FENAGESIC TABLET

Country: Malaysia

Language: English

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

Active ingredient:

MEFENAMIC ACID

Available from:

SUNWARD PHARMACEUTICAL SDN. BHD.

INN (International Name):

MEFENAMIC ACID

Units in package:

20 Tablets; 180 Tablets; 1000 Tablets; 2 strip x10 Tablets; 10 strip x10 Tablets; 50 strip x10 Tablets; 100 strip x10 Tablets

Manufactured by:

SUNWARD PHARMACEUTICAL SDN. BHD.

Patient Information leaflet

FENAGESIC TABLET
MEFENAMIC ACID (250MG)
1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1. What Fenagesic Tablet is used for
2. How Fenagesic Tablet works
3. Before you use Fenagesic Tablet
4. How to use Fenagesic Tablet
5. While you are using it
6. Side effects
7. Storage & Disposal of Fenagesic Tablet
8. Product Description
9. Manufacturer and Product Registration
Holder
10. Date of revision
WHAT FENAGESIC TABLET IS USED FOR
It is used for the treatment or primary dys-
menorrhea
(period
pain) and the relief of
moderate
pain
when
therapy
will
not
exceed one week.
HOW FENAGESIC TABLET WORKS
Fenagesic Tablet contains a substance called
Mefenamic
acid.
It
belongs
to
a
group
of
medicines
called
non
steroidal
anti-
inflammatory agents (NSAIDs) which reduces
fever, pain and inflammation.
BEFORE YOU USE FENAGESIC TABLET
_- When you must not use it _
Do not use Fenagesic Tablet:-

If you have allergy or hypersensitivity to
Mefenamic acid or any other ingredients
listed at the end of this leaflet.

If
you
have
had
asthma,
rhinitis
(Inflammation
of
the
nasal
mucous
membrane) , urticaria (itching or hives) or
the symptoms become worsen caused by
Aspirin or NSAIDs.

If you have active ulceration

If you have chronic inflammation of either
the upper or lower stomach and intestinal
tract

If you have kidney disease
_ _
_- Before you start to use it _
You should check with your doctor:-

If you have heart problem or stroke

If you have hypertension

If you have kidney or liver problem

If
you
are
concomitantly
taking
anti-
coagulant (blood thinning agent)

If you have or have had ulceration, bleeding
and perforation of the stomach and intesti-
nal

If
you
are
suffering
from
dyspepsia
(discomfort at the epigastric region due to
digestion problem).

Fenagesic
tablet
may
cause
severe
skin
reactions, e.g. exfoliative dermatitis, toxic
epidermal
necrolysis,
Steven-Johnson
Sydrome. Symptoms may include skin rash,
blisters and peel off. These could be signs
of a serious

Summary of Product characteristics

Tablet / 500 Tablet / Suspension
Tablet
: 250mg or 500mg Mefenamic Acid per tablet
Suspension
: 125mg of Mefenamic Acid per 5ml
PHARMACODYNAMICS:
It is a nonsteroidal agent with demonstrated anti-inflammatory,
analgesic and antipyretic activity. In animal studies, it was found to
inhibit
prostaglandin synthesis and to compete for binding at the
prostaglandin receptor site. Its exact mode of action is not known.
PHARMACOKINETICS:
Following a single one gram oral dose, peak plasma level of 10 mcg/ml
occurred in 2 to 4 hours with a half-life of 2 hours. Following
multiple doses, plasma levels are proportional to dose with no
evidence of drug accumulation. One gram of Mefenamic Acid given four
times daily produces peak blood level of 20 mcg/ml by the second day
of administration. Following a single dose, sixty-seven percent of the
total dose is excreted in the urine as unchanged drug or as one of two
metabolites. Twenty to twenty-five percent of the dose is excreted in
the faeces during the first three days.
INDICATIONS:
Mefenamic Acid is indicated for the treatment of primary dysmenorrhea
and the relief of moderate pain when therapy will not exceed
one week.
ADVERSE EFFECTS:
Mefenamic Acid may give rise to occasional gastro-intestinal upsets or
rashes. Gastro-intestinal haemorrhage may rarely occur. Other
haematological effects include haemolytic anaemia, agranulocytosis,
pancytopenia, thrombocytopenia, thrombocytopenic purpura and
bone marrow aplasia.
The occurrence of diarrhoea or skin rash is an indication for
discontinuing treatment.
PRECAUTIONS / WARNINGS:
Cardiovascular Thrombotic Events
Observational studies have indicated that non-selective NSAIDs may be
associated with an increased risk of serious cardiovascular events,
principally myocardial infarction, which may increase with dose or
duration of use. Patients with cardiovascular disease or
cardiovascular
risk of an adverse cardiovascular event in patient taking NSAID,
especially in those with cardiovascular risk factors, the lowest
effective
dose should b