SUNPROX 275MG TABLET

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

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

Δραστική ουσία:

NAPROXEN

Διαθέσιμο από:

SUNWARD PHARMACEUTICAL SDN. BHD.

INN (Διεθνής Όνομα):

NAPROXEN

Μονάδες σε πακέτο:

1000Tablet Tablets; 500Tablet Tablets; 100Tablet Tablets; 500 Tablets

Κατασκευάζεται από:

SUNWARD PHARMACEUTICAL SDN. BHD.

Φύλλο οδηγιών χρήσης

1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
SUNPROX 275MG TABLET
Naproxen ( 275 mg )
WHAT IS IN THIS LEAFLET
1.What Sunprox 275mg Tablet is used for
2. How Sunprox 275mg Tablet works
3. Before you use Sunprox 275mg Tablet
4. How to use Sunprox 275mg Tablet
5. While you are using Sunprox 275mg Tablet
6. Side Effects
7. Storage and Disposable of Sunprox 275mg
Tablet
8. Product Description
9. Manufacturer and Product Registration
Holder
10. Date of Revision
WHAT SUNPROX
275MG TABLET IS USED FOR
It is used for relief of mild to moderate pain
and
for
the
treatment
of
primary
dysmenorrhea (period paid). It also indicate
for
the
treament
of
rheumatoid
arthritis
(systemic inflammatory disorder that affects
joints),
osteoarthritis
(degenerative
joint
disease)ankylosing
spondylitis
(chronic
inflammatory
disease
of
the
skeleton),
tendinitis
(inflammation
of
the
tendon),
bursitis
(Inflammation
of
the
bursa)
and
acute gout.
HOW SUNPROX
275MG TABLET WORKS
Sunprox 275mg tablet contains a substance
called Naproxen. It belongs to a group of
medicines
called
non
steroidal
anti-
inflammatory
agents
(NSAIDs)
which
reduces fever and pain.
BEFORE YOU USE SUNPROX
275MG TABLET
_- When you must not use it _
Do not use Sunprox 275mg tablet:

If you have active peptic ulceration

If you are allergic to Naproxen, Aspirin,
other NSAIDs or other ingredients of this
medicine (listed in Product Description).

If
you
have
had
asthma,
rhinitis
(Inflammation
of
the
nasal
mucous
membrane) , urticaria (itching or hives),
nasal polyps and the symptoms become
worsen caused by Aspirin or NSAIDs.
_ _
_- Before you start to use it _
You should check with your doctor:-

if you have heart problem or stroke.

if
you
have
hypertension
(high
blood
pressure).

Naproxen may cause severe skin reactions,
e.g. exfoliative dermatitis, toxic epidermal
necrolysis,
Steven-Johnson
Syndrome.
Symptoms may include skin rash, blisters
and peel off. These could be signs of a
serious condition. If these reactions occur,
stop use and seek medical as

Αρχείο Π.Χ.Π.

WARNINGS AND PRECAUTIONS:
Cardiovascular Thrombotic Events
Observational studies have indicated that non-selective NSAIDs may be
associated with an increased risk of serious cardiovascular events,
principally myocardial infarction, which may increase with dose or
duration
of use. Patients with cardiovascular disease or cardiovascular risk of
an
adverse cardiovascular event in patient taking NSAID, especially in
those
with cardiovascular risk factors, the lowest effective dose should be
used
for the shortest possible duration.
There is no consistent evidence that the concurrent use of aspirin
mitigates
the possible increased risk of serious cardiovascular thrombotic
events
associated with NSAID use.
Hypertension
NSAIDs may lead to the onset of new hypertension or worsening the
pre-existing hypertension and patients taking antihypertensive with
NSAIDs may have an impaired anti-hypertensive response. Caution is
advised when prescribing NSAIDs to patients with hypertension. Blood
pressure should be monitored closely during initiation of NSAID
treatment
and at regular intervals thereafter.
Heart Failure
Fluid retention and oedema have been observed in some patients taking
NSAIDs, therefore caution is advised in patients with fluid retention
or heart
failure.
Severe Skin Reactions
NSAIDs may very rarely cause serious cutaneous adverse events such as
exfoliative dermatitis, toxic epidermal necrolysis (TEN) and Stevens -
Johnson Syndrome (SJS), which can be fatal and occur without warning.
These serious adverse events are idiosyncratic and are independent of
dose or duration of use. Patients should be advised of the signs and
symptoms of serious skin reactions and to consult their doctor at the
first
appearance of a skin rash or any other sign of hypersensitivity.
Measures such as the use of physical therapy and mild analgesic like
paracetamol (when inflammation is not a major factor) should be
instituted
prior to initiation of therapy with NSAID. NSAIDs should only be used
after
proper appraisal of potential risks to p