Fludalt DUO 25050mcg Inhalation Powder Hard Capsules

Land: Malaysia

Språk: engelsk

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

Aktiv ingrediens:

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Tilgjengelig fra:

DKSH MALAYSIA SDN BHD

INN (International Name):

FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE

Enheter i pakken:

60capsule Capsules

Produsert av:

Laboratorios Liconsa

Informasjon til brukeren

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
FLUDALT DUO
_Fluticasone / Salmeterol (250/50mcg) inhalation powder hard capsules
_
_Fluticasone / Salmeterol (500/50mcg) inhalation powder hard capsules
_
1
What is in this leaflet
1.
WHAT FLUDALT DUO IS USED
FOR
2.
HOW FLUDALT DUO WORKS
3.
BEFORE
YOU
USE
FLUDALT DUO
4.
HOW TO USE FLUDALT DUO
5.
WHILE YOU ARE USING IT
6.
SIDE EFFECTS
7.
STORAGE AND
DISPOSAL
OF FLUDALT DUO
8.
PRODUCT DESCRIPTION
9.
MANUFACTURER
AND
PRODUCT
REGISTRATION
HOLDER
10.
DATE OF REVISION
1.
WHAT FLUDALT DUO IS USED
FOR
Fludalt Duo is indicated in regular
treatment of:
-
Reversible
Obstructive
Airways
Disease
(ROAD),
including asthma
-
Chronic Obstructive
Pulmonary
Disease
(COPD),
including
chronic
bronchitis
and emphysema
2.
HOW FLUDALT DUO WORKS
Fludalt DUO contains two medicines,
fluticasone propionate and salmeterol:
•
Fluticasone
propionate
is
a
corticosteroid
which
reduces
swelling
and
irritation
in
the
lungs.
•
Salmeterol
is
a
long-acting
bronchodilator.
It
helps
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.
Fludalt
DUO
helps
to
stop
breathlessness
and
wheeziness
coming on. It does not work once
you are breathless or wheezy. If
that happens you need to use a fast
acting ‘reliever’ medication, such
as salbutamol.
3.
BEFORE
YOU
USE
FLUDALT
DUO
WHEN YOU MUST NOT USE IT
If you are allergic to fluticasone
propionate, salmeterol xinafoate or
to
the
other
ingredients
of
this
medicine (listed in section 8).
BEFORE YOU START TO USE IT
Talk to your doctor or, pharmacist
or
nurse
before
using
Fludalt
DUO.
Your doctor will supervise your
treatment more closely if you have
medical conditions such as:
•
Heart disease, including an
irregular or fast heartbeat
•
Overactive thyroid gland
•
High blood pressure
•
Diabetes
mellitus
(Fludalt
DUO
may
increase
your
blood sugar)
•
Low potassium in your blood
•
Tuberculosis (TB) now or in
the past
If you have ever had any of these
conditions, tell your docto

Preparatomtale

FRONT SIDE / PLEASE, INCLUDE YOUR DESIGN ON THIS KEYLINE
BACK SIDE / PLEASE, INCLUDE YOUR DESIGN ON THIS KEYLINE
7mm
126 mm
140 mm
7mm
540 mm
7mm
7mm
526 mm
LAETUS CENTERED WITHIN 37 MM
FINAL SIZE FOLDED
7mm
126 mm
140 mm
7mm
34 mm
34 mm
472 mm
READING DIRECTION
READING DIRECTION
LICONSA CODE
DKSH MALAYSIA SDN BHD
B-11-01, The Ascent, Paradigm, No.1, Jalan SS7/26A,
Kelana Jaya, 47301 Petaling Jaya, Selangor Darul Ehsan, Malaysia
LABORATORIOS LICONSA S.A.
Avenida Miralcampo 7, Polígono Industrial Miralcampo,
19200 Azuqueca de Henares, Guadalajara, SPAIN.
29 July 2020
DKSH MALAYSIA SDN BHD
B-11-01, The Ascent, Paradigm, No.1, Jalan SS7/26A,
Kelana Jaya, 47301 Petaling Jaya, Selangor Darul Ehsan, Malaysia
Material # / Product :
LF FLUTI-SALM 250/50MCG 500/50MCG EXELTIS MY
Date :
06.10.20
Version :
C
Substitutes mat. # :
-
****
BLACK
****
****
****
****
****
BLACK
****
****
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DIE CUT
Scale :
100 %
Dimensions :
140 x 540 ± 1 mm
Drawing:
0234
(*) Customer shall be responsible for the contents of the approved
artworks, text and colours of the printed material reflected in this
drawing. Therefore, Customer shall bear any
and all cost and/or expense, and it shall keep Laboratorios Liconsa
harmless from any claim, cost and/or expenses, related to the
correctness and accuracy of such information.
(*) PLEASE DON'T DELETE ANY
LAYERS FOR THE CORRECT REVISION
Cause:
LAUNCH
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INTERNAL CHANGE
LABORATORIOS LICONSA
MATERIAL TYPE :
LEAFLET
Pantones:
Line 1: Front Side
Line 2: Back Side
Line 3: Technical colour
Laetus :
*****
Folded:
Folded dimensions:
1 fold in horizontal to 140 x 270 mm + 3 folds in horizontal to 140 x
34 mm
NO
YES
PRINT SECURITY
MARGINS
FINAL FOLDED
Drawed by:
(Chemo Artwork Technician)
Approved by Customer :
(Regulatory Affair or Quality Assurance) / Signature & Date
With the signed proof of this file you commit to have had reviewed and
agreed with
the following points as part of your review:
- Keyline used / Free varnish areas / Colors / Text.
- Prefixes order for variable info (If the or