Panadol Cold+Flu-ND Caplet

Land: Malaysia

Sprog: engelsk

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

Aktiv bestanddel:

Paracetamol; Phenylephrine HCl

Tilgængelig fra:

GLAXOSMITHKLINE CONSUMER HEALTHCARE SDN. BHD.

INN (International Name):

Paracetamol; Phenylephrine HCl

Enheder i pakken:

12 Tablets

Fremstillet af:

Aspen Pharma Pty Ltd

Indlægsseddel

_Consumer Medication Information Leaflet (RiMUP) _
PANADOL COLD+FLU-ND
CAPLET
Paracetamol/Phenylephrine Hydrochloride (500mg/5mg)
1
WHAT IS IN THIS LEAFLET
1.
What Panadol Cold+Flu-ND
Caplet is used for
2.
How Panadol Cold+Flu-ND
Caplet works
3.
Before
you
use
Panadol
Cold+Flu-ND Caplet
4.
How
to
use
Panadol
Cold+Flu-ND Caplet
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Panadol
Cold+Flu-ND
Caplet
8.
Product Description
9.
Manufacturer
&
Product
Registration Holder
10.
Date of revision
WHAT
PANADOL
COLD+FLU-ND
CAPLET IS USED FOR
For fast acting and relief of nasal
congestion, sinus pain, bodyache,
headache and fever.
HOW PANADOL COLD+FLU-
ND CAPLET WORKS
Paracetamol
in
Panadol
Cold+Flu-ND
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-ND Caplet is a
decongestant
which
unblocks
your nose
and sinuses helping you breathe
more easily.
BEFORE
YOU
USE
PANADOL
COLD+FLU-ND CAPLET
_- When you must not use it_
Do not use if you are:
•
allergic
to
paracetamol,
phenylephrine 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), usually
used to treat depression.
Do not take Panadol Cold+Flu-
ND Caplet if you are pregnant,
trying to get pregnant, think you
may be pregnant or breastfeeding.
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
underweight
or
malnourished.
•
regularly drink alcohol.
You may need to avoid using this
product
altogether
or
limit
the
amount of paracetamol that you
take.
Check with your doctor before
use if:
•
you have a severe infection
as this may increase the risk
of
metabolic
acidosis.Signs
of
metabolic
acidiosis
include: deep, rapid, difficult
breathing,
feeling
nausea,
vomiting,
loss
of
appetite.
Contact a doctor immediate

Produktets egenskaber

PRODUCT DESCRIPTION
White capsule shaped caplet with flat edges 17.7 mm x 7.1 mm. One face
embossed with “
” within an oval.
Excipients: Maize starch, Pregelatinised starch, Povidone K-25,
Potassium sorbate, Sodium lauryl sulfate, Talc,
Stearic acid, Microcrystalline cellulose.
PHARMACOLOGICAL PROPERTIES
PHARMACOTHERAPEUTIC GROUP:
Other
analgesics
and
antipyretics,
paracetamol,
combinations
excluding
psycholeptics.
Nasal decongestant for systemic use, sympathomimetics, phenylephrine,
combinations.
_PHARMACODYNAMICS_
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.
_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 has nasal
decongestant activity and acts by
vasoconstriction to reduce oedema and swelling of the nasal mucosa.
_PHARMACOKINETICS_
PARACETAMOL is rapidly and almost completely absorbed from the
gastrointestinal tract. Binding to the plasma
proteins is minimal at therapeutic concentrations. Paracetamol is
metabolised in the liver and excreted in the
urine mainly as glucuronide and sulphate conjugates. Less than 5% is
excreted as unmodified paracetamol.
PHENYLEPHRINE HYDROCHLORIDE is irregularly absorbed from the
gastrointestinal tract. It undergoes first-pass
metabolism by monoamine oxidases in the gut and liv