Glenmark Airz F (Glycopyrronium 12.5mcg and Formoterol Fumarate 12mcg) Powder for Inhalation

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

GLYCOPYRRONIUM BROMIDE; FORMOTEROL FUMARATE

Boleh didapati daripada:

Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.

INN (Nama Antarabangsa):

GLYCOPYRRONIUM BROMIDE; FORMOTEROL FUMARATE

Unit dalam pakej:

3 X 10s Capsules

Dikeluarkan oleh:

Glenmark Pharmaceuticals Limited

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
GLENMARK AIRZ F
Glycopyrronium 12.5mcg and Formoterol Fumarate 12mcg Powder for
Inhalation
WHAT IS IN THIS LEAFLET
1.
What Glenmark Airz F is used for
2.
How Glenmark Airz F works
3.
Before you use Glenmark Airz F
4.
How to use Glenmark Airz F
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Glenmark Airz F
8.
Product Description
9.
Manufacturer and Product Registration Holder
10.
Date of revision
WHAT GLENMARK AIRZ F IS USED FOR
Glenmark
Airz
F
is
used
for
maintenance
treatment
of
_Chronic _
_Obstructive _
_Pulmonary _
_Disease_
(COPD). COPD is a chronic lung disease
that includes chronic bronchitis, emphysema, or
both. Glenmark Airz F is for long-term use and
should be taken 2 times each day to improve
symptoms of COPD for better breathing.
HOW GLENMARK AIRZ F WORKS
Anticholinergic
medicines
such
as
Glycopyrronium help the muscles around the
airways in your lungs stay relaxed to prevent
symptoms such as wheezing, coughing, chest
tightness, and shortness of breath.
Formoterol fumarate dihydrate makes breathing
easier
by
relaxing
muscle
spasms
in
the
air
passages of the lungs. It is also used to treat
breathing problems in patients with COPD.
BEFORE YOU USE GLENMARK AIRZ F
-
_When you must not use it _
_ _
Do not use Glenmark Airz F
•
if you are allergic (hypersensitive) to
Glycopyrronium or Formoterol Fumarate or any
of the other ingredients of this medicine.
•
to treat sudden symptoms of COPD
•
In children
Talk to your doctor if this applies to you.
-
_Before you start to use it _
_ _
Before you take Glenmark Airz F, make sure the
prescribing doctor knows
•
Have kidney problems.
•
Have eye problems such as glaucoma.
•
Have prostate or bladder problems, or problems
passing urine.
•
Have any other medical conditions.
•
suffer from any heart problems
•
have high blood pressure
•
have seizures
•
have an overactive thyroid gland
•
are diabetes
•
have an aneurysm (area where an artery is
swollen because the wall of the

Ciri produk

PANTONE
BLACK PROCESS C
SUPERSEDES
ARTWORK CODE:
PANTONE SHADE
ICONGRAPHICS CODE:
PHARMACODE:
NOTE:
“Dimensions, placement of text may
change during commercialization of
the product depending on machine
feasibility.”
SAME SIZE ARTWORK
LEAFLET SIZE : 264 mm x 640 mm
FOLDING SIZE: 66 mm x 40 mm
SPACE FOR
PHARMACODE
SPACE FOR
PHARMACODE
NAME OF THE MEDICINAL PRODUCT
Glycopyrronium 12.5mcg and Formoterol Fumarate 12mcg Powder for
Inhalation
QUALITATIVE AND QUANTITATIVE COMPOSITION
Glycopyrronium 12.5mcg and Formoterol Fumarate 12mcg Powder for
Inhalation
Each capsule contains:
Glycopyrrolate USP equivalent to
Glycopyrronium . . . . . . . . . . . . . . . 12.5 mcg
Formoterol Fumarate USP . . . . . . . . . 12 mcg
Source of Capsule: Synthetic Cellulose
PHARMACEUTICAL FORM
Powder for Inhalation (In capsule)
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Fixed Dose Combination of Glycopyrronium and Formoterol Fumarate
Powder for Inhalation is indicated as a maintenance bronchodilator
treatment to
relieve symptoms in adult patients with chronic obstructive pulmonary
disease (COPD).
Fixed Dose Combination of Glycopyrronium and Formoterol Fumarate
Powder for Inhalation is not indicated for the relief of an acute
deterioration of COPD.
POSOLOGY AND METHOD OF ADMINISTRATION
FOR ORAL INHALATION ONLY. DO NOT SWALLOW CAPSULES, AS THE INTENDED
EFFECTS ON THE LUNGS WILL NOT BE OBTAINED. CAPSULES SHOULD ONLY BE
USED WITH THE
INHALER DEVICE.
The recommended dose is the inhalation of the content of one capsule
twice daily using the inhaler.
Fixed Dose Combination of Glycopyrronium and Formoterol Fumarate
Powder for Inhalation is recommended to be administered, at the same
time of the day
each day (1 capsule in the morning and 1 capsule in the evening). More
frequent administration or a greater number of inhalations (more than
1 capsule twice-
daily) of Fixed Dose Combination of Glycopyrronium and Formoterol
Fumarate Powder for Inhalation is not recommended.
USE IN SPECIAL POPULATIONS
No dosage adjustment is required for geriatric pat