FENAGESIC CAPSULE 250MG

Negara: Malaysia

Bahasa: Inggris

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

Bahan aktif:

MEFENAMIC ACID

Tersedia dari:

SUNWARD PHARMACEUTICAL SDN. BHD.

INN (Nama Internasional):

MEFENAMIC ACID

Unit dalam paket:

500 Capsule Capsules; 100 Capsule Capsules; 1000 Capsule Capsules; 1000Capsule Capsules

Diproduksi oleh:

SUNWARD PHARMACEUTICAL SDN. BHD.

Selebaran informasi

FENAGESIC CAPSULE
MEFENAMIC ACID (250MG)
1
_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1. What Fenagesic Capsule is used for
2. How Fenagesic Capsule works
3. Before you use Fenagesic Capsule
4. How to use Fenagesic capsule
5. While you are using it
6. Side effects
7. Storage & Disposal of Fenagesic Capsule
8. Product Description
9. Manufacturer and Product Registration
Holder
10.Date of revision
WHAT FENAGESIC CAPSULE IS USED FOR
It
is
used
for
the
treatment
or
primary
dysmenorrhea (period pain) and the relief of
moderate pain when therapy will not exceed
one week.
HOW FENAGESIC CAPSULE WORKS
Fenagesic capsule 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 CAPSULE
_- When you must not use it _
Do not use Fenagesic capsule :

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 stoke

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 capsule 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 s

Karakteristik produk

Caution should be observed when anti-coagulant is administered
concomitantly with nonsteroidal anti-inflammatory
drugs (NSAIDS), to be certain that no change in anticoagulation dosage
is required . In addition to specific drug
interactions that might affect prothrombin time, NSAIDs can inhibit
platelet aggregation, and can cause
gastrointestinal bleeding, peptic ulceration and/or perforation.
Safety and effectiveness in children below the age of 14 have not been
established.
PREGNANCY AND LACTATION:
As there are no adequate and well-controlled studies in pregnant
women, this drug should be used only it clearly
needed. The use of this drug in late pregnancy is not recommended
because of the effects in the foetal cardiovascular
system. For the same reason, Mefenamic Acid should not be taken by
nursing mothers.
CONTRAINDICATIONS:
Mefenamic Acid should not be used in patients who have previously
exhibited hypersensitivity to it. Because the
potential exists for cross-sensitivity to aspirin or other NSAIDs,
mefenamic acid should not be given to patients in
whom these drugs induce symptoms of bronchospasm, allergic rhinitis or
urticaria.
Mefenamic Acid is contraindicated in patients with active ulceration
or chronic inflammation of either the upper or
lower gastrointestinal tract.
Mefenamic Acid should be avoided in patients with pre existing renal
disease. Since Mefenamic Acid is eliminated
primarily by the kidneys, the drug should not be administered to
patients with significantly impaired renal function.
DOSAGE:
Oral administration.
The recommended regimen in acute pain for adults and children over 14
years of age is 500mg three times daily,
usually not to exceed one week.
For the treatment of primary dysmenorrhoea, the recommended dosage is
500mg three times daily starting with the
onset of bleeding and associated symptoms.
Mefenamic Acid should not be used for more than 7 days at a time.
After assessing the risk/benefit ratio in each individual patient, the
lowest effective dose for the shortest possible
duration