Seroflo 50 100 Ciphaler

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE

Boleh didapati daripada:

CIPLA MALAYSIA SDN BHD

INN (Nama Antarabangsa):

SALMETEROL XINAFOATE; FLUTICASONE PROPIONATE

Unit dalam pakej:

60 ACTUATIONS

Dikeluarkan oleh:

Cipla Limited

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
SEROFLO CIPHALER
SALMETEROL / FLUTICASONE PROPIONATE (50/100, 50/250 MICROGRAMS)
____________________________________________________________________________________
Page | 1
WHAT IS IN THIS LEAFLET
1.
What SEROFLO is used for
2.
How SEROFLO works
3.
Before you use SEROFLO
4.
How to use SEROFLO
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of SEROFLO
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT SEROFLO IS USED FOR
The doctor has prescribed this medicine to
help with breathing problems in patients
who need regular treatment.
Asthma
is
a
long-term
condition
affecting the lungs.
Symptoms
of asthma
include
shortness
of
breath,
wheezing,
chest
tightness
and
cough.
Two
main
causes
of
asthma
symptoms
are
bronchoconstriction
(tightening
of
the
muscle
surrounding
the
airways)
and
inflammation
(swelling and irritation of
the airways).
Chronic obstructive pulmonary disease
(COPD) is a long-term, progressively
worsening condition affecting the lungs,
results
from
chronic
bronchitis
or
emphysema (linings of the air sacs in the
lungs damaged beyond repair).
HOW SEROFLO WORKS
SEROFLO
contains
two
medicines,
salmeterol and fluticasone propionate:
•
Salmeterol
is
a
long-acting
bronchodilator.
Bronchodilators
help
the airways in the lungs to stay open.
This makes it easier for air to get in and
out. The effects last for at least 12 hours
•
Fluticasone
propionate
is
a
corticosteroid which reduces swelling
and irritation in the lungs.
SEROFLO helps to stop breathlessness
and wheeziness coming on.
BEFORE YOU USE SEROFLO
_ _
_-When you must not use it _
Do not use SEROFLO to relieve a sudden
attack of breathlessness or wheezing. If
this happens you need to use a fast-acting
‘reliever’
(‘rescue’)
inhaler,
such
as
salbutamol. You should always have your
fast acting ‘rescue’ inhaler with you.
_ _
Do not take SEFOFLO: If you are allergic
to salmeterol, fluticasone propionate or to
the
other
ingredient,

Ciri produk

_For the use of a Registered Medical Practitioner or a Hospital or a
Laboratory only OR for _
_Specialist Use only _
SEROFLO 50 / 100 CIPHALER
Salmeterol/Fluticasone Propionate 50 Microgram / 100 Microgram / Dose
Inhalation Powder,
Pre-Dispensed BP
SEROFLO 50 / 250 CIPHALER
Salmeterol/Fluticasone Propionate 50 Microgram / 250 Microgram / Dose
Inhalation Powder,
Pre-Dispensed BP
COMPOSITION
_ _
SEROFLO 50 / 100 CIPHALER
Each single inhalation provides a deliver:
Dose (the dose leaving the mouthpiece) of 47 micrograms of salmeterol
(as salmeterol Xinafoate
BP/Ph. Eur) and 92 micrograms fluticasone propionate BP/Ph. Eur.
This
corresponds
to
a
pre-dispensed
dose
of
50
micrograms
of
salmeterol
(as
salmeterol
Xinafoate BP/Ph. Eur) and 100 micrograms fluticasone propionate BP/Ph.
Eur.
Also, contains: Lactose Monohydrate.
SEROFLO 50 / 250 CIPHALER
Each single inhalation provides a deliver:
Dose (the dose leaving the mouthpiece) of 47 micrograms of salmeterol
(as salmeterol Xinafoate
BP/Ph. Eur) and 231 micrograms fluticasone propionate BP/Ph. Eur.
This
corresponds
to
a
pre-dispensed
dose
of
50
micrograms
of
salmeterol
(as
salmeterol
Xinafoate BP/Ph. Eur) and 250 micrograms fluticasone propionate BP/Ph.
Eur.
Also, contains: Lactose Monohydrate.
DOSAGE FORM
Pre dispensed inhalation powder
PRODUCT DESCRIPTION
BULK FINISHED STAGE
Salmeterol/Fluticasone Propionate Inhalation powder, pre-dispensed BP,
is a white to off white
powder filled in a strip of 60 blisters
.
PACK FINISHED STAGE
Device Description
Each carton contains a multi-dose device packaged in a moisture
protective foil pouch
.
Multidose device with numeric dose counter displayed on the top of the
device containing blister
strip inside.
PHARMACOLOGY
_PHARMACODYNAMICS _
Pharmacotherapeutic Group: Adrenergics in combination with
corticosteroids or other drugs,
excl. Anticholinergics.
ATC Code: R03AK06
Mechanism of action and pharmacodynamic effects:
Salmeterol and Fluticasone inhalationdry powder contains salmeterol
and fluticasone propionate
which have differing mo