MUCOFLUX 80mg10ml syrup

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CYCLIDROL

Boleh didapati daripada:

MYLAN HEALTHCARE SDN. BHD.

INN (Nama Antarabangsa):

CYCLIDROL

Unit dalam pakej:

60ml mL; 30ml0 mL

Dikeluarkan oleh:

LABORATORIO FARMACOLOGICO

Risalah maklumat

MUCOFLUX
® CAPSULES / SYRUP
Cyclidrol (100mg, 80mg per 10ml)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Mucoflux
®
is used for
2.
How Mucoflux
®
works
3.
Before you use Mucoflux
®
4.
How to use Mucoflux
®
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Mucoflux
®
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT MUCOFLUX
® IS USED FOR
Mucoflux
®
is used in the disorders of the
respiratory
tract
characterized
by
excessive viscous mucus.
HOW MUCOFLUX
® WORKS
Mucoflux
®
contains cyclidrol which is a
mucolytic agent that works by dissolving
the
phlegm
so
that
it
is
easier
to
be
coughed out.
BEFORE YOU USE MUCOFLUX
®
-
_When you must not use it _
Do not use Mucoflux
®
in case of:
•
known hypersensitivity to cyclidrol
or
any
other
ingredients
of
this
medicine
(listed
in
Product
Description)
Mucoflux
®
is not for the use in children
younger than 2 years old.
-
_Before you start use it _
Tell your doctor if you have kidney
failure
as
you
may
require
doctor’s
supervision while on Mucoflux
®
.
_Pregnancy and lactation _
Please
consult
your
doctor
or
pharmacist
if
you
are
pregnant,
planning
for
pregnancy
or
breast-
feeding before using any medicine.
-
_Taking other medicines _
Tell your doctor if you are taking any
other medicines, including any that you
buy
without
a
prescription
from
a
pharmacy, supermarket or health food
shop.
Mucoflux®
may
be
combined
with
antibiotics, bronchodilators (medicine
that relaxes the airway), anti-asthmatic
and antituberculosis agents.
HOW TO USE MUCOFLUX
®
-
_How much to use _
Capsules:
Adults:
2 capsules twice daily
Syrup:
Adults:
10-20 ml twice daily.
Children over 2 years:
10 ml twice daily.
A measuring cup for the administration
of the recommended volume (10 ml)
of syrup is included in the package.
Follow all directions given to you by
your doctor and pharmacist carefully.
They may differ from the information
contained in this leaflet. If you do not
understand

Ciri produk

_Tipo materiale_
_Fustella/Formato_
_Codice_
_Corpo testo_
_Data impianto_
_Codice LFM_
_Tipo_
_Lingua_
_N. colori_
_1a Bozza_
_2a Bozza_
_3a Bozza_
_4a Bozza_
_5a Bozza_
_6a Bozza_
_Colori 1_
_DATA_
_DATA_
_DATA_
_DATA_
_DATA_
_DATA_
_Colori 2_
_Colori 3_
_Colori 4_
_Codice Laetus_
_Descrizione:_
Cod. 00007/8
250 X 160
25-01-2011
CIMU10P-2130
121
9
07/02/17
7CIS256E1
VENDITA
MALAYSIA
FOGLIO ILL.
MUCOFLUX
1
NERO
06-02-17
07-02-17
FRONTE
1.
TRADENAME OF THE MEDICINAL PRODUCT
MUCOFLUX
®
2.
QUALI-QUANTITATIVE COMPOSITION:
Each capsule contains:
_ _
_Active ingredient_
D,L-trans-1-methyl-4-(2-hydroxy-isopropyl)-cyclohex-1,2-en-6-ol or
Cyclidrol
(Sobrerol) 100 mg
_ _
_Excipients_
Starch, Talc, Magnesium stearate.
Hard-gelatine capsule: Gelatin, Titanium dioxide (E171), Yellow iron
oxide
(E172), Indigotin (E132)
100 ml of syrup contain:
_ _
_Active ingredient_
D,L-trans-1-methyl-4-(2-hydroxy-isopropyl)-cyclohex-1,2-en-6-ol or
Cyclidrol
(Sobrerol) 0.8 g
_ _
_Excipients_
Sucrose,
Methyl
p-hydroxybenzoate,
Propyl
p-hydroxybenzoate,
Monobasic
sodium
phospate,
Glicerine,
Caramel
(E150),
Cardamon
aroma,
Saccharin,
Sodium hydroxide, Ethyl alcohol, Purified water.
3.
PHARMACEUTICAL FORMS:
Capsules, syrup.
4.
DESCRIPTION:
Capsules: hard-gelatine, snap-fit light green opaque/white opaque
capsules (size
n°4), containing a white homogeneous, free-flowing powder.
Syrup:
clear
solution,
free
of
solid
matters,
with
a
yellow-brown
colour,
characteristic smell and sweet taste.
80 MG/10 ML SYRUP
100 MG CAPSULES
(Cyclidrol)
BRONCHIAL CLEANSER
MUCOFLUX
7CIS256E1
CIMU10P-2130
IMPORTER and DISTRIBUTOR:
ANTAH PHARMA SDN. BHD.
3 Jalan 19/1 - Petaling Jaya,
Selangor, Malaysia
7.
PHARMACEUTICAL PARTICULARS
7.1
INCOMPATIBILITIES:
Not known.
7.2
SHELF-LIFE:
Capsules: 30 months
Syrup: 24 months
7.3
SPECIAL PRECAUTIONS FOR STORAGE:
Store below 25°C.
7.4
NATURE AND CONTENTS OF CONTAINER:
Capsules: box of 4’s (sample pack), 100’s and 500’s.
Syrup: bottle of 30 ml (sample pack) and 60 ml.
7.5
MANUFACTURER:
Capsules:
Fulton Medicinali S.p.A.,