BENATUSSIL PAEDIATRIC EXPECTORANT

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DIPHENHYDRAMINE HYDROCHLORIDE; AMMONIUM CHLORIDE

Boleh didapati daripada:

Noripharma Sdn. Bhd.

INN (Nama Antarabangsa):

DIPHENHYDRAMINE HYDROCHLORIDE; AMMONIUM CHLORIDE

Unit dalam pakej:

60 ml; 90 ml; 90 ml; 100 ml; 120 ml; 60 ml; 100 ml; 120 ml

Dikeluarkan oleh:

Noripharma Sdn. Bhd.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
BENATUSSIL PAEDIATRIC EXPECTORANT
Diphenhydramine HCl /Ammonium Chloride 7mg/67.5mg per 5ml
WHAT IS IN THIS LEAFLET?
1.
What
Benatussil
Pediatric
Expectorant is used for.
2.
How
Benatussil
Pediatric
Expectorant works.
3.
Before use
Benatussil Pediatric
Expectorant
4.
How to use Benatussil Pediatric
Expectorant
5.
While you are using it.
6.
Side effects.
7.
Storage
and
disposal
of
Benatussil Pediatric Expectorant
8.
Product Description.
9.
Manufacturer
and
Product
Registration Holder.
10.
Date of revision.
WHAT
BENATUSSIL
PEDIATRIC
EXPECTORANT IS USED FOR
It is used as an expectorant for control
of cough due to cold or allergy.
HOW BENATUSSIL PEDIATRIC
EXPECTORANT WORKS
Diphenhydramine hydrochloride is an
antihistamine that suppresses the urge
to cough and dries up secretions in the
nose and chest. Ammonium chloride
is
an
expectorant
that
helps
loosen
phlegm.
BEFORE YOU USE BENATUSSIL PEDIATRIC
EXPECTORANT
_-_
_ _
_When you must not use it_
Do
not
use
Benatussil
Paediatric
Expectorant if your child is allergic to
Diphenhydramine
Hydrochloride
or
Ammonium
Chloride
or
any
of
the
other ingredients listed at the end of
the leaflet.
Do
not
use
Benatussil
Paediatric
Expectorant
if
your
child
is
taking
monoamine
oxidase
inhibitors
(MAOI) (a treatment for depression).
_-_
_ _
_Before you start to use it _
Before taking Benatussil Paediatric
Expectorant you must tell your doctor
or pharmacist if your child have, or
have had, any of the medical
conditions.
If you are not sure if your child have,
or have had, any of these conditions,
you
should
raise
those
concerns
with
your
doctor or
pha
r
m
aci
st
.
_Taking other medicines _
Inform your doctor or pharmacist
before taking Benatussil Pediatric
Expectorant.
Before using Benatussil Pediatric
Expectorant, it is important to tell
your doctor or pharmacist if your
child is taking any other medicines,
obtained with or without a doctor’s
prescription.
Benatussil Pediatric Expectorant may
enhance alcohol and medicines used to
help

Ciri produk

BENATUSSIL PAEDIATRIC EXPECTORANT
COMPOSITION
Each 5ml syrup contains :
Diphenhydramine HCL 7.0mg
Ammonium Chloride 67.5mg
Methylparaben (as preservative) 9.0mg
Propylparaben (as preservative) 0.1mg
PRODUCT DESCRIPTION
A clear, red liquid having raspberry flavour.
PHARMACODYNAMICS
The combination of Diphenhydramine Hydrochloride, an antihistamine and
Ammonium Chloride, an
expectorant, will provide rapid relief for cough which is associated
with common cold influenza or
allergic conditions.
PHARMACOKINETICS
Diphenhydramine hydrochloride is well absorbed from the
gastro-intestinal tract, though high first-
pass metabolism appears to affect systematic availability. Peak plasma
concentrations are achieved
about 1 to 4 hours after administration by mouth. A mean peak
plasma-diphenhydramine
concentration of 110 ng per mL has been reported after administration
of 50 mg four times daily by
mouth. Diphenhydramine is widely distributed throughout the body
including the CNS. It crosses the
placenta and has been detected in breast milk. Diphenhydramine is
highly bound to plasma proteins.
Metabolism is extensive. Diphenhydramine is excreted mainly in the
urine as metabolites; little is
excreted as unchanged drug. Excretion is almost complete within 24
hours of administration.
Ammonium chloride is absorbed from the gastro-intestinal tract. The
ammonium ion is converted
into urea in the liver; the anion thus liberated into the blood stream
and extracellular fluid causes a
metabolic acidosis and decreases the pH of the urine; this is followed
transient diuresis.
INDICATION
It is indicated as an expectorant for control of coughs due to colds
or allergy.
RECOMMENDED DOSAGE
Unless otherwise prescribed by the physician:
To be taken 4-6 hourly.
Children 2-5 years : 5ml, not to exceed 40 ml in 24 hours.
Children 6-12 years : 5-10 ml, not to exceed 60 ml in 24 hours.
Children above 12 years : 10 - 20 ml, not to exceed 120 ml in 24
hours.
ROUTE OF ADMINISTRATION
Oral administration
CONTRAINDICATIONS
Hypersensitivity to antihistamines or