DEXCHLORMINE SYRUP

Land: Malaysia

Språk: engelsk

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

Aktiv ingrediens:

DEXCHLORPHENIRAMINE MALEATE

Tilgjengelig fra:

DYNAPHARM (M) SDN BHD

INN (International Name):

DEXCHLORPHENIRAMINE MALEATE

Enheter i pakken:

60 ml

Produsert av:

DYNAPHARM (M) SDN BHD

Informasjon til brukeren

DEXCHLORMINE SYRUP
Dexchlorpheniramine Maleate (2 mg/5 ml)
1
Consumer Medication Information Leaflet (RiMUP)
What is in this leaflet
1.
What DEXCHLORMINE is used
for
2.
How DEXCHLORMINE works
3.
Before you use
DEXCHLORMINE
4.
How to use DEXCHLORMINE
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
DEXCHLORMINE
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
What DEXCHLORMINE is used
for
Indicated for the treatment of
•
Allergic rhinitis (hay fever)
•
Vasomotor (non-allergic)
rhinitis
•
Allergic conjunctivitis
(inflammation of the membrane
covering the eye)
•
Mild, uncomplicated allergic
skin manifestations of hives &
swelling under the skin.
•
Allergic reactions to blood or
plasma.
How DEXCHLORMINE works
Dexchlorpheniramine Maleate is an
antihistamine. It works by blocking
a certain natural substance
(histamine) that your body makes
during an allergic reaction. The
antimuscarinic action provides a
drying effect on the nasal lining.
Before you use
DEXCHLORMINE
-
When you must not use it
•
In new-born or premature
infants because of the
possibility of severe reactions
such as convulsions.
•
Together with MAOI
(monoamine oxidase
inhibitor) therapy.
•
To treat lower respiratory
tract symptoms.
•
Hypersensitivity to the
Dexchlorpheniramine
Maleate or other ingredients
in this product.
Pregnancy and lactation
It should not be used in the third
trimester of pregnancy. Use in
pregnancy has not been established.
It is not known whether
Dexchlorpheniramine is found in
human milk, therefore caution
should be exercised when used by
nursing mothers.
Ask your doctor or pharmacist for
advice before taking any medicine.
-
Before you start to use it
You should abstain from alcohol.
-
Taking other medicines
Tell your doctor if you are taking
any other medicines, including any
that you buy without a prescription
from a pharmacy, supermarket or
health food shop.
It may enhance the sedative effect of
central nervous system depressants
including barbitur

Preparatomtale

DEXCHLORMINE SYRUP
MAL19910823AZ
DESCRIPTION:
SYRUP
Colour
:
Yellow
Flavour
:
Banana
CONTENT:
Each 5 ml contains:
Dexchlorpheniramine Maleate ............... 2 mg
Preservatives: Sodium Benzoate 0.1% w/v, Methyl Paraben
0.1% w/v & Propyl Paraben 0.01% w/v.
PHARMACODYNAMICS:
Dexchlorpheniramine Maleate is an antihistamine which acts by
competing with histamine for Hi-receptor sites on effector cells.
It thereby prevents, but do not reverse responses mediated by
histamine alone. The antimuscarinic action provides a drying
effect on the nasal mucosa.
PHARMACOKINETICS:
Dexchlorpheniramine Maleate is readily absorbed after oral
administration. It is widely distributed in the body. It is
metabolised
in the liver and excreted in the urine.
INDICATION:
Indicated
for
the
treatment
of
perennial
&
seasonal
allergic
rhinitis;
vasomotor
rhinitis;
allergic
conjunctivitis;
mild,
uncomplicated allergic skin manifestations of urticaria & angioedema;
amelioration of allergic reactions to blood or plasma.
RECOMMENDED DOSE:
Adults and children above 12 years of age
:
1 teaspoonful (5 ml) every 4 - 6 hours.
Children aged 6 - 11 years
:
½ teaspoonful (2.5 ml) every 4 - 6 hours.
Children aged 2 - 5 years
:
¼ teaspoonful (1.25 ml) every 4 - 6 hours.
ROUTE OF ADMINISTRATION:
FOR ORAL USE ONLY
CONTRAINDICATION:
i.
Contraindicated in new-born or premature infants because of the
possibility of severe reactions such as convulsions.
ii.
Contraindicated for use in conjunction with MAOI (monoamine oxidase
inhibitor) therapy.
iii.
It should not be used to treat lower respiratory tract symptoms.
iv.
Hypersensitivity to the Dexchlorpheniramine Maleate.
WARNING AND PRECAUTIONS:
It may cause drowsiness and dulling of mental alertness. Patients
undergoing treatment with these drugs should not take charge
of vehicles or machinery. Patients should abstain from alcohol. It may
enhance the sedative effect of CNS depressants including
alcohol, barbiturates, hypnotics, narcotic analgesics, sedatives and
tranquillisers.
It should be used with caution in pa