Hosolvon DM Elixir (Sugar Free)

País: Malasia

Idioma: inglés

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

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Ficha técnica Ficha técnica (SPC)
23-02-2023

Ingredientes activos:

Bromhexine HCl; DEXTROMETHORPHAN HYDROBROMIDE

Disponible desde:

HOVID BERHAD

Designación común internacional (DCI):

Bromhexine HCl; DEXTROMETHORPHAN HYDROBROMIDE

Unidades en paquete:

120ml mL; 60ml mL; 60 mL; 120 mL

Fabricado por:

HOVID BERHAD

Información para el usuario

                                _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
HOSOLVON DM ELIXIR (SUGAR FREE)
Bromhexine Hydrochloride / Dextromethorphan Hydrobromide (4mg/15 mg)
1
WHAT IS IN THIS LEAFLET
1.
What Hosolvon DM Elixir (Sugar
Free) is used for
2.
How Hosolvon DM Elixir (Sugar
Free) works
3.
Before
you
use
Hosolvon
DM
Elixir (Sugar Free)
4.
How to use Hosolvon DM Elixir
(Sugar Free)
5.
While you are using Hosolvon DM
Elixir (Sugar Free)
6.
Side effects
7.
Storage and Disposal of Hosolvon
DM Elixir (Sugar Free)
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT
HOSOLVON
DM
ELIXIR
(SUGAR
FREE) IS USED FOR
To relief cough temporarily and reduce
mucus thickness.
HOW
HOSOLVON
DM
ELIXIR
(SUGAR
FREE) WORKS
The active ingredients in this medicine
are
bromhexine
hydrochloride
and
dextromethorphan
hydrobromide.
Bromhexine
hydrochloride
is
a
mucolytic
used
to
reduce
mucus
thickness.
Dextromethorphan
hydrobromide is a cough suppressant. It
inhibits
the
signal
in
the
brain
that
causes cough.
BEFORE YOU USE HOSOLVON DM ELIXIR
(SUGAR FREE)
-
_When you must not use it_
Do not take this medicine if:
•
you
are
allergic
to
bromhexine,
dextromethorphan
or
any
of
the
ingredients listed in the end of this
leaflet
•
you are pregnant or breastfeeding
•
your children are less than 2 years
of age
If you are not sure whether you should
start taking this medicine, talk to your
pharmacist or doctor.
_- Before you start to use it _
Tell your doctor/pharmacist if:
•
you have history of asthma
•
you have history of gastric ulcer
•
you have severe liver and kidney
problems
•
you have respiratory problem
•
your children aged between 2 to 6
are going to use it
•
you
are
pregnant,
think
you
are
pregnant or plan to get pregnant
•
you are breastfeeding or plan to
breastfeed
_- Taking other medicines _
Hosolvon DM Elixir (Sugar Free) may
affect or affected by other medicines
you are taking. Talk to your doctor or
pharmacist if you are taking any other
medicines in any form including any
that
you
buy
or
                                
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Ficha técnica

                                DESCRIPTION
Green, vanillin and peppermint flavoured liquid.
COMPOSITION
Each 5 ml contains:
Bromhexine Hydrochloride
4 mg
Dextromethorphan Hydrobromide
15 mg
_Preservatives:_
Methyl Paraben
0.12% w/v
Propyl Paraben
0.02% w/v
ACTIONS AND PHARMACOLOGY
Bromhexine
is
a
mucolytic
used
in
the
treatment
of
respiratory
disorders
associated
with
productive
cough,
where
it
changes
the
structure
of
bronchial
secretions
leading to a reduction in the viscosity of sputum.
Dextromethorphan Hydrobromide is a cough suppressant
used for the relief of non-productive cough. It has a central
action on the cough centre in the medulla. It is also an
antagonist
of
N-methyl-D-aspartate
(NMDA)
receptors.
Dextromethorphan has no classical analgesic properties and
little sedative activity.
PHARMACOKINETICS
Bromhexine is rapidly absorbed from the gastrointestinal tract
and undergoes extensive first-pass metabolism in the liver. It
is widely distributed to body tissues. About 85 to 90% of a
dose
is
excreted
in
the
urine
mainly
as
metabolites.
Bromhexine is highly bound to plasma proteins and has a
terminal elimination half-life of up to about 12 hours. It crosses
the blood-brain barrier and small amounts cross the placenta.
Dextromethorphan Hydrobromide is rapidly absorbed from
the
gastrointestinal
tract.
It
is
metabolized
in
the
liver
excreted in the urine as unchanged dextromethorphan and
demethylated
metabolites
including
dextrorphan.
It
is
reported to act within half an hour of administration by mouth
and to exert an effect for up to 6 hours.
INDICATIONS
For short term symptomatic relief of cough associated with
reduction in sputum viscosity.
CONTRAINDICATIONS
This
medication
is
contraindicated
with
patients
with
sensitivity to bromhexine and dextromethorphan or other
components of the formulation.
The presence of other medical problems may affect the use
of this medication. A doctor should be consulted before using
this medicine if any other medical problems exist, especially:
peptic ulceration, asthma, chronic bronchitis, productive
co
                                
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Información para el usuario Información para el usuario malayo 23-02-2023