CHLORITON FORTE SYRUP 4MG5ML

Country: Malaysia

Language: English

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

Active ingredient:

CHLORPHENIRAMINE MALEATE

Available from:

ZONTRON PHARMACEUTICALS SDN. BHD.

INN (International Name):

CHLORPHENIRAMINE MALEATE

Units in package:

60 ml mL; 120ml mL; 100 ml mL

Manufactured by:

TERAPUTICS SDN BHD

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
CHLORITON FORTE SYRUP
Chlorpheniramine maleate (4 mg per 5 ml)
1
WHAT IS IN THIS LEAFLET
1.
What Chloriton Forte Syrup is used
for
2.
How Chloriton Forte Syrup it works
3.
Before you use Chloriton Forte Syrup
4.
How to use Chloriton Forte Syrup
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Chloriton
Forte Syrup
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT CHLORITON FORTE SYRUP IS USED FOR
Chloriton
Forte
Syrup
is
used
to
treat
symptoms of allergies.
HOW CHLORITON FORTE SYRUP WORKS
Chloriton
Forte
Syrup
contains,
chlorpheniramine maleate, which blocks
production
of
certain
natural
substance
(histamine) that causes allergic reaction.
BEFORE YOU USE CHLORITON FORTE SYRUP
_- When you must not use it _
Do not take Chloriton Forte Syrup:

if
you
are
allergic
to
chlorpheniramine
maleate
or
any
other ingredients of this medicine
(listed in Product Description)
_Pregnancy and lactation _

Please
consult
your
doctor
or
pharmacist
if
you
are
pregnant,
planning for pregnancy or think you
may be pregnant.

Do not take Chloriton Forte Syrup if
you are breast-feeding.

You should stop nursing if you need
to take the medicine.
_- Before you start to use it _

Tell your doctor or pharmacist before
taking Chloriton Forte Syrup if:

you
have
urinary
related
problems
such
as
bladder
neck obstruction,
enlarged
prostate gland, urinary retention
etc.

you
have
glaucoma
(increased
eye pressure)

you have asthma

you have overactive thyroid

you have heart disease

you have high blood pressure

you
have
stomach
ulcer
or
intestinal obstruction

you have impaired kidney or
liver function.
Do not give to children less than 6 years
without consulting doctor or pharmacist's
advice.
_- Taking other medicines _
Tell your doctor or pharmacist if you are
taking:

alcohol

medicines
that
affects
neurological
function such as maprotiline

tricyclic
antidepressant
(for
depressio

Summary of Product characteristics

PRODUCT LITERATURE
CHLORITON FORTE SYRUP 4MG/5ML
EACH 5ML CONTAINS
Chlorpheniramine Maleate
4 mg
Preservatives:
Methyl Paraben
0.1% w/v
Propyl Paraben
0.01% w/v
PRODUCT DESCRIPTION
Red coloured clear syrup with sweet taste and fruity odour
PHARMACODYNAMICS / PHARMACOKINETICS
_MECHANISM OF ACTION/EFFECT: _
Antihistaminic
(H
1
-receptor):
Antihistamines
used
in
the
treatment of allergy act by competing with histamine for H
1
-
receptor sites on effector cells. They thereby prevent, but do not
reverse, responses mediated by histamine alone. Antihistamines
antagonize,
in
varying
degrees,
most
of
the
pharmacological
effects of histamine, including urticaria and pruritus. Also, the
anticholinergic actions of most antihistamines provide a drying
effect on the nasal mucosa.
Chlorpheniramine is readily absorbed from the GIT after oral
administration.
Protein binding
for
Chlorpheniramine
is
72%.
Onset of action is 15 - 60 minutes after oral administration while
time to peak concentration is 2 - 6 hours and time to peak effect is
6 hours after oral administration. It metabolised in the liver and
excreted as metabolites via urine within 24 hours. In children
Chlorpheniramine have been found to have shorter elimination
half-life values.
_ _
INDICATION:
Anti-histaminic therapy
RECOMMENDED DOSE:
To be taken 3 to 4 times a day
Adult
: 5ml (1 teaspoonful)
6 - 12 years
: 2.5ml (1/2 teaspoonful
Geriatric patients may be more sensitive to the effects of the usual
adult dosage. May be taken with food, water or milk to lessen
gastric irritation. Not recommended for children under 6 years of
age.
ROUTE OF ADMINISTRATION
Oral
CONTRAINDICATIONS:
_EXCEPT UNDER SPECIAL CIRCUMSTANCES, THIS MEDICATION SHOULD NOT _
_BE USED WHEN THE FOLLOWING MEDICAL PROBLEMS EXIST: _
- Hepatic and renal function impairment.
_RISK-BENEFIT SHOULD BE CONSIDERED WHEN THE FOLLOWING MEDICAL _
_PROBLEMS EXIST: _
-Bladder neck obstruction or symptomatic prostatic hypertrophy
or predisposition to urinary retention: anticholinergic effects may
precipitate or aggravate