DYFENAC TABLET 50MG

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DICLOFENAC SODIUM

Boleh didapati daripada:

DYNAPHARM (M) SDN BHD

INN (Nama Antarabangsa):

DICLOFENAC SODIUM

Unit dalam pakej:

100 Tablets; 1000 Tablets

Dikeluarkan oleh:

DYNAPHARM (M) SDN BHD

Risalah maklumat

Consumer Medication Information Leaflet (RiMUP
)
DYFENAC TABLET 50MG
Diclofenac Sodium (50mg)
1
What is in this leaflet
1.
What DYFENAC TABLET 50MG
is used for
2.
How DYFENAC TABLET 50MG
works
3.
Before you use DYFENAC TABLET
50MG
4.
How to use DYFENAC TABLET
50MG
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of DYFENAC
TABLET 50MG
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
What DYFENAC TABLET 50MG is
used for
To relieve pain and inflammation of
joints, cartilage, bone, spine and
following some surgical procedures.
How DYFENAC TABLET 50MG
works
It works by reducing the production of
prostaglandins (chemicals that cause
pain, fever and inflammation).
Diclofenac block the enzyme that makes
prostaglandins (cyclooxygenase),
resulting in lower production of
prostaglandins. As a consequence,
inflammation, pain and fever are
reduced.
Before you use DYFENAC TABLET
50MG
-
When you must not use it
Do not take DYFENAC TABLET
50MG if you have:
•
Peptic ulcer
•
Known hypersensitivity to
Diclofenac Sodium.
•
Asthma where attacks of asthma,
hives, or acute rhinitis are
precipitated by Aspirin or by other
drugs with prostaglandin-synthesis
inhibiting activity.
•
Severe cardiac failure
-
Before you start to use it
Tell your doctor if:
•
You are pregnant or breast feeding. It
should only be used for compelling
reasons during pregnancy. You
should not take DYFENAC TABLET
50MGs during the last 3 months of
pregnancy as it may affect the baby's
circulation. You should avoid taking
Diclofenac Sodium whilst breast
feeding.
•
You have bleeding disorders,
cardiovascular diseases, peptic
ulceration or a history of such
ulceration. In the rare instances
where peptic ulceration or
gastrointestinal bleeding occurs, the
drug should be withdrawn. During
prolonged treatment, blood counts
and monitoring of liver and kidney
function are indicated as
precautionary measures.
•
Severe skin reactions, including
Stevens-Johnson Syndrome and toxic
epidermal necrolysis (Ly

Ciri produk

DYFENAC TABLET 50MG
MAL19913381AZ
MYN2007AA2670
DESCRIPTION:
TABLET
Colour
:
Light Brown
Shape
:
Round and Biconvex
Coating
:
Enteric-coated
CONTENT:
Each Tablet Contains:
Diclofenac Sodium ...................................................
50 mg
PHARMACODYNAMICS:
Diclofenac may act to block pain impulse generation via a peripheral
action, which may involve inhibition of the synthesis of
prostaglandins, and
possibly inhibition of the synthesis or action of other substances,
which sensitize pain receptors to mechanical or chemical stimulation.
PHARMACOKINETICS:
Diclofenac is absorbed from the gastrointestinal tract. Peak plasma
concentrations occur about 2 hours after ingestion of enteric-coated
tablets. At
therapeutic concentrations, it is more than 99% bound to plasma
proteins. It is metabolised and excreted mainly in the urine. Small
amounts are
excreted in the bile.
INDICATIONS:
For the relief of pain and inflammation in conditions such as
rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute
gout, and following
some surgical procedures.
RECOMMENDED DOSE:
Adults: 75 - 150 mg daily in 2 or 3 divided doses.
In milder cases as well as for long-term therapy, 75 - 100 mg daily is
usually sufficient.
After assessing the risk/benefit ratio in each individual patient, the
lowest effective dose for the shortest possible duration should 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
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
cardiovas