FENADIUM TABLETS 25MG

Negara: Malaysia

Bahasa: Inggris

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

Bahan aktif:

DICLOFENAC SODIUM

Tersedia dari:

SUNWARD PHARMACEUTICAL SDN. BHD.

INN (Nama Internasional):

DICLOFENAC SODIUM

Unit dalam paket:

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

Diproduksi oleh:

SUNWARD PHARMACEUTICAL SDN. BHD.

Selebaran informasi

1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
FENADIUM TABLET
Diclofenac Sodium (25mg)
WHAT IS IN THIS LEAFLET
1. What Fenadium Tablet is used for
2. How Fenadium Tablet works
3. Before you use Fenadium Tablet
4. How to use Fenadium Tablet
5. While you are using it
6. Side effects
7. Storage & Disposal of Fenadium Tablet
8. Product Description
9. Manufacturer and Product Registration
Holder
10.Date of revision
WHAT FENADIUM TABLET IS USED FOR
It is used to relief;

inflammatory
and
degenerative
due
to
arthritis that affects bones and joints.

musculoskeletal aches and pains which do
not arise from joints.

acute attacks of gout.

mestrual pain.
HOW FENADIUM TABLET WORKS
Fenadium Tablet contains a substance called
Diclofenac.
It
belongs
to
a
group
of
medicines
called
non
steroidal
anti-
inflammatory
agents
(NSAIDs)
which
reduces fever, pain and inflammation.
BEFORE YOU USE FENADIUM TABLET
_- When you must not use it _
Do not use Fenadium Tablet:-

If you have allergy or hypersensitivity to
Diclofenac, Aspirin, other NSAIDs or any
other ingredients listed at the end of this
leaflet.

If you have had nasal polyps (growth in the
nasal),
angioedema
(swelling
around
the
eyes and lips and sometimes of the genitals,
hands,
and
feet),
bronchospastic
(constriction
of
the
airway)
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 high blood pressure.

Diclofenac
may
cause
severe
skin
reactions, e.g. toxic epidermal necrolysis,
Steven-Johnson Sydrome. 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 assistance right away.

If you have or have had ulceration, bleed-
ing
and
perforation
of
the
stomach
and
intestinal

If you suffering from dyspepsia (discomfort
at the epigastric region due to digestion
problem).

If you have bleeding disorder.

If you h

Karakteristik produk

PRODUCT DESCRIPTION:
Fenadium Tablets 25mg:
Round, convex, yellow, enteric-film coated tablet without markings.
Fenadium F Tablets 50mg:
Round, convex, beige, enteric-film coated tablets without markings.
PHARMACODYNAMICS:
Diclofenac sodium is a phenylacetic acid derivative which has
analgesic,
anti-pyretic and anti-inflammatory actions. Its mode of action, like
that of other
non-steroidal anti-inflammatory agents, is not completely understood,
but may
be related to prostaglandin synthetase inhibitor. It is usually used
in the
treatment of rheumatoid arthritis and other rheumatic disorders.
PHARMACOKINETICS:
Diclofenac
is
absorbed
from
the
gastro-intestinal
tract.
Peak
plasma
concentrations are generally attained one to two hours after
administration. At
therapeutic concentration, it is more than 99% bound to the plasma
proteins.
It is metabolised and excreted mainly in the urine. Small amounts are
excreted in the bile.
INDICATION:
It is indicated for inflammatory and degenerative forms of rheumatism;
rheumatoid arthritis; ankylosing spondylitis; osteoarthritis and
spondyloarthritis;
non-articular rheumatism; acute attacks of gout. Symptomatic treatment
for
primary dysmenorrhoea.
RECOMMENDED DOSAGE:
It is generally given in doses of 25mg to 50mg three times daily with
food.
As a general recommendation, the dose should be individually adjusted.
Adverse effects may be minimized by using the lowest effective dose
for
shortest duration necessary to control symptoms (see section WARNINGS
AND PRECAUTIONS).
ESTABLISHED CARDIOVASCULAR DISEASE OR SIGNIFICANT CARDIOVASCULAR RISK
FACTORS
Treatment with diclofenac is generally not recommended in patients
with
established cardiovascular disease (congestive heart failure,
established
ischemic
heart
disease,
peripheral
arterial
disease)
or
uncontrolled
hypertension. If needed, patients with established cardiovascular
disease,
uncontrolled
hypertension,
or
significant
risk
factors
for
cardiovascular
disease (e.g. hypertension, hyperlipidemia, diabetes mellitus and
smoking)
shoul