Colchimil 0.6mg Tablet

Country: Malaysia

Language: English

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

Active ingredient:

COLCHICINE

Available from:

MILRIN PHARMACEUTICAL CO. (M) SDN BHD

INN (International Name):

COLCHICINE

Units in package:

10 Tablets; 100 Tablets; 500 Tablets; 1000 Tablets

Manufactured by:

The United Drug (1996) Co.,Ltd.

Patient Information leaflet

COLCHIMIL 0.6MG TABLET
Colchicine 0.6mg
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Colchimil is used for
2.
How Colchimil works
3.
Before you use Colchimil
4.
How to take Colchimil
5.
While you are using Colchimil
6.
Side effects
7.
Storage
and
disposal
of
Colchimil
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10. Date of Revision
WHAT COLCHIMIL IS USED FOR
Colchicine is an anti-gout agent.
Colchimil 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 COLCHIMIL WORKS
The active ingredient in Colchimil
is colchicine. Uric acid is one of
the
body's
waste
products.
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 COLCHIMIL
_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
are
a
woman
of
childbearing
age,
unless
you
are
using
effective
contraception

you
have
severe
kidney
or
liver problems

you
are
undergoing
haemodialysis

you
have
kidney
or
liver
problems and you are taking
certain medicines
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 pha

Summary of Product characteristics

COLCHIMIL 0.6MG TABLET
NAME AND STRENGTH OF ACTIVE SUBSTANCE
Each tablet contains Colchicine 0.6mg
PRODUCT DESCRIPTION
The product is a white, round, and biconvex uncoated tablets with no
scores on either sides of the tablet.
PHARMACODYNAMICS
Colchine 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 pro- inflammatory enzymes that
occurs during phagocytosis and breaks the cycle that leads to the
inflammatory response.
PHARMACOKINETICS
Colchicine can reach the peak plasma concentration within 2 hours from
the dosing of oral administration. The
drug will partially undergo deacetylation process in the liver. The
remaining unchanged colchicine and its
metabolites will be expelled via excretion in the bile and intestinal
reabsorption. The compound of colchicine
usually can be found in leucocytes, kidneys and the liver and spleen
in high concentration. It will be expelled in
faeces but 10 to 20% will be excreted in the urine and this proportion
rises in patients with liver disorder.
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 DOSAGE
Patients vary widely in their ability to tolerate the drug. Dosage
should be varied according to body weight or
individual reaction to colchicine toxicity.
Acute gout
1-2 tablets every 2 hours until the pain is relieved or until nausea,
vomiting and diarrhea occurs. The usual
amount of colchicine required in a course of therapy may range from
4-8 mg.
Pain and swelling usually abate within 12 hours and are usually gone
within 48-72 hours.
Prophylaxis
Depending on the severity and patient’s response and tolerance, the
dosage varies from 1 tablet daily 1-4 times
weekly to 1 tablet daily.
Pseudogout
To relieve acute attack, 1-2 tablets every 2 hours until the pain is
relieved or until nausea, vomiting and diarrhea
occurs.
Pro