Panadol Cold+Flu-D Caplet

Country: Malaysia

Language: English

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

Active ingredient:

Paracetamol; Phenylephrine HCl; CHLORPHENIRAMINE MALEATE

Available from:

GLAXOSMITHKLINE CONSUMER HEALTHCARE SDN. BHD.

INN (International Name):

Paracetamol; Phenylephrine HCl; CHLORPHENIRAMINE MALEATE

Units in package:

12 Tablets

Manufactured by:

GLAXOSMITHKLINE AUSTRALIA PTY LTD

Patient Information leaflet

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
PANADOL COLD+FLU-D
CAPLET
Paracetamol/Phenylephrine Hydrochloride/Chlorpheniramine maleate
(500mg/5mg/2mg)
1
WHAT IS IN THIS LEAFLET
1.
What Panadol Cold+Flu-D
Caplet is used for
2.
How Panadol Cold+Flu-D
Caplet works
3.
Before you use Panadol
Cold+Flu-D Caplet
4.
How to use Panadol
Cold+Flu-D Caplet
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Panadol Cold+Flu-D
Caplet
8.
Product Description
9.
Manufacturer & Product
Registration Holder
10.
Date of revision
WHAT PANADOL COLD+FLU-D
CAPLET IS USED FOR
Effective relief of runny nose,
sneezing, sinus congestion and
pain, itching and watery eyes.
HOW PANADOL
COLD+FLU-D CAPLET
WORKS
Paracetamol in Panadol
Cold+Flu-D Caplet works to
stop the pain message from
getting through the brain.
Paracetamol also works in the
brain to reduce fever.
Phenylephrine hydrochloride in
Panadol Cold+Flu-D Caplet is
a decongestant which unblocks
your nose and sinuses helping
you breathe more easily.
Chlorphenamine maleate in
Panadol Cold+Flu-D is an
antihistamine which can help to
relieve the symptoms of
allergies.
BEFORE YOU USE PANADOL
COLD+FLU-D CAPLET
_- When you must not use it _
Do not use if you are:
•
allergic to paracetamol,
phenylephrine,
chlorpheniramine, other
antihistamines or any of
the other ingredients in the
product
•
taking or have taken in the
past two weeks drugs
called monoamine oxidase
inhibitors (MAOI’s)
•
taking other medicines for
the relief of colds and flu,
congestion or blocked
nose, stimulant drugs
called amphetamines
(sometimes used to treat
attention deficit disorders),
or appetite suppressants, or
other medicines containing
antihistamines (sometimes
used to treat allergy)
Do not take Panadol Cold+Flu-
D Caplet if you are pregnant,
trying to get pregnant or think
you may be pregnant.
Ask your doctor or pharmacist
for advice before taking any
medicine.
_- Before you start to use it _
Check with your doctor before
use if:
•
you have liver or kidney
problems.
•
are underweigh

Summary of Product characteristics

984630
AAAW-900
FRONT
PHARMA CODE REF. NO. 1266
PRODUCT DESCRIPTION
Green capsule shaped caplet with flat edges 17.7mm x 7.1mm. One face
embossed with “
”
within an oval.
PHARMACOLOGICAL PROPERTIES
_PHARMACODYNAMICS_
This is a combination of an analgesic (paracetamol), a nasal
decongestant (phenylephrine
hydrochloride) and an antihistamine (chlorpheniramine maleate) for the
treatment of symptoms
of colds and influenza.
PARACETAMOL is an analgesic and antipyretic. Its mechanism of action
is believed to include
inhibition of prostaglandin synthesis, primarily within the central
nervous system.
PHENYLEPHRINE HYDROCHLORIDE is a sympathomimetic agent with mainly
direct effects on
adrenergic receptors (predominantly alpha-adrenergic activity)
producing nasal decongestion.
CHLORPHENAMINE MALEATE is a potent antihistamine (H1-antagonist).
Antihistamines diminish
or abolish the actions of histamine in the body by competitive
reversible blockade of histamine
H1-receptor sites on tissues. Chlorpheniramine also has
anticholinergic activity.
_PHARMACODYNAMIC EFFECTS_
PARACETAMOL: The lack of peripheral prostaglandin inhibition confers
important pharmacological
properties such as the maintenance of the protective prostaglandins
within the gastrointestinal
tract. Paracetamol is, therefore, particularly suitable for patients
with a history of disease or on
concomitant medication, where peripheral prostaglandin inhibition
would be undesirable (such
as, for example, those with a history of gastrointestinal bleeding or
the elderly)
PHENYLEPHRINE HYDROCHLORIDE: Phenylephrine hydrochloride is a
sympathomimetic agent
with mainly direct effects on adrenergic receptors (predominantly
alpha-adrenergic activity)
producing nasal decongestion.
CHLORPHENIRAMINE
MALEATE:
Antihistamines
act
to
prevent
the
release
of
histamine,
prostaglandins
and
leukotrienes,
and
have
been
shown
to
prevent
the
migration
of
inflammatory mediators. The actions of chlorpheniramine include
inhibition of histamine on
smooth
muscle,
capillary
permeability
and
he