REXOM UNIZET SYRUP

Country: Malaysia

Language: English

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

Active ingredient:

DIPHENHYDRAMINE HYDROCHLORIDE; Bromhexine HCl; AMMONIUM CHLORIDE

Available from:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (International Name):

DIPHENHYDRAMINE HYDROCHLORIDE; Bromhexine HCl; AMMONIUM CHLORIDE

Units in package:

100 ml

Manufactured by:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
REXOM UNIZET SYRUP
Diphenhydramine Hydrochloride/Bromhexine Hydrochloride/Ammonium
Chloride (8mg/4mg/100mg per 5ml)
1
WHAT IS IN THIS LEAFLET
1.
What REXOM UNIZET is used for
2.
How REXOM UNIZET works
3.
Before you use REXOM UNIZET
4.
How to use REXOM UNIZET
5.
While
you
are
using
REXOM
UNIZET
6.
Side effects
7.
Storage
and
disposal
of
REXOM
UNIZET
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT REXOM UNIZET IS USED FOR
For productive cough and alleviation of
nasal stuffiness, sneezing, lachrymation
(flow of tears), mucolytic (to dissolve
thick
mucus
and
relieve
respiratory
difficulties) and bronchial congestion.
HOW REXOM UNIZET WORKS
Diphenhydramine
is
an
antihistamine
used
to
treat
sneezing,
runny
nose,
itching and other symptoms of allergies
and the common cold.
Bromhexine is a mucolytic agent which
works
by
thinning
the
mucus
in
the
airways,
thus
making
the
mucus
less
sticky and it facilitates the removal of the
mucus.
Ammonium
chloride
used
as
reflux
expectorant.
BEFORE YOU USE REXOM UNIZET
_- When you must not use it _
Do not use it when you have:

Hypersensitivity
to
any
of
the
ingredients.

Individual
on
monoamine
oxidase
inhibitor therapy within 14 days.

Diphenhydramine should not be given
to premature infants and neonates, they
have
increased
susceptibility
to
antimuscarinic effect (eg: dry mouth,
blurred vision, discomfort to the eyes,
heart
rhythm
disorder,
difficulty
in
urination, elevated body temperature
and eye disease that may cause vision
loss).

Children below 2 years old.
Pregnancy and lactation

It is recommended that Rexom Unizet
Syrup should not be used during
pregnancy particularly as the safety of
Rexom
Unizet
Syrup
in
human
pregnancy is not established.

It is recommended REXOM UNIZET
SYRUP
should
not
be
used
during
lactation particularly as the safety of
REXOM
UNIZET
SYRUP
during
lactation is not established.
_-Before you start to use it_
When used for treatment of cou

Summary of Product characteristics

REXOM UNIZET SYRUP
NAME AND STRENGTH OF ACTIVE INGREDIENT(S)
Each 5 ml contains:
Diphenhydramine Hydrochloride …………………………….. 8 mg
Bromhexine Hydrochloride
………………………..……….. 4 mg
Ammonium Chloride ………………………………………….
100 mg
Preservative:
Sodium Benzoate
………………………………........................ 5 mg
PRODUCT DESCRIPTION
Red colour liquid with orange flavor.
PHARMACODYNAMICS
Diphenhydramine, an ethanolamine derivative is an antihistamine with
antimuscarinic and
pronounced central sedative properties.
Bromhexine is a mucolytic agent used in the treatment of respiratory
disorders associated
with viscid or excessive mucus.
Ammonium chloride used as reflux expectorant.
PHARMACOKINETICS
Diphenhydramine Hydrochloride is well absorbed from the
gastrointestinal tract, although
high first pass metabolism appears to affect systemic availability.
Peak plasma concentrations
are achieved about 1 to 4 hours after administration by mouth.
Diphenhydramine is widely
distributed throughout the body including the CNS. It crosses the
placenta and has been
detected in breast milk. It is highly bound to plasma protein.
Bromohexine Hydrochloride is rapidly absorbed from the
gastrointestinal tract and about 85
to 90% of the dose is excreted in the urine mainly as metabolites.
Bromhexine is highly
bound to plasma proteins.
Ammonium Chloride is absorbed from the gastrointestinal tract. The
ammonium ion is
converted into urea in the liver, the anion thus liberated into the
bloodstream and extracellular
fluid causes a metabolic acidosis.
INDICATIONS
It
is
recommended
for
productive
cough
and
alleviation
of
nasal
stuffiness,
sneezing,
lachrymation, mucolytic and bronchial congestion.
RECOMMENDED DOSE
ADULTS:
10 ml (2 teaspoonfuls) of syrup 3 times a day, not to exceed 6 tsp in
24 hours.
CHILDREN AGED 6-12 YEARS
: 5 ml (1 teaspoonful) of syrup 3 times a day. Maximum daily
dose: 15 ml syrup.
Not
to
be
used
in
children
less
than
2
years
of
age.
To
be
used