INFLAFEN TABLETS 200MG

Land: Malaysia

Språk: engelsk

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

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Preparatomtale Preparatomtale (SPC)
14-03-2020

Aktiv ingrediens:

IBUPROFEN

Tilgjengelig fra:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (International Name):

IBUPROFEN

Enheter i pakken:

1000 Tablets

Produsert av:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

Informasjon til brukeren

                                _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
INFLAFEN TABLETS 200MG
Ibuprofen (200mg)
WHAT IS IN THIS LEAFLET
1.
What Inflafen Tablets is used
for
2.
How Inflafen Tablets works
3.
Before
you
use
Inflafen
Tablets
4.
How to use Inflafen Tablets
5.
While you are using Inflafen
Tablets
6.
Side effects
7.
Storage
and
Disposal
of
Inflafen Tablets
8.
Product description
9.
Manufacturer
and
Product
Registration holder
10.
Date of Revision
WHAT INFLAFEN TABLETS IS USED FOR
Ibuprofen is the active ingredient
of Inflafen Tablets.
Ibuprofen
is
used
in
the
management of mild to moderate
pain
in
conditions
such
as
menstrual
cramps,
migraine,
postoperative
pain,
osteoarthritis
(degenerative
joint
disease),
rheumatoid
arthritis
(systemic
inflammatory disorder that affects
joints),
ankylosing
spondylitis
(chronic
inflammatory
disease of
the
skeleton),
and
in
other
musculoskeletal and joint disorders
such as sprain and strain.
HOW INFLAFEN TABLETS WORKS
Ibuprofen is a non-steroidal anti-
inflammatory
drug
(NSAID).
It
works
by
reducing
hormone-like
substance called prostaglandin that
cause inflammation and pain in the
body.
It
helps
the
human
body
reduce a fever, decrease pain and
decrease inflammation.
BEFORE YOU USE INFLAFEN TABLETS
-
_When you must not use it _

If
you
have
known
hypersensitivity
to
ibuprofen
or
any
other
ingredients
of
Inflafen
Tablets.

If you have sensitivity to
aspirin
or
other
NSAID
drugs i.e. in patients who
develop
bronchospasm
(an abnormal contraction
of the smooth muscle of
the bronchi) , angiodema
(swelling
below
the
surface of the skin), nasal
polyps
(growths
in
the
nose) or urticaria (hives)
with
those
medicines
or
with
a
history
of
bronchial asthma.

If you have active gastro-
intestinal
bleeding
or
in
the
presence
of
peptic
ulceration
(stomach
ulcer).

If you are pregnant or a
nursing mother.
-
_Before you start to use it _
You must tell your doctor if:

You
have
bleeding
disorder.

You have heart disease or
stroke.

You have kidney or liver
disease.

You
have
or
hav
                                
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Preparatomtale

                                7033-04
INFLAFEN TABLETS 200MG
NAME AND STRENGTH OF ACTIVE INGREDIENT(S):
Each tablet contains:
Ibuprofen
…………………………………………………200mg
PRODUCT DESCRIPTION:
A white, scored, convex of diameter 9mm round tablet with ‘MPI’
logo.
PHARMACODYNAMICS
:
Ibuprofen is a non-steroidal anti-inflammatory agent that possess
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
concentration occur about 1 to 2 hours after ingestion.
Ibuprofen is extensively bound to plasma proteins and has 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:
Ibuprofen is used in the management of mild to moderate pain in
conditions such as dysmenorrhoea, migraine, postoperative pain,
ankylosing spondylitis, osteoarthritis, and rheumatoid arthritis, and
in other musculoskeletal and joint disorders such as sprain and
strain.
RECOMMENDED DOSAGE:
To be taken orally. It may be given with food or milk to reduce
gastro-intestinal disturbances.
Adults : 1.2-1.8g daily in divided doses.
Maintenance dose : 0.6 – 1.2g daily.
Doses should be reduced in patients with impaired renal function.
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, angiodema, 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 pregnancy and lactation are not recommended due to inhibition
of prostaglandin synthesis.
WARNINGS AND PRECAUTIONS:
1.
Ibuprofen should be given with care to patients
                                
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