AXCEL PARACETAMOL-250 SUSPENSION (ORANGE)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Paracetamol

Boleh didapati daripada:

KOTRA PHARMA (M) SDN. BHD.

INN (Nama Antarabangsa):

Paracetamol

Unit dalam pakej:

60 ml; 90 ml; 90 ml; 100 ml; 120 ml

Dikeluarkan oleh:

KOTRA PHARMA (M) SDN. BHD.

Risalah maklumat

AXCEL PARACETAMOL-250 SUSPENSION
Paracetamol (250mg/5ml)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
WHAT IS IN THIS LEAFLET
1.
What
Axcel
Paracetamol-250
Suspension is used for.
2.
How
Axcel
Paracetamol-250
Suspension works.
3.
Before
you
use
Axcel
Paracetamol-250 Suspension.
4.
How to use Axcel Paracetamol-
250 Suspension.
5.
While you are using it.
6.
Side effects.
7.
Storage
and
disposal
of
Axcel
Paracetamol-250 Suspension.
8.
Product description.
9.
Manufacturer
and
Product
Registration Holder.
10.
Date of revision.
WHAT
AXCEL
PARACETAMOL-250
SUSPENSION IS USED FOR
Axcel Paracetamol-250 Suspension is
used to relief:

Fever.

Symptoms of cold and influenza.

Teething pain.

Headache.
HOW
AXCEL
PARACETAMOL-250
SUSPENSION WORKS
Paracetamol
consists
of
analgesic
(medicine
to
relieve
pain)
and
antipyretic
(medicine
that
reduces
fever)
properties.
Paracetamol
relieves
pain
of
moderate
intensity
such as headache and muscle, joint,
and any nerve disorder outside the
central nervous system. It can also be
used to reduce fever.
BEFORE YOU USE AXCEL PARACETAMOL-
250 SUSPENSION
_-When you must not use it _
Do not take Axcel Paracetamol-250
Suspension if:

You are having kidney disease.

It is not prescribed by a qualified
doctor or pharmacist for you.

You are pregnant, trying to get
pregnant or think
you
may be
pregnant.

You
are
breast-feeding.
Ask
your
doctor
or
pharmacist
for
advice
before
taking
any
medicine.
_ _
_ _
_ _
_-Before you start to use it _
Tell your doctor if:_ _

You
are
allergic
to
any
medicines, food and dyes.

You
are
taking
any
other
medicines
(including
those
not
prescribed
by
your
doctor)
especially those which contains
paracetamol

You are having impaired kidney
or liver functions.
_-Taking other medicines _
You
should
tell
your
doctor
or
pharmacist
if
you
are
taking
the
following medicine as it may interact
with
your
Axcel
Paracetamol-250
Suspension:

Oral
anticoagulants
(medicine
used to prevent the formation of
blood clots).

Medicines
containin

Ciri produk

COMPOSITION:
Each 5ml contains
Paracetamol 250mg
Methylparaben
0.1%
w/v
as
preservative.
Sunset Yellow Dye 0.015% w/v as colourant.
PRESENTATION:
An
orange
coloured
and
orange
flavoured
suspension.
INDICATIONS:
For the relief of fever, symptoms of cold and
influenza, teething pain and headache.
DOSAGE AND ADMINISTRATION:
For oral administration only.
SHAKE WELL BEFORE USE.
Children
1-6 years old : 2.5 - 5ml.
7-12 years old : 5 - 10ml.
To be taken 3 or 4 times a day.
Children 3 months to 1 year are advised to use
Axcel Paracetamol-120 Syrup.
CONTRAINDICATION:
Contraindicated in patients with nephropathy.
PRECAUTIONS:
It should be given with care to patients with
impaired kidney or liver functions. Chronic use
should be avoided.
Allergy alert : Paracetamol may cause severe
skin reactions. Symptoms may include skin
reddening, blisters or rash. These could be
signs of a serious condition. If these reactions
occur, stop use and seek medical assistance
right away.
SIDE EFFECTS:
Cutaneous hypersensitivity reactions including
skin rashes, angioedema, Stevens Johnson
Syndrome / Toxic Epiderma Necrolysis have
been reported.
DRUG INTERACTION:
The
prothrombinopenic
effect
of
the
oral
anticoagulants may be increased by chronic
administration of full doses of paracetamol.
OVERDOSAGE & TREATMENT:
In non-fatal cases, the hepatic lesions are reversible over a
period of weeks or months. Measurement of the plasma
half-life
of
paracetamol
during
the
first
day
of
acute
poisoning provides an early indication of the severity of the
liver injury. Hepatic necrosis should be anticipated if the
half-time exceeds 4 hours, and hepatic coma is likely if the
half-time is greater than 12 hours. Encephalopathy should
also be anticipated if serum bilirubin concentration exceeds
4mg / 100ml during the first 5 days. Treatment of acute
paracetamol overdosage is purely symptomatic, vigorous
supportive
therapy
is
essential
in
severe
intoxication.
Induction of vomiting or gastric lavage should be performed
in
all cases,
follow
by
oral
administration
of