REMETHAN 50 E.C. TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DICLOFENAC SODIUM

Boleh didapati daripada:

EUCOGEN SDN BHD

INN (Nama Antarabangsa):

DICLOFENAC SODIUM

Unit dalam pakej:

1000 Tablets

Dikeluarkan oleh:

Remedica Limited

Risalah maklumat

REMETHAN 50 E.C. TABLET
Diclofenac Sodium (50mg)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Remethan is used for
2.
How Remethan works
3.
Before you use Remethan
4.
How to use Remethan
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Remethan
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT REMETHAN
IS USED FOR
Remethan belongs to a group of
medicines called “non-steroidal anti-
inflammatory drugs” (NSAIDs), which
are used to treat pain and inflammation
as listed below:
•
Rheumatoid
arthritis
(systemic
inflammatory
disorder
that
affects
joints),
ankylosing
spondylitis
(chronic
inflammatory
disease
of
skeleton),
osteoarthrosis
(degenerative joint disease), low back
pain,
frozen
shoulder,
tendinitis
(inflammation
of
tendon),
tenosynovitis (inflammation of tendon
sheath
called
synovium),
bursitis
(inflammation of fluid sacs between
joints named bursa), strains, sprains
and acute gout.
•
Control of pain and inflammation in
bones, joints, and ligaments, dental
and other minor surgery.
Indicated for treatment for children:
•
Juvenile
chronic
arthritis
(severe
arthritis in children
HOW REMETHAN WORKS
Remethan
relieves
the
symptoms
of
inflammation, such as pain and swelling,
by
blocking
the
production
of
the
molecules
(prostaglandins)
responsible
for inflammation, pain and fever. It has no
effect on the causes of inflammation or
fever.
BEFORE YOU USE REMETHAN_ _
-
_When you must not use it _
_ _
Do not take this medicine if:
_ _
•
You are allergic to diclofenac sodium
or
any
other
ingredients
of
this
medicine
(listed
in
Product
Description)
•
or to any of the other ingredients of
Remethan
listed
at
the
end
of
this
leaflet.
•
If
you
have
ever
had
an
allergic
reaction after taking medicines to treat
inflammation
or
pain
(e.g.
acetylsalicylic acid/ aspirin, diclofenac
or ibuprofen). Reactions may include
asthma, runny nose, skin rash and face
swelling.
•
If you have stomach or intestinal ulcer.
•

Ciri produk

my-pi-remethan-50mg-tabs-a2
Page 1 of 2
REMETHAN
TM
ANALGESIC, ANTIPYRETIC, ANTI-INFLAMMATORY
PHARMACEUTICAL FORM, STRENGTH
Enteric-coated tablets, 50mg
COMPOSITION
The active ingredient of Remethan is
Diclofenac sodium
PRODUCT DESCRIPTION:
Remethan 50: Yellow, round, enteric-coated tablets.
PROPERTIES:
Remethan is a non-steroidal phenylacetic acid derivative which has
marked analgesic, antipyretic and anti-inflammatory properties.
Remethan is absorbed from the gastro-intestinal tract reaching peak
plasma concentrations in two hours after ingestion of the enteric-
coated tablets. Remethan is metabolised and excreted mainly in the
urine.
MECHANISM OF ACTION:
Inhibits prostaglandin synthesis by decreasing the activity of the
enzyme, cyclo- oxygenase, which results in decreased formation
of prostaglandin precursors.
PHARMACODYNAMICS/KINETICS:
Absorption: Completely absorbed. Protein binding: 99%.
Metabolism: Metabolised in the liver to inactive metabolites.
Half-life: 2 hours.
Time to peak serum concentration: Within 2 hours.
Elimination: Excreted primarily in the urine.
INDICATIONS:
Remethan is indicated for the treatment of rheumatoid arthritis,
ankylosing, spondylitis, osteoarthrosis, low back pain, frozen
shoulder, tendinitis, tenosynovitis, bursitis, strains, sprains and
acute gout. Remethan is also indicated for the control of pain and
inflammation in orthopaedic, dental and other minor surgery.
In children, Remethan is indicated for the treatment of Juvenile
chronic arthritis.
DOSAGE:
The recommended adult dose of Remethan is 75-150mg daily given in two
or three divided doses. Children should be given
1,3mg/kg per day in divided doses.
For elderly patients the standard adult dose may be used.
As a general recommendation, the dose should be individually adjusted.
Adverse effects may be minimized by using the lowest
effective dose for the shortest duration necessary to control symptoms
(see section Precautions and Warnings).
ROUTE OF ADMINISTRATION:
For oral administration only
ESTABLISHED CARDIOVASCULAR DISEAS