GOUTNOR 0.5MG TABLET

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

COLCHICINE

Boleh didapati daripada:

Noripharma Sdn. Bhd.

INN (Nama Antarabangsa):

COLCHICINE

Unit dalam pakej:

60tablet Tablets; 100tablet Tablets; 1000tablet Tablets; 500tablet Tablets

Dikeluarkan oleh:

Noripharma Sdn. Bhd.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
GOUTNOR TABLET
Colchicine (0.5mg, 0.6mg)
1
WHAT IS IN THIS LEAFLET
1.
What Goutnor is used for
2.
How Goutnor works
3.
Before you use Goutnor
4.
How to take Goutnor
5.
While you are using Goutnor
6.
Side effects
7.
Storage
and
disposal
of
Goutnor
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT GOUTNOR IS USED FOR
Colchicine is an anti-gout agent.
Goutnor are used to treat acute
gout. They are also used to
prevent flare-ups of gout when
treatment
is
started
with
allopurinol and uricosuric drugs.
HOW GOUTNOR WORKS
In gout, crystals of uric acid are
deposited in joints causing pain
and
inflammation.
Colchicine
is
considered
to
act
against
the
inflammatory
response
to
urate
crystals, by possibly inhibiting the
migration of granulocytes into the
inflamed area. Other properties of
colchicine,
such
as
interaction
with the microtubules, could also
contribute to the operation.
BEFORE YOU USE GOUTNOR
_When you must not use it _
Do not take Colchicine if:

you are allergic to colchicine or
any of the other ingredients of
this medicine

you have blood disorder

you are pregnant

you are breast-feeding

you
have
severe
kidney
or
liver problems

you
are
undergoing
haemodialysis

you have uric acid kidney stone

You are under 2 years of age
If you are not sure whether any of
the above apply to you, talk to
your doctor or pharmacist before
taking colchicine tablets.
_Before you start to use it _
Talk to your doctor or pharmacist
before taking Colchicine Tablets if
you:

have problems with your heart,
kidneys,
liver
or
digestive
system

are elderly and weak

have a blood disorder

have intolerance to some sugars
(This product contains lactose)
_Taking other medication _
Tell your doctor or pharmacist if
you
are
taking,
have
recently
taken
or
might
take
any
other
medicines.
When
Colchicine
Tablets are taken together
with
any of the following medicines,
side
effects
due
to
colchicine
toxicity are m

Ciri produk

1
GOUTNOR 0.5MG TABLET
COMPOSITION:
Each tablet contains Colchicine 0.5mg
DESCRIPTION:
A white to off white round shaped tablet with ‘C’ engraved on one
side.
PHARMACODYNAMICS:
Colchicine acts against the inflammatory response to urate crystals,
by possibly inhibiting the
migration of granulocytes into the inflamed area. This reduces the
release of lactic acid and
proinflammatory enzymes that occurs during phagocytosis and breaks the
cycle that leads to the
inflammatory response.
PHARMACOKINETICS:
Peak plasma concentrations of colchicines are reached within 2 hours
of oral administration.
Colchicine is partially deacetylated in the liver and unchanged drug
and its metabolites are
excreted in the bile and undergo intestinal reabsorption. Colchicine
is found in high concentration
in leucocytes, kidneys and the liver and spleen. Most of the drug is
excreted in the faeces but
10% to 20% is excreted in the urine and this proportion rises in
patients with liver disorders.
INDICATION:
For the treatment of acute gout, and for the prophylaxis of recurrent
gout and to prevent acute
attacks during initial therapy with allopurinol and uricosuric drugs.
RECOMMENDED DOSE:
For oral administration
For treatment of acute gout:
1mg initially then 0.5mg every 2-3 hours until pain is relieved or
diarrhoea or vomiting or until a
total dose of 6mg is reached.
Do not repeat the course of treatment within 3 days.
For prophylaxis;
0.5mg two or three times daily.
ROUTE OF ADMINISTRATION:
Oral administration
CONTRAINDICATION:
The use of colchicine is contraindicated in

pregnancy and lactation

people who are hypersensitive to colchicines

children under 2 years of age

blood dyscrasias

uric acid kidney stones
Colchicine should not be used in patients undergoing haemodialysis
since it cannot be removed
by dialysis or exchange transfusion.
WARNING AND PRECAUTIONS:
Colchicine should be given with care to elderly and debilitated
patients who may be particularly
susceptible to cumulative toxicity; and to those with cardiac,