FENAGESIC TABLET 500MG

Nazione: Malesia

Lingua: inglese

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

Principio attivo:

MEFENAMIC ACID

Commercializzato da:

SUNWARD PHARMACEUTICAL SDN. BHD.

INN (Nome Internazionale):

MEFENAMIC ACID

Confezione:

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

Prodotto da:

SUNWARD PHARM PTE LTD

Foglio illustrativo

FENAGESIC TABLET
MEFENAMIC ACID (500 MG)
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
intestinal.

If
you
are
suffering
from
dyspepsia
(discomfort at the epigastric region due to
digestion problem).

Fenagesic
tablet
may
cause
severe
skin
reactions,
example
exfoliative
dermatitis,
toxic epidermal necrolysis, Steven-Johnson
Sydrome. Symptoms may include skin rash,
blisters and peel off. These could be signs of
a seriou

Scheda tecnica

FENAGESIC
Capsule / 250 Tablet / 500 Tablet
Capsule : 250mg of Mefenamic Acid per capsule
Tablet
: 250 or 500mg Mefenamic Acid per tablet
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 ug/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 ug/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 s