SYNFLEX TABLETS 275MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

NAPROXEN SODIUM

Boleh didapati daripada:

DKSH MALAYSIA SDN BHD

INN (Nama Antarabangsa):

NAPROXEN SODIUM

Unit dalam pakej:

100Tablet Tablets

Dikeluarkan oleh:

Fourrts (India) Laboratories Pvt. Limited

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
SYNFLEX
®
Naproxen Sodium (275mg &550mg)
1
WHAT IS IN THIS LEAFLET
1.
What Synflex is used for
2.
How Synflex works
3.
Before you use Synflex
4.
How to use Synflex
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Synflex
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT SYNFLEX IS USED FOR
Synflex
belongs
to
a
family
of
medicines called Non-Steroidal Anti-
Inflammatory Drugs (NSAIDs).
Synflex
relieves
pain
and
reduces
inflammation
(swelling,
redness
and
soreness) that may occur
•
after delivery
•
after IUD insertion
•
acute gout
•
following surgery
•
following orthopedic surgery
•
in soft tissue injuries/inflammation
•
in menstrual cramps (period pain)
•
due to migraine headache
Your
doctor
may
have
prescribed
Synflex for another purpose.
Although
Synflex
can
relieve
the
symptoms of pain and inflammation, it
will not cure your condition.
Ask
your
doctor
if
you
have
any
questions
why
Synflex
has
been
prescribed for you.
This medicine is available only with a
doctor's prescription.
Synflex is not addictive.
HOW SYNFLEX WORKS
Naproxen
is
a
nonsteroidal
anti-
inflammatory
drug
(NSAID).
Naproxen
works
by
blocking
the
production
of
prostaglandins,
substances in the body that play a role
in causing pain and inflammation.
BEFORE YOU USE SYNFLEX
-
_When you must not use it_
_ _
Do not take Synflex if you have an
allergy to:
•
Synflex or any ingredients listed at
the end of this leaflet
•
aspirin or any other NSAID
medicine
Many medicines used to treat headache,
period pain and other aches and pains
contain aspirin or NSAID medicines. If
you are not sure if you are taking any
of
these
medicines,
ask
your
pharmacist.
Symptoms of an allergic reaction to
these medicines may include:
•
asthma, wheezing or shortness of
breath
•
swelling of the face, lips or tongue
which
may
cause
difficulty
in
swallowing or breathing
•
hives, itching or skin rash
•
fainting
•
sudden blocked or runn

Ciri produk

MY 704-5651 02
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
Non-steroidal anti-inflammatory agent.
1.2
TYPE OF DOSAGE FORM
_Synflex Tablets:_
275 mg: Light blue, oval film-coated tablet, with
marking NPS 275 on one side.
550 mg: Dark blue, oblong film-coated tablet, with
marking NPS 550 on one side.
1.3
ROUTE OF ADMINISTRATION
_Oral_
1.4
STERILE / RADIOACTIVE STATEMENT
_Not applicable_
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient: naproxen sodium._
Synflex Tablets: film-coated tablets containing
naproxen sodium 275 mg, 550 mg Naproxen sodium
is a white to creamy white, crystalline solid, freely
soluble in water at neutral pH.
LIST OF EXCIPIENTS
Microcrystalline cellulose, povidone K29/32, talc,
magnesium stearate, purified water, opadry
(YS-1-4215/16).
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
Synflex (naproxen sodium) is indicated in the
relief of mild to moderate pain including post
partum pain, pain following IUD insertion, post-
operative pain and pain due to orthopedic surgery,
for the treatment of primary dysmenorrhea and
for the relief (prophylaxis) of migraine headache.
It is also indicated for the treatment of the signs
and symptoms of mild to moderately severe,
acute or chronic, musculoskeletal and soft tissue
inflammation and acute gout.
2.2
DOSAGE AND ADMINISTRATION
_GENERAL _
After assessing the risk/benefit ratio in each
individual patient, the lowest effective dose for the
shortest possible duration should be used.
Although naproxen and naproxen-sodium-
containing products all circulate in the plasma as
naproxen, they have pharmacokinetic differences
that may affect onset of action. Onset of pain
relief can begin within 30 minutes in patients
taking Synflex and within 1 hour in patients taking
Naprosyn.
The recommended strategy for initiating therapy is
to choose a formulation and a starting dose likely
to be effective for the patient and then adjust the
dosage based on observation of benefit and/or
adverse events.
A lower dose should be considered in