FENAGESIC CAPSULE 250MG

Quốc gia: Malaysia

Ngôn ngữ: Tiếng Anh

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

Thành phần hoạt chất:

MEFENAMIC ACID

Sẵn có từ:

SUNWARD PHARMACEUTICAL SDN. BHD.

INN (Tên quốc tế):

MEFENAMIC ACID

Các đơn vị trong gói:

1000Capsule Capsules; 500Capsule Capsules; 100 Capsule Capsules

Sản xuất bởi:

SUNWARD PHARM PTE LTD

Tờ rơi thông tin

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
1
FENAGESIC CAPSULE
MEFENAMIC ACID (250MG)
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 serious

Đặc tính sản phẩm

Manufacturer:
SUNWARD PHARMACEUTICAL PTE. LTD.
11, Wan Lee Road,
Singapore 627943.
Product Registration Holder:
SUNWARD PHARMACEUTICAL SDN. BHD.
No. 9, 11 & 17, Jalan Kempas 4,
Taman Perindustrian Tampoi Indah,
81200 Johor Bahru, Johor, Malaysia.
CL501A-R11
Revision Date: 18/04/2023
Fenagesic Tablet 250MG
Fenagesic Tablet 500MG
Fenagesic Capsule 250MG
Pack sizes
(Export only)
Bottle
1000 tablets
180 tablets
20 tablets
Blister
-
2 x 10,10 x 10, 50 x 10 and
100 x 10 tablets per strip
Pack sizes
-
Blister
10 x 10, 50 x 10 and
100 x 10 capsules per strip
-
Bottle
-
Blister
-
10 x 10, 50 x 10 and
100 x 10 tablets per strip
Bottle
1000 tablets
90 tablets
-
FURTHER INFORMATION CONCERNING THIS DRUG CAN BE OBTAINED FROM YOUR
FAMILY PHYSICIAN / LOCAL GENERAL
PRACTITIONER / PHARMACIST. AMENDED PACKAGE INSERT
FENAGESIC
Capsule 250MG / Tablet 250MG / Tablet 500MG
Capsule : 250mg of Mefenamic Acid per capsule
Tablet : 250mg or 500mg Mefenamic Acid per tablet
PRODUCT DESCRIPTION:
Capsule 250MG : Ivory/blue, size 1 capsule.
Tablet 250MG : Round, yellow, convex, film-coated tablet.
Tablet 500MG : Oval, yellow, convex, film-coated tablet with “P-O”
debossed on one side and a single score on the other side.
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 i