Seebri Breezhaler 50mcg Inhalation Powder Hard Capsule

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

GLYCOPYRRONIUM BROMIDE

Boleh didapati daripada:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

GLYCOPYRRONIUM BROMIDE

Unit dalam pakej:

30 capsules & 1 inhalerunits Capsules; 30 capsules & 1 inhaler units Capsules

Dikeluarkan oleh:

NOVARTIS FARMACEUTICA S.A.

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP)_
SEEBRI
® BREEZHALER
® INHALATION POWDER
HARD CAPSULES
Glycopyrronium bromide (50 microgram)
1
WHAT IS IN THIS LEAFLET
1.
WHAT SEEBRI
BREEZHALER IS
USED FOR
2.
HOW SEEBRI
BREEZHALER
WORKS
3.
BEFORE YOU USE SEEBRI
BREEZHALER
4.
HOW TO USE SEEBRI
BREEZHALER
5.
WHILE USING SEEBRI
BREEZHALER
6.
SIDE EFFECTS
7.
STORAGE AND DISPOSAL OF
SEEBRI
BREEZHALER
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER AND PRODUCT
REGISTRATION HOLDER
10.
DATE OF REVISION
11.
SERIAL NUMBER
12.
INSTRUCTIONS FOR USE OF SEEBRI
BREEZHALER INHALER
WHAT SEEBRI
BREEZHALER
IS USED
FOR
This medicine contains an active
substance called glycopyrronium
bromide. This belongs 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).
HOW SEEBRI
BREEZHALER WORKS
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 Seebri Breezhaler
_ _
once a
day, it will help to reduce the
effects of COPD on your everyday
life.
BEFORE YOU USE SEEBRI BREEZHALER
_When you must not use it _
_DO NOT USE SEEBRI BREEZHALER _
If you are allergic to
glycopyrronium bromide or any of
the other ingredients of this
medicine (listed under Product
Description)
_PREGNANCY, BREAST-FEEDING AND _
_FERTILITY _
If you are pregnant or breast-
feeding, think that you may be
pregnant or are planning to have a
baby, ask your doctor or pharmacist
for advice before taking this
medicine.
There are no data from the use of
this medicine in pregnant women
and it is not known whether the
active substance of this medicine
passes into human milk.
_CHILDREN AND ADOLESCENTS _
Do not give this medicine to
children or adolescents below the
age of 18 years.
_ _
_Before you start to use it _
_WARNINGS AND PRECAUTIONS _
Talk to your
doctor before us

Ciri produk

1
Drug Regulatory Affairs
SEEBRI
 BREEZHALER

(GLYCOPYRRONIUM BROMIDE)
50 microgram Inhalation powder hard capsules
MALAYSIA PACKAGE INSERT (APR 20 - EU JAN 20)
FOR PROMOTIONAL MATERIALS PLEASE QUOTE:
PI SEEBRI RD 11 FEB 2020; APPR
Effective date:
11-Feb-2020
Safety Label Change (SLC)
Tracking number:
N/A
Document status:
Final
Novartis
Page 2
Malaysia Package Leaflet
11 Feb 2020
Seebri Breezhaler
2
1.
NAME OF THE MEDICINAL PRODUCT
Seebri Breezhaler 50 mcg Inhalation Powder Hard Capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 63 micrograms of glycopyrronium bromide
equivalent to 50 micrograms of
glycopyrronium.
Each delivered dose (the dose that leaves the mouthpiece of the
inhaler) contains 55 micrograms of
glycopyrronium bromide equivalent to 44 micrograms of glycopyrronium.
Excipient(s) with known effect:
Each capsule contains 23.6 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
_ _
3.
PHARMACEUTICAL FORM
Inhalation powder, hard capsule (inhalation powder).
Transparent orange capsules containing a white powder, with the
product code “GPL50” printed in
black above a black bar and the company logo (
) printed in black below a black bar.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Seebri Breezhaler is indicated as a
once-daily
maintenance bronchodilator treatment to relieve
symptoms 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 Seebri
Breezhaler inhaler.
Seebri Breezhaler is recommended to be administered, at the same time
of the day each day. If a dose
is missed, the next dose should be taken as soon as possible. Patients
should be instructed not to take
more than one dose in a day.
Special populations
_Elderly population _
Seebri Breezhaler can be used at the recommended dose in elderly
patients (75 years of age and older)
(see section 4.8).
_ _
_Renal impairment _
Seebri Bre