DYNAFLEX TABLET 550MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

NAPROXEN SODIUM

Boleh didapati daripada:

DYNAPHARM (M) SDN BHD

INN (Nama Antarabangsa):

NAPROXEN SODIUM

Unit dalam pakej:

500 Tablets

Dikeluarkan oleh:

DYNAPHARM (M) SDN BHD

Risalah maklumat

DYNAFLEX TABLET
Naproxen Sodium (275 mg, 550 mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What DYNAFLEX is used for
2.
How DYNAFLEX works
3.
Before you use DYNAFLEX
4.
How to use DYNAFLEX
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
DYNAFLEX
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT DYNAFLEX IS USED FOR
For rheumatic disorders, mild to
moderate pain and in acute gout.
HOW DYNAFLEX WORKS
Naproxen is a non-steroidal anti-
inflammatory drug (NSAID) with pain
relieving and fever reducing properties.
BEFORE YOU USE DYNAFLEX
-
_When you must not use it _
Do not use this medicine in:
-
Individuals allergic to Aspirin and
Naproxen
-
Individuals in whom Aspirin or other
Non-Steroidal Anti-Inflammatory
Drugs (NSAIDs) induce asthma,
rhinitis or urticaria.
-
Peptic ulcer.
_Pregnancy and lactation _
Do not take DYNAFLEX if you are
pregnant, trying to get pregnant or think
you may be pregnant.
Do not take DYNAFLEX if you are
breast-feeding. Ask your doctor or
pharmacist for advice before taking any
medicine.
-
_Before you start use it _
Tell your doctor or pharmacist if you
have
1.
Blood clot in heart and blood vessels
2.
High blood pressure
3.
Heart failure
4.
Stomach and intestine problems
5.
Severe skin reactions
-
_Taking other medicines _
Tell your doctor if you are taking any
other medicines, including any that you
buy without a prescription from a
pharmacy, supermarket or health food
shop.
HOW TO USE DYNAFLEX
-
_How much to use _
Take the medication orally, with or after
meals._ _
The daily dose should not exceed 1375
mg.
Not recommended for use in children
under 16 years of age.
There is a greater risk of NSAID-induced
gastrointestinal bleeding in the elderly.
It is therefore recommended that
individuals in this age group, especially
those 70 years of age or older, be given
half the usual adult dose initially.
After assessing the risk/benefit ratio in
each individual patient, the lowest

Ciri produk

DYNAFLEX
DESCRIPTION
CONTENT
DYNAFLEX TABLET
275MG
MAL05051065AZ
TABLET
Colour
: Light Blue
Shape
: Oval and Biconvex
Each Tablet Contains:
Naproxen Sodium 275 mg Equivalent To Naproxen 250 mg
DYNAFLEX TABLET
550MG
MAL19950335AZ
TABLET
Colour
: White
Shape
:
Oblong
Each Tablet Contains:
Naproxen Sodium 550 mg Equivalent To Naproxen 500 mg
PHARMACODYNAMICS:
Naproxen is a non-steroidal anti-inflammatory analgesic compound with
antipyretic properties as has been demonstrated in
classical animal test systems. Naproxen exhibits its anti-inflammatory
effect even in adrenalectomised animals, indicating that
its action is not mediated through the pituitary-adrenal axis.
Naproxen inhibits prostaglandin synthetase (as do other NSAIDs). As
with other NSAIDs, however, the exact mechanism of its
anti-inflammatory action is not known.
PHARMACOKINETICS:
Naproxen is completely absorbed from the gastrointestinal tract, and
peak plasma levels are reached in 2 to 4 hours. Naproxen
is present in the blood mainly as unchanged drug, extensively bound to
plasma proteins. The plasma half-life is between 12 and
15 hours, enabling a steady state to be achieved within 3 days of
initiation of therapy on a twice daily dose regimen. The degree
of absorption is not significantly affected by either foods or most
antacids. Excretion is almost entirely via the urine, mainly as
conjugated Naproxen, with some unchanged drug. Metabolism in children
is similar to that in adults. Chronic alcoholic liver
disease reduces the total plasma concentration of Naproxen but the
concentration of unbound Naproxen increases. In the
elderly, the unbound plasma concentration of Naproxen is increased
although total plasma concentration is unchanged.
INDICATION:
For rheumatic disorders such as ankylosing spondylitis, osteoarthritis
and rheumatoid arthritis. Mild to moderate pain such as
dysmenorrhoea, migraine and some musculoskeletal disorders and in
acute gout.
RECOMMENDED DOSE:
Take the medication orally, with or after meals.
Dysmenorrhoea, pain following IUD inse