TULLYX ELIXIR

Maa: Malesia

Kieli: englanti

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

Aktiivinen ainesosa:

Dextromethorphan Hydrobromide Monohydrate; Bromhexine HCl

Saatavilla:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

INN (Kansainvälinen yleisnimi):

Dextromethorphan Hydrobromide Monohydrate; Bromhexine HCl

Kpl paketissa:

60 ml; 90 ml; 120 ml

Valmistaja:

XEPA-SOUL PATTINSON (MALAYSIA) SDN BHD

Pakkausseloste

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
WHAT IS IN THIS LEAFLET
1.
What
_Tullyx_
is used for
2.
How
_Tullyx_
works
3.
Before you use
_Tullyx_
4.
How to use
_Tullyx_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Tullyx_
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _TULLYX_ IS USED FOR
_Tullyx_
helps
to
relieve
resistant
dry
cough and promote mucus clearance.
HOW _TULLYX_ WORKS
Dextromethorphan
is
a
cough
suppressant
and
Bromhexine
is
a
mucolytic
that
alters
the
structure
of
mucus to decrease its viscosity thereby
facilitating
mucus
removal
by
ciliary
action or expectoration.
BEFORE YOU USE _TULLYX_
_- When you must not to use it _
Do not use
_Tullyx_
if you are known
hypersensitivity to any ingredients in
this medicine.
_ _
_Pregnancy and lactation _
•
Do not take
_Tullyx_
if you are pregnant,
trying to get pregnant or think you
may be pregnant.
•
Do not take
_Tullyx _
if you are breast-
feeding.
Ask
your
doctor
or
pharmacist
for
advice
before
taking
any medicine.
_ _
_- Before you start to use it _
Tell your doctor or 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 _
_Tullyx_
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 obtained
without a prescription.
They include:
•
central
nervous
system
(CNS)
depressants
(to
treat
anxiety
and
sleep disorders)
•
monoamine
oxidase
(MAO)
inhibitors
including
furazolidone,
phenelzine,
procarbazine,
selegiline and tranylcypromine (to
ease depression)
•
other
enzyme
inhibitors
like
amiodarone
or
fluoxetine
or
quinidine
(to
maintain
regular
heartbeat

Valmisteyhteenveto

Important information. Please read carefully.
_TULLYX _
ELIXIR
COMPOSITION
Each 5ml
contains Dextromethorphan Hydrobromide Monohydrate 15mg and Bromhexine
Hydrochloride 4mg.
Methyl Hydroxybenzoate 0.08% w/v and Propyl Hydroxybenzoate 0.03% w/v
as preservatives.
PHARMACODYNAMICS
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
Tullyx helps for short term symptomatic relief of cough associated
with reduction in sputum
viscosity.
DOSAGE AND ADMINISTRATION
For oral use only.
Adult and children over 12 years:
10 ml (2 teaspoons), 3 times daily.
Children 6 to 12 years:
5 ml (1 teaspoon), 3 times daily.
Children 2 to 6 years:
A doctor’s direction is recommended as young children have a greater
chance of experiencing
serious adverse effects.
The recommended dosage should not exceed 3ml