MEFEMIN Mefenamic Acid 250mg Capsules

Negara: Malaysia

Bahasa: Inggris

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

Bahan aktif:

MEFENAMIC ACID

Tersedia dari:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (Nama Internasional):

MEFENAMIC ACID

Unit dalam paket:

20 Capsules; 1000 Capsules; 10 Capsules; 100 Capsules

Diproduksi oleh:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

Selebaran informasi

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
MEFEMIN MEFENAMIC ACID 250MG CAPSULES
Mefenamic Acid (250mg)
1
WHAT IS IN THIS LEAFLET
1.
What MEFEMIN is used for
2.
How MEFEMIN works
3.
Before you use MEFEMIN
4.
How to use MEFEMIN
5.
While you are using MEFEMIN
6.
Side effects
7.
Storage and Disposal of MEFEMIN
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT MEFEMIN IS USED FOR
Mefenamic acid is used to relieve:

Pain due to rheumatoid arthritis
including Still's Disease,

Pain due to osteoarthritis,

Muscle pain,

Trauma-related pain,

Pain after injury,

Toothaches,

Headaches,

Pain following an operation,

Pain after childbirth,

Painful menstruation

(dysmenorrhea),

Pre-menstrual syndrome

Abnormally
heavy
bleeding
due
to
dysfunctional causes or the presence of
an intrauterine device (IUD)

Fever in children over 6 months of age.
HOW MEFEMIN WORKS
MEFEMIN contains mefenamic acid as
the active ingredient. It has non-steroidal
anti-inflammatory drug (NSAID)
with
anti-
inflammatory,
analgesic
and
antipyretic properties. Mefenamic acid
inhibits the action of
chemical called
prostaglandin.
BEFORE YOU USE MEFEMIN
_-When you must not use it _
Tell your doctor before using MEFEMIN
if you

are hypersensitive to mefenamic acid
or any of the excipients.

have active or history of recurrent
peptic ulcer/haemorrhage

have
shown
hypersensitivity
reactions in response to ibuprofen,
aspirin, or other non-steroidal anti-
inflammatory drugs.

have severe hepatic, renal and cardiac
failure.

are
pregnant
and
are
in
the
last
trimester of pregnancy.

have
history
of
gastrointestinal
bleeding
or
perforation,
and
inflammatory bowel disease.

are going through pain treatment after
coronary artery bypass graft (CABG)
surgery.
_-Pregnancy and lactation _
Tell your doctor or pharmacist if you are
pregnant, planning to get pregnant or
breast-feeding before using MEFEMIN.
It is advised that mefenamic aci

Karakteristik produk

MEFEMIN MEFENAMIC ACID 250MG CAPSULES
NAME AND STRENGTH OF ACTIVE SUBSTANCES
Each capsule contains:
Mefenamic acid…………………………. 250mg
PRODUCT DESCRIPTION
Blue cap ivory body capsule
PHARMACODYNAMICS
Mefenamic acid is a non-steroidal anti-inflammatory drug (NSAID) with
anti- inflammatory, analgesic and antipyretic properties. Mefenamic
acid
inhibits the action of prostaglandin synthetase (cyclooxygenase). This
results in a reduction in the rate of prostaglandin synthesis and
reduced
prostaglandin levels.
PHARMACOKINETICS
_Absorption and Distribution _
Mefenamic acid is absorbed from the gastro intestinal tract. Peak
levels of 10 mg/l occur two hours after the administration of a 1g
oral dose to
adults.
_Biotransformation _
Mefenamic acid is predominantly metabolised by cytochrome P450 enzyme
CYP2C9 in the liver, first to a 3-hydroxymethyl derivative (metabolite
I) and then a 3-carboxyl derivative (metabolite II). Both metabolites
undergo secondary conjugation to form glucuronides. Therefore, in
patients
who are known or suspected to be poor CYP2C9 metabolisers based on
previous history/experience with other CYP2C9 substrates, mefenamic
acid should be administered with caution as they may have abnormally
high plasma levels due to reduced metabolic clearance.
_Elimination _
Fifty two percent of a dose is recovered from the urine, 6% as
mefenamic acid, 25% as metabolite I and 21% as metabolite II. Assay of
stools over
a 3-day period accounted for 10-20 % of the dose chiefly as
unconjugated metabolite II. The plasma levels of unconjugated
mefenamic acid decline
with a half life of approximately two hours.
INDICATIONS
Mefenamic acid is indicated for:
1) The symptomatic relief of rheumatoid arthritis (including Still's
Disease), osteoarthritis, and pain including muscular, traumatic and
dental
pain, headaches of most etiology, post-operative and postpartum pain
2) The symptomatic relief of primary dysmenorrhea
3) Menorrhagia due to dysfunctional causes or the presence of an
intrauterine device (IUD) wh