INDOMEN CAPSULE

Land: Malaysia

Språk: engelska

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

Aktiva substanser:

INDOMETHACIN

Tillgänglig från:

Y.S.P. INDUSTRIES (M) SDN BHD

INN (International namn):

INDOMETHACIN

Enheter i paketet:

1500 Capsule Capsules; 1000 Capsule Capsules; 10 x 10 Units; 10 x 50 Units

Tillverkad av:

Y.S.P. INDUSTRIES (M) SDN BHD

Bipacksedel

_Consumer Medication Information Leaflet (RiMUP)_
1 |
INDOMEN CAPSULE
Indomethacin (25mg)
WHAT IS IN THIS LEAFLET
1.
What INDOMEN CAPSULE is used
for
2.
How INDOMEN CAPSULE works
3.
Before
you
use
INDOMEN
CAPSULE
4.
How to use INDOMEN CAPSULE
5.
While
you
are
using
INDOMEN
CAPSULE
6.
Side effects
7.
Storage and disposal of INDOMEN
CAPSULE
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT INDOMEN CAPSULE
IS USED FOR
INDOMEN CAPSULE is used for arthritis,
rheumatism,
arthritis
deforman
(inflammation
joint
disease)
,
and
other
inflammatory conditions.
HOW INDOMEN CAPSULE
WORKS
INDOMEN
CAPSULE
consists
of
active
ingredient
Indomethacin.
Indomethacin
belongs to the group of medicine called Non-
Steroidal Anti-
inflammatory Drug (NSAIDs)
which works by relief of pain, and reduction of
fever and swelling.
BEFORE YOU USE INDOMEN CAPSULE
_-When you must not use it _
Do not use INDOMEN CAPSULE:
If
you
are
hypersensitivity
to
Indomethacin or other ingredients listed at
the
end
of
this
leaflet.
Symptoms
of
allergic might include asthma, runny nose,
skin rash, and face swelling. If you think
you may be allergic, ask your doctor for
advice.
_Pregnancy and lactation _
Please consult your doctor before start to use
INDOMEN CAPSULE if you are pregnant,
plan
to
become
pregnant,
breast-feeding
or
intend to breast-feed. Your doctor will have
weighed the risks of you taking INDOMEN
CAPSULE against the benefits they expect it
will have for you.
_-Before you start to use it _
Tell your doctor if you have or have had:
- Hypersensitive to, or have had an allergic
reaction to aspirin or other NSAIDs.
- kidney problem;
- bleeding disorders;
- seizure;
- Parkinson disease;
- psychiactric disorder;
- heart disease or stroke;
- high blood pressure;
- fluid retention;
- ulcer, bleeding or perforation of the
stomach or intestinal.
Indomethacin
may
cause
severe
skin
reactions,
e.g.
exfoliative
dermatitis,
toxic
epidermal
necrolysis,
Steven-
Johnson
Syndrome.
Symptoms
may
include skin rash, blisters

Produktens egenskaper

_J
INDOMEN
CAPSULE
LNGREDIENT(S):
Each capsule contains:
lndomethacin
....................................................................................................................................
25mg
PHARMACODYNAMICS:
1.
lndomethacin is a potent inhibitor
of
prostaglandin synthesis in vitro. Concentrations are reached
during therapy which have been demonstrated to have
an
effect
in
vivo as well.Prostaglandins sensitize
afferent nerves and potentiate the action
of
bradykinin, inducing pain in animal models. Moreover,
prostaglandins are known to be among the mediators
of
inflammation. Since lndomethacin is
an
inhibitor
of
prostaglandin synthesis, its mode
of
action may
be
due to a decrease
of
prostaglandins
in peripheral tissues.
2.
lndomethacin has been shown to be an effective anti-inflammatory
agent, appropriate for long term
use in rheumatoid arthritis, ankylosing spondylitis, and
osteoarthritis.
3.
lndomethacin suppresses inflammation
in
rheumatoid arthritis as demonstrated by relief
of
pain, and
reduction
of
fever, swelling and tenderness. Improvement in patients treated with
lndomethacin for
rheumatoid arthritis has been demonstrated by a reduction in joint
swelling, average number
of
joints involved, and morning stiffness; by increasing mobility as
demonstrated by a decrease
in
walking lime; and by improving functional capability as demonstrated
by
an
increase
in
grip strength.
PHARMACOKINETICS:
lndomethacin is readily absorbed from the gastrointestinal tract with
peak plasma concentrations being
reached about 2 hours after a dose. II has a half-life
of
about 4.5 hours and about 99
%
is bound to
plasma proteins. II is metabolized and undergoes enterohepatic
circulation. Excretion
of
lndomethacin
and
metabolites as glucuronide conjugates,
are
predominantly
in
the urine with
lesser amount
appearing
in
the feces.
LNDICATION(S):
Arthritis, Rheumatism, Arthritis deformans, and other inflammatory
conditions.
DOSAGE AND ADMINISTRATION:
Usual adult dose is 1 capsule 1 - 3 times daily.
The initial dose is 1