FENADIUM F TABLETS 50MG

البلد: ماليزيا

اللغة: الإنجليزية

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

العنصر النشط:

DICLOFENAC SODIUM

متاح من:

SUNWARD PHARMACEUTICAL SDN. BHD.

INN (الاسم الدولي):

DICLOFENAC SODIUM

الوحدات في الحزمة:

1000Tablet Tablets; 100Tablet Tablets; 500 Tablet Tablets; 100 Tablets; 90 Tablets; 1000 Tablets

المصنعة من قبل:

SUNWARD PHARMACEUTICAL SDN. BHD.

نشرة المعلومات

1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
FENADIUM F TABLET
Diclofenac Sodium (50mg)
WHAT IS IN THIS LEAFLET
1. What Fenadium F Tablet is used for
2. How Fenadium F Tablet works
3. Before you use Fenadium F Tablet
4. How to use Fenadium F Tablet
5. While you are using it
6. Side effects
7. Storage & Disposal of Fenadium F Tablet
8. Product Description
9. Manufacturer and Product Registration
Holder
10.Date of revision
WHAT FENADIUM F TABLET IS USED FOR
It is used for:-

Inflammatory
and
degenerative
forms
of
rheumatism: rheumatoid arthritis (systemic
inflammatory disorder that affects joints);
ankylosing spondylitis (chronic inflammatory
disease
of
the
skeleton);
osteoarthritis
(degenerative
joint
disease)
and
spondylarthritis (inflammation of the joint).

Non articular rheumatism (musculoskeletal
aches and pains which do not arise from
joints).

Acute attacks of gout.

Symptomatic
treatment
for
primary
dysmenorrhoea (period pain).
HOW FENADIUM F TABLET WORKS
Fenadium F 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 F TABLET
_- When you must not use it _
Do not use Fenadium F 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 react

خصائص المنتج

FENADIUM TABLET / FENADIUM F TABLET
Each Fenadium Tablet contains
: Diclofenac sodium 25 mg
Each Fenadium F Tablet contains : Diclofenac sodium 50 mg
PHARMACOLOGY:
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 prostanglandin synthetase inhibition.
It is usually used in the treatment of rheumatoid arthritis and other
rheumatic
disorders.
Diclofenac
is
absorbed
from
the
gastrointestinal
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.
INDICATIONS:
It is indicated for inflammatory and degenerative forms of rheumatism;
rheumatoid arthritis; ankylosing spondylitis; osteoarthritis and
spondylarthritis;
non-articular rheumatism; acute attacks of gout. Symptomatic treatment
for
primary dysmenorrhoea.
DOSAGE AND ADMINISTRATION:
Oral administration.
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,
uncontrollled hypertension, or significant risk factors for
carvdiovascular
disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus and
smoking)
should be treated with diclofenac only after caref