DEXCHLORMINE TABLET

Land: Malaysia

Språk: engelsk

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

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Preparatomtale Preparatomtale (SPC)
17-06-2023

Aktiv ingrediens:

DEXCHLORPHENIRAMINE MALEATE

Tilgjengelig fra:

DYNAPHARM (M) SDN BHD

INN (International Name):

DEXCHLORPHENIRAMINE MALEATE

Enheter i pakken:

1000 Tablets

Produsert av:

DYNAPHARM (M) SDN BHD

Informasjon til brukeren

                                DEXCHLORMINE TABLET
Dexchlorpheniramine Maleate (2mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What DEXCHLORMINE TABLET
is used for
2.
How DEXCHLORMINE TABLET
works
3.
Before you use DEXCHLORMINE
TABLET
4.
How to use DEXCHLORMINE
TABLET
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
DEXCHLORMINE TABLET
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT DEXCHLORMINE TABLET
IS USED FOR
Indicated for the treatment of

Allergic rhinitis (hay fever) such as
seasonal allergic rhinitis and
Allergic conjunctivitis
(inflammation of the membrane
covering the eye)

Skin allergic reaction such as hives

Contact dermatitis (inflammation
caused by contact with a foreign
substance)

Ectopic dermatitis or eczema (skin
becomes dry, itchy, and easily
irritated)

Persistent itch around the anus and
vulva

Medicine reactions attributable to
allergic phenomena particularly
those characterised by itch, hives
and swelling under the skin.
HOW DEXCHLORMINE TABLET
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
TABLET
-
_When you must not use it _

In new-born or premature
infants.

Individuals with acute attack of
asthma

Hypersensitivity to the
Dexchlorpheniramine Maleate.
_Pregnancy and lactation _
Safety during pregnancy has not been
established. It is not known whether
Dexchlorpheniramine is found in
human milk, and therefore caution
should be exercised when used by
nursing mothers.
It should be used with caution in
pregnant women.
Ask your doctor or pharmacist for
advice before taking any medicine.
-
_Before you start 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 prescripti
                                
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Preparatomtale

                                DEXCHLORMINE TABLET
MAL20014499AZ
DESCRIPTION:
TABLET
Colour : White
Shape : Round, Flat and Scored
EACH TABLET CONTAINS:
Dexchlorpheniramine Maleate ...................... 2 mg
PHARMACODYNAMICS:
Dexchlorpheniramine Maleate is an antihistamine that acts by competing
with histamine for H1-receptor sites on
effector cells. It thereby prevents, but does 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:
Allergic rhinitis (hay fever) i.e. seasonal allergic rhinitis &
conjunctivitis.
Allergic dermatoses (i) acute & chronic urticaria (ii) contact
dermatitis, ectopic dermatitis (iii) pruritus including
pruritus ani & pruritus vulvae.
Drug reactions attributable to allergic phenomena particularly those
characterised by itch, urticaria & angioedema.
RECOMMENDED DOSE:
Adults
:
1 mg (½ tablet) – 2 mg (1 tablet) every 4 - 6 hourly as needed
(maximum of 12 mg daily).
Children 6 – 12 years
:
1 mg (½ tablet) every 4 - 6 hourly (maximum of 6 mg daily).
CONTRAINDICATION:
Contraindicated in new-born or premature infants and patients with
acute attack of asthma.
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 should be used with care in conditions such as narrow angle
glaucoma, pregnancy, prostatic hypertrophy, urinary
retention, cardiovascular disease, increased intraocular pressure &
hyperthyroidism.
DRUG INTERACTIONS:
Avoid concomitant administration with monoamine oxidase inhibitors
(MAOI), tricyclic antidepressants, barbiturates,
other central nervous system depressants, and oral anticoagulants.
PREGNANCY AND LACTATION:
Safety during pregnancy has not been established. It is not known

                                
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