PRUFEN ORAL SUSPENSION 100mg5ml

Država: Malezija

Jezik: angleščina

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

Aktivna sestavina:

IBUPROFEN

Dostopno od:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (mednarodno ime):

IBUPROFEN

Enote v paketu:

60 ml

Izdeluje:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

Navodilo za uporabo

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
PRUFEN ORAL SUSPENSION 100MG/5ML
Ibuprofen (100mg/5ml)
WHAT IS IN THIS LEAFLET:
1.
What Prufen Oral Suspension is
used for
2.
How
Prufen
Oral
Suspension
works
3.
Before
you
use
Prufen
Oral
Suspension
4.
How
to
use
Prufen
Oral
Suspension
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Prufen
Oral Suspension
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT PRUFEN ORAL SUSPENSION IS
USED FOR
Ibuprofen is the active ingredient of
Prufen
Oral
Suspension.
It
is
indicated for the relief of fever and
pain
the
children
older
than
6
months
and
control
of
symptoms
associated
with
juvenile
arthritis
(inflammation of the synovium in
children aged 16 or younger) and
dysmenorrhoea
(painful
menstruation).
HOW
PRUFEN
ORAL
SUSPENSION
WORKS
Ibuprofen
is
a
non-steroidal
anti-
inflammatory agent that possesses
analgesic (relieve pain), antipyretic
(reduce
fever)
and
anti-
inflammatory activities. The mode
of action, like that of other NSAIDs
may
be
related
to
prostaglandin
synthetase
inhibition
(prevent
production of prostaglandin).
BEFORE
YOU
USE
PRUFEN
ORAL
SUSPENSION
-
_When you must not use it _

If
you
are
allergic
(hypersensitive)
to
ibuprofen
and
other
ingredients
of
the
oral
suspension.

If
you
are
sensitive
to
aspirin
or
other
NSAID
drugs
i.e
if
you
develop
bronchospasm
(constriction
of
the
airway),
angioedema
(swelling
of
your
skin),
nasal
polyps
or
urticaria
(itching
or
hives)
with
those
drugs
or
with
a
history
of
bronchial
asthma.

If you have stomach and
intestinal bleeding or in the
presence
of
peptic
ulceration.

If
you are pregnant or a
nursing mother
-
_Before you start to use it_
You must tell your doctor if:

You have allergies to any
medicine which you have
taken
previously
to
treat
your current condition.

You are pregnant, trying to
become pregnant or breast-
feeding.

You
have
bleeding
disorders.

You have kidney, heart or
liver problem.

You
have
or
have
had
ulcer

Lastnosti izdelka

7119-06
PRUFEN ORAL SUSPENSION 100MG/5ML
NAME AND STRENGTH OF ACTIVE INGREDIENT(S):
Each 5ml of suspension contains:
IBUPROFEN
…………………………………………………100mg
PRODUCT DESCRIPTION:
An orange coloured suspension with tutti frutti flavour and sweet sour
taste.
PHARMACODYNAMICS
:
Ibuprofen is a non-steroidal anti-inflammatory agent that possesses
analgesic, antipyretic and anti-inflammatory activities. Its
mode of action, like that of other NSAIDs, is not completely
understood, but may be related to prostaglandin synthetase inhibition.
PHARMACOKINETICS:
Ibuprofen is absorbed from the gastro-intestinal tract and peak plasma
concentrations occur about 1 to 2 hours after ingestion.
Ibuprofen is extensively bound to plasma proteins and has a half-life
of about 2 hours. It is rapidly excreted in the urine mainly as
metabolites and their conjugates. About 1% is excreted in urine as
unchanged ibuprofen and about 14% as conjugated ibuprofen.
INDICATION:
It is indicated for the relief of fever and pain in children older
than 6 months, control of symptoms associated with juvenile arthritis
and dysmenorrhoea.
RECOMMENDED DOSAGE:
To be taken orally. It may be given with food or milk to reduce
gastro-intestinal disturbances.
_SHAKE WELL PRIOR TO ADMINISTRATION. _
Fever : Children 6 months to 12 years old : 5 –10 mg/kg body weight
up to maximum of daily dose 40 mg/kg daily for temperature
below or above 39

C, respectively. This can be achieved as follows :
6 months – 2 years : 2.5 ml, three to four times a day
3 – 7 years : 5 ml, three to four times a day
8 –12 years : 10 ml, three to four times a day
ROUTE OF ADMINISTRATION:
Oral
CONTRAINDICATIONS:
1.
Known hypersensitivity to ibuprofen.
2.
Sensitivity to aspirin or other NSAID drugs i.e. in patients who
develop bronchospasm, angioedema, nasal polyps or urticaria
with those drugs or with a history of bronchial asthma.
3.
Ibuprofen should not be used in active gastro-intestinal bleeding or
in the presence of peptic ulceration.
4.
Use in p