SAFROSYN S TABLET 275MG

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
28-12-2021
Ciri produk Ciri produk (SPC)
28-12-2021

Bahan aktif:

NAPROXEN SODIUM

Boleh didapati daripada:

PHARMANIAGA MANUFACTURING BERHAD

INN (Nama Antarabangsa):

NAPROXEN SODIUM

Unit dalam pakej:

500 Tablets

Dikeluarkan oleh:

PHARMANIAGA MANUFACTURING BERHAD

Risalah maklumat

                                SAFROSYN S TABLET
Naproxen Sodium (275mg, 550mg)
1
Consumer Medication Information Leaflet (RiMUP)
What is in this leaflet
1.
What Safrosyn S Tablet is used for
2.
How Safrosyn S Tablet works
3.
Before you use Safrosyn S Tablet
4.
How to use Safrosyn S Tablet
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Safrosyn S
Tablet
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
What Safrosyn S Tablet is used for
It
contains
naproxen
sodium
which
belongs to a group of medicines called
non-steroidal
anti-inflammatory
drugs
(NSAIDs),
which
are
used
to
reduce
inflammation
and
pain
in
joints
and
muscles.
Safrosyn S Tablet is used to treat:
•
Musculoskeletal
and
joints
disorders
such as ankylosing spondylitis (arthritis
of the spine), osteoarthritis (arthritis in
joints)
and
rheumatoid
arthritis
(autoimmune
disease
in
which
your
body’s
immune
system,
mistakenly
attacks
your
joints
and
causes
inflammation).
Safrosyn S Tablet cannot cure arthritis but
is used to give relief of some symptoms
such as inflammation, swelling, stiffness
and joint pain.
•
In
mild
to
moderate
pain
such
as
dysmenorrhea
(period
pain)
and
migraine.
• Signs and symptoms of acute gout.
How Safrosyn S Tablet works
Safrosyn S Tablet works by blocking the
effect
of
chemicals
called
cyclo-
oxygenase
(COX)
enzymes.
These
enzymes help to make other chemicals in
the body, called prostaglandins.
Some prostaglandins are produced at sites
of injury or damage, and cause pain and
inflammation. By blocking the effect of
COX enzymes, fewer prostaglandins are
produced,
which
means
pain
and
inflammation, are eased.
Before you use Safrosyn S Tablet
-When you must not use it
Do not take Safrosyn S Tablet if you:-

are
allergic
(hypersensitive)
to
naproxen,
aspirin
and
other
non-
steroid anti-inflammatory drugs

have serious liver, kidney and heart
failure

In the last trimester of pregnancy

have
active
or
previous
history
of
recurrent stomach ulcer or bleeding

Have bleeding or perforat
                                
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Ciri produk

                                SAFROSY
S TABLET
Idealprins Industries Sdn Bhd
Amendment 17
07-12-21
Safrosyn S Tablet Leaflet (F)
Size: 300mm (W) x 150mm (L)
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.
GASTROINTESTINAL BLEEDING, ULCERATION AND PERFORATION
GI bleeding, ulceration or perforation, which can be fatal, has been
reported with
all NSAIDs at any time during treatment, with or without warning
symptoms or
a previous history of serious GI events. Debilitated patients seems to
tolerate
ulceration or bleeding less well than others. Most of the fatal
gastrointestinal
events associated with NSAIDs occurred in the elderly and/or
debilitated
patients. The risk of GI bleeding, ulceration or perforation is higher
with
increasing NSAID doses, in patients with a history of ulcer,
particularly if
complicated with haemorrhage or perforation, and in the elderly. These
patients
should commence treatment on the lowest dose available. Combination
therapy
with protective agents (e.g. misoprostol or proton pump inhibitors)
should be
considered for these patients, and also for patients requiring
concomitant low
dose aspirin, or other drugs likely to increase gastrointestinal risk.
Naproxen has
been found to be well tolerated by patients exhibiting dyspepsia with
other
similar agents. Nonetheless, episodes of gastro-intestinal bleeding
have been
reported in patients with naproxen therapy. Patients with a history of
GI toxicity,
particularly when elderly, should report any unusual abdominal
symptoms
(especially GI bleeding) particularly in the initial stages of
treatment. Caution
should be advised in patients receiving concomitant medications, which
could
increase the risk of ulceration, or bleeding, such as cortic
                                
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