BENATUSSIL FORTE EXPECTORANT

Land: Malasía

Tungumál: enska

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

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10-05-2023

Virkt innihaldsefni:

DIPHENHYDRAMINE HYDROCHLORIDE; AMMONIUM CHLORIDE

Fáanlegur frá:

Noripharma Sdn. Bhd.

INN (Alþjóðlegt nafn):

DIPHENHYDRAMINE HYDROCHLORIDE; AMMONIUM CHLORIDE

Einingar í pakka:

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

Framleitt af:

Noripharma Sdn. Bhd.

Upplýsingar fylgiseðill

                                1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
BENATUSSIL FORTE EXPECTORANT
Diphenhydramine hydrochloride/Ammonium chloride (14mg/135mg per 5ml)
What is in this leaflet?
1.
What Benatussil Forte Expectorant
is used for
2.
How Benatussil Forte Expectorant
works
3.
Before you use Benatussil Forte
Expectorant
4.
How to use Benatussil Forte
Expectorant
5.
While you are using Benatussil Forte
Expectorant
6.
Side effects
7.
Storage and Disposal of Benatussil
Forte Expectorant
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT BENATUSSIL FORTE EXPECTORANT IS
USED FOR
It is used as an expectorant for control
of cough due to cold or allergy
HOW BENATUSSIL FORTE EXPECTORANT
WORKS
Diphenhydramine Hydrochloride is an
antihistamine that works by blocking a
certain
natural
substance
(histamine)
that your body makes during an allergic
reaction. Its drying effects are caused
by blocking another natural substance
made
by
your
body
(acetylcholine).
Ammonium Chloride is an expectorant
that
helps
to
liquefy
and
loosen
stubborn phlegm in airways.
BEFORE YOU USE BENATUSSIL FORTE
EXPECTORANT
_When you must not take it _
Do not take Benatussil Forte
Expectorant
• are allergic to any ingredients in this
medicine.
• not to be used in children less than 2
years of age.
• to be used with caution and on
doctor’s or pharmacist’s advice in
children 2 to 6 years of age.
_Before you start to take it _
Tell your doctor or pharmacist before
using Benatussil Forte Expectorant if
you:
• are pregnant or plan to get pregnant.
• are breast-feeding or plan to start
breast-feeding.
• have liver and/or kidney problems
_ _
_Taking other medicines _
Tell your doctor or pharmacist if you
are taking alcohol, tranquilizers,
sedativehypnotics and CNS
depressant which will increase CNS
depression and MAO inhibitors which
will increase anticholinergic effects.
This includes any medicines which
you have bought without a
prescription.
HOW TO USE BENATUSSIL FORTE
EXPECTORANT
- _How much to use_
Adul
                                
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                                BENATUSSIL FORTE EXPECTORANT
COMPOSITION
Each 5ml syrup contains:
Diphenhydramine HCL
14.0mg
Ammonium Chloride
135.0mg
Methylparaben (as preservative)
10.0mg
PRODUCT DESCRIPTION
A brown colour 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
gastrointestinal
tract.
Peak
plasma
concentrations are achieved about 1 to 4 hours after oral doses.
Diphenhydramine is widely distributed
throughout
the
body
including
the
CNS.
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. The elimination half-life has been
reported to range from 2.4 to 9.3 hours.
Ammonium chloride is absorbed from the gastrointestinal tract.
The ammonium ion is converted into urea in the liver, the anion thus
liberated into the blood and
extracellular fluid causes a metabolic acidosis and decreases the pH
of the urine; this is followed by
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
Adults and children over 12 years: 5 to 10 ml every 4 or 6 hours (not
to exceed 60 ml in 24 hours).
Children 6 to 12 years: 2.5 to 5 ml every 4 to 6 hours (not to exceed
30 ml in 24 hours).
Children 2 to 5 years: 2.5 ml every 4 to 6 hours (not to exceed 20 ml
in 24 hours).
Do not exceed the stated dose.
ROUTE OF ADMINISTRATION
Oral administration
CONTRAINDICATIONS
Hypersensitivity to antihistamines or to any of the ingredients and
Patients who are receiving
Monoamine Oxidase Inhibitors (MAOIs) therapy.
WARNINGS AND PRECAUTIONS
Benatussil Forte Expectorant may enhance the sedative effect of
central depressants including alcohol,
barbiturat
                                
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