (110/50 microgram)
1
WHAT IS IN THIS LEAFLET
1.
WHAT ULTIBRO BREEZHALER IS USED
FOR
2.
HOW ULTIBRO BREEZHALER WORKS
3.
BEFORE YOU USE ULTIBRO
BREEZHALER
4.
HOW TO USE ULTIBRO BREEZHALER
5.
WHILE YOU ARE USING IT
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL OF ULTIBRO
BREEZHALER
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER AND PRODUCT
REGISTRATION HOLDER
10.
DATE OF REVISION
11.
SERIAL NUMBER
12.
INSTRUCTIONS FOR USE OF ULTIBRO
BREEZHALER INHALER
WHAT ULTIBRO BREEZHALER IS USED FOR
This medicine contains two active
substances called indacaterol and
glycopyrronium. These belong to a
group of medicines called
bronchodilators.
This medicine is used to make breathing
easier for adult patients who have
breathing difficulties due to a lung
disease called chronic obstructive
pulmonary disease (COPD). In COPD
the muscles around the airways tighten.
This makes breathing difficult. This
medicine blocks the tightening of these
muscles in the lungs, making it easier
for air to get in and out of the lungs.
If you use this medicine once a day, it
will help to reduce the effects of COPD
on your everyday life.
HOW ULTIBRO BREEZHALER WORKS
In COPD the muscles around the
airways tighten, making breathing
difficult. Ultibro breezhaler blocks
tightening of these muscles in the lungs
and also relaxes the muscles in the walls
of the small air passages in the lungs.
This helps open up the airways, making
it easier for air to get in and out.
If you have any questions about how
Ultibro Breezhaler works or why this
medicine has been prescribed for you,
ask your doctor.
BEFORE YOU USE ULTIBRO BREEZHALER
Follow all the doctor’s instructions
carefully. They may differ from the
general information contained in this
leaflet.
_When you must not use it _
Do not use Ultibro Breezhaler
•
If you are allergic to indacaterol or
glycopyrronium, or any of the other
ingredients of this medicine (listed
in sec

Ciri produk

Novartis
Page 2
Malaysia Package Leaflet
23 Jun 2020
Ultibro Breezhaler
2
1.
NAME OF THE MEDICINAL PRODUCT
Ultibro Breezhaler 110/50mcg Inhalation Powder Hard Capsule
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 143 micrograms of indacaterol maleate equivalent
to 110 micrograms of
indacaterol and 63 micrograms of glycopyrronium bromide equivalent to
50 micrograms of
glycopyrronium.
Each delivered dose (the dose that leaves the mouthpiece of the
inhaler) contains 110 micrograms of
indacaterol maleate equivalent to 85 micrograms of indacaterol and 54
micrograms of glycopyrronium
bromide equivalent to 43 micrograms of glycopyrronium.
Excipient(s) with known effect
Each capsule contains 23.5 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Inhalation powder, hard capsule (inhalation powder).
Capsules with transparent yellow cap and natural transparent body
containing a white to almost white
powder, with the product code “IGP110.50” printed in blue under
two blue bars on the body and the
company logo (
) printed in black on the cap.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ultibro Breezhaler is indicated as a once-daily maintenance
bronchodilator treatment to relieve
symptoms and reduce exacerbations in adult patients with chronic
obstructive pulmonary disease
(COPD).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose is the inhalation of the content of one capsule
once daily using the Ultibro
Breezhaler inhaler.
Ultibro Breezhaler is recommended to be administered at the same time
of the day each day. If a dose
is missed, it should be taken as soon as possible on the same day.
Patients should be instructed not to
take more than one dose in a day.
Special populations
_Elderly population _
Ultibro Breezhaler can be used at the recommended dose in elderly
patients (75 years of age and
older).
Novartis
Page 3
Malaysia Package Leaflet
23 Jun 2020
Ultibro Breezhaler
3
_Renal impairment _
Ultibro Breezhaler can be u