COREDIN PAEDIATRIC LINCTUS

Country: Malaysia

Language: English

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

Active ingredient:

DIPHENHYDRAMINE HYDROCHLORIDE; AMMONIUM CHLORIDE; SODIUM CITRATE/TRISODIUM CITRATE

Available from:

TERAPUTICS SDN BHD

INN (International Name):

DIPHENHYDRAMINE HYDROCHLORIDE; AMMONIUM CHLORIDE; SODIUM CITRATE/TRISODIUM CITRATE

Units in package:

60 ml; 120ml mL; 60ml mL

Manufactured by:

TERAPUTICS SDN BHD

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
COREDIN PAEDIATRIC LINCTUS
Diphenhydramine Hydrochloride / Ammonium Chloride (7mg/67.5mg per 5ml)
1
WHAT IS IN THIS LEAFLET
1. What Coredin Paediatric Linctus is
used for
2. How Coredin Paediatric Linctus
works
3. Before you use Coredin Paediatric
Linctus
4. How to use Coredin Paediatric
Linctus
5. While you are using it
6. Side effects
7. Storage and Disposal of Coredin
Paediatric Linctus
8. Product Description
9. Manufacturer and Product
Registration Holder
10. Date of revision
WHAT
COREDIN
PAEDIATRIC
LINCTUS
USED FOR
Coredin Paediatric Linctus is used for
the
treatment
of
cough
and
airway
congestion due to cold and allergy.
HOW
COREDIN
PAEDIATRIC
LINCTUS
WORKS
Coredin
Paediatric
Linctus
contains
diphenhydramine
hydrochloride
and
ammonium
hydrochloride
Diphenhydramine
is
an
antitussive
which
helps
to
reduce
cough
by
blocking the action of histamine. The
medicine
also
contains
ammonium
chloride which helps to loosen phlegm
so that it is easier to be coughed out.
BEFORE
YOU
USE
COREDIN
PAEDIATRIC
LINCTUS
_- When you must not use it _
Do not take Coredin Paediatric Linctus
if you have:

hypersensitivity
to
diphenhydramine
hydrochloride,
ammonium chloride or any other
ingredients of this medicine (listed
in Product Description)
_ _
_- Before you start to use it _
Inform your doctor if you have:

urinary retention

glaucoma or other eye problems

enlarged prostate or bladder neck

hypersensitivity
to
other
antihistamines
_ _
_- Taking other medicines _
Tell your doctor or pharmacist if you
are taking:

Monoamine
oxidase
(MAOIs)
inhibitors
(antidepressant),
including
furazolidone
(treat
diarrhea) and procarbazine (to treat
certain types of Hodgkins disease)
types of cancer that begin in a type
of white blood cells that normally
fights infection.

Dimenhydrinate
(to
treat
nausea,
vomiting
and
dizziness)
or
hydroxyzine
for
(to
help
control
anxiety
and
tension
caused
by
nervous and emotional conditions).

Alcohol

medicines
that
affects
nerve

Summary of Product characteristics

PRODUCT LITERATURE
COREDIN PAEDIATRIC LINCTUS
EACH 5 ML CONTAINS
Diphenhydramine Hydrochloride
7.0 mg
Ammonium Chloride
67.5 mg
PRESERVATIVE
Methyl Paraben
0.1 %w/v
Propyl Paraben
0.01 %w/v
DESCRIPTION
Red-coloured clear syrup with sweat taste and fruity odour.
PHARMACODYNAMICS PROPERTIES
Mechanism of action:
Antihistaminic (H
1
-receptor) - Antihistamines used in 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 urticarial and
pruritus. Also, the anticholinergic of
the most antihistamines provide a drying effect on the nasal mucosa.
Antidyskinetic- The actions of diphenhydramine in parkinsonism and in
drug-induced dyskinesias
appear to be related to a central inhibition of the actions of
acetylcholine, which are mediated via
muscarinic receptors (anticholinergic action), and to its sedative
effects.
Antitussive- Diphenhydramine suppresses the cough reflex by a direct
effect on the cough center in
the medulla of the brain.
PHARMACOKINETICS PROPERTIES
Absorption:
Well absorbed after oral administration.
Protein binding:
Diphenhydramine 98-99%.
Biotransformation:
Hepatic (cytochrome P-450 system); some renal.
Half-life:
Elimination; Diphenhydramine- 1 to 4 hours
Onset of action:
Most first-generation antihistamines; 15 to 60 minutes.
Time to peak concentration:
Diphenhydramine; 1 to 4 hours
Elimination:
Most of the antihistamines studied (except cetirizine) are excreted as
metabolites within 24 hours.
INDICATION
For the treatment of cough and upper respiratory congestion due to
cold and allergy.
RECOMMENDED DOSE
TO BE TAKEN 3 OR 4 TIMES A DAY.
Children (2 - 3 Years)
: ½-1 teaspoonful (2.5 ml)
(3 - 6 Years)
: 1 teaspoonful (5 ml)
(6- 12 Years)
: 1-2 teaspoonfuls (5 ml - 10 ml)
ROUTE OF ADMINISTRATION
Oral
CONTRAINDICATIONS
_Risk-benefit should be considered when the following medical p