KOTAMIN TABLET 4MG

Krajina: Malajzia

Jazyk: angličtina

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

Aktívna zložka:

CHLORPHENIRAMINE MALEATE

Dostupné z:

DUOPHARMA (M) SDN. BHD.

INN (Medzinárodný Name):

CHLORPHENIRAMINE MALEATE

Počet v balení:

100 Tablet Tablets; 1000 Tablet Tablets; 5000 Tablet Tablets

Výrobca:

DUOPHARMA (M) SDN. BHD.

Príbalový leták

_Consumer Medication Information Leaflet (RIMUP) _
KOTAMIN TABLET
Chlorpheniramine Maleate 4mg
WHAT IS IN THE LEAFLET?
1.
What
KOTAMIN
is
used
for
2.
How KOTAMIN works
3.
Before you use KOTAMIN
4.
How to use KOTAMIN
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
KOTAMIN
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT KOTAMIN IS USED FOR
KOTAMIN
is
used
to
treat
allergies.
It
relieves
the
itchiness,
redness,
swelling,
tenderness
and
irritation
associated
with
many
skin
problems.
KOTAMIN
also
relieves
the
sneezing
and
itching,
watery
eyes and nose associated with
hay fever.
Ask your doctor if you have
any questions about why this
medicine has been prescribed
for you. Your doctor may have
prescribed
this
medicine
for
another reason.
HOW KOTAMIN WORKS
The name of your medicine is
KOTAMIN.
It
contains
the
active
ingredient
chlorpheniramine
maleate
which
is
an
antihistamine.
Histamine
is
a
chemical
released into the body during
an allergic reaction. It causes
itching and inflammation.
KOTAMIN works by blocking
the
effects
of
histamine,
calming
down
the
body's
allergic reaction and starting to
relieve the symptoms.
BEFORE YOU USE KOTAMIN
_When you must not use it _
Do not take this medicine if:
• You are hypersensitive to, or
have had an allergic reaction to
chlorpheniramine or any of the
ingredients listed at the end of
this leaflet.
•
You
are
taking
a
class
of
medicine
known
as
‘monoamine
oxidase
inhibitors’
(MAOIs)
(often
taken for depression).
• The expiry date (EXP) printed
on the pack has passed.
• The packaging is torn, shows
signs of tampering or it does
not look quite right.
_Before you start to use it _
You must tell your doctor if:
•
you have a known allergy to
KOTAMIN
or
any
of
the
ingredients listed at the end
of this leaflet.
•
you are pregnant or intend to
become pregnant.
•
you
are
breast-feeding
or
plan to breast-feed.
•
you have epilepsy, glaucoma
(eye
disease
causing
optic
nerve
damage
which
can
lead
to
vision
l

Súhrn charakteristických

[DUOPHARMA (M) SDN BHD]
Page 1 of 1
[REVISION DATE: 10.08.2020]
KOTAMIN TABLET 4MG
DESCRIPTION:
A 7mm round, scored tablet, yellow colour with marking ‘duo’.
COMPOSITION:
Each tablet contains Chlorpheniramine Maleate 4mg.
PHARMACODYNAMICS:
Antihistamine. KOTAMIN is a member of the alkylamine group of
antihistamines, which are among the most active H
1
blockers. They are effective in low dosage, have a wide safety margin,
and a very low
incidence of side effects such as dizziness and drowsiness.
PHARMACOKINETICS:
Chlorpheniramine maleate is absorbed relatively slowly from the
gastro-intestinal tract, peak plasma concentrations occurring about
2.5 to 6 hours after administration by mouth.
Bioavailability is low, values of 25 to 50% having been reported.
Chlorpheniramine appears to undergo considerable first pass
metabolism. About 70% of chlorpheniramine in the circulation is bound
to
plasma proteins. Chlorpheniramine is widely distributed in the body,
including passage into the CNS.
Chlorpheniramine maleate is extensively metabolized. Metabolites
include desmethyl- and didesmethylchlorpheniramine. Unchanged drug and
metabolites are excreted primarily in the urine; excretion is
dependent on urinary pH and flow rate. Only trace amounts have been
found in the faeces. Duration of action of 4 to 6 hours has been
reported; this is shorter than may be predicted from pharmacokinetic
parameters.
More rapid and extensive absorption, faster clearance, and a shorter
half-life have been reported in children.
INDICATION:
For all conditions requiring antihistamine therapy such as hay fever,
vasomotor rhinitis, urticaria, angioneurotic oedema, food allergies,
drug and serum reactions, atopic and contact dermatitis, allergic
eczema, pruritus ani et vulvae, insect bites.
RECOMMENDED DOSAGE:
TABLET: ADULTS – One tablet, up to four times daily as required.
CHILDREN – 6 -12years: 2-4mg t.d.s or q.i.d.
ROUTE OF ADMINISTRATION: Oral
CONTRAINDICATIONS:
Hypersensitivity to chlorpheniramine.
Traditional antihistamines such as chlorp